AMA CODE OF MEDICAL ETHICS
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AMA CODE OF MEDICAL
This edition of Code
of Medical Ethics: Current Opinions with Annotations of the Council on
Ethical and Judicial Affairs replaces all previous editions and includes
Opinions based on Reports adopted through December 2001. It is one
component of the American Medical Association (AMA)'s Code; the other
components are the Principles of Medical Ethics, and the Reports of the
Council on Ethical and Judicial Affairs. The Principles precede the
Opinions in this volume. Reports are available separately. The
Principles of Medical Ethics are the primary component of the Code. They
establish the core ethical principles from which the other components of
the Code are derived. Most recently, the Principles were revised in
2001. The Code of Medical Ethics: Current Opinions with Annotations
reflects the application of the Principles of Medical Ethics to more
than 175 specific ethical issues in medicine, including health care
rationing, genetic testing, withdrawal of life-sustaining treatment, and
family violence. Much as courts of law elaborate on constitutional
principles in their holdings, the Council develops the meaning of the
Principles of Medical Ethics in its opinions. Accordingly, each Opinion
is followed by one or more roman numerals that identify the Principle(s)
from which the Opinion is derived. Each Opinion is also followed by a
list of annotations reflecting citations to the opinion in judicial
rulings and the medical, ethical, and legal literature.
which many of the opinions are derived--discuss the rationale behind the
Council's Opinions, providing a detailed analysis of the relevant
ethical considerations. It is necessary to consult all three components
of the AMA's Code of Medical Ethics to determine the Association's
positions on ethical issues. In addition, the AMA's House of Delegates
periodically issues statements on ethical issues. These statements are
contained in the AMA's electronic policy database, the PolicyFinder.
Because the Council on Ethical and Judicial Affairs is responsible for
determining the AMA's positions on ethical issues, statements by the
House of Delegates should be construed as the view of the House of
Delegates but not as the ethics policy of the Association. Medical
ethics involve the professional responsibilities and obligations of
physicians. Behavior relating to medical etiquette or custom is not
addressed in the Code. The Opinions which follow are intended as guides
to responsible professional behavior.
No one Principle of
Medical Ethics can stand alone or be individually applied to a
situation. In all instances, it is the overall intent and influence of
the Principles of Medical Ethics which shall measure ethical behavior
for the physician. Council Opinions are issued under its authority to
interpret the Principles of Medical Ethics and to investigate general
ethical conditions and all matters pertaining to the relations of
physicians to one another and to the public.
The Code of Medical
Ethics is published biennially. New Opinions, which are issued twice a
year at the AMA's meetings of the House of Delegates, are available
through the Council on Ethical and Judicial Affairs' website
(http://www.ama-assn.org/go/ceja) and through the PolicyFinder. The
Council on Ethical and Judicial Affairs encourages comments and
suggestions for future editions of this publication..2
The Oath of
Hippocrates, a brief statement of principles, has come down through
history as a living statement of ideals to be cherished by the
physician. This Oath was conceived some time during the period of
Grecian greatness, probably in the fifth century B.C. It protected
rights of the patient and appealed to the inner and finer instincts of
the physician without imposing sanctions or penalties on him or her.
Other civilizations subsequently developed written principles, but the
Oath of Hippocrates (Christianized in the tenth or eleventh century A.D.
to eliminate reference to pagan gods) has remained in Western
Civilization as an expression of ideal conduct for the physician.
The most significant
contribution to Western medical ethical history subsequent to
Hippocrates was made by Thomas Percival, an English physician,
philosopher, and writer. In 1803, he published his Code of Medical
Ethics. His personality, his interest in sociological matters, and his
close association with the Manchester Infirmary led to the preparation
of a scheme of professional conduct relative to hospitals and other
charities from which he drafted the code that bears his name.
At the first
official meeting of the American Medical Association at Philadelphia in
1847, the two principal items of business were the establishment of a
code of ethics and the creation of minimum requirements for medical
education and training. Although the Medical Society of the State of New
York and the Medico-Chirurgical Society of Baltimore had formal written
codes of medical ethics prior to this time, it is clear the AMA's first
adopted Code of Ethics was based on Percival's Code.
In general, the
language and concepts of the original Code adopted by the Association in
1847 remained the same throughout the years. There were revisions, of
course, which reflected the temper of the times and the eternal quest to
express basic concepts with clarity. Major revisions did occur in 1903,
1912, 1947, and 1994.
In December 1955, an
attempt was made to distinguish medical ethics from matters of
etiquette. A draft of a two-part code seeking to accomplish this was
submitted to the House of Delegates at that time but was not accepted.
This proposal was, in effect, a separation of then existing statements
found in the Principles into two categories. Little or no change was
made in the language of the 48 sections of the Principles. Subsequently,
in June 1956, a seemingly radical proposal was submitted to the House of
Delegates for consideration. This proposal, a short version of the
Principles, was discussed at the December 1956 session of the House
after wide publication and broad consideration among members of the
medical profession. It was postponed for final consideration until the
June 1957 meeting of the House of Delegates, when the short version was
The format of the
Principles adopted in June 1957 is a change from the format of the
Principles promulgated by Percival in 1803 and accepted by the
Association in 1847. Ten short sections, preceded by a preamble,
succinctly express the fundamental concepts embodied in the present
(1955) Principles, according to the report of the Council on
Constitution and Bylaws. That Council assured the House of Delegates in
its June 1957 report that "every basic principle has been preserved; on
the other hand, as much as possible of the prolixity and ambiguity which
in the past obstructed ready explanation, practical codification and
particular selection of basic concepts has been eliminated."
In 1977, the
Judicial Council recommended to the House of Delegates that the AMA
Principles of Medical Ethics be revised to clarify and update the
language, to eliminate reference to gender, and to seek a proper.3 and
reasonable balance between professional standards and contemporary legal
standards in our changing society. Given the desire of the Judicial
Council for a new version of the Principles to be widely accepted and
accurately understood, in 1978 the Judicial Council recommended that a
special committee of the
House be appointed
to consider such a revision. This was done in 1980, and the House of
Delegates adopted the revision of the AMA Principles of Medical Ethics
at its Annual Meeting in June 1980. In June 2001, the AMA's House of
Delegates adopted revised Principles of Medical Ethics. In June 1985,
the Judicial Council became the Council on Ethical and Judicial Affairs.
profession has long subscribed to a body of ethical statements developed
primarily for the benefit of the patient. As a member of this
profession, a physician must recognize responsibility to patients first
and foremost, as well as to society, to other health professionals, and
to self. The following Principles adopted by the American Medical
Association are not laws, but standards of conduct which define the
essentials of honorable behavior for the physician.
I. A physician shall
be dedicated to providing competent medical care, with compassion and
respect for human dignity and rights.
II. A physician
shall uphold the standards of professionalism, be honest in all
professional interactions, and strive to report physicians deficient in
character or competence, or engaging in fraud or deception, to
III. A physician
shall respect the law and also recognize a responsibility to seek
changes in those requirements which are contrary to the best interests
of the patient.
IV. A physician
shall respect the rights of patients, colleagues, and other health
professionals, and shall safeguard patient confidences and privacy
within the constraints of the law.
V. A physician shall
continue to study, apply, and advance scientific knowledge, maintain a
commitment to medical education, make relevant information available to
patients, colleagues, and the public, obtain consultation, and use the
talents of other health professionals when indicated.
VI. A physician
shall, in the provision of appropriate patient care, except in
emergencies, be free to choose whom to serve, with whom to associate,
and the environment in which to provide medical care.
VII. A physician
shall recognize a responsibility to participate in activities
contributing to the improvement of the community and the betterment of
VIII. A physician
shall, while caring for a patient, regard responsibility to the patient
IX. A physician
shall support access to medical care for all people.
Adopted June 1957;
revised June 1980; revised June 2001.4
The term "ethical"
is used in opinions of the Council on Ethical and Judicial Affairs to
refer to matters involving (1) moral principles or practices and (2)
matters of social policy involving issues of morality in the practice of
medicine. The term "unethical" is used to refer to professional conduct
which fails to conform to these moral standards or policies.
Many of the
Council's opinions lay out specific duties and obligations for
physicians. Violation of these principles and opinions represents
unethical conduct and may justify disciplinary action such as censure,
suspension, or expulsion from medical society membership. (II) Issued
prior to April 1977; Updated June 1994 and June 1996.
E-1.02 The Relation
of Law and Ethics.
statements are intended to clarify the relationship between law and
ethics. Ethical values and legal principles are usually closely related,
but ethical obligations typically exceed legal duties. In some cases,
the law mandates unethical conduct. In general, when physicians believe
a law is unjust, they should work to change the law. In exceptional
circumstances of unjust laws, ethical responsibilities should supersede
The fact that a
physician charged with allegedly illegal conduct is acquitted or
exonerated in civil or criminal proceedings does not necessarily mean
that the physician acted ethically. (III) Issued prior to April 1977;
Updated June 1994.
E-2.00 Opinions on
Social Policy Issues
The Principles of
Medical Ethics of the AMA do not prohibit a physician from performing an
abortion in accordance with good medical practice and under
circumstances that do not violate the law. (III, IV) Issued prior to
Parental Consent to Abortion.
ascertain the law in their state on parental involvement to ensure that
their procedures are consistent with their legal obligations. Physicians
should strongly encourage minors to discuss their pregnancy with their
parents. Physicians should explain how parental involvement can be
helpful and that parents are generally very understanding and
supportive. If a minor expresses concerns about parental involvement,
the physician should ensure that the minor's reluctance is not based on
any misperceptions about the likely consequences of parental
not feel or be compelled to require minors to involve their parents
before deciding whether to undergo an abortion. The patient, even an
adolescent, generally must decide whether, on.5 balance, parental
involvement is advisable. Accordingly, minors should ultimately be
allowed to decide whether parental involvement is appropriate.
Physicians should explain under what circumstances (e.g.,
life-threatening emergency) the minor's confidentiality will need to be
abrogated. Physicians should try to ensure that minor patients have made
an informed decision after giving careful consideration to the issues
involved. They should encourage their minor patients to consult
alternative sources if parents are not going to be involved in the
abortion decision. Minors should be urged to seek the
advice and counsel
of those adults in whom they have confidence, including professional
counselors, relatives, friends, teachers, or the clergy. (III, IV)
Issued June 1994 based on the report "Mandatory
Parental Consent to
Abortion;" adopted June 1992. (JAMA. 1993; 269: 82-86)
E-2.02 Abuse of
Spouses, Children, Elderly Persons, and Others at Risk.
The following are
guidelines for detecting and treating family violence:
Due to the
prevalence and medical consequences of family violence, physicians
should routinely inquire about physical, sexual, and psychological abuse
as part of the medical history. Physicians must also consider abuse in
the differential diagnosis for a number of medical complaints,
particularly when treating women.
Physicians who are
likely to have the opportunity to detect abuse in the course of their
work have an obligation to familiarize themselves with protocols for
diagnosing and treating abuse and with community resources for battered
women, children, and elderly persons.
Physicians also have
a duty to be aware of societal misconceptions about abuse and prevent
these from affecting the diagnosis and management of abuse. Such
misconceptions include the belief that abuse is a rare occurrence; that
abuse does not occur in "normal" families; that abuse is a private
problem best resolved without outside interference; and that victims are
responsible for the abuse. In order to improve physician knowledge of
family violence, physicians must be better trained to identify signs of
abuse and to work cooperatively with the range of community services
currently involved. Hospitals should require additional training for
those physicians who are likely to see victims of abuse. Comprehensive
training on family violence should be required in medical school
curricula and in residency programs for specialties in which family
violence is likely to be encountered.
The following are
guidelines for the reporting of abuse:
Laws that require
the reporting of cases of suspected abuse of children and elderly
persons often create a difficult dilemma for the physician. The parties
involved, both the suspected offenders and the victims, will often plead
with the physician that the matter be kept confidential and not be
disclosed or reported for investigation by public authorities.
Children, who have
been seriously injured, apparently by their parents, may nevertheless
try to protect their parents by saying that the injuries were caused by
an accident, such as a fall. The reason may stem from the natural
parent-child relationship or fear of further punishment. Even
institutionalized elderly patients who have been physically maltreated
may be concerned that disclosure of what has occurred might lead to
further and more drastic maltreatment by those responsible..6 The
physician should comply with the laws requiring reporting of suspected
cases of abuse of spouses, children, elderly persons, and others.
concerned with the welfare of children and elderly persons have
expressed the opinion that the incidence of physical violence to these
persons is rapidly increasing and that a very substantial percentage of
such cases is unreported by hospital personnel and physicians. A child
or elderly person brought to a physician with a suspicious injury is the
patient whose interests require the protection of law in a particular
situation, even though the physician may also provide services from time
to time to parents or other members of the family.
The obligation to
comply with statutory requirements is clearly stated in the Principles
of Medical Ethics. Absent such legal requirement, for mentally
competent, adult victims of abuse, physicians should not report to state
authorities without the consent of the patient. Physicians, however, do
have an ethical obligation to intervene. Actions should include, but
would not be limited to: suggesting the possibility of abuse with the
adult patient, discussing the safety mechanisms available to the adult
patient (eg, reporting to the police or appropriate state authority),
making available to the adult patient a list of community and legal
resources, providing ongoing support, and documenting the situation for
future reference. Physicians must discuss possible interventions and the
problem of family violence with adult patients in privacy and safety.
(I, III) Issued December 1982; Updated June 1994 based on the report
"Physicians and Family Violence: Ethical Considerations," adopted
December 1991 (JAMA. 1992; 267: 3190-93); updated June 1996; and updated
June 2000 based on the report "Domestic Violence Intervention," adopted
E-2.03 Allocation of
Limited Medical Resources.
A physician has a
duty to do all that he or she can for the benefit of the individual
patient. Policies for allocating limited resources have the potential to
limit the ability of physicians to fulfill this obligation to patients.
Physicians have a responsibility to participate and to contribute their
professional expertise in order to safeguard the interests of patients
in decisions made at the societal level regarding the allocation or
rationing of health resources.
the allocation of limited medical resources among patients should
consider only ethically appropriate criteria relating to medical need.
These criteria include likelihood of benefit, urgency of need, change in
quality of life, duration of benefit, and, in some cases, the amount of
resources required for successful treatment. In general, only very
substantial differences among patients are ethically relevant; the
greater the disparities, the more justified the use of these criteria
becomes. In making quality of life judgments, patients should first be
prioritized so that death or extremely poor outcomes are avoided; then,
patients should be prioritized according to change in quality of life,
but only when there are very substantial differences among patients.
Non-medical criteria, such as ability to pay, age, social worth,
perceived obstacles to treatment, patient contribution to illness, or
past use of resources should not be considered. Allocation decisions
should respect the individuality of patients and the particulars of
individual cases as much as possible. When very substantial differences
do not exist among potential recipients of treatment on the basis of the
appropriate criteria defined above, a "first-come-first-served" approach
or some other equal opportunity mechanism should be employed to make
final allocation decisions. Though there are several ethically
acceptable strategies for implementing these criteria, no single
strategy is ethically mandated. Acceptable approaches include a
three-tiered system, a minimal threshold approach, and a weighted
formula. Decision-making mechanisms should be objective, flexible, and
consistent to ensure that all patients are treated equally..7
physician must remain a patient advocate and therefore should not make
allocation decisions. Patients denied access to resources have the right
to be informed of the reasoning behind the decision. The allocation
procedures of institutions controlling scarce resources should be
disclosed to the public as well as subject to regular peer review from
the medical profession. (I,VII) Issued March 1981; Updated June 1994
based on the report "Ethical Considerations in the Allocation of Organs
and Other Scarce Medical Resources Among Patients," adopted June 1993
(Archive of Internal Medicine 1995; 155: 29-40).
E-2.035 Futile Care.
Physicians are not
ethically obligated to deliver care that, in their best professional
judgment, will not have a reasonable chance of benefiting their
patients. Patients should not be given treatments simply because they
demand them. Denial of treatment should be justified by reliance on
openly stated ethical principles and acceptable standards of care, as
defined in Opinion 2.03, "Allocation of Limited Medical Resources," and
Opinion 2.095, "The Provision of Adequate Health Care," not on the
concept of "futility," which cannot be meaningfully defined. (I, IV)
Issued June 1994.
Futility in End-of-Life Care.
intervention to prolong the life of a patient becomes futile, physicians
have an obligation to shift the intent of care toward comfort and
closure. However, there are necessary value judgments involved in coming
to the assessment of futility. These judgments must give consideration
to patient or proxy assessments of worthwhile outcome. They should also
take into account the physician or other provider's perception of intent
in treatment, which should not be to prolong the dying process without
benefit to the patient or to others with legitimate interests. They may
also take into account community and institutional standards, which in
turn may have used physiological or functional outcome measures.
conflicts between the parties may persist in determining what is
futility in the particular instance. This may interrupt satisfactory
decision-making and adversely affect patient care, family satisfaction,
and physician-clinical team functioning. To assist in fair and
satisfactory decision-making about what constitutes futile intervention:
(1) All health care
institutions, whether large or small, should adopt a policy on medical
(2) Policies on
medical futility should follow a due process approach. The following
seven steps should be included in such a due process approach to
declaring futility in specific cases.
(a) Earnest attempts
should be made in advance to deliberate over and negotiate prior
understandings between patient, proxy, and physician on what constitutes
futile care for the patient, and what falls within acceptable limits for
the physician, family, and possibly also the institution.
decision-making should occur between patient or proxy and physician to
the maximum extent possible.
(c) Attempts should
be made to negotiate disagreements if they arise, and to reach
resolution within all parties' acceptable limits, with the assistance of
consultants as appropriate.
(d) Involvement of
an institutional committee such as the ethics committee should be
requested if disagreements are irresolvable.
(e) If the
institutional review supports the patient's position and the physician
remains unpersuaded, transfer of care to another physician within the
institution may be arranged.
(f) If the process
supports the physician's position and the patient/proxy remains
unpersuaded, transfer to another institution may be sought and, if done,
should be supported by the transferring and receiving institution..8
(g) If transfer is
not possible, the intervention need not be offered. (I, V) Issued June
1997 based on the report "Medical Futility in End-of-Life Care," adopted
December 1996 (JAMA. 1999; 281: 937-41).
Insemination by Known Donor.
Any individual or
couple contemplating artificial insemination by husband, partner, or
other known donor should be counseled about the full range of infectious
and genetic diseases for which the donor or recipient can be screened,
including HIV infection. Full medical history disclosure and appropriate
diagnostic screening should be recommended to the donor and recipient
but are not required.
Informed consent for
artificial insemination should include disclosure of risks, benefits,
and likely success rate of the method proposed and potential alternative
methods. Individuals should receive information about screening, costs,
and procedures for confidentiality, when applicable. The prospective
parents or parent should be informed of the laws regarding the rights of
children conceived by artificial insemination, as well as the laws
regarding parental rights and obligations. If the donor is married to
the recipient, resultant children will have all the rights of a child
If the donor and
recipient are not married, an appropriate legal rule would treat the
situation as if the donor were anonymous: the recipient would be
considered the sole parent of the child except in cases where both donor
and recipient agree to recognize a paternity right. Sex selection of
sperm for the purposes of avoiding a sex-linked inheritable disease is
appropriate. However, physicians should not participate in sex selection
for reasons of gender preference. Physicians should encourage a
prospective parent or parents to consider the value of both sexes.
If semen is frozen
and the donor dies before it is used, the frozen semen should not be
used or donated for purposes other than those originally intended by the
donor. If the donor left no instructions, it is reasonable to allow the
remaining partner to use the semen for artificial insemination but not
to donate it to someone else. However, the donor should be advised of
such a policy at the time of donation and be given an opportunity to
override it. (I, V) Issued June 1993.
Insemination by Anonymous Donor.
histories must be taken of all candidates for anonymous semen donation.
All potential donors must also be screened for infectious or inheritable
diseases which could adversely affect the recipient or the resultant
child. Frozen semen should be used for artificial insemination because
it enables the donor to be tested for HIV infection at the time of
donation, and again after an interval before the original semen is used,
thus increasing the likelihood that the semen is free of HIV infection.
Physicians should rely on the guidelines formulated by relevant
professional organizations, such as the American
Reproductive Medicine, the Centers for Disease Control and Prevention,
and the Food and Drug Administration, in determining the interval
between the initial and final HIV test, which disorders to screen for,
and which procedures to use in screening.
maintain a permanent record which includes both identifying and
non-identifying health and genetic screening information. Other than
exceptional situations where identifying information may be required,
physicians should release only non-identifying health-related
information in order to preserve the confidentiality of the semen donor.
Physicians should maintain permanent records of donors to fulfill the
following obligations: (1) to exclude individuals from the donor pool
who test positive for infectious or.9 inheritable diseases, (2) to limit
the number of pregnancies resulting from a single donor source so as to
avoid future consanguineous marriages or reproduction, (3) to notify
donors of screening results which indicate the presence of an infectious
or inheritable disease, and (4) to notify donors if a child born through
artificial insemination has a disorder which may have been transmitted
by the donor.
Informed consent for
artificial insemination should include disclosure of risks, benefits,
likely success rate of the method proposed and potential alternative
methods, and costs. Both recipients and donors should be informed of the
reasons for screening and confidentiality. They should also know the
extent of access to non-identifying and identifying information about
the donor. Participants should be advised to consider the legal
ramifications, if any, of artificial insemination by anonymous donor.
The consent of the
husband is ethically appropriate if he is to become the legal father of
the resultant child from artificial insemination by anonymous donor.
Anonymous donors cannot assume the rights or responsibilities of
parenthood for children born through therapeutic donor insemination, nor
should they be required to assume them.
In the case of
single women or women who are part of a homosexual couple, it is not
unethical to provide artificial insemination as a reproductive option.
Sex selection of
sperm for the purposes of avoiding a sex-linked inheritable disease is
appropriate. However, physicians should not participate in sex selection
of sperm for reasons of gender preference. Physicians should encourage a
prospective parent or parents to consider the value of both sexes. In
general, it is inappropriate to offer compensation to donors to
encourage donation over and above reimbursement for time and actual
expenses. (I, V) Issued June 1993.
Conduct in Assisted Reproductive Technology.
guidelines are intended to emphasize the value of existing standards to
ensure ethical practices in assisted reproductive technology (ART):
(1) The medical
profession's development of technical and ethical guidelines for ART
should continue. Education of the profession and patients should be
pursued through widely disseminated information. Such material should
include information on clinic-specific success rates.
laboratories not currently participating in a credible professional
accreditation program are encouraged to do so. Professional
self-regulation is also encouraged through signed pledges to meet
established ethical standards and to comply with laboratory
accreditation efforts. Physicians who become aware of unethical
practices must report such conduct to the appropriate body. Physicians
also should be willing to provide expert testimony when needed.
Specialty societies should discuss the development of mechanisms for
disciplinary action, such as revocation of membership, for members who
fail to comply with ethical standards.
(3) Patients should
be fully informed about all aspects of ART applicable to their
particular clinical profile. A well-researched, validated informed
consent instrument would be useful for the benefit of patients and
professionals. Payment based on clinical outcome is unacceptable.
(4) Physicians and
clinicians practicing ART should use accurate descriptors of available
services, success rates, and fee structure and payment obligations in
If legislation on
regulation of ART laboratories, advertising practices, or related issues
is adopted, it should include adequate financial resources to ensure the
intended action can be implemented. Improved legislative.10 protection
may be needed to protect physicians and their professional organizations
when they provide testimony on unethical conduct of colleagues. (I, V)
Issued December 1998 based on the report "Issues of Ethical Conduct in
Assisted Reproductive Technology," adopted June 1996.
opinion on capital punishment is the personal moral decision of the
individual. A physician, as a member of a profession dedicated to
preserving life when there is hope of doing so, should not be a
participant in a legally authorized execution. Physician participation
in execution is defined generally as actions which would fall into one
or more of the following categories: (1) an action which would directly
cause the death of the condemned; (2) an action which would assist,
supervise, or contribute to the ability of another individual to
directly cause the death of the condemned; (3) an action which could
automatically cause an execution to be carried out on a condemned
participation in an execution includes, but is not limited to, the
following actions: prescribing or administering tranquilizers and other
psychotropic agents and medications that are part of the execution
procedure; monitoring vital signs on site or remotely (including
monitoring electrocardiograms); attending or observing an execution as a
physician; and rendering of technical advice regarding execution. In the
case where the method of execution is lethal injection, the following
actions by the physician would also constitute physician participation
in execution: selecting injection sites; starting intravenous lines as a
port for a lethal injection device; prescribing, preparing,
administering, or supervising injection drugs or their doses or types;
inspecting, testing, or maintaining lethal injection devices; and
consulting with or supervising lethal injection personnel.
actions do not constitute physician participation in execution: (1)
testifying as to medical history and diagnoses or mental state as they
relate to competence to stand trial, testifying as to relevant medical
evidence during trial, testifying as to medical aspects of aggravating
or mitigating circumstances during the penalty phase of a capital case,
or testifying as to medical diagnoses as they relate to the legal
assessment of competence for execution; (2) certifying death, provided
that the condemned has been declared dead by another person; (3)
witnessing an execution in a totally nonprofessional capacity; (4)
witnessing an execution at the specific voluntary request of the
condemned person, provided that the physician observes the execution in
a nonprofessional capacity; and (5) relieving the acute suffering of a
condemned person while awaiting execution, including providing
tranquilizers at the specific voluntary request of the condemned person
to help relieve pain or anxiety in anticipation of the execution.
not determine legal competence to be executed. A physician's medical
opinion should be merely one aspect of the information taken into
account by a legal decision maker such as a judge or hearing officer.
When a condemned prisoner has been declared incompetent to be executed,
physicians should not treat the prisoner for the purpose of restoring
competence unless a commutation order is issued before treatment begins.
The task of re-evaluating the prisoner should be performed by an
independent physician examiner. If the incompetent prisoner is
undergoing extreme suffering as a result of psychosis or any other
illness, medical intervention intended to mitigate the level of
suffering is ethically permissible. No physician should be compelled to
participate in the process of establishing a prisoner's competence or be
involved with treatment of an incompetent, condemned prisoner if such
activity is contrary to the physician's personal beliefs. Under those
circumstances, physicians should be permitted to transfer care of the
prisoner to another physician..11
Organ donation by
condemned prisoners is permissible only if (1) the decision to donate
was made before the prisoner's conviction, (2) the donated tissue is
harvested after the prisoner has been pronounced dead and the body
removed from the death chamber, and (3) physicians do not provide advice
on modifying the method of execution for any individual to facilitate
donation. (I) Issued July 1980. Updated June 1994 based on the report
"Physician Participation in Capital Punishment," adopted December 1992,
(JAMA. 1993; 270: 365-368); updated June 1996 based on the report
"Physician Participation in Capital
Evaluations of Prisoner Competence to be Executed; Treatment to Restore
Competence to be Executed," adopted in June 1995; Updated December 1999;
and Updated June 2000 based on the report "Defining Physician
Participation in State Executions," adopted June 1998.
Court-Initiated Medical Treatments in Criminal Cases.
ethically participate in court-initiated medical treatments only if the
procedure being mandated is therapeutically efficacious and is therefore
undoubtedly not a form of punishment or solely a mechanism of social
control. While a court has the authority to identify criminal behavior,
a court does not have the ability to make a medical diagnosis or to
determine the type of treatment that will be administered. In accordance
with ethical practice, physicians should treat patients based on sound
medical diagnoses, not court-defined behaviors. This is particularly
important where the treatment involves in-patient therapy, surgical
intervention, or pharmacological treatment. In these cases, diagnosis
can be made initially by the physician who will do the treatment, but
must then be confirmed by an independent physician or a panel of
physicians not responsible to the state. A second opinion is not
necessary in cases of court-ordered counseling or referrals for
authoritative medical body, such as a national specialty society, should
pre-establish scientifically valid treatments for medically determined
diagnoses. Such pre-established acceptable treatments should then be
applied on a case-by-case basis.
The physician who
will perform the treatment must be able to conclude, in good conscience
and to the best of his or her professional judgment, that the informed
consent was given voluntarily to the extent possible, recognizing the
element of coercion that is inevitably present. In cases involving
in-patient therapy, surgical intervention, or pharmacological treatment,
an independent physician or a panel of physicians not responsible to the
state should confirm that the informed consent was given in accordance
with these guidelines. (I, III) Issued December 1998 based on the report
"Court-Initiated Medical Treatment in Criminal Cases," adopted June
Torture refers to
the deliberate, systematic, or wanton administration of cruel, inhumane,
and degrading treatments or punishments during imprisonment or
detainment. Physicians must oppose and must not participate in torture
for any reason. Participation in torture includes, but is not limited
to, providing or withholding any services, substances, or knowledge to
facilitate the practice of torture. Physicians must not be present when
torture is used or threatened. Physicians may treat prisoners or
detainees if doing so is in their best interest, but physicians should
not treat individuals to verify their health so that torture can begin
or continue. Physicians who treat torture victims should not be
persecuted. Physicians should help provide support for victims of
torture and, whenever possible, strive to change situations in which
torture is practiced or the potential for torture is great. (I, III)
Issued December 1999..12
guidelines are intended to aid physicians in fulfilling their ethical
responsibilities when they engage in the clinical investigation of new
drugs and procedures.
(1) A physician may
participate in clinical investigation only to the extent that those
activities are a part of a systematic program competently designed,
under accepted standards of scientific research, to produce data which
are scientifically valid and significant.
(2) In conducting
clinical investigation, the investigator should demonstrate the same
concern and caution for the welfare, safety, and comfort of the person
involved as is required of a physician who is furnishing medical care to
a patient independent of any clinical investigation.
(3) Minors or
mentally incompetent persons may be used as subjects in clinical
investigation only if:
(a) The nature of
the investigation is such that mentally competent adults would not be
(b) Consent, in
writing, is given by a legally authorized representative of the subject
under circumstances in which informed and prudent adults would
reasonably be expected to volunteer themselves or their children as
(4) In clinical
investigation primarily for treatment:
(a) The physician
must recognize that the patient-physician relationship exists and that
professional judgment and skill must be exercised in the best interest
of the patient.
written consent must be obtained from the patient, or from the patient's
legally authorized representative if the patient lacks the capacity to
consent, following: (i) disclosure that the physician intends to use an
investigational drug or experimental procedure, (ii) a reasonable
explanation of the nature of the drug or procedure to be used, risks to
be expected, and possible therapeutic benefits, (iii) an offer to answer
any inquiries concerning the drug or procedure, and (iv) a disclosure of
alternative drugs or procedures that may be available. Physicians should
be completely objective in discussing the details of the drug or
procedure to be employed, the pain and discomfort that may be
anticipated, known risks and possible hazards, the quality of life to be
expected, and particularly the alternatives. Especially, physicians
should not use persuasion to obtain consent which otherwise might not be
forthcoming, nor should expectations be encouraged beyond those which
the circumstances reasonably and realistically justify.
(i) In exceptional
circumstances, where the experimental treatment is the only potential
treatment for the patient and full disclosure of information concerning
the nature of the drug or experimental procedure or risks would pose
such a serious psychological threat of detriment to the patient as to be
medically contraindicated, such information may be withheld from the
patient. In these circumstances, such information should be disclosed to
a responsible relative or friend of the patient where possible.
consent should be in writing, except where the physician deems it
necessary to rely upon consent in other than written form because of the
physical or emotional state of the patient.
(5) In clinical
investigation primarily for the accumulation of scientific knowledge:
safeguards must be provided for the welfare, safety, and comfort of the
subject. It is fundamental social policy that the advancement of
scientific knowledge must always be secondary to primary concern for the
(b) Consent, in
writing, should be obtained from the subject, or from a legally
authorized representative if the subject lacks the capacity to consent,
following: (i) disclosure of the fact that an investigational drug or
procedure is to be used, (ii) a reasonable explanation of the nature of
the procedure to be used and risks to be expected, and (iii) an offer to
answer any inquiries concerning the drug or procedure.
(6) No person may be
used as a subject in clinical investigation against his or her will.
(7) The overuse of
institutionalized persons in research is an unfair distribution of
research risks. Participation is coercive and not voluntary if the
participant is subjected to powerful incentives and persuasion.
(8) The ultimate
responsibility for the ethical conduct of science resides within the
institution (academic, industrial, public, or private) which conducts
scientific research and with the individual scientist. Research.13
institutions should assure that rigorous scientific standards are upheld
by each of their faculty, staff, and students and should extend these
standards to all reports, publications, and databases produced by the
institution. All medical schools and biomedical research institutions
should implement guidelines for a review process for dealing with
allegations of fraud. These guidelines should ensure that (a) the
process used to resolve allegations of fraud does not damage science,
(b) all parties are treated fairly and justly with a sensitivity to
reputations and vulnerabilities, (c) the highest degree of
confidentiality is maintained, (d) the integrity of the process is
maintained by an avoidance of real or apparent conflicts of interest,
(e) resolution of charges is expeditious, (f) accurate and detailed
documentation is kept throughout the process, and (g) responsibilities
to all involved individuals, the public, research sponsors, the
scientific literature, and the scientific community is met after
resolution of charges. Academic institutions must be capable of, and
committed to, implementing effective procedures for examining
allegations of scientific fraud. No system of external monitoring should
replace the efforts of an institution to set its own standards which
fulfill its responsibility for the proper conduct of science and the
training of scientists.
(9) With the
approval of the patient or the patient's lawful representative,
physicians should cooperate with the press and media to ensure that
medical news concerning the progress of clinical investigation or the
patient's condition is available more promptly and more accurately than
would be possible without their assistance. On the other hand, the
Council does not approve of practices designed to create fanfare,
sensationalism to attract media attention, and unwarranted expressions
of optimism because of short-term progress, even though longer range
prognosis is known from the beginning to be precarious. With the
approval of the patient or the patient's family, the Council, however,
encourages the objective disclosure to the press and media of pertinent
information. If at all possible, the identity of the patient should
remain confidential if the patient or the patient's family so desires.
The situation should not be used for the commercial ends of
participating physicians or the institutions involved. (I, III, V)
Issued prior to April 1977; Updated June 1994 and June 1998.
Selection for Clinical Trials.
considerations in clinical research have traditionally focused on
protecting research subjects. These protections may be especially
important for those from socioeconomically diasdavantaged populations
who may be more vulnerable to coercive pressures. The benefits from
altruism that result from participation in research, particularly for
severely chronically ill persons, may justify equitable consideration of
historically disadvantaged populations such as the poor. With these
considerations in mind, the following guidelines are offered:
(1) Although the
burdens of research should not fall disproportionately on
socioeconomically disadvantaged populations, neither should such
populations be categorically excluded, or discouraged, from research
(2) Inclusion and
exclusion criteria for a clinical study should be based on sound
scientific principles. Conversely, participants in a clinical trial
should be drawn from the qualifying population in the general geographic
area of the trial without regard to race, ethnicity, economic status, or
gender. If a subject's primary care physician determines that the
subject received a clear medical benefit from the experimental
intervention which is now moving towards marketing approval and chooses
to seek authorization from the Food and Drug Administration (FDA) for
continued use of the investigational therapy during the time period
between the end of the protocol and the availability of the drug on the
market, the investigator should work with the primary care physician,
the product sponsor, and the FDA to allow continued availability of the
product. (I, V, VII) Issued June 1998 based on the report "Subject
Selection for Clinical Trials," adopted December 1997 (IRB. 1998;
E-2.075 The Use of
Placebo Controls in Clinical Trials.
Placebo controls are
an important part of medicine's commitment to ensuring that the safety
and efficacy of new drugs are sufficiently established. Used
appropriately, placebo controls can safely provide valuable data and
should continue to be considered in the design of clinical trials. The
existence of an accepted therapy does not necessarily preclude the use
of such controls; however, physician-investigators should adhere to the
following guidelines to ensure that the interests of patients who
participate in clinical trials are protected.
must be extremely thorough in obtaining informed consent from patients.
To the extent that research is dependent upon the willingness of
patients to accept a level of risk, their understanding of the potential
harms involved must be a top priority of any clinical investigation. The
possibility presented in some studies that patients often do not fully
understand the research protocol and therefore truly can not give
informed consent demonstrates a need to heighten the efforts of
researchers to impress upon their subjects the nature of clinical
research and the risks involved. Patients are capable of making
decisions when presented with sufficient information and it is the
responsibility of the institutional review board (IRB) and the
individual investigators involved to ensure that each subject has been
adequately informed and has given voluntary consent. Each patient must
also be made aware that they can terminate their participation in a
study at any time.
(2) Informed consent
cannot be invoked to justify an inappropriate trial design. IRBs as well
as investigators have an obligation to evaluate each study protocol to
determine whether a placebo control is necessary and whether an
alternative study design with another type of control would be
sufficient for the purposes of research. Protocols that involve
conditions causing death or irreversible damage cannot ethically employ
a placebo control if alternative treatment would prevent or slow the
illness progression. When studying illnesses characterized by severe or
painful symptoms, investigators should thoroughly explore alternatives
to the use of placebo controls. In general, the more severe the
consequences and symptoms of the illness under study, the more difficult
it will be to justify the use of a placebo control when alternative
therapy exists. Consequently, there will almost certainly be conditions
for which placebo controls cannot be justified. Similarly, the use of a
placebo control will more easily be justified as the severity and number
of negative side-effects of standard therapy increase.
(3) Researchers and
IRBs should continue to minimize the amount of time patients are given
placebo. The rationale provided by investigators for the length of study
will give IRBs the opportunity to ensure that patients are given placebo
therapy for as short a time as possible to provide verifiable results.
Additionally, the interim data analysis and monitoring currently in
practice will allow researchers to terminate the study because of either
positive or negative results, thus protecting patients from remaining on
placebo unnecessarily. (I, V) Issued June 1997 based on the report
"Ethical Use of Placebo Controls in Clinical Trials," adopted June 1996.
The term surgical
"placebo" controls refers to the control arm of a research study where
subjects undergo surgical procedures that have the appearance of
therapeutic interventions, but during which the essential therapeutic
maneuver is omitted.
of a surgical "placebo" control should be evaluated on the basis of
guidelines provided in Opinion 2.07, "Clinical Investigation," as well
as the following requirements:.15
"placebo" controls should be used only when no other trial design will
yield the requisite data.
attention must be paid to the informed consent process when enrolling
subjects in trials that use surgical "placebo" controls. Careful
explanation of the risks of the operations must be disclosed, along with
a description of the differences between the trial arms emphasizing the
essential procedure that will or will not be performed. Additional
safeguards around the informed consent process may be appropriate such
as using a neutral third party to provide information and get consent,
or using consent monitors to oversee the consent process.
(3) The use of
surgical "placebo" controls is not justified when testing the
effectiveness of an innovative surgical technique that represents a
minor modification of an existing surgical procedure.
(4) When a new
surgical procedure is developed with the prospect of treating a
condition for which no known surgical therapy exists, using surgical
"placebo" controls may be justified, but must be evaluated in light of
whether the current standard of care includes a non-surgical treatment
and the benefits, risks, and side effects of that treatment.
(a) If foregoing
standard treatment would result in significant injury and the standard
treatment is efficacious and acceptable to the patient (in terms of side
effects, personal beliefs, etc), then it must be offered as part of the
(b) When the
standard treatment is not fully efficacious, or not acceptable to the
patient, surgical "placebo"
controls may be used
and the standard treatment foregone, but additional safeguards must be
put in place around the informed consent process. (I, V) Issued December
2000 based on the report "Surgical Placebo Controls," adopted June 2000
(Ann Surg. 2002; 235: 303-07)
Considerations in International Research.
in their role as investigators or as decision-makers involved in the
deliberations related to the funding or the review of research, hold an
ethical obligation to ensure the protection of research participants.
When the research is to be conducted in countries with differing
cultural traditions, health care systems, and ethical standards, and in
particular in countries with developing economies and with limited
health care resources, U.S. physicians should respect the following
(1) First and
foremost, physicians involved in clinical research that will be carried
out internationally should be satisfied that a proposed research design
has been developed according to a sound scientific design. Therefore,
investigators must ascertain that there is genuine uncertainty within
the clinical community about the comparative merits of the experimental
treatment and the one to be offered as a control in the population among
which the study is to be undertaken. In some instances, a three-pronged
protocol, which offers the standard treatment in use in the U.S., a
treatment that meets a level of care that is attainable and sustainable
by the host country, and a placebo (see Opinion 2.075, "Surgical
`Placebo' Controls"), may be the best method to evaluate the safety and
efficacy of a treatment in a given population. When U.S. investigators
participate in international research they must obtain approval for such
protocols from U.S. Institutional Review Boards (IRBs).
(2) IRBs, which are
responsible for ensuring the protection of research participants, must
determine that risks have been minimized and that the protocol's ratio
of risks to benefits is favorable to participants. In evaluating the
risks and benefits that a protocol presents to a population, IRBs should
obtain relevant input from representatives from the host country and
from the research population. It is also appropriate for IRBs to
consider the harm that is likely to result from forgoing the research.
(3) Also, IRBs are
required to protect the welfare of individual participants. This can
best be achieved by assuring that a suitable informed consent process is
in place. Therefore, IRBs should ensure that individual potential
participants will be informed of the nature of the research endeavor and
that their voluntary.16 consent will be sought. IRBs should recognize
that, in some instances, information will be meaningful only if it is
communicated in ways that are consistent with local customs.
(4) Overall, to
ensure that the research does not exploit the population from which
participants are recruited, IRBs should ensure that the research
corresponds to a medical need in the region where it is undertaken.
Furthermore, they should foster research with the potential for lasting
benefits, especially when it is undertaken among populations that are
severely deficient in health care resources. This can be achieved by
facilitating the development of a health care infrastructure that will
be of use during and beyond the conduct of the research. Additionally,
physicians conducting studies must encourage research sponsors to
continue to provide beneficial study interventions to all study
participants at the conclusion of the study. (I, IV, VII, VIII, IX)
Issued December 2001 based on the report "Ethical Considerations in
International Research," adopted June 2001.
in the Use of DNA Databanks in Genomic Research
safeguards should be applied to the use of databases for the purpose of
population-based genomic research:
(1) Physicians who
participate as investigators in genomic research should have adequate
training in genomic research and related ethical issues so as to be able
to discuss these issues with patients and/or potential research
(2) If research is
to be conducted within a defined subset of the general population, that
is, an identifiable community, then investigators should consult with
the community to design a study that will minimize harm not only for
individual subjects, but also for the community. When substantial
opposition to the research is expressed within the community,
investigators should not conduct the study. When the community supports
a proposal, investigators nevertheless should obtain individual consent
in the usual manner. The same procedure should be followed whether the
investigators intend to collect new samples and data or whether they
wish to use previously archived data sets.
(3) When obtaining
the informed consent of individuals to participate in genomic research,
standard informed consent requirements apply (see Opinion 2.07,
"Clinical Investigation"). In addition:
(a) Special emphasis
should be placed on disclosing the specific standards of privacy
contained in the study: whether the material will be coded (i.e.:
encrypted so that only the investigator can trace materials back to
specific individuals) or be completely de-identified (i.e.: stripped of
(b) If data are to
be coded, subjects should be told whether they can expect to be
contacted in the future to share in findings or to consider
participating in additional research, which may relate to the current
protocol or extend to other research purposes.
should always be free to refuse the use of their biological materials in
research, without penalty.(d) Disclosure should include information
about whether investigators or subjects stand to gain financially from
research findings (see Opinion 2.08, "Commercial Use of Human Tissue").
Such disclosure should refer to the possible conflicts of interest of
the investigators (see Opinion 8.0315, "Managing Conflicts of Interest
in the Conduct of Clinical Trials").(e) Subjects should be informed of
when, if ever, and how archived information and samples will be
(4) To strengthen
the protection of confidentiality, genomic research should not be
conducted using information and samples that identify the individuals
from whom they were obtained (i.e.: by name or social security number).
Furthermore, to protect subsets of the population from such harms as
stigmatization and discrimination, demographic information not required
for the study's purposes should be coded. (I, IV, V,.17 VII) Issued June
2002 based on the report "The Use of DNA Databanks in Genomic Research:
The Imperative of Informed Consent,"adopted December 2001.
Use of Human Tissue.
The rapid growth of
the biotechnology industry has resulted in the commercial availability
of numerous therapeutic and other products developed from human tissue.
Physicians contemplating the commercial use of human tissue should abide
by the following guidelines:
(1) Informed consent
must be obtained from patients for the use of organs or tissues in
commercial applications must be disclosed to the patient before a profit
is realized on products developed from biological materials.
(3) Human tissue and
its products may not be used for commercial purposes without the
informed consent of the patient who provided the original cellular
(4) Profits from the
commercial use of human tissue and its products may be shared with
patients, in accordance with lawful contractual agreements.
(5) The diagnostic
and therapeutic alternatives offered to patients by their physicians
should conform to standards of good medical practice and should not be
influenced in any way by the commercial potential of the patient's
tissue. (II, V) Issued June 1994 based on the report "Who Should Profit
from the Economic Value of Human Tissue? An Ethical Analysis," adopted
should be conscious of costs and not provide or prescribe unnecessary
services, concern for the quality of care the patient receives should be
the physician's first consideration. This does not preclude the
physician, individually or through medical or other organizations, from
participating in policy-making with respect to social issues affecting
health care. (I, VII) Issued March 1981; Updated June 1994 and June
Provision of Adequate Health Care.
Because society has
an obligation to make access to an adequate level of health care
available to all of its members regardless of ability to pay, physicians
should contribute their expertise at a policy-making level to help
achieve this goal. In determining whether particular procedures or
treatments should be included in the adequate level of health care, the
following ethical principles should be considered: (1) degree of benefit
(the difference in outcome between treatment and no treatment), (2)
likelihood of benefit, (3) duration of benefit, (4) cost, and (5) number
of people who will benefit (referring to the fact that a treatment may
benefit the patient and others who come into contact with the patient,
as with a vaccination or antimicrobial drug).
require that a just process be used to determine the adequate level of
health care. To ensure justice, the process for determining the adequate
level of health care should include the following considerations: (1)
democratic decision making with broad public input at both the
developmental and final approval stages, (2) monitoring for variations
in care that cannot be explained on medical grounds with.18 special
attention to evidence of discriminatory impact on historically
disadvantaged groups, and (3) adjustment of the adequate level over time
to ensure continued and broad public acceptance. Because of the risk
that inappropriate biases will influence the content of the basic
benefits package, it may be desirable to avoid rigid or precise formulas
to define the specific components of the basic benefits package. After
applying the five ethical values listed above, it will be possible to
designate some kinds of care as either clearly basic or clearly
discretionary. However, for care that is not clearly basic or
discretionary, seemingly objective formulas may result in choices that
are inappropriately biased. For that care, therefore, it may be
desirable to give equal consideration (e.g., through a process of random
selection) to the different kinds of care when deciding which will be
included in the basic benefits package. The mechanism for providing an
adequate level of health care should ensure that the health care
benefits for the poor will not be eroded over time. (VII) Issued June
1994 based on the report "Ethical Issues in Health System Reform: The
Provision of Adequate Health Care," adopted December 1993 (JAMA. 1994;
guidelines are offered as aids to physicians when they are engaged in
(1) Physicians may
participate in fetal research when their activities are part of a
competently designed program, under accepted standards of scientific
research, to produce data which are scientifically valid and
(2) If appropriate,
properly performed clinical studies on animals and nongravid humans
should precede any particular fetal research project.
(3) In fetal
research projects, the investigator should demonstrate the same care and
concern for the fetus as a physician providing fetal care or treatment
in a non-research setting.
(4) All valid
federal or state legal requirements should be followed.
(5) There should be
no monetary payment to obtain any fetal material for fetal research
(6) Competent peer
review committees, review boards, or advisory boards should be
available, when appropriate, to protect against the possible abuses that
could arise in such research.
(7) Research on the
so-called dead fetus, macerated fetal material, fetal cells, fetal
tissue, or fetal organs should be in accord with state laws on autopsy
and state laws on organ transplantation or anatomical gifts.
(8) In fetal
research primarily for treatment of the fetus:
(a) Voluntary and
informed consent, in writing, should be given by the gravid woman,
acting in the best interest of the fetus.
treatment or methods of care, if any, should be carefully evaluated and
fully explained. If simpler and safer treatment is available, it should
(9) In research
primarily for treatment of the gravid female:
(a) Voluntary and
informed consent, in writing, should be given by the patient.
treatment or methods of care should be carefully evaluated and fully
explained to the patient. If simpler and safer treatment is available,
it should be pursued.
(c) If possible, the
risk to the fetus should be the least possible, consistent with the
gravid female's need for treatment.
(10) In fetal
research involving a fetus in utero, primarily for the accumulation of
(a) Voluntary and
informed consent, in writing, should be given by the gravid woman under
circumstances in which a prudent and informed adult would reasonably be
expected to give such consent.
(b) The risk to the
fetus imposed by the research should be the least possible.
(c) The purpose of
research is the production of data and knowledge which are
scientifically significant and which cannot otherwise be obtained..19
(d) In this area of
research, it is especially important to emphasize that care and concern
for the fetus should be demonstrated. (I, III, V) Issued March 1980;
Updated June 1994.
A patent grants the
holder the right, for a limited amount of time, to prevent others from
commercializing his or her inventions. At the same time, the patent
system is designed to foster information sharing. Full disclosure of the
invention--enabling another trained in the art to replicate it--is
necessary to obtain a patent. Patenting is also thought to encourage
private investment into research. Arguments have been made that the
patenting of human genomic material sets a troubling precedent for the
ownership or commodification of human life. DNA sequences, however, are
not tantamount to human life, and it is unclear where and whether
qualities uniquely human are found in genetic material.
holds great potential for achieving new medical therapies. It remains
unclear what role patenting will play in ensuring such development. At
this time the Council concludes that granting patent protection should
not hinder the goal of developing new beneficial technology and offers
the following guidelines:
(1) Patents on
processes--for example, processes used to isolate and purify gene
sequences, genes and proteins, or vehicles of gene therapy--do not raise
the same ethical problems as patents on the substances themselves and
are thus preferable.
patents on purified proteins present fewer ethical problems than patents
on genes or DNA sequences and are thus preferable.
descriptions should be carefully constructed to ensure that the patent
holder does not limit the use of a naturally occurring form of the
substance in question. This includes patents on proteins, genes, and
One of the goals of
genetic research is to achieve better medical treatments and
technologies. Granting patent protection should not hinder this goal.
Individuals or entities holding patents on genetic material should not
allow patents to languish and should negotiate and structure licensing
agreements in such a way as to encourage the development of better
medical technology. (V, VII) Issued June 1998 based on the report
"Patenting the Human Genome," adopted December 1997.
E-2.11 Gene Therapy.
involves the replacement or modification of a genetic variant to restore
or enhance cellular function or to improve the reaction of non-genetic
Two types of gene
therapy have been identified: (1) somatic cell therapy, in which human
cells other than germ cells are genetically altered, and (2) germ line
therapy, in which a replacement gene is integrated into the genome of
human gametes or their precursors, resulting in expression of the new
gene in the patient's offspring and subsequent generations. The
fundamental difference between germ line therapy and somatic cell
therapy is that germ line therapy affects the welfare of subsequent
generations and may be associated with increased risk and the potential
for unpredictable and irreversible results. Because of the far-reaching
implications of germ line therapy, it is appropriate to limit genetic
intervention to somatic cells at this time. The goal of both somatic
cell and germ line therapy is to alleviate human suffering and disease
by remedying disorders for which available therapies are not
satisfactory. This goal should be pursued only within the ethical
tradition of medicine, which gives primacy to the welfare of the patient
whose safety and.20 well-being must be vigorously protected. To the
extent possible, experience with animal studies must be sufficient to
assure the effectiveness and safety of the techniques used, and the
predictability of the results. Moreover, genetic manipulation generally
should be utilized only for therapeutic purposes. Efforts to enhance
"desirable" characteristics through the insertion of a modified or
additional gene, or efforts to "improve" complex human traits “the
eugenic development of offspring” are contrary not only to the ethical
tradition of medicine, but also to the egalitarian values of our
society. Because of the potential for abuse, genetic manipulation to
affect non-disease traits may never be acceptable and perhaps should
never be pursued. If it is ever allowed, at least three conditions would
have to be met before it could be deemed ethically acceptable: (1) there
would have to be a clear and meaningful benefit to the person, (2) there
would have to be no trade-off with other characteristics or traits, and
(3) all citizens would have to have equal access to the genetic
technology, irrespective of income or other socioeconomic
characteristics. These criteria should be viewed as a minimal, not an
exhaustive, test of the ethical propriety of non-disease-related genetic
intervention. As genetic technology and knowledge of the human genome
develop further, additional guidelines may be required.
As gene therapy
becomes feasible for a variety of human disorders, there are several
practical factors to consider to ensure safe application of this
technology in society. First, any gene therapy research should meet the
Council's guidelines on clinical investigation (Opinion 2.07) and
investigators must adhere to the standards of medical practice and
professional responsibility. The proposed procedure must be fully
discussed with the patient and the written informed consent of the
patient or the patient's legal representative must be voluntary.
be thorough in their attempts to eliminate any unwanted viral agents
from the viral vector containing the corrective gene. The potential for
adverse effects of the viral delivery system must be disclosed to the
patient. The effectiveness of gene therapy must be evaluated fully,
including the determination of the natural history of the disease and
follow-up examination of subsequent generations.
Gene therapy should
be pursued only after the availablity or effectiveness of other possible
therapies is found to be insufficient. These considerations should be
reviewed, as appropriate, as procedures and scientific information
develop. (I, V) Issued December 1988; Updated June 1994 based on the
report "Prenatal Genetic Screening," adopted December 1992 (Arch Fam
Med. 1994; 2: 633-642), and updated June 1996.
Three primary areas
of prenatal genetic testing are: (1) screening or evaluating prospective
parents for genetic disease before conception to predict the likelihood
of conceiving an affected child; (2) analysis of a pre-embryo at the
preimplantation stage of artificial reproductive techniques; and (3) in
utero testing after conception, such as ultrasonography, amniocentesis,
fetoscopy, and chorionic villus sampling, to determine the condition of
the fetus. Physicians engaged in genetic counseling are ethically
obligated to provide prospective parents with the basis for an informed
decision for childbearing. Counseling should include reasons for and
against testing as well as discussion of inappropriate uses of genetic
testing. Prenatal genetic testing is most appropriate for women or
couples whose medical histories or family backgrounds indicate an
elevated risk of fetal genetic disorders. Women or couples without an
elevated risk of genetic disease may legitimately request prenatal
diagnosis, provided they understand and accept the risks involved. When
counseling prospective parents, physicians should avoid the imposition
of their personal moral values and the substitution of their own moral
judgment for that of the prospective parents..21 The physician should be
aware that where a genetic defect is found in the fetus, prospective
parents may request or refuse an abortion. Physicians who consider the
legal and ethical requirements applicable to genetic counseling to be in
conflict with their moral values and conscience may choose to limit
their services to preconception diagnosis and advice or not provide any
genetic services. However, the physician who is so disposed is
nevertheless obligated to alert prospective parents when a potential
genetic problem does exist, so that the patient may decide whether to
seek further genetic counseling from another qualified specialist.
refers to the abortion or discard of a fetus or pre-embryo with a
genetic abnormality. In general, it is ethically permissible for
physicians to participate in genetic selection to prevent, cure, or
treat genetic disease. However, selection to avoid a genetic disease may
not always be appropriate, depending on factors such as the severity of
the disease, the probability of its occurrence, the age at onset, and
the time of gestation at which selection would occur. It would not be
ethical to engage in selection on the basis of non-disease- related
characteristics or traits. (II, IV, V, VI) Issued June 1983; Updated
June 1994 based on the report "Prenatal Genetic Screening," adopted
December 1992 (Arch Fam Med. 1994; 3: 633-642).
Recombinant DNA Advisors Committee and the Food and Drug Administration
oversee and regulate gene splicing, recombinant DNA research, chemical
synthesis of DNA molecules, and other genetic engineering research.
However, for genetic engineering technologies that represents a
significant departure from familiar practices there should be
independent input from the scientific community, organized medicine,
industry, the public, and others, in addition to the federal government,
to prevent abuse from any sector of society, private or public. Such
departures include the use of novel vectors, gene transfer in utero,
potential germ line modification, and gene transfer to normal
volunteers. If and when gene replacement with normal DNA becomes a
practical reality for the treatment of human disorders, the following
factors should be considered:
(1) If procedures
are performed in a research setting, reference should be made to the
Council's guidelines on clinical investigation.
(2) If procedures
are performed in a non-research setting, adherence to usual and
customary standards of medical practice and professional responsibility
would be required.
(3) Full discussion
of the proposed procedure with the patient would be required. The
consent of the patient or the patient's legal representative should be
informed, voluntary and written.
(4) There must be no
hazardous or other unwanted virus on the viral DNA containing the
replacement or corrective gene.
(5) The inserted DNA
must function under normal control within the recipient cell to prevent
metabolic damage that could damage tissue and the patient.
effectiveness of the gene therapy should be evaluated as well as
possible. This will include determination of the natural history of the
disease and follow-up examination of subsequent generations.
(7) Such procedures
should be undertaken in the future only after careful evaluation of the
availability and effectiveness of other possible therapy. If simpler and
safer treatment is available, it should be pursued..22
considerations should be reviewed, as appropriate, as procedures and
scientific information are developed in the future. (I, V, VII) Issued
March 1980; Updated June 1996.
Testing by Employers.
As a result of the
human genome project, physicians will be able to identify a greater
number of genetic risks of disease. Among the potential uses of the
tests that detect these risks will be screening of potential workers by
employers. Employers may want to exclude workers with certain genetic
risks from the workplace because these workers may become disabled
prematurely, impose higher health care costs, or pose a risk to public
safety. In addition, exposure to certain substances in the workplace may
increase the likelihood that a disease will develop in the worker with a
genetic risk for the disease.
(1) It would
generally be inappropriate to exclude workers with genetic risks of
disease from the workplace because of their risk. Genetic tests alone do
not have sufficient predictive value to be relied upon as a basis for
excluding workers. Consequently, use of the tests would result in unfair
discrimination against individuals who have positive test results. In
addition, there are other ways for employers to serve their legitimate
interests. Tests of a worker's actual capacity to meet the demands of
the job can be used to ensure future employability and protect the
public's safety. Routine monitoring of a worker's exposure can be used
to protect workers who have a genetic susceptibility to injury from a
substance in the workplace. In addition, employees should be advised of
the risks of injury to which they are being exposed.
(2) There may be a
role for genetic testing in the exclusion from the workplace of workers
who have a genetic susceptibility to injury. At a minimum, several
conditions would have to be met:
develops so rapidly that serious and irreversible injury would occur
before monitoring of either the worker's exposure to the toxic substance
or the worker's health status could be effective in preventing the harm.
(b) The genetic
testing is highly accurate, with sufficient sensitivity and specificity
to minimize the risk of false negative and false positive test results.
(c) Empirical data
demonstrate that the genetic abnormality results in an unusually
elevated susceptibility to occupational injury.
(d) It would require
undue cost to protect susceptible employees by lowering the level of the
toxic substance in the workplace. The costs of lowering the level of the
substance must be extraordinary relative to the employer's other costs
of making the product for which the toxic substance is used. Since
genetic testing with exclusion of susceptible employees is the
alternative to cleaning up the workplace, the cost of lowering the level
of the substance must also be extraordinary relative to the costs of
using genetic testing.
(e) Testing must not
be performed without the informed consent of the employee or applicant
for employment. (IV) Issued June 1991 based on the report "Genetic
Testing by Employers," adopted June 1991 (JAMA 1991; 266: 1827-1830).
Companies and Genetic Information..23
not participate in genetic testing by health insurance companies to
predict a person's predisposition for disease. As a corollary, it may be
necessary for physicians to maintain separate files for genetic testing
results to ensure that the results are not sent to health insurance
companies when requests for copies of patient medical records are
fulfilled. Physicians who withhold testing results should inform
insurance companies that, when medical records are sent, genetic testing
results are not included. This disclosure should occur with all
patients, not just those who have undergone genetic testing. (IV) Issued
June 1994 based on the report "Physician Participation in Genetic
Testing by Health Insurance Companies," adopted June 1993; Updated June
Information and the Criminal Justice System.
The release of
genetic information from a physician's records without the consent of
the patient constitutes a breach of confidentiality. Opinion 5.05,
"Confidentiality," acknowledges that law and overriding social
considerations may permit physicians to disclose confidential
information in limited circumstances. However, such circumstances
present ethical challenges. The following guidelines are intended to aid
physicians in considering the ethical basis for the release of genetic
information to the criminal justice system:
should release a patient's genetic information only with the patient's
consent or in compliance with a warrant or other order of a court of
law. The circumstances in which law enforcement may seek a suspect's
genetic information from the suspect's physician depend on whether any
specific suspect has been identified, and if the suspect is in custody.
(a) If law
enforcement personnel have identified a suspect and the suspect cannot
be located to provide a genetic sample, physicians should release
clinical genetic information only when a warrant or court order mandates
such a release.
(b) When law
enforcement personnel have identified a suspect, and the suspect has
been located but refuses to provide a sample or is deceased (but his or
her body is available), physicians should not be required to release
genetic information as in these circumstances a court can authorize
collection of a sample from the suspect or from postmortem tissue.
clinical and research databases of genetic information, or extracting
and analyzing DNA from clinical or research tissue repositories, should
not be conducted for the mere possibility that there is a match to a
suspect's DNA unless there is a warrant or court order to do so.
(2) When genetic
information is provided to the judicial system, physicians should
provide the minimum amount of information necessary for the explicit
identification procedure being performed. Other elements of the medical
record, or the results of any genetic testing or genetic diagnosis,
should not be released without the patient's consent or further warrant
or order of the court.
(3) It is unethical
for any genetic information obtained from a physician for identification
purposes to be used subsequently for other purposes, such as research,
unless appropriate ethical guidelines are followed and the informed
consent of the individual is obtained (or the legally appropriate
surrogate if the individual is incompetent or deceased, in compliance
with Opinion 5.051, "Confidentiality of Medical Information
(4) Databases that
contain only the genetic identifiers from the specific loci that are
typically used for identification purposes do not present the same
ethical concerns that are presented by databases which contain genotypic
or phenotypic information. Physicians participating in the creation of
genetic databases for the exclusive use of the criminal justice system
should ensure that the database is not used inappropriately for purposes
other than identification.
(5) In general,
requiring that the genetic sample be destroyed or returned after the
analysis necessary for identification is performed affords protection
against inappropriate uses.
(6) When the
criminal justice system seeks genetic information for the purposes of
identifying a deceased victim, the above relevant guidelines also apply.
(III, IV) Issued June 2001 based on the report "Genetic.24 Information
and the Criminal Justice System," adopted June 2000. (J. Law, Med. &
Ethics. 2002: 30; 88- 94).
Issues in Carrier Screening of Genetic Disorders.
All carrier testing
must be voluntary, and informed consent from screened individuals is
results is to be maintained. Results of testing should not be disclosed
to third parties without the explicit informed consent of the screened
individual. Patients should be informed as to potential uses for the
genetic information by third parties, and whether other ways of
obtaining the information are available when appropriate. Carrier
testing should be available uniformly among the at-risk population being
screened. One legitimate exception to this principle is the limitation
of carrier testing to individuals of childbearing age. In pursuit of
uniform access, physicians should not limit testing only to patients
specifically requesting testing. If testing is offered to some patients,
it should be offered to all patients within the same risk category.
The direction of
future genetic screening tests should be determined by well-thought-out
and well-coordinated social policy. Third parties, including insurance
companies or employers, should not be permitted to discriminate against
carriers of genetic disorders through policies which have the ultimate
effect of influencing decisions about testing and reproduction. (IV, V)
Issued June 1994 based on the report "Ethical Issues in Carrier
Screening for Cystic Fibrosis and Other Genetic Disorders," adopted June
Testing of Children.
Genetic testing of
children implicates important concerns about individual autonomy and the
interest of the patients. Before testing of children can be performed,
there must be some potential benefit from the testing that can
reasonably be viewed as outweighing the disadvantages of testing,
particularly the harm from abrogating the children's future choice in
knowing their genetic status. When there is such a potential benefit,
parents should decide whether their children will undergo testing. If
parents unreasonably request or refuse testing of their child, the
physician should take steps to change or, if necessary, use legal means
to override the parents' choice. Applying these principles to specific
circumstances yields the following conclusions:
(1) When a child is
at risk for a genetic condition for which preventive or other
therapeutic measures are available, genetic testing should be offered
or, in some cases, required.
(2) When a child is
at risk for a genetic condition with pediatric onset for which
preventive or other therapeutic measures are not available, parents
generally should have discretion to decide about genetic testing.
(3) When a child is
at risk for a genetic condition with adult onset for which preventive or
other therapeutic measures are not available, genetic testing of
children generally should not be undertaken. Families should still be
informed of the existence of tests and given the opportunity to discuss
the reasons why the tests are generally not offered for children.
(4) Genetic testing
for carrier status should be deferred until either the child reaches
maturity, the child needs to make reproductive decisions, or, in the
case of children too immature to make their own reproductive decisions,
reproductive decisions need to be made for the child.
(5) Genetic testing
of children for the benefit of a family member should not be performed
unless the testing is necessary to prevent substantial harm to the
family member..25 When a child's genetic status is determined
incidentally, the information should be retained by the physician and
entered into the patient record. Discussion of the existence of this
finding should then be taken up when the child reaches maturity or needs
to make reproductive decisions, so that the individual can decide
whether to request disclosure of the information. It is important that
physicians be consistent in disclosing both positive and negative
results in the same way since if physicians raise the existence of the
testing results only when the results are positive, individuals will
know what the results must be. This information should not be disclosed
to third parties. Genetic information should be maintained in a separate
portion of the medical record to prevent mistaken disclosure. When a
child is being considered for adoption, the guidelines for genetic
testing should be the same as for other children. (IV) Issued June 1996
based on the report "Testing Children for Genetic Status," adopted June
testing--where tests are offered for several different medical
conditions in a single session—presents a series of challenges to
adequate communication between the patient and the physician. It
increases the total number of marginally indicated or non-indicated
tests, thereby bolstering the rate of false results. These results may
lead to psychological stress and misinformed life-altering decisions,
and may also impact the ability of a physician to obtain informed
consent. Multiplex testing and its resultant information may also have
widespread societal implications that include discriminatory practices
against not only individuals but specific ethnic groups that have been
designated "at risk" populations. Before such tests reach health care
providers, clinics, and drugstores, the ethical and social implications
of these tests must be well-understood, and careful restrictions and
regulations must be established. The following guidelines are offered on
the future possibilities of multiplex genetic testing:
should not routinely order tests for multiple genetic conditions.
(2) Tests for more
than one genetic condition should be ordered only when clinically
relevant and after the patient has had full counseling and has given
informed consent for each test.
(3) Efforts should
be made to educate clinicians and society about the uncertainty
surrounding genetic testing. (IV, V) Issued June 1998 based on the
report "Multiplex Genetic Testing," adopted December 1996 (Hastings
Center Report. 1998; 28(4): 15-21).
E-2.14 In Vitro
The technique of in
vitro fertilization and embryo transplantation enables certain couples
previously incapable of conception to bear a child. It is also useful in
the field of research directed toward an understanding of how genetic
defects arise and are transmitted and how they might be prevented or
treated. Because of serious ethical and moral concerns, however, any
fertilized egg that has the potential for human life and that will be
implanted in the uterus of a woman should not be subjected to laboratory
research. All fertilized ova not utilized for implantation and that are
maintained for research purposes shall be handled with the strictest
adherence to the Principles of Medical Ethics, to the guidelines for
research and medical practice expressed in the Council's opinion on
fetal research, and to the highest standards of medical practice. (I, V,
VII) Issued June 1983.
The practice of
freezing extra pre-embryos harvested during the in vitro fertilization
process (IVF) has enhanced the ability of infertile couples to preserve
embryos for future implantation. This practice has also posed a number
of ethical and legal dilemmas, including questions regarding
decision-making authority over the pre-embryos and appropriate uses of
cultural and legal traditions indicate that the logical persons to
exercise control over a frozen pre-embryo are the woman and man who
provided the gametes (the ovum and sperm). The gamete providers have a
fundamental interest at stake, their potential for procreation. In
addition, the gamete providers are the parties most concerned with the
interests of a frozen pre-embryo and most likely to protect those
should be able to use the pre-embryos themselves or donate them for use
by other parties, but not sell them. In addition, research on
pre-embryos should be permitted as long as the pre-embryos are not
destined for transfer to a woman for implantation and as long as the
research is conducted in accordance with the Council's guidelines on
fetal research. Frozen pre-embryos may also be allowed to thaw and
The gamete providers
should have an equal say in the use of their pre-embryos and, therefore,
the pre-embryos should not be available for use by either provider or
changed from their frozen state without the consent of both providers.
The man and woman each has contributed half of the pre-embryo's genetic
code. In addition, whether a person chooses to become a parent and
assume all of the accompanying obligations is a particularly personal
and fundamental decision. Even if the individual could be absolved of
any parental obligations, he or she may have a strong desire not to have
offspring. The absence of a legal duty does not eliminate the moral duty
many would feel toward any genetic offspring. Advance agreements are
recommended for deciding the disposition of frozen pre-embryos in the
event of divorce or other changes in circumstances. Advance agreements
can help ensure that the gamete providers undergo IVF and pre-embryo
freezing after a full ontemplation of the consequences but should not be
mandatory. (I, III, IV, V) Issued March 1992 based on the report "Frozen
Pre-Embryos," adopted December 1989 (JAMA. 1990; 263: 2484-2487);
Updated June 1994.
The technique of
splitting in vitro fertilized pre-embryos may result in multiple
genetically identical siblings.
The procedure of
pre-embryo splitting should be available so long as both gamete
providers agree. This procedure may greatly increase the chances of
conception for an infertile couple or for a couple whose future
reproductive capacity will likely be diminished. Pre-embryo splitting
also can reduce the number of invasive procedures necessary for egg
retrieval and the necessity for hormonal stimulants to generate multiple
eggs. The use and disposition of any pre-embryos that are frozen for
future use should be consistent with the Council's opinion on frozen
pre-embryos. (Opinion 2.141, "Frozen Pre-embryos.") The use of frozen
pre-embryo identical siblings many years after one child has been born
raises new ethical issues. Couples might wait until they can discover
the mental and physical characteristics of a child before transferring a
genetically identical sibling for implantation, they might sell their
frozen pre-embryos based upon the outcome of a genetically identical
child, or they might decide to transplant a genetically identical
sibling based on the need to harvest the child's tissue..27
The Council does not
find that these considerations are sufficient to prohibit pre-embryo
splitting for the following reasons:
(1) It would take
many years to determine the outcome of a child and most families want to
complete their childbearing within a shorter time.
(2) The sale of
pre-embryos can and should be prohibited.
(3) The small number
of couples who might bear identical siblings solely for purposes of
harvesting their tissue does not outweigh the benefits which might be
derived from pre-embryo splitting. Additionally, it is not evident that
a sibling would have negative psychological or emotional consequences
from having acted as an organ or tissue donor. Indeed, the child may
derive psychological benefits from having saved the life of a sibling.
To the extent possible, discussion of these issues should be had with
gamete providers prior to pre-embryo splitting and freezing so as to
inform the prospective parents of possible future ethical dilemmas. (I,
III, IV, V) Issued June 1994.
nuclear transfer" is the process in which the nucleus of a somatic cell
of an organism is transferred into an enucleated oocyte. "Human cloning"
is the application of somatic nuclear transfer technology to the
creation of a human being that shares all of its nuclear genes with the
person donating the implanted nucleus. In order to clarify the many
existing misconceptions about human cloning, physicians should help
educate the public about the intrinsic limits of human cloning as well
as the current ethical and legal protections that would prevent abuses
of human cloning. These include the following: (1) using human cloning
as an approach to terminal illness or mortality is a concept based on
the mistaken notion that one's genotype largely determines one's
individuality. A clone-child created via human cloning would not be
identical to his or her clone-parent. (2) Current ethical and legal
standards hold that under no circumstances should human cloning occur
without an individual's permission. (3) Current ethical and legal
standards hold that a human clone would be entitled to the same rights,
freedoms, and protections as every other individual in society. The fact
that a human clone's nuclear genes would derive from a single individual
rather than two parents would not change his or her moral standing.
Physicians have an
ethical obligation to consider the harms and benefits of new medical
procedures and technologies. Physicians should not participate in human
cloning at this time because further investigation and discussion
regarding the harms and benefits of human cloning is required. Concerns
include: (1) unknown physical harms introduced by cloning. Somatic cell
nuclear transfer has not yet been refined and its long-term safety has
not yet been proven. The risk of producing individuals with genetic
anomalies gives rise to an obligation to seek better understanding
of-and potential medical therapies for-the unforeseen medical
consequences that could stem from human cloning. (2) Psychosocial harms
introduced by cloning, including violations of privacy and autonomy.
Human cloning risks limiting, at least psychologically, the seemingly
unlimited potential of new human beings and thus creating enormous
pressures on the clone-child to live up to expectations based on the
life of the clone-parent. (3) The impact of human cloning on familial
and societal relations. The family unit may be altered with the
introduction of cloning, and more thought is required on a societal
level regarding how to construct familial relations. (4) Potential
effects on the gene pool. Like other interventions that can change
individuals' reproductive patterns and the resulting genetic
characteristics of a population, human cloning has the potential to be
used in a eugenic or discriminatory fashion--practices that are
incompatible with the ethical norms of medical practice. Moreover,
human.28 cloning could alter irreversibly the gene pool and exacerbate
genetic problems that arise from deleterious genetic mutations,
resulting in harms to future generations.
realistic and possibly appropriate medical uses of human cloning are for
assisting individuals or couples to reproduce and for the generation of
tissues when the donor is not harmed or sacrificed. Given the unresolved
issues regarding cloning identified above, the medical profession should
not undertake human cloning at this time and pursue alternative
approaches that raise fewer ethical concerns.
technology is not limited to the United States, physicians should help
establish international guidelines governing human cloning. (V) Issued
December 1999 based of the report "The Ethics of Human Cloning," adopted
Incentives for Organ Donation.
donation of organs in appropriate circumstances is to be encouraged.
However, it is not ethical to participate in a procedure to enable a
living donor to receive payment, other than for the reimbursement of
expenses necessarily incurred in connection with removal, for any of the
donor's non-renewable organs.
financial incentives for cadaveric organ donors should have adequate
safeguards to ensure that the health of donors and recipients is in no
way jeopardized, and that the quality of the organ supply is not
degraded. Incentives should be limited to future contracts offered to
prospective donors. By entering into a future contract, an adult would
agree while still competent to donate his or her organs after death. In
return, the donor's family or estate would receive some financial
remuneration after the organs have been retrieved and judged medically
suitable for transplantation. Several other conditions would apply:
(1) Only the
potential donor, and not the donor's family or other third party, may be
given the option of accepting financial incentives for cadaveric organ
donation. In addition, the potential donor must be a competent adult
when the decision to donate is made, and the donor must not have
(2) Any incentive
should be of moderate value and should be the lowest amount that can
reasonably be expected to encourage organ donation. By designating a
state agency to administer the incentive, full control over the level of
incentive can be maintained.
(3) Payment should
occur only after the organs have been retrieved and judged medically
suitable for transplantation. Suitability should continue to be
determined in accordance with the procedures of the Organ Procurement
and Transplantation Network.
should play no part in the allocation of donated organs among potential
transplant recipients. The distribution of organs for transplantation
should continue to be governed only by ethically appropriate criteria
relating to medical need. (I, III, V) Issued June 1984; Updated June
1994 based on the report "Financial Incentives for Organ Procurement:
Ethical Aspects of Future Contracts for Cadaveric Donors," adopted
December 1993 (Arch Intern Med. 1995; 155: 581-89).
Choice and Presumed Consent for Cadaveric Organ Donation.
A system of mandated
choice for organ donation, in which individuals are required to express
their preferences regarding organ donation when renewing their drivers'
licenses or performing some other state-mandated task, is an ethically
appropriate strategy for encouraging donation and should be pursued. To
be.29 effective, information on the importance of organ donation and the
success of organ transplantation should be provided when the donation
decision is made.
A system of presumed
consent for organ donation, in which individuals are assumed to consent
to be organ donors after death unless they indicate their refusal to
consent, raises serious ethical concerns. For presumed consent to be
ethically acceptable, effective mechanisms for documenting and honoring
refusals to donate must be in place. In addition, when there is no
documented refusal by the individual decedent, the family of the
decedent would have to be contacted to verify that they do not know of
any objections to donation by the decedent while living. (I, III, V)
Issued June 1994 based on the report "Strategies for Cadaveric Organ
Procurement: Mandated Choice and Presumed Consent," adopted December
1993 (JAMA. 1994; 272: 809-12).
Procurement Following Cardiac Death.
Given the increasing
need for donor organs, protocols for procurement following cardiac death
have been developed. In some instances, patients or their surrogate
decision makers request withdrawal of life support and choose to serve
as organ donors. In these cases, the organs can be preserved best by
discontinuation of life support in the operating room so that organs can
be removed two minutes following cardiac death. In other scenarios,
patients who suffer unexpected cardiac death may be cannulated and
perfused with cold preserving fluid (in situ preservation) to maintain
organs. Both of these methods may be ethically permissible, with
attention to certain safeguards.
(1) When securing
consent for life support withdrawal and organ retrieval, the health care
team must be certain that consent is voluntary. This is particularly
true where surrogate decisions about life-sustaining treatment may be
influenced by the prospect of organ donation. If there is any reason to
suspect undue influence, a full ethics consultation should be required.
(2) In all
instances, it is critical that there be no conflict of interest in the
health care team. Those health care professionals providing care at the
end of life must be separated from providers participating in the
(3) Further pilot
programs should assess the success and acceptability of organ removal
following withdrawal of life-sustaining treatment.
(4) In cases of in
situ preservation of cadaveric organs, the prior consent of the decedent
or the consent of the decedent's surrogate decision maker makes
perfusion ethically permissible. Perfusion without either prior specific
consent to perfusion or general consent to organ donation violates
requirements for informed consent for medical procedures and should not
(5) The recipients
of such procured organs should be informed of the source of the organs
as well as any potential defects in the quality of the organs, so that
they may decide with their physicians whether to accept the organs or
wait for more suitable ones.
(6) Clear clinical
criteria should be developed to ensure that only appropriate candidates,
whose organs are reasonably likely to be suitable for transplantation,
are considered eligible to donate organs under these protocols. (I, III,
V) Issued June 1996 based on the reports "Ethical Issues in the
Procurement of Organs Following Cardiac Death: The Pittsburgh Protocol"
and "Ethical Issues in Organ Procurement Following Cardiac Death: In
Situ Preservation of Cardaveric Organs," adopted December 1994..30
statement is offered for guidance of physicians as they seek to maintain
the highest level of ethical conduct in the transplanting of human
(1) In all
professional relationships between a physician and a patient, the
physician's primary concern must be the health of the patient. The
physician owes the patient primary allegiance. This concern and
allegiance must be preserved in all medical procedures, including those
which involve the transplantation of an organ from one person to another
where both donor and recipient are patients. Care must, therefore, be
taken to protect the rights of both the donor and the recipient, and no
physician may assume a responsibility in organ transplantation unless
the rights of both donor and recipient are equally protected. A
prospective organ transplant offers no justification for a relaxation of
the usual standard of medical care for the potential donor.
(2) When a vital,
single organ is to be transplanted, the death of the donor shall have
been determined by at least one physician other than the recipient's
physician. Death shall be determined by the clinical judgment of the
physician, who should rely on currently accepted and available
(3) Full discussion
of the proposed procedure with the donor and the recipient or their
responsible relatives or representatives is mandatory. The physician
should ensure that consent to the procedure is fully informed and
voluntary, in accordance with the Council's guidelines on informed
consent. The physician's interest in advancing scientific knowledge must
always be secondary to his or her concern for the patient.
procedures of body organs should be undertaken (a) only by physicians
who possess special medical knowledge and technical competence developed
through special training, study, and laboratory experience and practice,
and (b) in medical institutions with facilities adequate to protect the
health and well-being of the parties to the procedure.
(5) Recipients of
organs for transplantation should be determined in accordance with the
Council's guidelines on the allocation of limited medical resources.
(6) Organs should be
considered a national, rather than a local or regional, resource.
Geographical priorities in the allocation of organs should be prohibited
except when transportation of organs would threaten their suitability
(7) Patients should
not be placed on the waiting lists of multiple local transplant centers,
but rather on a single waiting list for each type of organ. (I, III, V)
Issued prior to April 1977; Updated June 1994 based on the report
"Ethical Considerations in the Allocation of Organs and Other Scarce
Medical Resources Among Patients," adopted June 1993.
Applications of Fetal Tissue Transplantation.
ethical concern in the use of human fetal tissue for transplantation is
the degree to which the decision to have an abortion might be influenced
by the decision to donate the fetal tissue. In the application of fetal
tissue transplantation the following safeguards should apply: (l) The
Council on Ethical and Judicial Affairs' guidelines on clinical
investigation and organ transplantation are followed, as they pertain to
the recipient of the fetal tissue transplant (see Opinion 2.07, Clinical
Investigation, and Opinion 2.16, Organ Transplantation Guidelines); (2)
a final decision regarding abortion is made before initiating a.31
discussion of the transplantation use of fetal tissue; (3) decisions
regarding the technique used to induce abortion, as well as the timing
of the abortion in relation to the gestational age of the fetus, are
based on concern for the safety of the pregnant woman; (4) fetal tissue
is not provided in exchange for financial remuneration above that which
is necessary to cover reasonable expenses; (5) the recipient of the
tissue is not designated by the donor; (6) health care personnel
involved in the termination of a particular pregnancy do not participate
in or receive any benefit from the transplantation of tissue from the
abortus of the same pregnancy; and (7) informed consent on behalf of
both the donor and the recipient is obtained in accordance with
applicable law. (I, IV, V) Issued March 1992 based on the report
"Medical Applications of Fetal Tissue Transplantation," adopted June
1989 (JAMA. 1990; 263: 565-570); Updated June 1996.
Neonates as Organ Donors.
Anencephaly is a
congenital absence of major portion of the brain, skull, and scalp.
Anencephalic neonates are thought to be unique from other brain-damaged
beings because of a lack of past consciousness with no potential for
provide anencephalic neonates with ventilator assistance and other
medical therapies that are necessary to sustain organ perfusion and
viability until such time as a determination of death can be made in
accordance with accepted medical standards, relevant law, and regional
organ procurement organization policy. Retrieval and transplantation of
the organs of anencephalic infants are ethically permissible only after
such determination of death is made, and only in accordance with the
Council's guidelines for transplantation. (I, III, V) Issued March 1992
based on the report "Anencephalic Infants as Organ Donors," adopted
December 1988; Updated June 1994; Updated December 1994 based on the
report "The Use of Anencephalic Neonates as Organ Donors," adopted
December 1994; and updated June 1996 based on the report "Anencephalic
Infants as Organ Donors - Reconsideration," adopted December 1995.
Umbilical Cord Blood.
Human umbilical cord
blood has been identified as a viable source of hematopoietic stem cells
that can be used as an alternative to bone marrow for transplantation.
It is obtained by clamping the umbilical cord immediately after
The use of umbilical
cord blood raises two main ethical problems. First, the exact timing of
the clamping has a significant impact on the neonate. Studies indicate
that early clamping may cause an abrupt surge in arterial pressure,
resulting in intraventricular hemorrhage (particularly in premature
infants). Second, there is a risk that the infant donor will develop a
need for his or her own cord blood later in life. If that child was a
donor and this later need arises, he or she might be without blood, when
he or she could have had his or her own blood stored.
To avoid health
risks, normal clamping protocol should be followed and not altered in
such a way that might endanger the infant. Additionally, parents of the
infant must be fully informed of the risks of the donation and written
consent should be obtained from them.
The second concern,
that the child may need the blood later in life, is more complex. The
possibility that an infant donor would be in need of his or her own
umbilical cord blood is highly speculative. There are a number of
reasons why the infant may not need the blood later. The diseases that
are treated by bone marrow transplantation are not common, and there may
be other treatment alternatives available,.32 particularly in the future
when the illness would occur. Additionally, the demand for fetal
umbilical cord blood will increase as it becomes medically certain that
the blood may be used in persons unrelated to the donor. This situation
will reduce the need to store a particular infant's blood since
umbilical cord blood from other donors would be available. If the blood
is sufficient for use in unrelated individuals, then the donor may
obtain the cord blood from another donor later in life, making the need
to store his or her own blood unnecessary. These original donors,
however, should be given priority in receipt of such blood if they need
a donation later in life.
For all of these
reasons, it would generally not be unethical to use the cord blood.
However, if the child-donor is known to be at risk for an illness that
is treated by bone marrow donation, the child should not be used as a
donor, and his or her blood should be stored for future use. (I, V)
Issued June 1994; Updated June 1996.
E-2.167 The Use of
Minors as Organ and Tissue Donors.
Minors need not be
prohibited from acting as sources of organs, but their participation
should be limited. Different procedures pose different degrees of risk
and do not all require the same restrictions. In general, minors should
not be permitted to serve as a source when there is a very serious risk
of complications (eg, partial liver or lung donation, which involve a
substantial risk of serious immediate or long-term morbidity). If the
safeguards in the remainder of this opinion are followed, minors may be
permitted to serve as a source when the risks are low (eg, blood or skin
donation, in which the donated tissue can regenerate and spinal or
general anesthesia is not required), moderate (eg, bone marrow donation,
in which the donated tissue can regenerate but brief general or spinal
anesthesia is required), or serious (eg, kidney donation, which involve
more extensive anesthesia and major invasive surgery).
If a child is
capable of making his or her own medical treatment decisions, he or she
should be considered capable of deciding whether to be an organ or
tissue donor. However, physicians should not perform organ retrievals of
serious risk without first obtaining court authorization. Courts should
confirm that the mature minor is acting voluntarily and without
If a child is not
capable of making his or her own medical decisions, all transplantations
should have parental approval, and those which pose a serious risk
should receive court authorization. In the court authorization process,
the evaluation of a child psychiatrist or psychologist must be sought
and a guardian ad litem should be assigned to the potential minor donor
in order to fully represent the minor's interests. When deciding on
behalf of immature children, parents and courts should ensure that
transplantation presents a "clear benefit" to the minor source, which
entails meeting the following requirements:
(1) Ideally the
minor should be the only possible source. All other available sources of
organs, both donor pools and competent adult family members, must be
medically inappropriate or significantly inferior. An unwilling
potential donor does not qualify him/her as medically inappropriate.
transplantations of moderate or serious risk, the transplantation must
be necessary with some degree of medical certainty to provide a
substantial benefit; that is, it both prevents an extremely poor quality
of life and ensures a good quality of life for the recipient. A
transplant should not be allowed if it merely increases the comfort of
the recipient. If a transplant is not presently considered to provide a
substantial benefit but is expected to do so within a period of time,
the transplant need not be delayed until it meets this criterion,
especially if the delay would significantly decrease the benefits
derived from the transplant by the recipient.
(3) The organ or
tissue transplant must have a reasonable probability of success in order
for transplantation to be allowed. What constitutes a reasonable chance
of success should be based on medical.33 judgments about the physical
condition of the recipient and the likelihood that the transplant will
not be rejected, futile, or produce benefits which are very transient.
Children should not be used for transplants that are considered
experimental or non-standard.
minors should be allowed to serve as a source only to close family
(5) Psychological or
emotional benefits to the potential source may be considered, though
evidence of future benefit to the minor source should be clear and
convincing. Possible benefits to a child include continued emotional
bonds between the minor and the recipient, increased self-esteem, and
prevention of adverse reaction to death of a sibling. Whether a child
will capture these benefits depends upon the child's specific
circumstances. A minor's assent or dissent to a procedure is an
important piece of evidence that demonstrates whether the transplant
will offer psychological benefits to the source. Dissent from
incompetent minors should be powerful evidence that the donation will
not provide a clear benefit, but may not present an absolute bar. Every
effort should be made to identify and address the child's concerns in
(6) It is essential
to ensure that the potential source does not have any underlying
conditions that create an undue individual risk. (I, V) Issued June 1994
based on the report "The Use of Minors as Organ and Tissue Donors,"
adopted December 1993.
E-2.169 The Ethical
Implications of Xenotransplantation.
includes any procedure that involves the transplantation, implantation,
or infusion into a human recipient of either (a) live cells, tissues, or
organs from a non-human animal source or (b) human body fluids, cells,
tissues or organs that have had ex vivo contact with live non-human
animal cells, tissues, or organs. Although xenotransplantation offers a
potential source of tissue, and organs for medical procedures, research
in this area may uncover physical and psychological conditions that
require medical attention. As such, physicians need to be involved in
developing and implementing guidelines for continued research.
Therefore, the following guidelines are offered for the medical and
should encourage education and public discussion of xenotransplantation
because of the potential unique risks such procedures pose to individual
patients and the public.
(2) The medical and
scientific communities should support oversight for the development of
clinical trial protocols and of ongoing xenotransplantation research.
(3) Given the
uncertain risk xenotransplantation poses to society, participants in
early clinical trials may have to agree to (a) post-operative measures
such as life-long surveillance, disclosure of sexual contacts, autopsy;
and (b) a waiver of the traditional right to withdraw from a clinical
trial until the risk of late xenozoonoses is reasonably known not to
exist. These requirements may continue even if the transplanted tissue
is rejected or removed. The informed consent process should include a
discussion of the above issues as well as potential risks to third
parties and psychological concerns associated with receiving an organ or
tissue graft from an animal. Careful attention must be paid to both the
content of the consent disclosure and the manner in which consent is
(4) It would be
ethical to include children and incompetent adults in
xenotransplantation research protocols only when the patients are
terminally ill and alternative treatments are not available.
protocols must be fair and in accordance with Opinion 2.03,"Allocation
of Limited Medical Resources," which recommends that decisions regarding
the allocation of medical resources among patients be based only on
ethically appropriate criteria relating to medical need. These criteria
include, but are not limited to, the likelihood of benefit, the urgency
of need, the change in quality of life, the duration of benefit, and, in
some cases, the amount of resources required for treatment.
(6) Sponsors of
xenotransplantation research should assure that adequate funding exists
for life-long surveillance and treatment of complications arising from
xenotransplantation procedures on research subjects..34
(7) At a minimum,
all on-going research should adhere to the Public Health Service
Guideline on Infectious Disease Issues in Xenotransplantation, FDA
guidelines relating to xenotransplantation, Opinion 2.07 "Clinical
Research," and any additional precautionary measures believed to
minimize potential risks to the public or to patients. It is
inappropriate to participate in xenograft procedures outside federal
xenotransplantation research should continue to promote high standards
of care and humane treatment of all animals used in research (H-460.979,
"Use of Animals in Research") and to apply these standards to the care
and treatment of animals used as sources of transplantation material.
(IV, VII) Issued June 2001 based on the report "The Ethical Implications
of Xenotransplantation," adopted December 2000.
E-2.17 Quality of
In the making of
decisions for the treatment of seriously disabled newborns or of other
persons who are severely disabled by injury or illness, the primary
consideration should be what is best for the individual patient and not
the avoidance of a burden to the family or to society. Quality of life,
as defined by the patient's interests and values, is a factor to be
considered in determining what is best for the individual. It is
permissible to consider quality of life when deciding about
life-sustaining treatment in accordance with Opinions 2.20, "Withholding
or Withdrawing Life-Sustaining Medical Treatment," 2.215, "Treatment
Decisions for Seriously Ill Newborns," and 2.22, "Do-Not-Resuscitate
Orders." (I, III, IV) Issued March 1981; Updated June 1994.
motherhood involves the artificial insemination of a woman who agrees,
usually in return for payment, to give the resulting child to the
child's father by surrendering her parental rights. Often, the father's
infertile wife becomes the child's adoptive mother. The woman bearing
the child is in most cases genetically related to the child, though
gestational surrogacy (in which the ovum is provided by the father's
infertile wife or other donor) is possible as well.
Ethical, social, and
legal problems may arise in surrogacy arrangements. Surrogate motherhood
may commodify children and women's reproductive capacities, exploit poor
women whose decision to participate may not be wholly voluntary, and
improperly discourage or interfere with the formation of a natural
maternal-fetal or maternal-child bond. Psychological impairment may
occur in a woman who deliberately conceives with the intention of
bearing a child which she will give up. In addition, the woman who has
contracted to bear the child may decide to have an abortion or to refuse
to relinquish her parental rights. Alternatively, if there is a
subsequent birth of a disabled child, prospective parents and the birth
mother may not want to or will be unable to assume the responsibilities
of parenthood. On the other hand, surrogate motherhood arrangements are
often the last hope of prospective parents to have a child that is
genetically related to at least one of them. In addition, most surrogacy
arrangements are believed by the parties involved to be mutually
beneficial, and most are completed without mishap or dispute. In light
of the concerns expressed above, however, some safeguards are necessary
to protect the welfare of the child and the birth mother. The Council
believes that surrogacy contracts, while permissible, should grant the
birth mother the right to void the contract within a reasonable period
of time after the birth of the child. If the contract is voided, custody
of the child should be determined according to the child's best
surrogacy, in which the surrogate mother has no genetic tie to the
fetus, the justification for allowing the surrogate mother to void the
contract becomes less clear. Gestational surrogacy contracts.35 should
be strictly enforceable (i.e., not voidable by either party). (I, II,
IV) Issued December 1983; Updated June 1994.
not provide, prescribe, or seek compensation for services that they know
are unnecessary. (II, VII) Issued prior to April 1977; Updated June
or Withdrawing Life-Sustaining Medical Treatment.
commitment of the physician is to sustain life and relieve suffering.
Where the performance of one duty conflicts with the other, the
preferences of the patient should prevail. The principle of patient
autonomy requires that physicians respect the decision to forego
life-sustaining treatment of a patient who possesses decision-making
capacity. Life-sustaining treatment is any treatment that serves to
prolong life without reversing the underlying medical condition.
Life-sustaining treatment may include, but is not limited to, mechanical
ventilation, renal dialysis, chemotherapy, antibiotics, and artificial
nutrition and hydration.
There is no ethical
distinction between withdrawing and withholding life-sustaining
treatment. A competent, adult patient may, in advance, formulate and
provide a valid consent to the withholding or withdrawal of life-support
systems in the event that injury or illness renders that individual
incompetent to make such a decision. A patient may also appoint a
surrogate decision maker in accordance with state law. If the patient
receiving life-sustaining treatment is incompetent, a surrogate decision
maker should be identified. Without an advance directive that designates
a proxy, the patient's family should become the surrogate decision
maker. Family includes persons with whom the patient is closely
associated. In the case when there is no person closely associated with
the patient, but there are persons who both care about the patient and
have sufficient relevant knowledge of the patient, such persons may be
appropriate surrogates. Physicians should provide all relevant medical
information and explain to surrogate decision makers that decisions
regarding withholding or withdrawing life-sustaining treatment should be
based on substituted judgment (what the patient would have decided) when
there is evidence of the patient's preferences and values. In making a
substituted judgment, decision makers may consider the patient's advance
directive (if any); the patient's values about life and the way it
should be lived; and the patient's attitudes towards sickness,
suffering, medical procedures, and death. If there is not adequate
evidence of the incompetent patient's preferences and values, the
decision should be based on the best interests of the patient (what
outcome would most likely promote the patient's well-being).
surrogate's decision for the incompetent patient should almost always be
accepted by the physician, there are four situations that may require
either institutional or judicial review and/or intervention in the
decision-making process: (1) there is no available family member willing
to be the patient's surrogate decision maker, (2) there is a dispute
among family members and there is no decision maker designated in an
advance directive, (3) a health care provider believes that the family's
decision is clearly not what the patient would have decided if
competent, and (4) a health care provider believes that the decision is
not a decision that could reasonably be judged to be in the patient's
best interests. When there are disputes among family members or between
family and health care providers, the use of ethics committees
specifically designed to facilitate sound decision making is recommended
before resorting to the courts..36
When a permanently
unconscious patient was never competent or had not left any evidence of
previous preferences or values, since there is no objective way to
ascertain the best interests of the patient, the surrogate's decision
should not be challenged as long as the decision is based on the
decision maker's true concern for what would be best for the patient.
Physicians have an
obligation to relieve pain and suffering and to promote the dignity and
autonomy of dying patients in their care. This includes providing
effective palliative treatment even though it may foreseeably hasten
death. Even if the patient is not terminally ill or permanently
unconscious, it is not unethical to discontinue all means of
life-sustaining medical treatment in accordance with a proper
substituted judgment or best interests analysis. (I, III, IV, V) Issued
December 1984 as Opinion 2.18, Withholding or Withdrawing
Life-Prolonging Medical Treatment, and Opinion 2.19, Withholding or
Withdrawing Life-Prolonging Medical Treatment -- Patients' Preferences.
In 1989, these Opinions were renumbered 2.20 and 2.21, respectively.
Updated June 1994 based on the reports "Decisions Near the End of Life"
and "Decisions to Forego Life-Sustaining Treatment for Incompetent
Patients," both adopted June 1991 (Decisions Near the End of Life. JAMA.
1992; 267: 2229-2233), and updated June 1996. [In March 1981, the
Council on Ethical and Judicial Affairs issued Opinion 2.11, Terminal
Illness. The Opinion was renumbered 2.15 in 1984 and was deleted in
Euthanasia is the
administration of a lethal agent by another person to a patient for the
purpose of relieving the patient's intolerable and incurable suffering.
It is understandable, though tragic, that some patients in extreme
duress--such as those suffering from a terminal, painful, debilitating
illness--may come to decide that death is preferable to life. However,
permitting physicians to engage in euthanasia would ultimately cause
more harm than good. Euthanasia is fundamentally incompatible with the
physician's role as healer, would be difficult or impossible to control,
and would pose serious societal risks. The involvement of physicians in
euthanasia heightens the significance of its ethical prohibition. The
physician who performs euthanasia assumes unique responsibility for the
act of ending the patient's life. Euthanasia could also readily be
extended to incompetent patients and other vulnerable populations.
Instead of engaging in euthanasia, physicians must aggressively respond
to the needs of patients at the end of life. Patients should not be
abandoned once it is determined that cure is impossible. Patients near
the end of life must continue to receive emotional support, comfort
care, adequate pain control, respect for patient autonomy, and good
communication. (I, IV) Issued June 1994 based on the report "Decisions
Near the End of Life," adopted June 1991 (JAMA. 1992; 267: 2229-2233);
Updated June 1996.
suicide occurs when a physician facilitates a patient's death by
providing the necessary means and/or information to enable the patient
to perform the life-ending act (e.g., the physician provides sleeping
pills and information about the lethal dose, while aware that the
patient may commit suicide)..37 It is understandable, though tragic,
that some patients in extreme duress--such as those suffering from a
terminal, painful, debilitating illness--may come to decide that death
is preferable to life. However, allowing physicians to participate in
assisted suicide would cause more harm than good. Physician-assisted
suicide is fundamentally incompatible with the physician's role as
healer, would be difficult or impossible to control, and would pose
serious societal risks.
participating in assisted suicide, physicians must aggressively respond
to the needs of patients at the end of life. Patients should not be
abandoned once it is determined that cure is impossible.
interventions should be sought including specialty consultation, hospice
care, pastoral support, family counseling, and other modalities.
Patients near the end of life must continue to receive emotional
support, comfort care, adequate pain control, respect for patient
autonomy, and good communication. (I, IV) Issued June 1994 based on the
reports "Decisions Near the End of Life," adopted June 1991, and
"Physician-Assisted Suicide," adopted December 1993 (JAMA. 1992; 267:
2229-33); Updated June 1996.
Decisions for Seriously Ill Newborns.
consideration for decisions regarding life-sustaining treatment for
seriously ill newborns should be what is best for the newborn. Factors
that should be weighed are: (1) the chance that therapy will succeed,
(2) the risks involved with treatment and nontreatment, (3) the degree
to which the therapy, if successful, will extend life, (4) the pain and
discomfort associated with the therapy, and (5) the anticipated quality
of life for the newborn with and without treatment. Care must be taken
to evaluate the newborn's expected quality of life from the child's
perspective. Life-sustaining treatment may be withheld or withdrawn from
a newborn when the pain and suffering expected to be endured by the
child will overwhelm any potential for joy during his or her life. When
an infant suffers extreme neurological damage, and is consequently not
capable of experiencing either suffering or joy, a decision may be made
to withhold or withdraw life-sustaining treatment. When life-sustaining
treatment is withheld or withdrawn, comfort care must not be
discontinued. When an infant's prognosis is largely uncertain, as is
often the case with extremely premature newborns, all life-sustaining
and life-enhancing treatment should be initiated. Decisions about
life-sustaining treatment should be made once the prognosis becomes more
certain. It is not necessary to attain absolute or near absolute
prognostic certainty before life-sustaining treatment is withdrawn,
since this goal is often unattainable and risks unnecessarily prolonging
the infant's suffering. Physicians must provide full information to
parents of seriously ill newborns regarding the nature of treatments,
therapeutic options, and expected prognosis with and without therapy, so
that parents can make informed decisions for their children about
life-sustaining treatment. Counseling services and an opportunity to
talk with persons who have had to make similar decisions should be
available to parents. Ethics committees or infant review committees
should also be utilized to facilitate parental decision making. These
committees should help mediate resolutions of conflicts that may arise
among parents, physicians, and others involved in the care of the
infant. These committees should also be responsible for referring cases
to the appropriate public agencies when it is concluded that the
parents' decision is not a decision that could reasonably be judged to
be in the best interests of the infant. (I, III, IV, V) Issued June 1994
based on the report "Treatment Decisions for Seriously Ill Newborns,"
adopted June 1992..38
Efforts should be
made to resuscitate patients who suffer cardiac or respiratory arrest
except when circumstances indicate that cardiopulmonary resuscitation
(CPR) would be inappropriate or not in accord with the desires or best
interests of the patient.
Patients at risk of
cardiac or respiratory failure should be encouraged to express in
advance their preferences regarding the use of CPR, and this should be
documented in the patient's medical record. These discussions should
include a description of the procedures encompassed by CPR and, when
possible, should occur in an outpatient setting when general treatment
preferences are discussed, or as early as possible during
hospitalization. The physician has an ethical obligation to honor the
resuscitation preferences expressed by the patient. Physicians should
not permit their personal value judgments about quality of life to
obstruct the implementation of a patient's preferences regarding the use
of CPR. If a patient is incapable of rendering a decision regarding the
use of CPR, a decision may be made by a surrogate decision maker, based
upon the previously expressed preferences of the patient or, if such
preferences are unknown, in accordance with the patient's best
If, in the judgment
of the attending physician, it would be inappropriate to pursue CPR, the
attending physician may enter a do-not-resuscitate (DNR) order into the
patient's record. Resuscitative efforts should be considered
inappropriate by the attending physician only if they cannot be expected
either to restore cardiac or respiratory function to the patient or to
meet established ethical criteria, as defined in the
Medical Ethics and Opinions 2.03, "Allocation of Limited Medical
Resources" and 2.095, "The Provision of Adequate Health Care." When
there is adequate time to do so, the physician must first inform the
patient, or the incompetent patient's surrogate, of the content of the
DNR order, as well as the basis for its implementation. The physician
also should be prepared to discuss appropriate alternatives, such as
obtaining a second opinion (e.g., consulting a bioethics committee) or
arranging for transfer of care to another physician. DNR orders, as well
as the basis for their implementation, should be entered by the
attending physician in the patient's medical record. DNR orders only
preclude resuscitative efforts in the event of cardiopulmonary arrest
and should not influence other therapeutic interventions that may be
appropriate for the patient. (I, IV) Issued March 1992 based on the
report "Guidelines for the Appropriate Use of Do-Not-Resuscitate
Orders," adopted December 1990 (JAMA. 1991; 265: 1868-1871); Updated
E-2.225 Optimal Use
of Orders - Not - To - Intervene and Advance Directives.
efforts in advance care planning are required in order to tailor
end-of-life care to the preferences of patients so that they can
experience a satisfactory last chapter in their lives. There is need for
better availability and tracking of advance directives, and more uniform
adoption of form documents that can be honored in all states of the
United States. The discouraging evidence of inadequate end-of-life
decision-making indicates the necessity of several improvement
(1) Patients and
physicians should make use of advisory as well as statutory documents.
Advisory documents aim to accurately represent a patient's wishes and
are legally binding under law. Statutory documents give physicians
immunity from malpractice for following a patient's wishes. If a form is
not available that combines the two, an advisory document should be
appended to the state statutory form..39
documents should be based on validated worksheets, thus ensuring
reasonable confidence that preferences for end-of-life treatment can be
fairly and effectively elicited and recorded, and that they are
applicable to medical decisions.
should directly discuss the patient's preferences with the patient and
the patient's proxy. These discussions should be held ahead of time
wherever possible. The key steps of structuring a core discussion and of
signing and recording the document in the medical record should not be
delegated to a junior member of the health care team.
repositories should be established so that completed advisory documents,
state statutory documents, identification of a proxy, and identification
of the primary physician can be obtained efficiently in emergency and
urgent circumstances as well as routinely.
(5) Health care
facilities should honor, and physicians use, a range of orders on the
Doctor's Order Sheet to indicate patient wishes regarding avoidable
treatments that might otherwise be given on an emergency basis or by a
covering physician with less knowledge of the patient's wishes.
Treatment avoidance orders might include, along with a Do Not
Resuscitate (DNR) order, some of the following: Full Comfort Care Only
(FCCO); Do Not Intubate (DNI); Do Not Defibrillate (DND); Do Not Leave
Home (DNLH); Do Not Transfer (DNTransfer); No Intravenous Lines (NIL);
No Blood Draws (NBD); No Feeding Tube (NFT); No Vital Signs (NVS); and
so forth. One common new order, Do Not Treat (DNT), is specifically not
included in this list, since it may unintentionally convey the message
that no care should be given and the patient may lose the intense
attention due to a dying person; FCCO serves the same purpose without
the likely misinterpretation. As with DNR orders, these treatment
avoidance orders should be revisited periodically to ensure their
continued applicability. Active comfort care orders might include Allow
Hours (AVEH) and Inquire About Comfort (IAC) b.i.d. (twice daily). (I,
IV) Issued June 1998 based on the report "Optimal Use of Orders - not -
to - Intervene and Advance Directives," adopted June 1997 (Pyschology,
Public Policy, and Law. 1998; 4: 668-75).
E-2.23 HIV Testing.
immunodeficiency virus (HIV) testing is appropriate and should be
encouraged for diagnosis and treatment of HIV infection or for medical
conditions that may be affected by HIV. Treatment may prolong the lives
of those with AIDS and prolong the symptom-free period in those with an
asymptomatic HIV infection. Wider testing is imperative to ensure that
individuals in need of treatment are identified and treated.
ensure that HIV testing is conducted in a way that respects patient
autonomy and assures patient confidentiality as much as possible.
The physician should
secure the patient's informed consent specific for HIV testing before
testing is performed. Because of the need for pretest counseling and the
potential consequences of an HIV test on an individual's job, housing,
insurability, and social relationships, the consent should be specific
for HIV testing. Consent for HIV testing cannot be inferred from a
general consent to treatment. When a health care provider is at risk for
HIV infection because of the occurrence of puncture injury or mucosal
contact with potentially infected bodily fluids, it is acceptable to
test the patient for HIV infection even if the patient refuses consent.
When testing without consent is performed in accordance with the law,
the patient should be given the customary pretest counseling.
of the results of HIV testing must be maintained as much as possible and
the limits of a patient's confidentiality should be known to the patient
before consent is given..40 Exceptions to confidentiality are
appropriate when necessary to protect the public health or when
necessary to protect individuals, including health care workers, who are
endangered by persons infected with HIV. If a physician knows that a
seropositive individual is endangering a third party, the physician
should, within the constraints of the law: (1) attempt to persuade the
infected patient to cease endangering the third party; (2) if persuasion
fails, notify authorities; and (3) if the authorities take no action,
notify the endangered third party.
In order to limit
the public spread of HIV infection, physicians should encourage
voluntary testing of patients at risk for infection.
It is unethical to
deny treatment to HIV-infected individuals because they are HIV
seropositive or because they are unwilling to undergo HIV testing,
except in the instance where knowledge of the patient's HIV status is
vital to the appropriate treatment of the patient. When a patient
refuses to be tested after being informed of the physician's medical
opinion, the physician may transfer the patient to a second physician
who is willing to manage the patient's care in accordance with the
patient's preferences about testing. (I, IV) Issued March 1992 based on
the report "Ethical Issues Involved in the Growing AIDS Crisis," adopted
December 1987 (JAMA. 1988; 259: 1360-61); Updated June 1994.
Drivers and Their Physicians
The purpose of this
report is to articulate physicians' responsibility to recognize
impairments in patients' driving ability that pose a strong threat to
public safety and which ultimately may need to be reported to the
Department of Motor Vehicles. It does not address the reporting of
medical information for the purpose of punishment or criminal
should assess patients' physical or mental impairments that might
adversely affect driving abilities. Each case must be evaluated
individually since not all impairments may give rise to an obligation on
the part of the physician. Nor may all physicians be in a position to
evaluate the extent or the effect of an impairment (e.g., physicians who
treat patients on a short-term basis). In making evaluations, physicians
should consider the following factors:
(a) the physician
must be able to identify and document physical or mental impairments
that clearly relate to the ability to drive;
(b) the driver must
pose a clear risk to public safety.
reporting, there are a number of initial steps physicians should take. A
tactful but candid discussion with the patient and family about the
risks of driving is of primary importance. Depending on the patient's
medical condition, the physician may suggest to the patient that he or
she seek further treatment, such as substance abuse treatment or
occupational therapy. Physicians also may encourage the patient and the
family to decide on a restricted driving schedule. Efforts made by
physicians to inform patients and their families, advise them of their
options, and negotiate a workable plan may render reporting unnecessary.
should use their best judgement when determining when to report
impairments that could limit a patient's ability to drive safely. In
situations where clear evidence of substantial driving impairment
implies a strong threat to patient and public safety, and where the
physician's advice to discontinue driving privileges is ignored, it is
desirable and ethical to notify the Department of Motor Vehicles.
(4) The physician's
role is to report medical conditions that would impair safe driving as
dictated by his or her state's mandatory reporting laws and standards of
medical practice. The determination of the inability to drive safely
should be made by the state's Department of Motor Vehicles.
should disclose and explain to their patients this responsibility to
should protect patient confidentiality by ensuring that only the minimal
amount of information is reported and that reasonable security measures
are used in handling that information..41
should work with their state medical societies to create statutes that
uphold the best interests of patients and community and that safeguard
physicians from liability when reporting in good faith. (I, III, IV,
VII) Issued June 2000 based on the report "Impaired Drivers and Their
Physicians," adopted December 1999.
from Unethical Experiments.
experiments using human subjects should undergo proper ethical
evaluation by a human studies review board before being undertaken.
Responsibility for revealing that the data are from unethical
experiments lies in the hands of authors, peer reviewers, and editors of
medical texts that publish results of experimental studies. Each
publication should adopt a standard regarding publication of data from
If data from
unethical experiments can be replaced by existing ethically sound data
and achieve the same ends, then such must be done. If ethically tainted
data that have been validated by rigorous scientific analysis are the
only data of that nature available, and such data are necessary in order
to save lives, then the utilization of such data by physicians and
editors may be appropriate.
and/or authors decide to publish an experiment or data from an
experiment that does not reach standards of contemporary ethical
conduct, a disclaimer should be included. Such disclosure would by no
means rectify unethical conduct or legitimize the methods of collection
of data gathered from unethical experimentation. This disclaimer should:
(1) clearly describe the unethical nature of the origin of any material
being published; (2) clearly state that publication of the data is
needed in order to save human lives; (3) pay respect to the victims; (4)
avoid trivializing trauma suffered by the participants; (5) acknowledge
the unacceptable nature of the experiments; and (6) endorse higher
ethical standards. Based on both scientific and moral grounds, data
obtained from cruel and inhumane experiments, such as data collected
from the Nazi experiments and data collected from the Tuskegee Study,
should virtually never be published or cited. In the extremely rare case
when no other data exist and human lives would certainly be lost without
the knowledge obtained from use of such data, publication or citation is
permissible. In such a case, the disclosure should cite the specific
reasons and clearly justify the necessity for citation.
accepted historical data may be cited without a disclaimer, though a
disclosure of the ethical issues would be valuable and desirable. (II,
V, VII) Issued December 1998 based on the report "Information from
Unethical Experiments," adopted June 1998.
E-3.00 Opinions on
It is unethical to
engage in or to aid and abet in treatment which has no scientific basis
and is dangerous, is calculated to deceive the patient by giving false
hope, or which may cause the patient to delay in seeking proper care.
also be mindful of state laws which prohibit a physician from aiding and
abetting an unlicensed person in the practice of medicine, aiding or
abetting a person with a limited license in providing.42 services beyond
the scope of his or her license, or undertaking the joint medical
treatment of patients under the foregoing circumstances.
otherwise free to accept or decline to serve anyone who seeks their
services, regardless of who has recommended that the individual see the
physician. (III, VI) Issued prior to April 1977; Updated June 1994 and
The primary bond
between the practices of medicine and nursing is mutual ethical concern
for patients. One of the duties in providing reasonable care is
fulfilled by a nurse who carries out the orders of the attending
physician. Where orders appear to the nurse to be in error or contrary
to customary medical and nursing practice, the physician has an ethical
obligation to hear the nurse's concern and explain those orders to the
nurse involved. The ethical physician should neither expect nor insist
that nurses follow orders contrary to standards of good medical and
nursing practice. In emergencies, when prompt action is necessary and
the physician is not immediately available, a nurse may be justified in
acting contrary to the physician's standing orders for the safety of the
patient. Such occurrences should not be considered to be a breakdown in
professional relations. (IV, V) Issued June 1983; Updated June 1994.
E-3.03 Allied Health
practice in concert with allied health professionals such as, but not
limited to, optometrists, nurse anesthetists, nurse midwives, and
physician assistants in the course of delivering appropriate medical
care to their patients. In doing so, physicians should be guided by the
(1) It is ethical
for a physician to work in consultation with or employ allied health
professionals, as long as they are appropriately trained and duly
licensed to perform the activities being requested.
(2) Physicians have
an ethical obligation to the patients for whom they are responsible to
ensure that medical and surgical conditions are appropriately evaluated
(3) Physicians may
teach in recognized schools for the allied health professionals for the
purpose of improving the quality of their education. The scope of
teaching may embrace subjects which are within the legitimate scope of
the allied health profession and which are designed to prepare students
to engage in the practice of the profession within the limits prescribed
(4) It is
inappropriate to substitute the services of an allied health
professional for those of a physician when the allied health
professional is not appropriately trained and duly licensed to provide
the medical services being requested. (I, V, VII) Issued December 1997.
E-3.04 Referral of
A physician may
refer a patient for diagnostic or therapeutic services to another
physician, limited practitioner, or any other provider of health care
services permitted by law to furnish such services, whenever he or she
believes that this may benefit the patient. As in the case of referrals
to physician-specialists, referrals to limited practitioners should be
based on their individual competence and ability to perform the services
needed by the patient. A physician should not so refer a patient unless
the physician is confident that the services provided on referral will
be performed competently and in accordance with accepted scientific
standards and legal requirements. (V, VI) Issued prior to April 1977..43
It is ethical for a
physician to associate professionally with chiropractors provided that
the physician believes that such association is in the best interests of
his or her patient. A physician may refer a patient for diagnostic or
therapeutic services to a chiropractor permitted by law to furnish such
services whenever the physician believes that this may benefit his or
her patient. Physicians may also ethically teach in recognized schools
of chiropractic. (V, VI) Issued March 1992.
Deleted in June
assist athletes to make informed decisions about their participation in
amateur and professional contact sports which entail risks of bodily
responsibility of the physician who serves in a medical capacity at an
athletic contest or sporting event is to protect the health and safety
of the contestants. The desire of spectators, promoters of the event, or
even the injured athlete that he or she not be removed from the contest
should not be controlling. The physician's judgment should be governed
only by medical considerations. (I, VII) Issued June 1983; Updated June
Deleted in June
Harassment and Exploitation Between Medical Supervisors and Trainees.
may be defined as sexual advances, requests for sexual favors, and other
verbal or physical conduct of a sexual nature when (l) such conduct
interferes with an individual's work or academic performance or creates
an intimidating, hostile, or offensive work or academic environment or
(2) accepting or rejecting such conduct affects or may be perceived to
affect employment decisions or academic evaluations concerning the
individual. Sexual harassment is unethical.
between medical supervisors and their medical trainees raise concerns
because of inherent inequalities in the status and power that medical
supervisors wield in relation to medical trainees and may adversely
affect patient care. Sexual relationships between a medical trainee and
a supervisor even when consensual are not acceptable regardless of the
degree of supervision in any given situation. The supervisory role
should be eliminated if the parties involved wish to pursue their
relationship. (II, IV, VII) Issued March 1992 based on the report
"Sexual Harassment and Exploitation Between Medical Supervisors and
Trainees," adopted June 1989; Updated June 1994.
Students Performing Procedures on Fellow Students.
(1) In the context
of learning basic clinical skills, medical students must be asked
specifically to consent to procedures being performed by fellow
students. The stringency of standards for ensuring the explicit and
non-coerced informed consent increases as the invasiveness and intimacy
of the procedure increase..44
should explain to students how the procedures will be performed, making
certain that students are not placed in situations that violate their
privacy or sense of propriety. The confidentiality, consequences, and
appropriate management of a diagnostic finding should also be discussed.
(3) Students should
be given the choice of whether to participate prior to entering the
classroom and there should be no requirement that the students provide a
reason for their unwillingness to participate.
(4) Students should
not be penalized for refusal to participate. Thus instructors must
refrain from evaluating students' overall performance in terms of their
willingness to volunteer as "patients." (IV, V) Issued June 2000 based
on the report "Medical Students Performing Procedures on Fellow
Students," adopted June 1999.
E-4.00 Opinions on
Charging a separate
and distinct fee for the incidental, administrative, non-medical service
the physician performs in securing the admission of a patient to a
hospital is unethical. Physicians should derive their income from
medical services rendered, in keeping with the traditions of the
American Medical Association. (IV) Issued prior to April 1977; Updated
It is improper to
condition medical staff membership or privileges on compulsory
assessments for any purpose. However, self-imposed assessments by vote
of the medical staff are acceptable. (IV) Issued prior to April 1977;
Updated June 1994.
E-4.03 Billing for
Housestaff and Student Services.
When a physician
assumes responsibility for the services rendered to a patient by a
resident or student, the physician may ethically bill the patient for
services which were performed under the physician's direct personal
observation, direction, and supervision. (II) Issued prior to April
1977; Updated June 1994.
Incentives and Levels of Care.
obligation of the hospital medical staff is to safeguard the quality of
care provided within the institution. The medical staff has the
responsibility to perform essential functions on behalf of the hospital
in accordance with licensing laws and accreditation requirements.
Treatment or hospitalization that is willfully excessive or inadequate
constitutes unethical practice. The organized medical staff has an
obligation to avoid wasteful practices and unnecessary treatment that
may cause the hospital needless expense. In a situation where the
economic interests of the hospital are in conflict with patient welfare,
patient welfare takes priority. (I, II, IV, V, VI) Issued June 1986.
medical staff performs essential hospital functions even though it may
often consist primarily of independent practicing physicians who are not
hospital employees. As a practical matter, however, the organized
medical staff may enjoy a dual status. In addition to functioning as a
division of the hospital, members of the organized medical staff may
choose to act as a group for the purpose of communicating and dealing
with the governing board and others with respect to matters that concern
the.45 interest of the organized medical staff and its members. This is
ethical so long as there is no adverse interference with patient care or
violation of applicable laws. (IV, VI) Issued July 1983; Updated June
Physician-Hospital Contractual Relations.
There are various
financial or contractual arrangements that physicians and hospitals may
enter into and find mutually satisfactory. A physician may, for example,
be a hospital employee, a hospital-associated medical specialist, or an
independent practitioner with staff privileges. The form of the
contractual or financial arrangement between physicians and hospitals
depends on the facts and circumstances of each situation. A physician
may be employed by a hospital for a fixed annual amount, for a certain
amount per hour, or pursuant to other similar arrangements that are
related to the professional services, skill, education, expertise, or
time involved. (VI) Issued March 1981; Updated June 1994.
The mutual objective
of both the governing board and the medical staff is to improve the
quality and efficiency of patient care in the hospital. Decisions
regarding hospital privileges should be based upon the training,
experience, and demonstrated competence of candidates, taking into
consideration the availability of facilities and the overall medical
needs of the community, the hospital, and especially patients.
Privileges should not be based on numbers of patients admitted to the
facility or the economic or insurance status of the patient. Personal
friendships, antagonisms, jurisdictional disputes, or fear of
competition should not play a role in making these decisions. Physicians
who are involved in the granting, denying, or termination of hospital
privileges have an ethical responsibility to be guided primarily by
concern for the welfare and best interests of patients in discharging
this responsibility. (IV, VI, VII) Issued July 1983; Updated June 1994.
E-5.00 Opinions on
Confidentiality, Advertising, and Communications Media
and Managed Care Organizations.
A physician may
provide medical services to members of a prepaid medical care plan or to
members of a health maintenance organization which seeks members or
subscribers through advertising. Physicians practicing in prepaid plans
or managed care organizations are subject to the same ethical principles
as are other physicians. Advertising which would lead prospective
members or subscribers to believe that the services of a named physician
who has a reputation for outstanding skill would be routinely available
to all members or subscribers, if in fact this is not so, is deceptive.
However, the publication by name of the roster of physicians who provide
services to members, the type of practice in which each is engaged, and
biographical and other relevant information is not a deceptive practice.
(II, VI) Issued prior to April 1977; Updated June 1996.
Direct-to-Consumer Advertisements of Prescription Drugs
profession needs to take an active role in ensuring that proper
advertising guidelines are enforced and that the care patients receive
is not compromised as a result of direct-to-consumer advertising. Since
the Food and Drug Administration (FDA) has a critical role in
determining future directions of direct-to-consumer advertising of
prescription drugs, physicians should work to ensure that the FDA.46
remains committed to advertising standards that protect patients' health
and safety. Moreover, physicians should encourage and engage in studies
regarding the effect of direct-to-consumer advertising on patient health
and medical care. Such studies should examine whether direct-to-consumer
advertising improves the communication of health information; enhances
the patient-physician relationship; and contains accurate and reasonable
information on risks, precautions, adverse reactions, and costs.
Physicians must maintain professional standards of informed consent when
prescribing. When a patient comes to a physician with a request for a
drug he or she has seen advertised, the physician and the patient should
engage in a dialogue that would assess and enhance the patient's
understanding of the treatment. Although physicians should not be biased
against drugs that are advertised, physicians should resist commercially
induced pressure to prescribe drugs that may not be indicated.
Physicians should deny requests for inappropriate prescriptions and
educate patients as to why certain advertised drugs may not be suitable
treatment options, providing, when available, information on the cost
effectiveness of different options.
remain vigilant to assure that direct-to-consumer advertising does not
promote false expectations. Physicians should be concerned about
advertisements that do not enhance consumer education; do not convey a
clear, accurate, and responsible health education message; do not refer
patients to their physicians for more information; do not identify the
target population at risk; and fail to discourage consumer
self-diagnosis and self-treatment. Physicians may choose to report these
concerns directly to the pharmaceutical company that sponsored the
To assist the FDA in
enforcing existing law and tracking the effects of direct-to-consumer
advertising, physicians should, whenever reasonably possible, report to
them advertisements that: (1) do not provide a fair and balanced
discussion of the use of the drug product for the disease, disorder, or
condition; (2) do not clearly explain warnings, precautions, and
potential adverse reactions associated with the drug product; (3) do not
present summary information in language that can be understood by the
consumer; (4) do not comply with applicable FDA rules, regulations,
policies, and guidelines as provided by the FDA; or (5) do not provide
collateral materials to educate both physicians and consumers. (II, III)
Issued June 1999 based on the report "Direct-to-Consumer Advertisement
of Prescription Drugs," adopted December 1998 (Food and Drug Law
Journal. 2000; 55: 119-24).
There are no
restrictions on advertising by physicians except those that can be
specifically justified to protect the public from deceptive practices. A
physician may publicize him or herself as a physician through any
commercial publicity or other form of public communication (including
any newspaper, magazine, telephone directory, radio, television, direct
mail, or other advertising) provided that the communication shall not be
misleading because of the omission of necessary material information,
shall not contain any false or misleading statement, or shall not
otherwise operate to deceive. Because the public can sometimes be
deceived by the use of medical terms or illustrations that are difficult
to understand, physicians should design the form of communication to
communicate the information contained therein to the public in a readily
comprehensible manner. Aggressive, high-pressure advertising and
publicity should be avoided if they create unjustified medical
expectations or are accompanied by deceptive claims. The key issue,
however, is whether advertising or publicity, regardless of format or
content, is true and not materially misleading..47
may include: (1) the educational background of the physician; (2) the
basis on which fees are determined (including charges for specific
services); (3) available credit or other methods of payment; and (4) any
other nondeceptive information.
Nothing in this
opinion is intended to discourage or to limit advertising and
representations which are not false or deceptive within the meaning of
Section 5 of the Federal Trade Commission Act. At the same time,
however, physicians are advised that certain types of communications
have a significant potential for deception and should therefore receive
special attention. For example, testimonials of patients as to the
physician's skill or the quality of the physician's professional
services tend to be deceptive when they do not reflect the results that
patients with conditions comparable to the testimoniant's condition
generally receive. Objective claims regarding experience, competence,
and the quality of physicians and the services they provide may be made
only if they are factually supportable. Similarly, generalized
statements of satisfaction with a physician's services may be made if
they are representative of the experiences of that physician's patients.
have an ethical obligation to share medical advances, it is unlikely
that a physician will have a truly exclusive or unique skill or remedy.
Claims that imply such a skill or remedy therefore can be deceptive.
Statements that a physician has an exclusive or unique skill or remedy
in a particular geographic area, if true, however, are permissible.
Similarly, a statement that a physician has cured or successfully
treated a large number of cases involving a particular serious ailment
is deceptive if it implies a certainty of result and creates unjustified
and misleading expectations in prospective patients.
federal regulatory standards which apply to commercial advertising, a
physician who is considering the placement of an advertisement or
publicity release, whether in print, radio, or television, should
determine in advance that the communication or message is explicitly and
implicitly truthful and not misleading. These standards require the
advertiser to have a reasonable basis for claims before they are used in
advertising. The reasonable basis must be established by those facts
known to the advertiser, and those which a reasonable, prudent
advertiser should have discovered. Inclusion of the physician's name in
advertising may help to assure that these guidelines are being met. (II)
Issued prior to April 1977; Updated June 1996.
Advisory or Referral Services by Telecommunication.
advisory services, by way of phone, fax, or computer, distinct from an
existing patient-physician relationship can be a helpful source of
medical information for the public. Often, people are not sure where to
turn for information of a general medical nature or do not have easy
access to other sources of information. Individuals also may be
embarrassed about directly bringing up certain questions with their
physicians. Although telecommunication advisory services can provide
only limited medical services, they can be a useful complement to more
comprehensive services, if used properly.
telecommunication advisory service should employ certain safeguards to
prevent misuse. For example, the physician responding to the call should
not make a clinical diagnosis. Diagnosis by telecommunication is done
without the benefit of a physician examination or even a face-to-face
meeting with the caller. Critical medical data may be unavailable to the
physician. Physicians who respond to callers should therefore act within
the limitations of telecommunication services and ensure that callers
understand the limitations of the services. Under no circumstances
should medications be prescribed..48 Physicians who respond to the calls
should elicit all necessary information from the callers. When callers
are charged by the minute, they may try to hurry their calls to limit
their costs. As a result, important information may not be disclosed to
the physician. Physicians should also ensure that callers do not incur
large bills inadvertently or without understanding the billing system.
services can also offer important information to the public. Referral
services are often provided by medical societies, hospitals, and
for-profit entities. To ensure that the service bases its recommendation
on medically legitimate considerations rather than the likelihood of
being paid by the physician, when the service charges physicians a fee
to participate, physicians should not pay the service per referral.
Also, callers should be told how the list is created. For example,
callers should be informed whether the list includes physicians who pay
a flat fee to be listed, members of a particular hospital staff or
medical society, or physicians who meet some general quality-based
safeguards are described as applying primarily to telephone services,
they should be considered equally applicable to any other communication
media, such as radio or television, in which the physician and patient
do not meet face-to-face. (I, IV, VI) Issued June 1994; Updated June
Communications Media: Press Relations
Issued prior to
April 1977; Deleted in June 1996 and combined with Opinion 5.04.
Communications Media: Standards of Professional Responsibility.
ethically and legally required to protect the personal privacy and other
legal rights of patients. When information concerning a specific patient
is requested by the media, the physician must obtain the consent of the
patient or an authorized representative before releasing such
information. The physician may release only the authorized information
or that which is public knowledge. The patient-physician relationship
and its confidential nature must be maintained.
considerations in mind, the physician may assist the representatives of
the media in every way possible. When the patient or authorized
representative consents to the release of information, physicians should
cooperate with the press to ensure that medical news is available more
promptly and more accurately than would be possible without their
assistance. Inasmuch as a diagnosis may be made only by a physician and
may depend upon X-ray and laboratory studies, no statement regarding
diagnosis should be made except by or on behalf of the attending
physician. For the same reason, prognosis will be given only by the
attending physician or at the attending physician's direction.
Statements regarding the circumstances surrounding shootings, knifings,
and poisonings are properly police matters, and questions whether they
were accidental should be referred to the appropriate authorities.
Certain news that is part of the public record, such as deaths, may be
made available without the consent of the patient or authorized
representative. (IV) Issued prior to April 1977; Updated June 1994 and
Patients in Health Care Settings.
The use of any
medium to film, videotape, or otherwise record (hereafter film) patient
interactions with their health care providers requires the utmost
respect for the privacy and confidentiality of the patient. The.49
following guidelines are offered to assure that the rights of the
patient are protected. These guidelines specifically address filming
with the intent of broadcast for public viewing, and do not address
other uses such as in medical education, forensic or diagnostic filming,
or the use of security cameras.
(1) Educating the
public about the health care system should be encouraged, and filming of
patients may be one way to accomplish this. This educational objective
is not severely compromised by filming only patients who can consent;
when patients cannot consent, dramatic reenactments utilizing actors
should be considered instead of violating patient privacy.
(2) Filming patients
without consent is a violation of the patient's privacy. Consent is
therefore an ethical requirement for both initial filming and subsequent
broadcast for public viewing. Because filming cannot benefit a patient
medically, and moreover has the potential of causing harm to the
patient, it is appropriate to limit filming to instances where the party
being filmed can explicitly consent. Consent by a surrogate
decision-maker is not an ethically appropriate substitute for consent by
the patient because the role of surrogates is to make medically
necessary decisions in the best interest of the patient. A possible
exception exists when the person in question is permanently or
indefinitely incompetent (eg, permanent vegetative state or minor
child). In such circumstances, if a parent or legal guardian provides
consent, filming may occur.
(a) Patients should
have the right to have filming stopped upon request at any time and the
film crew removed from the area. Also, persons involved in the direct
medical care of the patient who feel that the filming may jeopardize
patient care should request that the film crew be removed from the
patient care area.
(b) The initial
granting of consent does not preclude the patient from withdrawing
consent at a later time. After filming has occurred, patients who have
been filmed should have the opportunity to rescind their consent up
until a reasonable time period before broadcast for public viewing. The
consent process should include a full disclosure of whether the tape
will be destroyed if consent is rescinded, and the degree to which the
patient is allowed to view and edit the final footage before broadcast
for public viewing.
(c) Due to the
potential conflict of interest, informed consent should be obtained by a
disinterested third party, and not a member of the film crew or
obtained in the course of filming medical encounters between patients
and physicians is confidential. Persons who are not members of the
health care team, but who may be present for filming purposes, must
demonstrate that they understand the confidential nature of the
information and are committed to respecting it. Where possible, it is
desirable for stationary cameras or health care professionals to perform
advocates for their patients, should not allow financial or promotional
benefit to the health care institution to influence their advice to
patients regarding participation in filming. Because physician
compensation for participation in filming may cause an undue influence
to recruit patients, physicians should not be compensated directly. To
protect the best interests of patients, physicians should participate in
institutional review of requests to film. (I, IV, VII, VIII) Issued
December 2001 based on the report "Filming Patients in Health Care
Settings," adopted June 2001.
disclosed to a physician during the course of the relationship between
physician and patient is confidential to the greatest possible degree.
The patient should feel free to make a full disclosure of information to
the physician in order that the physician may most effectively provide
needed services. The patient should be able to make this disclosure with
the knowledge that the physician will respect the confidential nature of
the communication. The physician should not reveal confidential
communications or information without the express consent of the
patient, unless required to do so by law..50
The obligation to
safeguard patient confidences is subject to certain exceptions which are
ethically and legally justified because of overriding social
considerations. Where a patient threatens to inflict serious bodily harm
to another person or to him or herself and there is a reasonable
probability that the patient may carry out the threat, the physician
should take reasonable precautions for the protection of the intended
victim, including notification of law enforcement authorities. Also,
communicable diseases and gun shot and knife wounds should be reported
as required by applicable statutes or ordinances. (IV) Issued December
1983; Updated June 1994.
Confidentiality of Medical Information Postmortem.
related confidences disclosed by a patient to a physician and
information contained within a deceased patient's medical record,
including information entered postmortem, should be kept confidential to
the greatest possible degree. However, the obligation to safeguard
patient confidences is subject to certain exceptions that are ethically
and legally justifiable because of overriding societal considerations
(Opinion 5.05, "Confidentiality"). At their strongest, confidentiality
protections after death would be equal to those in force during a
patient's life. Thus, if information about a patient may be ethically
disclosed during life, it likewise may be disclosed after the patient
medical information postmortem for research and educational purposes is
appropriate as long as confidentiality is maintained to the greatest
possible degree by removing any individual identifiers. Otherwise, in
determining whether to disclose identified information after the death
of a patient, physicians should consider the following factors:
(1) The imminence of
harm to identifiable individuals or the public health.
(2) The potential
benefit to at-risk individuals or the public health (eg, if a
communicable or inherited disease is preventable or treatable).
(3) Any statement or
directive made by the patient regarding postmortem disclosure.
(4) The impact
disclosure may have on the reputation of the deceased patient. and
(5) Personal gain
for the physician that may unduly influence professional obligations of
confidentiality. When a family member or other decision maker has given
consent to an autopsy, physicians may disclose the results of the
autopsy to the individual(s) that granted consent to the procedure. (IV)
Issued December 2000 based on the report "Confidentiality of Medical
Information Postmortem," adopted June 2000. Updated December 2001 (Arch
Pathol Lab Med. 2001; 125:1189-92).
Care for Minors.
Physicians who treat
minors have an ethical duty to promote the autonomy of minor patients by
involving them in the medical decision-making process to a degree
commensurate with their abilities. When minors request confidential
services, physicians should encourage them to involve their parents.
This includes making efforts to obtain the minor's reasons for not
involving their parents and correcting misconceptions that may be
motivating their objections.
Where the law does
not require otherwise, physicians should permit a competent minor to
consent to medical care and should not notify parents without the
patient's consent. Depending on the seriousness of the decision,
competence may be evaluated by physicians for most minors. When
necessary, experts in adolescent medicine or child psychological
development should be consulted. Use of the courts for competence
determinations should be made only as a last resort..51
When an immature
minor requests contraceptive services, pregnancy-related care (including
pregnancy testing, prenatal and postnatal care, and delivery services),
or treatment for sexually transmitted disease, drug and alcohol abuse,
or mental illness, physicians must recognize that requiring parental
involvement may be counterproductive to the health of the patient.
Physicians should encourage parental involvement in these situations.
However, if the minor continues to object, his or her wishes ordinarily
should be respected. If the physician is uncomfortable with providing
services without parental involvement, and alternative confidential
services are available, the minor may be referred to those services. In
cases when the physician believes that without parental involvement and
guidance, the minor will face a serious health threat, and there is
reason to believe that the parents will be helpful and understanding,
disclosing the problem to the parents is ethically justified. When the
physician does breach confidentiality to the parents, he or she must
discuss the reasons for the breach with the minor prior to the
disclosure. For minors who are mature enough to be unaccompanied by
their parents for their examination, confidentiality of information
disclosed during an exam, interview, or in counseling should be
maintained. Such information may be disclosed to parents when the
patient consents to disclosure. Confidentiality may be justifiably
breached in situations for which confidentiality for adults may be
breached, according to Opinion 5.05, "Confidentiality." In addition,
confidentiality for immature minors may be ethically breached when
necessary to enable the parent to make an informed decision about
treatment for the minor or when such a breach is necessary to avert
serious harm to the minor. (IV) Issued June 1994 based on the report
"Confidential Care for Minors," adopted June 1992; Updated June 1996.
Confidentiality of HIV Status on Autopsy Reports.
maintain the confidentiality of HIV status on autopsy reports to the
greatest extent possible. Physicians who perform autopsies or who have
access to autopsy information regarding a patient's HIV status should be
familiar with state law governing: (1) the reporting of HIV and AIDS to
public health authorities; (2) obligations to inform third parties who
may be at risk for HIV infection through contact with an HIV-infected
decedent; (3) other parties to whom reporting may be required (ie,
funeral directors, health care personnel involved in the care of the
patient); and (4) the extent of confidentiality of autopsy records.
HIV status which
appears on autopsy records performed under the authority of a hospital
are part of the decedent's medical record and should be held
confidential. The physician should comply with state laws regarding
disclosure to public health authorities and at-risk third parties and,
where such laws are absent, fulfill ethical obligations to notify
endangered third parties (eg, identified sexual or needle-sharing
partners). This includes reporting to organ or tissue procurement
agencies if any parts of the decedent's body were taken for use in
HIV status which
appears on autopsy records performed by a medical examiner in the case
of suspicious, accidental, or unexplained death should be kept
confidential where autopsy records are not accessible to the public. The
physician should comply with state laws regarding disclosure to public
health authorities and at-risk third parties, and, where such laws are
absent, fulfill ethical obligations to notify endangered third parties
(eg, sexual and needle-sharing partners). This includes reporting to
organ or tissue procurement agencies if any parts of the decedent's body
were taken for use in transplantation..52 In cases where autopsies are
done under the auspices of the medical examiner's office and state law
mandates that the autopsy information be accessible to the public, then
physicians should comply with state law. However, in these instances,
HIV status should only be recorded when the HIV status of the decedent
would be relevant to determining the patient's cause of death. In
addition, although a patient's HIV status may be learned from public
records in some jurisdictions, it is still unethical for a physician to
make a public disclosure of an individual patient's HIV status
independent of the legal requirements governing the filing or processing
of autopsy records. The physician should comply with state laws
regarding disclosure to public health authorities and at-risk third
parties, and, where such laws are absent, fulfill ethical obligations to
notify endangered third parties (eg, sexual and needle-sharing
partners). This includes reporting to organ or tissue procurement
agencies if any parts of the decedent's body were taken for use in
transplantation. (IV) Issued June 1994 based on the report
"Confidentiality of HIV Status on Autopsy Reports," adopted June 1992
(Arch Patho. Lab Med.1992; 116: 1120-23).
E-5.059 Privacy in
the Context of Health Care
In the context of
health care, emphasis has been given to confidentiality, which is
defined as information told in confidence or imparted in secret.
However, physicians also should be mindful of patient privacy, which
encompasses information that is concealed from others outside of the
patient-physician relationship. Physicians must seek to protect patient
privacy in all of its forms, including (1) physical, which focuses on
individuals and their personal spaces, (2) informational, which involves
specific personal data, (3) decisional, which focuses on personal
choices, and (4) associational, which refers to family or other intimate
relations. Such respect for patient privacy is a fundamental expression
of patient autonomy and is a prerequisite to building the trust that is
at the core of the patient-physician relationship.
Privacy is not
absolute, and must be balanced with the need for the efficient provision
of medical care and the availability of resources. Physicians should be
aware of and respect the special concerns of their patients regarding
privacy. Patients should be informed of any significant infringement on
their privacy of which they may otherwise be unaware. (I, IV) Issued
June 2002 based on the report "Privacy in the Context of Health Care,"
adopted December 2001.
Confidentiality: Attorney-Physician Relation.
history, diagnosis, treatment, and prognosis may be discussed with the
patient's lawyer with the consent of the patient or the patient's lawful
representative. A physician may testify in court or before a worker's
compensation board or the like in any personal injury or related case.
(IV) Issued prior to April 1977.
The utmost effort
and care must be taken to protect the confidentiality of all medical
records, including computerized medical records.
The guidelines below
are offered to assist physicians and computer service organizations in
maintaining the confidentiality of information in medical records when
that information is stored in computerized data bases:.53
medical information should be entered into the computer-based patient
record only by authorized personnel. Additions to the record should be
time and date stamped, and the person making the additions should be
identified in the record.
(2) The patient and
physician should be advised about the existence of computerized data
bases in which medical information concerning the patient is stored.
Such information should be communicated to the physician and patient
prior to the physician's release of the medical information to the
entity or entities maintaining the computer data bases. All individuals
and organizations with some form of access to the computerized data
bases, and the level of access permitted, should be specifically
identified in advance. Full disclosure of this information to the
patient is necessary in obtaining informed consent to treatment. Patient
data should be assigned a security level appropriate for the data's
degree of sensitivity, which should be used to control who has access to
(3) The physician
and patient should be notified of the distribution of all reports
reflecting identifiable patient data prior to distribution of the
reports by the computer facility. There should be approval by the
patient and notification of the physician prior to the release of
patient-identifiable clinical and administrative data to individuals or
organizations external to the medical care environment. Such information
should not be released without the express permission of the patient.
dissemination of confidential medical data should be limited to only
those individuals or agencies with a bona fide use for the data. Only
the data necessary for the bona fide use should be released. Patient
identifiers should be omitted when appropriate. Release of confidential
medical information from the data base should be confined to the
specific purpose for which the information is requested and limited to
the specific time frame requested. All such organizations or individuals
should be advised that authorized release of data to them does not
authorize their further release of the data to additional individuals or
organizations, or subsequent use of the data for other purposes.
(5) Procedures for
adding to or changing data on the computerized data base should indicate
individuals authorized to make changes, time periods in which changes
take place, and those individuals who will be informed about changes in
the data from the medical records.
(6) Procedures for
purging the computerized data base of archaic or inaccurate data should
be established and the patient and physician should be notified before
and after the data has been purged. There should be no mixing of a
physician's computerized patient records with those of other computer
service bureau clients. In addition, procedures should be developed to
protect against inadvertent mixing of individual reports or segments
(7) The computerized
medical data base should be on-line to the computer terminal only when
authorized computer programs requiring the medical data are being used.
Individuals and organizations external to the clinical facility should
not be provided on-line access to a computerized data base containing
identifiable data from medical records concerning patients. Access to
the computerized data base should be controlled through security
measures such as passwords, encryption (encoding) of information, and
scannable badges or other user identification.
(8) Back-up systems
and other mechanisms should be in place to prevent data loss and
downtime as a result of hardware or software failure.
(9) Security: (a)
Stringent security procedures should be in place to prevent unauthorized
access to computer-based patient records. Personnel audit procedures
should be developed to establish a record in the.54 event of
unauthorized disclosure of medical data. Terminated or former employees
in the data processing environment should have no access to data from
the medical records concerning patients.
(b) Upon termination
of computer services for a physician, those computer files maintained
for the physician should be physically turned over to the physician.
They may be destroyed (erased) only if it is established that the
physician has another copy (in some form). In the event of file erasure,
the computer service bureau should verify in writing to the physician
that the erasure has taken place. (IV) Issued prior to April 1977;
Updated June 1994 and June 1998.
Confidentiality: Disclosure of Records to Data Collection Companies.
Data collection from
computerized or other patient records for marketing purposes raises
serious ethical concerns. In some cases, firms have sought to amass
information on physicians' prescribing practices on behalf of
pharmaceutical houses for marketing purposes. Often, physicians are
offered incentives such as computer hardware and software packages in
return for agreeing to such an arrangement. They may be told that
data-collecting software does not capture patients' names.
may violate principles of informed consent and patient confidentiality.
Patients divulge information to their physicians only for purposes of
diagnosis and treatment. If other uses are to be made of the
information, patients must give their permission after being fully
informed about the purpose of such disclosures. If permission is not
obtained, physicians violate patient confidentiality by sharing specific
and intimate information from patients' records with commercial
interests. Arrangements of this kind may also violate Opinion 8.061,
Gifts to Physicians From Industry. Finally, these arrangements may harm
the integrity of the patient-physician relationship. The trust that is
fundamental to this relationship is based on the principle that the
physicians are the agents first and foremost of their patients. (I, II,
IV) Issued June 1994; Updated June 1998.
Confidentiality: Insurance Company Representative.
prognosis, and the like acquired during the physician-patient
relationship may be disclosed to an insurance company representative
only if the patient or a lawful representative has consented to the
disclosure. A physician's responsibilities to patients are not limited
to the actual practice of medicine. They also include the performance of
some services ancillary to the practice of medicine. These services
might include certification that the patient was under the physician's
care and comment on the diagnosis and therapy in the particular case.
See also Opinion 2.135. (IV) Issued prior to April 1977.
Confidentiality: Industry-Employed Physicians and Independent Medical
Where a physician's
services are limited to performing an isolated assessment of an
individual's health or disability for an employer, business, or insurer,
the information obtained by the physician as a result of such
examinations is confidential and should not be communicated to a third
party without the individual's prior written consent, unless required by
law. If the individual authorized the release of medical information to
an employer or a potential employer, the physician should release only
that information which is reasonably relevant to the employer's decision
regarding that individual's ability to perform the work required by the
When a physician
renders treatment to an employee with a work-related illness or injury,
the release of medical information to the employer as to the treatment
provided may be subject to the provisions of worker's compensation laws.
The physician must comply with the requirements of such laws, if
applicable. However, the physician may not otherwise discuss the
employee's health condition with the employer without the employee's
consent or, in the event of the employee's incapacity, the appropriate
information about employees' health is released, all employee identities
should be deleted. (IV) Issued July 1983; Updated June 1994; updated
June 1996; updated December 1999 based on the report "Patient-Physician
Relationship in the Context of Work-Related and Independent Medical
Examinations," adopted June 1999.
E-6.00 Opinions on
Fees and Charges
If a physician's fee
for medical service is contingent on the successful outcome of a claim,
such as a malpractice or worker's compensation claim, there is the
ever-present danger that the physician may become less of a healer and
more of an advocate or partisan in the proceedings. Accordingly, a
physician's fee for medical services should be based on the value of the
service provided by the physician to the patient and not on the
uncertain outcome of a contingency that does not in any way relate to
the value of the medical service.
A physician's fee
should not be made contingent on the successful outcome of medical
treatment. Such arrangements are unethical because they imply that
successful outcomes from treatment are guaranteed, thus creating
unrealistic expectations of medicine and false promises to consumers.
(VI) Issued prior to April 1977; Updated June 1994.
Payment by or to a
physician solely for the referral of a patient is fee splitting and is
unethical. A physician may not accept payment of any kind, in any form,
from any source, such as a pharmaceutical company or pharmacist, an
optical company, or the manufacturer of medical appliances and devices,
for prescribing or referring a patient to said source.
In each case, the
payment violates the requirement to deal honestly with patients and
colleagues. The patient relies upon the advice of the physician on
matters of referral. All referrals and prescriptions must be based on
the skill and quality of the physician to whom the patient has been
referred or the quality and efficacy of the drug or product prescribed.
(II) Issued prior to April 1977; Updated June 1994.
Splitting: Referrals to Health Care Facilities.
laboratories, hospitals, or other health care facilities that compensate
physicians for referral of patients are engaged in fee splitting which
is unethical. Health care facilities should not compensate a physician
who refers patients there for the physician's cognitive services in
prescribing, monitoring, or revising the patient's course of treatment.
Payment for.56 these cognitive services is acceptable when it comes from
patients, who are the beneficiaries of the physician's services, or from
the patient's designated third-party payer. Offering or accepting
payment for referring patients to research studies (finder's fees) is
also unethical. (II) Issued prior to April 1977; Updated June 1994 and
updated June 1996 based on the report "Finder's Fees: Payment for the
Referral of Patients to Clinical Research Studies," adopted December
Splitting: Drug or Device Prescription Rebates.
The previous Opinion
6.04, "Fee Splitting: Drug or Device Presciption Rebates," issued March
1980, was deleted in June 2002 and combined with the current Opinion
8.06, "Prescribing and Dispensing Drugs and Devices."
6.05 Fees for
A physician should
not charge or collect an illegal or excessive fee. For example, an
illegal fee occurs when a physician accepts an assignment as full
payment for services rendered to a Medicare patient and then bills the
patient for an additional amount. A fee is excessive when after a review
of the facts a person knowledgeable as to current charges made by
physicians would be left with a definite and firm conviction that the
fee is in excess of a reasonable fee. Factors to be considered as guides
in determining the reasonableness of a fee include the following:
(1) the difficulty
and/or uniqueness of the services performed and the time, skill, and
(2) the fee
customarily charged in the locality for similar physician services;
(3) the amount of
the charges involved;
(4) the quality of
(5) the experience,
reputation, and ability of the physician in performing the kind of
services involved. (II) Issued prior to April 1977; Updated June 1994.
E-6.06 Fees: Group
Issued in March
1981; Deleted in June 1994.
Form Completion Charges.
physician should complete without charge the appropriate "simplified"
insurance claim form as a part of service to the patient to enable the
patient to receive his or her benefits. A charge for more complex or
multiple forms may be made in comformity with local custom. (II) Issued
prior to April 1977; Updated June 1994.
Charges and Finance Charges.
Although harsh or
commercial collection practices are discouraged in the practice of
medicine, a physician who has experienced problems with delinquent
accounts may properly choose to request that payment be made at the time
of treatment or add interest or other reasonable charges to delinquent
accounts. The.57 patient must be notified in advance of the interest or
other reasonable finance or service charges by such means as the posting
of a notice in the physician's waiting room, the distribution of
leaflets describing the office billing practices, and appropriate
notations on the billing statement. The physician must comply with state
and federal laws and regulations applicable to the imposition of such
charges. Physicians are encouraged to review their accounting/collection
policies to ensure that no patient's account is sent to collection
without the physician's knowledge. Physicians who choose to add an
interest or finance charge to accounts not paid within a reasonable time
are encouraged to use compassion and discretion in hardship cases. (II)
Issued prior to April 1977; Updated June 1994.
When it is not
possible for the laboratory bill to be sent directly to the patient, the
referring physician's bill to the patient should indicate the actual
charges for laboratory services, including the name of the laboratory,
as well as any separate charges for the physician's own professional
services. (II) Issued prior to April 1977.
Provided by Multiple Physicians.
engaged in the care of the patient is entitled to compensation
commensurate with the value of the service he or she has personally
No physician should
bill or be paid for a service which is not performed; mere referral does
not constitute a professional service for which a professional charge
should be made or for which a fee may be ethically paid or received.
When services are
provided by more than one physician, each physician should submit his or
her own bill to the patient and be compensated separately, if possible.
A physician should not charge a markup, commission, or profit on the
services rendered by others.
It is ethically
permissible in certain circumstances, however, for a surgeon to engage
other physicians to assist in the performance of a surgical procedure
and to pay a reasonable amount for such assistance, provided the nature
of the financial arrangement is made known to the patient. This
principle applies whether or not the assisting physician is the
referring physician. (II) Issued prior to April 1977; Updated June 1994.
and among physicians and other health care practitioners on the basis of
competitive factors such as quality of services, skill, experience,
miscellaneous conveniences offered to patients, credit terms, fees
charged, etc, is not only ethical but is encouraged. Ethical medical
practice thrives best under free market conditions when prospective
patients have adequate information and opportunity to choose freely
between and among competing physicians and alternate systems of medical
care. (VII) Issued July 1983.
or Waiver of Insurance Co-payments.
Under the terms of
many health insurance policies or programs, patients are made more
conscious of the cost of their medical care through co-payments. By
imposing co-payments for office visits and other.58 medical services,
insurers hope to discourage unnecessary health care. In some cases,
financial hardship may deter patients from seeking necessary care if
they would be responsible for a co-payment for the care. Physicians
commonly forgive or waive co-payments to facilitate patient access to
needed medical care. When a co-payment is a barrier to needed care
because of financial hardship, physicians should forgive or waive the
A number of clinics
have advertised their willingness to provide detailed medical
evaluations and accept the insurer's payment but waive the co-payment
for all patients. Cases have been reported in which some of these
clinics have conducted excessive and unnecessary medical testing while
certifying to insurers that the testing is medically necessary. Such
fraudulent activity exacerbates the high cost of health care, violates
Opinion 2.19, and is unethical.
Physicians should be
aware that forgiveness or waiver of co-payments may violate the policies
of some insurers, both public and private; other insurers may permit
forgiveness or waiver if they are aware of the reasons for the
forgiveness or waiver. Routine forgiveness or waiver of co-payments may
constitute fraud under state and federal law. Physicians should ensure
that their policies on co-payments are consistent with applicable law
and with the requirements of their agreements with insurers. (II) Issued
courtesy refers to the provision of medical care to physician colleagues
or their families free of charge or at a reduced rate. While
professional courtesy is a long-standing tradition in the medical
profession, it is not an ethical requirement. Physicians should use
their own judgment in deciding whether to waive or reduce their fees
when treating fellow physicians or their families. Physicians should be
aware that accepting insurance payments while waiving patient
co-payments may violate Opinion 6.12. (II, IV) Issued June 1994.
E-7.00 Opinions on
E-7.01 Records of
Physicians: Availability of Information to Other Physicians.
The interest of the
patient is paramount in the practice of medicine, and everything that
can reasonably and lawfully be done to serve that interest must be done
by all physicians who have served or are serving the patient. A
physician who formerly treated a patient should not refuse for any
reason to make records of that patient promptly available on request to
another physician presently treating the patient. Proper authorization
for the use of records must be granted by the patient. Medical reports
should not be withheld because of an unpaid bill for medical services.
(IV) Issued prior to April 1977.
E-7.02 Records of
Physicians: Information and Patients.
Notes made in
treating a patient are primarily for the physician's own use and
constitute his or her personal property. However, on request of the
patient, a physician should provide a copy or a summary of the record to
the patient or to another physician, an attorney, or other person
designated by the patient. Most states have enacted statutes that
authorize patient access to medical records. These statutes vary in
scope and mechanism for permitting patients to review or copy medical
records. Access to mental health records, particularly, may be limited
by statute or regulation. A physician should become familiar with the
applicable laws, rules, or regulations on patient access to medical
The record is a
confidential document involving the patient-physician relationship and
should not be communicated to a third party without the patient's prior
written consent, unless required by law or to protect the welfare of the
individual or the community. Medical reports should not be withheld
because of an unpaid bill for medical services. Physicians may charge a
reasonable fee for copying medical records. (IV) Issued prior to April
1977; Updated June 1994.
E-7.025 Records of
Physicians: Access by Non-Treating Medical Staff
Physicians who use
or receive information from medical records share in the responsibility
for preserving patient confidentiality and should play an integral role
in the designing of confidentiality safeguards in health care
institutions. Physicians have a responsibility to be aware of the
appropriate guidelines in their health care institution, as well as the
applicable federal and state laws.
consultations that involve the disclosure of detailed medical
information are appropriate in the absence of consent only if the
patient cannot be identified from the information.
Only physicians or
other health care professionals who are involved in managing the
patient, including providing consultative, therapeutic, or diagnostic
services, may access the patient's confidential medical information. All
others must obtain explicit consent to access the information.
Monitoring user access to electronic or written medical information is
an appropriate and desirable means for detecting breaches of
confidentiality. Physicians should encourage the development and use of
such monitoring systems.
This Opinion focuses
on the issue of access to medical records by medical staff not involved
in the treatment or diagnosis of patients. It does not address the need
to access medical records for clinical research, epidemiological
research, quality assurance, or administrative purposes. (IV) Issued
December 1999 based on the report "Records of Physicians: Access by
Non-Treating Medical Staff," adopted June 1999.
E-7.03 Records of
Physicians upon Retirement or Departure from a Group.
A patient's records
may be necessary to the patient in the future not only for medical care
but also for employment, insurance, litigation, or other reasons. When a
physician retires or dies, patients should be notified and urged to find
a new physician and should be informed that upon authorization, records
will be sent to the new physician. Records which may be of value to a
patient and which are not forwarded to a new physician should be
retained, either by the treating physician, another physician, or such
other person lawfully permitted to act as a custodian of the records.
The patients of a
physician who leaves a group practice should be notified that the
physician is leaving the group. Patients of the physician should also be
informed of the physician's new address and offered the opportunity to
have their medical records forwarded to the departing physician at his
or her new practice location. It is unethical to withhold such
information upon request of a patient. If the responsibility for
notifying patients falls to the departing physician rather than to the
group, the group should not interfere with the discharge of these duties
by withholding patient lists or other necessary information. (IV) Issued
prior to April 1977; Updated June 1994, June 1996 and February 2002..60
E-7.04 Sale of a
A physician or the
estate of a deceased physician may sell the elements that comprise his
or her practice, such as furniture, fixtures, equipment, office
leasehold, and goodwill. In the sale of a medical practice, the
purchaser is buying not only furniture and fixtures, but also goodwill,
ie, the opportunity to take over the patients of the seller. A patient's
records may be necessary to the patient in the future not only for
medical care but also for employment, insurance, litigation,
matriculation, or other reasons. Therefore, the transfer of records of
patients is subject to the following:
(1) The physician
(or the estate) must ensure that all medical records are transferred to
another physician or entity who is held to the same standards of
confidentiality and is lawfully permitted to act as custodian of the
(2) All active
patients should be notified that the physician (or the estate) is
transferring the practice to another physician or entity who will retain
custody of their records and that at their written request, within a
reasonable time as specified in the notice, the records (or copies) will
be sent to another physician or entity of their choice.
(3) A reasonable
charge may be made for the cost of locating, duplicating, and mailing
records. (IV) Issued July 1983; Updated June 2000.
E-7.05 Retention of
Physicians have an
obligation to retain patient records which may reasonably be of value to
a patient. The following guidelines are offered to assist physicians in
meeting their ethical and legal obligations:
considerations are the primary basis for deciding how long to retain
medical records. For example, operative notes and chemotherapy records
should always be part of the patient's chart. In deciding whether to
keep certain parts of the record, an appropriate criterion is whether a
physician would want the information if he or she were seeing the
patient for the first time.
(2) If a particular
record no longer needs to be kept for medical reasons, the physician
should check state laws to see if there is a requirement that records be
kept for a minimum length of time. Most states will not have such a
provision. If they do, it will be part of the statutory code or state
(3) In all cases,
medical records should be kept for at least as long as the length of
time of the statute of limitations for medical malpractice claims. The
statute of limitations may be three or more years, depending on the
state law. State medical associations and insurance carriers are the
best resources for this information.
(4) Whatever the
statute of limitations, a physician should measure time from the last
professional contact with the patient.
(5) If a patient is
a minor, the statute of limitations for medical malpractice claims may
not apply until the patient reaches the age of majority.
records always must be kept.
(7) The records of
any patient covered by Medicare or Medicaid must be kept at least five
(8) In order to
preserve confidentiality when discarding old records, all documents
should be destroyed..61
discarding old records, patients should be given an opportunity to claim
the records or have them sent to another physician, if it is feasible to
give them the opportunity. (IV, V) Issued June 1994.
E-8.00 Opinions on
A physician may
charge a patient for a missed appointment or for one not cancelled 24
hours in advance if the patient is fully advised that the physician will
make such a charge. (VI) Issued prior to April 1977; Updated June 1994.
Guidelines for Physicians in Management Positions and Other Non-Clinical
administrative and other non-clinical roles must put the needs of
patients first. At least since the time of Hippocrates, physicians have
cultivated the trust of their patients by placing patient welfare before
all other concerns. The ethical obligations of physicians are not
suspended when a physician assumes a position that does not directly
involve patient care. (I, VII) Issued June 1994 based on the report
"Ethical Guidelines for Medical Consultants," adopted December 1992;
Updated June 1998.
Obligations of Medical Directors
Assuming a title or
position that removes the physician from direct patient-physician
relationships does not override professional ethical obligations. The
term "medical directors," as used here, refers to physicians who are
employed by third-party payers in the health care delivery system (ie,
insurance companies, managed care organizations, self-insured employers)
or by entities that perform medical appropriateness determinations on
behalf of payers. These types of medical directors have specific
functions, such as making coverage determinations, which go beyond mere
administrative responsibility. The following stem from this
employ professional knowledge and values gained through medical training
and practice, and in so doing affect individual or group patient care,
they are functioning within the professional sphere of physicians and
must uphold ethical obligations, including those articulated by the
AMA's Code of Medical Ethics.
acting within the professional sphere, such as when making decisions
regarding medical appropriateness, have an overriding ethical obligation
to promote professional medical standards.
professional medical standards includes:
(1) Placing the
interests of patients above other considerations, such as personal
interests (eg, financial incentives) or employer business interests (eg,
profit). This entails applying the plan parameters to each patient
equally and engaging in neither discrimination nor favoritism.
(2) Using fair and
just criteria when making care-related determinations. This entails
contributing professional expertise to help craft plan guidelines that
ensure fair and equal consideration of all plan enrollees. In addition,
medical directors should review plan policies and guidelines to ensure
that decision-making mechanisms are objective, flexible, and consistent,
and apply only ethically appropriate criteria, such as those identified
by the Council in Opinion 2.03, "Allocation of Limited Medical
(3) Working towards
achieving access to adequate medical services. This entails encouraging
employers to provide services that would be considered part of an
adequate level of health care, as articulated in Opinion 2.095, "The
Provision of Adequate Health Care." (I, III, VII) Issued December 1999
based on the report "Ethical Obligations of Medical Directors," adopted
E-8.03 Conflicts of
circumstances may physicians place their own financial interests above
the welfare of their patients. The primary objective of the medical
profession is to render service to humanity; reward or financial gain is
a subordinate consideration. For a physician to unnecessarily
hospitalize a patient, prescribe a drug, or conduct diagnostic tests for
the physician's financial benefit is unethical. If a conflict develops
between the physician's financial interest and the physician's
responsibilities to the patient, the conflict must be resolved to the
patient's benefit. (II) Issued July 1986; Updated June 1994.
E-8.031 Conflicts of
Interest: Biomedical Research.
Avoidance of real or
perceived conflicts of interest in clinical research is imperative if
the medical community is to ensure objectivity and maintain individual
and institutional integrity. All medical centers should develop specific
guidelines for their clinical staff on conflicts of interest. These
guidelines should include the following rules: (1) once a clinical
investigator becomes involved in a research project for a company or
knows that he or she might become involved, she or he, as an individual,
cannot ethically buy or sell the company's stock until the involvement
ends and the results of the research are published or otherwise
disseminated to the public; (2) any remuneration received by the
researcher from the company whose product is being studied must be
commensurate with the efforts of the researcher on behalf of the
company; (3) clinical investigators should disclose any material ties to
companies whose products they are investigating including: financial
ties, participation in educational activities supported by the
companies, participation in other research projects funded by the
companies, consulting arrangements, and any other ties. The disclosures
should be made in writing to the medical center where the research is
conducted, organizations that are funding the research, and journals
that publish the results of the research. An explanatory statement that
discloses conflicts of interest should accompany all published research.
Other types of publications, such as a letters to the editor, should
also include an explanatory statement that discloses any potential
conflict of interest.
In addition, medical
centers should form review committees to examine disclosures by clinical
staff about financial associations with commercial corporations. (II,
IV) Issued March 1992 based on the report "Conflicts of Interest in
Biomedical Research," adopted December 1989 (JAMA. 1990; 263:
2790-2793); Updated June 1999 based on the report "Conflicts of
Interest: Biomedical Research," adopted December 1998.
Conflicts of Interest in the Conduct of Clinical Trials.
As the biotechnology
and pharmaceutical industries continue to expand research activities and
funding of clinical trials, and as increasing numbers of physicians both
within and outside academic health centers become involved in
partnerships with industry to perform these activities, greater
safeguards against conflicts of interest are needed to ensure the
integrity of the research and to protect the welfare of human subjects.
Physicians should be mindful of the conflicting roles of investigator
and clinician and of the financial conflicts of interest that arise from
incentives to conduct trials and to recruit subjects. In particular,
physicians involved in clinical research should heed the following
should agree to participate as investigators in clinical trials only
when it relates to their scope of practice and area of medical
expertise. They should have adequate training in the conduct of research
and should participate only in protocols which they are satisfied are
should be familiar with the ethics of research, and should agree to
participate in trials only if they are satisfied that an Institutional
Review Board has reviewed the protocol, that the research does not
impose undue risks upon research subjects, and that the research
conforms to government regulations.
(3) When a physician
has treated or continues to treat a patient who is eligible to enroll as
a subject in a clinical trial that the physician is conducting, the
informed consent process must differentiate between the physician's
roles as clinician and investigator. This is best achieved when someone
other than the treating physician obtains the participant's informed
consent to participate in the trial. This individual should be protected
from the pressures of financial incentives, as described in the
(4) Any financial
compensation received from trial sponsors must be commensurate with the
efforts of the physician performing the research. Financial compensation
should be at fair market value and the rate of compensation per patient
should not vary according to the volume of subjects enrolled by the
physician, and should meet other existing legal requirements.
Furthermore, according to Opinion 6.03, "Fee Splitting: Referral to
Health Care Facilities," it is unethical for physicians to accept
payment solely for referring patients to research studies.
should ensure that protocols include provisions for the funding of
subjects' medical care in the event of complications associated with the
research. Also, a physician should not bill a third-party payor when he
or she has received funds from a sponsor to cover the additional
expenses related to conducting the trial.
(6) The nature and
source of funding and financial incentives offered to the investigators
must be disclosed to a potential participant as part of the informed
consent process. Disclosure to participants also should include
information on uncertainties that may exist regarding funding of
treatment for possible complications that may arise during the course of
the trial. Physicians should ensure that such disclosure is included in
any written informed consent.
(7) When entering
into a contract to perform research, physicians should ensure themselves
that the presentation or publication of results will not be unduly
delayed or otherwise obstructed by the sponsoring company. (II, V)
Issued June 2001 based on the report "Managing Conflicts of Interest in
the Conduct of Clinical Trials," adopted December 2000 (JAMA. 2002; 287:
E-8.032 Conflicts of
Interest: Health Facility Ownership by a Physician.
interests in commercial ventures can provide important benefits in
patient care. Physicians are free to enter lawful contractual
relationships, including the acquisition of ownership interests in
health facilities, products, or equipment. However, when physicians
refer patients to facilities in which they have an ownership interest, a
potential conflict of interest exists. In general, physicians should not
refer patients to a health care facility which is outside their office
practice and at which they do not directly provide care or services when
they have an investment interest in that facility. The requirement that
the physician directly provide the care or services should be
interpreted as commonly understood. The physician needs to have personal
involvement with the provision of care on site.
There may be
situations in which a needed facility would not be built if referring
physicians were prohibited from investing in the facility. Physicians
may invest in and refer to an outside facility, whether or not they
provide direct care or services at the facility, if there is a
demonstrated need in the community for the facility and alternative
financing is not available. Need might exist when there is no facility
of reasonable quality in the community or when use of existing
facilities is onerous for patients. Self-referral based on demonstrated
need cannot be justified simply if the facility would offer some
marginal improvement over the quality of services in the community. The
potential benefits of the facility should be.64 substantial. The use of
existing facilities may be considered onerous when patients face undue
delays in receiving services, delays that compromise the patient's care
or affect the curability or reversibility of the patient's condition.
The requirement that alternative financing not be available carries a
burden of proof. The builder would have to undertake efforts to secure
funding from banks, other financial institutions, and venture
capitalists before turning to self-referring physicians.
Where there is a
true demonstrated need in the community for the facility, the following
requirements should also be met: (l) physicians should disclose their
investment interest to their patients when making a referral, provide a
list of effective alternative facilities if they are available, inform
their patients that they have free choice to obtain the medical services
elsewhere, and assure their patients that they will not be treated
differently if they do not choose the physician-owned facility; (2)
individuals not in a position to refer patients to the facility should
be given a bona fide opportunity to invest in the facility on the same
terms that are offered to referring physicians; (3) the opportunity to
invest and the terms of investment should not be related to the past or
expected volume of referrals or other business generated by the
physician investor or owner; (4) there should be no requirement that a
physician investor make referrals to the entity or otherwise generate
business as a condition for remaining an investor; (5) the return on the
physician's investment should be tied to the physician's equity in the
facility rather than to the volume of referrals; (6) the entity should
not loan funds or guarantee a loan for physicians in a position to refer
to the entity; (7) investment contracts should not include
"noncompetition clauses" that prevent physicians from investing in other
facilities; (8) the physician's ownership interest should be disclosed
to third party payers upon request; (9) an internal utilization review
program should be established to ensure that investing physicians do not
exploit their patients in any way, as by inappropriate or unnecessary
utilization; (10) when a physician's commercial interest conflicts to
the detriment of the patient, the physician should make alternative
arrangements for the care of the patient. (II, III, IV) Issued prior to
April 1977; Updated 1989; Updated March 1992 based on the report
"Conflicts of Interest: Physician Ownership of Medical Facilities,"
adopted December 1991 (JAMA. 1992; 267: 2366-69); and Updated June 1994.
E-8.035 Conflicts of
Interest in Home Health Care.
Physicians who refer
patients to home care providers or any other outside facility should
avoid possible conflicts of interest by not accepting payment from those
providers or facilities for referrals or as compensation for their
cognitive services in prescribing, monitoring, or revising a patient's
course of treatment. Payment for these cognitive services is acceptable
when it comes from patients who are the beneficiaries of the physician's
services, or from the patients' designated third-party payers. In
accordance with Opinion 8.032, "Conflicts of Interest: Health Facility
Ownership by a Physician," physicians may refer patients to home care
facilities in which they have an ownership interest if they actively
participate on-site in the care provided to patients. Since the
appropriate frequency and duration of home visits is a medical decision
that should be made on a case-by-case basis, there is no specific
minimum number of home visits that may be identified as a conclusive
test of the physician's involvement in the patient's home care regimen.
Although different patients will have different needs, physicians who
directly provide care in the patient's home on at least every fourth
visit may presumptively be considered to have made home care a true
extension of practice. (II, III, IV) Issued June 1994 based on the
report "Conflicts of Interest: Update on Home Care," adopted December
1993; Updated 1998.
obtain consultation whenever they believe that it would be medically
indicated in the care of the patient or when requested by the patient or
the patient's representative. When a patient is referred to a
consultant, the referring physician should provide a history of the case
and such other information as the consultant may need, calling to the
attention of the consultant any specific questions about which guidance
is sought, and the consultant should advise the referring physician of
the results of the consultant's examination and recommendations. (V)
Issued prior to April 1977; Updated June 1992 and June 1996.
recommend that a patient obtain a second opinion whenever they believe
it would be helpful in the care of the patient. When recommending a
second opinion, physicians should explain the reasons for the
recommendation and inform their patients that patients are free to
choose a second-opinion physician on their own or with the assistance of
the first physician. Patients are also free to obtain second opinions on
their own initiative, with or without their physician's knowledge.
With the patient's
consent, the first physician should provide a history of the case and
such other information, as the second-opinion physician may need,
including the recommendations about management. The second-opinion
physician should maintain the confidentiality of the evaluation and
should report to the first physician if the consent of the patient has
After evaluating the
patient, a second-opinion physician should provide the patient with a
clear understanding of the opinion, whether or not it agrees with the
recommendations of the first physician. When a patient initiates a
second opinion, it is inappropriate for the primary physician to
terminate the patient-physician relationship solely because of the
patient's decision to obtain a second opinion. In some cases, patients
may ask the second-opinion physician to provide the needed medical care.
In general, second-opinion physicians are free to assume responsibility
for the care of the patient. It is not unethical to enter into a
patient-physician relationship with a patient who has been receiving
care from another physician. By accepting second-opinion patients for
treatment, physicians affirm the right of patients to have free choice
in the selection of their physicians.
There are situations
in which physicians may choose not to treat patients for whom they
provide second opinions. Physicians may decide not to treat the patient
in order to avoid any perceived conflict of interest or loss of
objectivity in rendering the requested second opinion. However, the
concern about conflicts of interest does not require physicians to
decline to treat second-opinion patients. This inherent conflict in the
practice of medicine is resolved by the responsible exercise of
Physicians may agree
not to treat second-opinion patients as part of their arrangements with
insurers or other third party payers. Physicians who enter into such
contractual agreements must honor their commitments.
decide independently of their colleagues whether to treat second-opinion
patients. Physicians may not establish an agreement or understanding
among themselves that they will refuse to treat each others' patients
when asked to provide a second opinion. Such agreements compromise the
ability of patients to receive care from the physicians of their choice
and are therefore not only unethical but also unlawful. (IV, V) Issued
June 1992; Updated June 1996..66
Implications of Surgical Co-Management
For the purpose of
this Opinion, the term "surgical co-management" refers to the practice
of allotting specific responsibilities of patient care to designated
caregivers. The following guidelines stem from this understanding:
should engage in co-management arrangements only to assure the highest
quality of care.
(2) When surgical
co-management arrangements are made between duly licensed physicians,
their responsibilities should be delineated according to the scope of
the physicians' expertise. Likewise, when physicians enter into surgical
co-management arrangements with allied health professionals, each
caregiver's responsibility should correspond to his or her
(3) Even though
different caregivers will be responsible for rendering specific portions
of the patient's care, a single physician should be ultimately
responsible for ensuring that the care is delivered in a coordinated and
appropriate manner. Other caregivers should support this obligation by
communicating with this physician.
(4) The treating
physicians are responsible for ensuring that the patient has consented
not only to take part in the surgical co-management arrangement but also
to the services that will be provided within the arrangement. In
addition to disclosing medical facts to the patient, the patient should
also be informed of other significant aspects of the surgical
co-management arrangement such as the credentials of the other
caregivers, the specific services each will provide, and the billing
should ensure that their surgical co-management arrangements do not
violate the ethical or legal restrictions on self-referral.
(6) Referrals to
another caregiver should be based only on that caregiver's skill and
ability to meet the patient's needs and not on expected further
referrals or other self-serving bases. Physicians who participate in
surgical co-management arrangements must avoid such financial agreements
as fee-splitting, which are both unethical and illegal.
(7) Physicians who
participate in surgical co-management arrangements should employ
appropriate safeguards to ensure that confidential information is
protected. (I, II, IV, V) Issued June 2000 based on the report "Ethical
Implications of Surgical Co-Management," adopted December 1999.
relationships that physicians assume when they join or affiliate with
group practices or agree to provide services to the patients of an
insurance plan are varied.
may include hourly wages for physicians working part time, annual
salaries for those working full time, and share of group income for
physicians who are partners in groups that are somewhat autonomous and
contract with plans to provide the required medical care. Arrangements
also usually include a range of fringe benefits, such as paid vacations,
insurance, and pension plans. Physicians may work directly for plans or
may be employed by the medical group or the hospital that has contracted
with the plan to provide services. In the operation of such plans,
physicians should not be.67 subjected to lay interference in
professional medical matters and their primary responsibility should be
to the patients they serve. (VI) Issued prior to April 1977; Updated
June 1994 and June 1996.
E-8.051 Conflict of
Interest Under Capitation.
The application of
capitation to physicians' practices can result in the provision of
cost-effective, quality medical care. It is important to note, however,
that the potential for conflict exists under such systems. Physicians
who contract with health care plans should attempt to minimize these
conflicts and to ensure that capitation is applied in a manner
consistent with patients' interests.
(1) Physicians have
an obligation to evaluate a health plan's capitation payments prior to
contracting with that plan to ensure that the quality of patient care is
not threatened by inadequate rates of capitation. Physicians should
advocate that capitation payments be calculated primarily on the basis
of relevant medical factors, available outcomes data, the costs
associated with involved providers, and consensus-oriented standards of
necessary care. Furthermore, the predictable costs resulting from
existing conditions of enrolled patients should be considered when
determining the rate of capitation. Different populations of patients
have different medical needs and the costs associated with those needs
should be reflected in the per member per month payment. Physicians
should seek agreements with plans that provide sufficient financial
resources for all care that is the physician's obligation to deliver and
should refuse to sign agreements that fail in this regard.
(2) Physicians must
not assume inordinate levels of financial risk and should therefore
consider a number of factors when deciding whether or not to sign a
provider agreement. The size of the plan and the time period over which
the rate is figured should be considered by physicians evaluating a plan
as well as in determinations of the per member per month payment. The
capitation rate for large plans can be calculated more accurately than
for smaller plans because of the mitigating influence of probability and
the behavior of large systems. Similarly, length of time will influence
the predictability of the cost of care. Therefore, physicians should
advocate for capitation rates calculated for large plans over an
extended period of time.
(3) Stop-loss plans
can prevent the potential of catastrophic expenses from influencing
physician behavior. Physicians should ensure that such arrangements are
finalized prior to signing an agreement to provide services in a health
(4) Physicians must
be prepared to discuss with patients any financial arrangements, which
could impact patient care. Physicians should avoid reimbursement systems
that, if disclosed to patients, could negatively affect the
patient-physician relationship. (II, III, VI) Issued December 1997 based
on the report "The Ethical Implications of Capitation," adopted June
1997; updated June 2002.
Discounts for Specialty Care.
entitled to all the benefits outlined in their insurance plan.
Therefore, it is unethical for a referring physician to restrict the
referral options of patients who have chosen a plan that provides for
access to an unlimited or broad selection of specialist physicians. It
is also unethical to base the referral of these patients on a discount
for the capitated patients in a primary care physician's practice. (II)
Issued December 1997 based on the report "Ethical Issues in Negotiating
Discounts for Specialty Care," adopted June 1996..68
on Disclosure in Health Care Plan Contracts.
requirements demanding full disclosure of treatment options regardless
of limitations imposed by plan coverage, some health care plans include
clauses in their employment contracts that directly inhibit the ability
of physicians to keep their patients fully informed. These types of
contract clauses erect inappropriate barriers to necessary
communications between physicians and patients, labeled "gag clauses" by
some observers. Restrictive clauses of this type impact the ability of
physicians to provide information to their patients and to act
effectively as a patient advocate. They also threaten to undermine
individual and public trust in the profession of medicine.
(1) Health care
plans have the right to protect proprietary information. However,
physicians should oppose any such protection that inhibits them from
disclosing relevant information to patients. For this reason, physicians
should advocate for the elimination of contract clauses that could
prevent them from raising or discussing matters relevant to patients'
(2) The right of
patients to be informed of all pertinent medical information must be
reaffirmed by the medical profession, and individual physicians must
continue to uphold their ethical obligation to disclose such
individually or through their representative, should review their
contracts carefully to ensure that they are able to fulfill their
ethical obligations to patients. (II, III, VI) Issued June 1998 based on
the report "Restrictions on Disclosure in Managed Care Contracts,"
adopted June 1996; updated June 2002.
Incentives and the Practice of Medicine.
In order to achieve
the necessary goals of patient care and to protect the role of
physicians as advocates for individual patients, the following statement
is offered for the guidance of physicians:
physicians have an obligation to consider the needs of broader patient
populations within the context of the patient-physician relationship,
their first duty must be to the individual patient. This obligation must
override considerations of the reimbursement mechanism or specific
financial incentives applied to a physician's clinical practice.
individually or through their representatives, should evaluate the
financial incentives associated with participation in a health plan
before contracting with that plan. The purpose of the evaluation is to
ensure that the quality of patient care is not compromised by
unrealistic expectations for utilization or by placing that physician's
payments for care at excessive risk. In the process of making judgments
about the ethical propriety of such reimbursement systems, physicians
should refer to the following general guidelines:
incentives may be judged in part on the basis of their size. Large
incentives may create conflicts of interest that can in turn compromise
clinical objectivity. While an obligation has been established to
resolve financial conflicts of interest to the benefit of patients, it
is important to recognize that sufficiently large incentives can create
an untenable position for physicians;
(b) The proximity of
large financial incentives to individual treatment decisions should be
limited in order to prevent physicians' personal financial concerns from
creating a conflict with their role as individual patient advocates.
When the proximity of incentives cannot be mitigated, as in the case of
fee-for-service.69 payments, physicians must behave in accordance with
prior Council recommendations limiting the potential for abuse. This
includes the Council's prohibitions on fee-splitting arrangements, the
provision of unnecessary services, unreasonable fees, and self-referral.
For incentives that can be distanced from clinical decisions, physicians
should consider the following factors in order to evaluate the
correlation between individual act and monetary reward or penalty:
(i) In general,
physicians should favor incentives that are applied across broad
physician groups. This dilutes the effect any one physician can have on
his or her financial situation through clinical recommendations, thus
allowing physicians to provide those services they feel are necessary in
each case. Simultaneously, however, physicians are encouraged by the
incentive to practice efficiently.
(ii) The size of the
patient pool considered in calculations of incentive payments will
affect the proximity of financial motivations to individual treatment
decisions. The laws of probability dictate that in large populations of
patients, the overall level of utilization remains relatively stable and
predictable. Physicians practicing in plans with large numbers of
patients in a risk pool therefore have greater freedom to provide the
care they feel is necessary based on the likelihood that the needs of
other plan patients will balance out decisions to provide extensive
should advocate for the time period over which incentives are determined
to be long enough to accommodate fluctuations in utilization resulting
from the random distribution of patients and illnesses. For example,
basing incentive payments on an annual analysis of resource utilization
is preferable to basing them on monthly review.
rewards or penalties that are triggered by specific points of
utilization may create enormous incentives as a physician's practice
approaches the established level. Therefore, physicians should advocate
that incentives be calculated on a continuum of utilization rather than
a bracketed system with tiers of widely varied bonuses or penalties.
should ascertain that a stop-loss plan is in place to prevent the costs
associated with unusual outliers from significantly impacting the reward
or penalty offered to a physician.
(3) Physicians also
should advocate for incentives that promote efficient practice, but are
not designed to realize cost savings beyond those attainable through
efficiency. As a counterbalance to the focus on utilization reduction,
physicians also should advocate for incentives based on quality of care
and patient satisfaction.
(4) Patients must be
informed of financial incentives that could impact the level or type of
care they receive. Although this responsibility should be assumed by the
health plan, physicians, individually or through their representatives,
must be prepared to discuss with patients any financial arrangements
that could impact patient care. Physicians should avoid reimbursement
systems that, if disclosed to patients, could negatively affect the
patient-physician relationship. (II, III) Issued June 1998 based on the
report "Financial Incentives and the Practice of Medicine," adopted
December 1997; updated June 2002.
and Dispensing Drugs and Devices.
should prescribe drugs, devices, and other treatments based solely upon
medical considerations and patient need and reasonable expectations of
the effectiveness of the drug, device or other treatment for the
(2) Physicians may
not accept any kind of payment or compensation from a drug company or
device manufacturer for prescribing its products. Furthermore,
physicians should not be influenced in the prescribing of drugs,
devices, or appliances by a direct or indirect financial interest in a
firm or other supplier, regardless of whether the firm is a
manufacturer, distributor, wholesaler, or repackager of the products
(3) Physicians may
own or operate a pharmacy, but generally may not refer their patients to
the pharmacy. Exceptionally, a physician may refer patients to his or
her pharmacy in accord with guidelines established
in Opinion 8.032
"Conflicts of Interest: Health Facility Ownership by a Physician."
Physicians may dispense drugs within their office practices provided
such dispensing primarily benefits the patient.
(4) In all
instances, physicians should respect the patient's freedom of choice in
selecting who will fill their prescriptions as they are in the choice of
a physician and, therefore, have the right to have a prescription filled
wherever they wish. (See Opinions 9.06 "Free Choice" and 8.03 "Conflicts
of Interest: Guidelines.") Physicians should not urge patients to fill
prescriptions from an establishment which has entered into a business or
other preferential arrangement with the physician with respect to the
filling of the physician's prescriptions.
(5) A third party's
offer to indemnify a physician for lawsuits arising from the physician's
prescription or use of the third party's drug, device, or other product,
introduces inappropriate incentives into medical decision making. Such
offers, regardless of their limitations, therefore constitute
unacceptable gifts. This does not address contractual assignments of
liability between employers or in research arrangements, nor does it
address government indemnification plans.
(6) Patients have an
ethically and legally recognized right to prompt access to the
information contained in their individual medical records. Since a
prescription is part of the patient's medical record, the patient is
entitled to a copy of the physician's prescription for drugs or devices,
including eyeglasses and contact lenses. Therefore, physicians should
not discourage patients from requesting a written copy of a
prescription. (II, III, IV, V) Consolidation of Opinions 8.06 "Drugs and
Devices: Prescribing," 6.04 "Fee Splitting: Drug or Device Prescription
Rebates," and 8.07 "Gifts to Physicians: Offers of Indemnity." Issued
E-8.061 Gifts to
Physicians from Industry.
Many gifts given to
physicians by companies in the pharmaceutical, device, and medical
equipment industries serve an important and socially beneficial
function. For example, companies have long provided funds for
educational seminars and conferences. However, there has been growing
concern about certain gifts from industry to physicians. Some gifts that
reflect customary practices of industry may not be consistent with the
Principles of Medical Ethics. To avoid the acceptance of inappropriate
gifts, physicians should observe the following guidelines:
(1) Any gifts
accepted by physicians individually should primarily entail a benefit to
patients and should not be of substantial value. Accordingly, textbooks,
modest meals, and other gifts are appropriate if they serve a genuine
educational function. Cash payments should not be accepted. The use of
drug samples for personal or family use is permissible as long as these
practices do not interfere with patient access to drug samples. It would
not be acceptable for non-retired physicians to request free
pharmaceuticals for personal use or use by family members.
(2) Individual gifts
of minimal value are permissible as long as the gifts are related to the
physician's work (eg, pens and notepads)..71
(3) The Council on
Ethical and Judicial Affairs defines a legitimate "conference" or
"meeting" as any activity, held at an appropriate location, where (a)
the gathering is primarily dedicated, in both time and effort, to
promoting objective scientific and educational activities and discourse
(one or more educational presentation(s) should be the highlight of the
gathering), and (b) the main incentive for bringing attendees together
is to further their knowledge on the topic(s) being presented. An
appropriate disclosure of financial support or conflict of interest
should be made.
(4) Subsidies to
underwrite the costs of continuing medical education conferences or
professional meetings can contribute to the improvement of patient care
and therefore are permissible. Since the giving of a subsidy directly to
a physician by a company's representative may create a relationship that
could influence the use of the company's products, any subsidy should be
accepted by the conference's sponsor who in turn can use the money to
reduce the conference's registration fee. Payments to defray the costs
of a conference should not be accepted directly from the company by the
physicians attending the conference.
(5) Subsidies from
industry should not be accepted directly or indirectly to pay for the
costs of travel, lodging, or other personal expenses of physicians
attending conferences or meetings, nor should subsidies be accepted to
compensate for the physicians' time. Subsidies for hospitality should
not be accepted outside of modest meals or social events held as a part
of a conference or meeting. It is appropriate for faculty at conferences
or meetings to accept reasonable honoraria and to accept reimbursement
for reasonable travel, lodging, and meal expenses. It is also
appropriate for consultants who provide genuine services to receive
reasonable compensation and to accept reimbursement for reasonable
travel, lodging, and meal expenses. Token consulting or advisory
arrangements cannot be used to justify the compensation of physicians
for their time or their travel, lodging, and other out-of-pocket
(6) Scholarship or
other special funds to permit medical students, residents, and fellows
to attend carefully selected educational conferences may be permissible
as long as the selection of students, residents, or fellows who will
receive the funds is made by the academic or training institution.
Carefully selected educational conferences are generally defined as the
major educational, scientific or policy-making meetings of national,
regional, or specialty medical associations.
(7) No gifts should
be accepted if there are strings attached. For example, physicians
should not accept gifts if they are given in relation to the physician's
prescribing practices. In addition, when companies underwrite medical
conferences or lectures other than their own, responsibility for and
control over the selection of content, faculty, educational methods, and
materials should belong to the organizers of the conferences or
lectures. (II) Issued June 1992 based on the report "Gifts to Physicians
from Industry," adopted December 1990 (JAMA. 1991; 265: 501); Updated
June 1996 and June 1998.
E-8.062 Sale of
Non-Health-Related Goods from Physicians' Offices.
The sale of
non-health-related goods by physicians presents a conflict of interest
and threatens to erode the primary obligation of physicians to serve the
interests of their patients before their own. Furthermore, this activity
risks placing undue pressure on the patient and risks demeaning the
practice of medicine. Physicians should not sell non-health-related
goods from their offices or other treatment settings, with the exception
noted below. Physicians may sell low-cost non-health-related goods from
their offices for the benefit of community organizations, provided that
(1) the goods in question are low-cost; (2) the physician takes no share
in profit from their sale; (3) such sales are not a regular part of the
physician's business; (4) sales are conducted in a dignified manner; and
(5) sales are conducted in such a way as to assure that patients are not
pressured into making purchases. (I, II) Issued June 1998 based on the
report "Sale of Non-Health-Related Goods from Physicians' Offices,"
adopted December 1997..72
E-8.063 Sale of
Health-Related Products from Physicians' Offices
products" are any products that, according to the manufacturer or
distributor, benefit health. "Selling" refers to the activity of
dispensing items that are provided from the physician's office in
exchange for money and also includes the activity of endorsing a product
that the patient may order or purchase elsewhere that results in direct
remuneration for the physician. This Opinion does not apply to the sale
of prescription items which is already addressed in Opinion 8.06, Drugs
and Devices: Prescribing. Physicians who engage in in-office sales
practices should be aware of the related guidelines presented in Opinion
8.062, Sale of Non-Health-Related Goods from Physicians' Offices;
Opinion 8.06, Drugs and Devices: Prescribing; Opinion 8.032, Conflicts
of Interest: Health Facility Ownership by a Physician; Opinion 3.01,
Nonscientific Practitioners; Opinion 8.20, Invalid Medical Treatment; as
well as the Reports from which these Opinions are extracted. In-office
sale of health-related products by physicians presents a financial
conflict of interest, risks placing undue pressure on the patient, and
threatens to erode patient trust and undermine the primary obligation of
physicians to serve the interests of their patients before their own.
(1) Physicians who
choose to sell health-related products from their offices should not
sell any health-related products whose claims of benefit lack scientific
validity. When judging the efficacy of a product, physicians should rely
on peer-reviewed literature and other unbiased scientific sources that
review evidence in a sound, systematic, and reliable fashion.
(2) Because of the
risk of patient exploitation and the potential to demean the profession
of medicine, physicians who choose to sell health-related products from
their offices must take steps to minimize their financial conflicts of
interest. The following guidelines apply:
(a) In general,
physicians should limit sales to products that serve the immediate and
pressing needs of their patients. For example, if traveling to the
closest pharmacy would in some way jeopardize the welfare of the patient
(e.g., forcing a patient with a broken leg to travel to a local pharmacy
for crutches), then it may be appropriate to provide the product from
the physician's office. These conditions are explained in more detail in
the Council's Opinion 8.06, Drugs and Devices: Prescribing, and are
analogous to situations that constitute exceptions to the permissibility
(b) Physicians may
distribute other health-related products to their patients free of
charge or at cost, in order to make useful products readily available to
their patients. When health-related products are offered free or at
cost, it helps to ensure removal of the elements of personal gain and
financial conflicts of interest that may interfere, or appear to
interfere, with the physician's independent medical judgment.
(3) Physicians must
disclose fully the nature of their financial arrangement with a
manufacturer or supplier to sell health-related products. Disclosure
includes informing patients of financial interests as well as about the
availability of the product or other equivalent products elsewhere.
Disclosure can be accomplished through face-to-face communication or by
posting an easily understandable written notification in a prominent
location that is accessible by all patients in the office. In addition,
physicians should, upon request, provide patients with understandable
literature that relies on scientific standards in addressing the risks,
benefits and limits of knowledge regarding the health-related product.
should not participate in exclusive distributorships of health-related
products which are available only through physicians' offices.
Physicians should encourage manufacturers to make products of.73
established benefit more fairly and more widely accessible to patients
than exclusive distribution mechanisms allow. (II) Issued December 1999
based on the report "Sale of Health-Related Products from Physicians'
Offices," adopted June 1999.
E-8.07 Gifts to
Physicians: Offers of Indemnity.
The previous Opinion
8.07, "Gifts to Physicians: Offers of Indemnity," issued June 1992, was
deleted in June 2002 and combined with the current Opinion 8.06,
"Prescribing and Dispensing Drugs and Devices."
The patient's right
of self-decision can be effectively exercised only if the patient
possesses enough information to enable an intelligent choice. The
patient should make his or her own determination on treatment. The
physician's obligation is to present the medical facts accurately to the
patient or to the individual responsible for the patient's care and to
make recommendations for management in accordance with good medical
practice. The physician has an ethical obligation to help the patient
make choices from among the therapeutic alternatives consistent with
good medical practice. Informed consent is a basic social policy for
which exceptions are permitted: (1) where the patient is unconscious or
otherwise incapable of consenting and harm from failure to treat is
imminent; or (2) when risk disclosure poses such a serious psychological
threat of detriment to the patient as to be medically contraindicated.
Social policy does not accept the paternalistic view that the physician
may remain silent because divulgence might prompt the patient to forego
needed therapy. Rational, informed patients should not be expected to
act uniformly, even under similar circumstances, in agreeing to or
refusing treatment. (I, II, III, IV, V) Issued March 1981.
Competent adults may
formulate, in advance, preferences regarding a course of treatment in
the event that injury or illness causes severe impairment or loss of
decision-making capacity. These preferences should be followed by the
health care team out of respect for patient autonomy. Patients may
establish an advance directive by documenting their treatment
preferences and goals or by designating a proxy to make health care
decisions on their behalf. If an incompetent patient is to receive
medical treatment, a reasonable effort should be made to identify the
presence of an advance directive. When such a patient lacks a documented
advance directive, or when reasonable efforts have failed to uncover
such documentation, physicians should defer to state law to identify a
surrogate decision maker. In the absence of state law specifying either
appropriate surrogate decision makers or a process to identify them, the
patient's family should become the surrogate decision maker. Family
includes persons with whom the patient is closely associated such as
close friends or unmarried living partners. In the case when there is no
family, but there are persons who have some relevant knowledge of the
patient, such persons should participate in the decision-making process.
In all other instances, a physician may wish to utilize an ethics
committee to aid in identifying a surrogate decision maker or to
facilitate sound decision making.
When there is
evidence of the patient's preferences and values, decisions concerning
the patient's care should be made by substituted judgment. This entails
considering the patient's advance directive (if any), the patient's
values about life and how it should be lived, how the patient
constructed his or her identity or life story, and the patient's
attitudes towards sickness, suffering, and certain medical
procedures..74 In some instances, a patient with diminished or impaired
decision-making capacity can participate in various aspects of health
care decision making. The attending physician should promote the
autonomy of such individuals by involving them to a degree commensurate
with their capabilities. If there is no reasonable basis on which to
interpret how a patient would have decided, the decision should be based
on the best interests of the patient, or the outcome that would best
promote the patient's well-being.
Factors that should
be considered when weighing the harms and benefits of various treatment
options include the pain and suffering associated with treatment, the
degree of and potential for benefit, and any impairments that may result
from treatment. Any quality of life considerations should be measured as
the worth to the individual whose course of treatment is in question,
and not as a measure of social worth. One way to ensure that a decision
using the best interest standard is not inappropriately influenced by
the surrogate's own values is to determine the course of treatment that
most reasonable persons would choose for themselves in similar
recognize the proxy or surrogate as an extension of the patient,
entitled to the same respect as the competent patient. Physicians should
provide advice, guidance, and support; explain that decisions should be
based on substituted judgment when possible and otherwise on the best
interest principle; and offer relevant medical information as well as
medical opinions in a timely manner. In addition to the physician, other
hospital staff or ethics committees are often helpful to providing
support for the decision makers.In general, physicians should respect
decisions made by the appropriately designated surrogate on the basis of
sound substituted judgment reasoning or the best interest standard. In
cases where there is a dispute among family members, physicians should
work to resolve the conflict through mediation. Physicians or an ethics
committee should try to uncover the reasons that underlie the
disagreement and present information that will facilitate decision
making. When a physician believes that a decision is clearly not what
the patient would have decided or could not be reasonably judged to be
within the patient's best interests, the dispute should be referred to
an ethics committee before resorting to the courts. Physicians should
encourage their patients to document their treatment preferences or to
appoint a health care proxy with whom they can discuss their values
regarding health care and treatment. Because documented advance
directives are often not available in emergency situations, physicians
should emphasize to patients the importance of discussing treatment
preferences with individuals who are likely to act as their surrogates.
(I, III, VIII) Issued December 2001 based on the report "Surrogate
Decision Making," adopted June 2001.
E-8.085 Waiver of
Informed Consent for Research in Emergency Situations.
The current state of
emergency medicine and research has resulted in the application of
standard treatments that often have not been scientifically evaluated
for safety and effectiveness and may render unsatisfactory outcomes.
Given the insufficiency of standard treatment alternatives, it is
appropriate, in certain situations and with special safeguards, to
provide experimental treatments without obtaining the informed consent
of the subject. However, in order to protect the rights and welfare of
the subjects, several conditions must be met:
(1) This type of
research is limited to emergency, life-threatening situations, and may
involve only experimental treatments that are ready for trials involving
(2) The subject must
lack the capacity to give informed consent for participation in the
(3) The window of
opportunity for intervention must be so narrow as to make obtaining
surrogate consent unfeasible.
prospective informed consent for the protocol must not be feasible (ie,
the life threatening emergency situation could not have been
(5) The experimental
treatment must have a realistic probability of benefit equal to or
greater than standard care.
(6) The risks
associated with the research should be reasonable in light of the
critical nature of the conditions and the risks associated with standard
(7) Where informed
consent is waived, subjects or their representatives must be informed as
soon as possible about inclusion in the study and asked to consent to
further participation. Subjects, or their representatives, may choose to
discontinue participation at any time after being fully informed about
the possible consequences. Additionally, if the patient dies while
participating in the research protocol, the patient's family or
representative must be informed that the patient was involved in an
(8) Community input
should be sought prior to approval of the protocol, and public
disclosure should be made of study results. Fair randomization of
research subjects should be given thorough consideration. Moreover, an
independent data monitoring board should be established to oversee the
ongoing trial. (I, V) Issued December 1997 based on the report "Waiver
of Informed Consent for Research in Emergency Situations," adopted June
Student Involvement in Patient Care.
(1) Patients and the
public benefit from the integrated care that is provided by health care
teams that include medical students. Patients should be informed of the
identity and training status of individuals involved in their care and
all health care professionals share the responsibility for properly
identifying themselves. Students and their supervisors should refrain
from using terms that may be confusing when describing the training
status of students.
(2) Patients are
free to choose from whom they receive treatment. When medical students
are involved in the care of patients, health care professionals should
relate the benefits of medical student participation to patients and
should ensure that they are willing to permit such participation.
Generally, attending physicians are best suited to fulfill this
(3) In instances
where the patient will be temporarily incapacitated (eg, anesthetized)
and where student involvement is anticipated, involvement should be
discussed before the procedure is undertaken whenever possible.
Similarly, in instances where a patient may not have the capacity to
make decisions, student involvement should be discussed with the
surrogate decision-maker involved in the care of the patient whenever
possible. (V, VII) Issued June 2001 based on the report "Medical Student
Involvement in Patient Care," adopted December 2000 (J Clin Ethics.
2001; 12 :111-15).
(1) A physician
should not misrepresent or aid in the misrepresentation of laboratory
services performed and supervised by a non-physician as the physician's
professional services. Such situations could involve a laboratory owned
by a physician who directs and manages its financial and business
affairs with no professional medical services being provided; laboratory
work being performed by technicians and directly supervised by a medical
technologist with no participation by the physician; or the physician's
name being used in connection with the laboratory so as to create the
appearance that it is owned, operated, and supervised by a physician
when this is not so.
(2) If a laboratory
is owned, operated, and supervised by a non-physician in accordance with
state law and performs tests exclusively for physicians who receive the
results and make their own medical interpretations, the following
considerations would apply: The physician's ethical responsibility is to
provide patients with high quality services. This includes services that
the physician performs personally and those that are delegated to
others. A physician should.76 not utilize the services of any
laboratory, irrespective of whether it is operated by a physician or
non-physician, unless she or he has the utmost confidence in the quality
of its services. A physician must always assume personal responsibility
for the best interests of his or her patients. Medical judgment based
upon inferior laboratory work is likewise inferior. Medical
considerations, not cost, must be paramount when the physician chooses a
laboratory. The physician who disregards quality as the primary
criterion or who chooses a laboratory solely because it provides
low-cost laboratory services on which the patient is charged a profit,
is not acting in the best interests of the patient. However, if
reliable, quality laboratory services are available at lower cost, the
patient should have the benefit of the savings. As a professional, the
physician is entitled to fair compensation for his or her services. A
physician should not charge a markup, commission, or profit on the
services rendered by others. A markup is an excessive charge that
exploits patients if it is nothing more than a tacked on amount for a
service already provided and accounted for by the laboratory. A
physician may make an acquisition charge or processing charge. The
patient should be notified of any such charge in advance. (I, II, III,
IV, V) Issued prior to April 1977; Updated June 1994.
Clinical Test Results: General Guidelines.
patients' anxieties, physicians should report clinical test results to
patients within a reasonable time frame. Since many variables contribute
to the urgency of a particular situation, physicians should use their
best professional judgment when determining what length of time is
reasonable for the particular situation at hand. Anticipated delays
should be explained to patients at the time of testing.
adopt a consistent reporting policy that accommodates the demands of
their practice while at the same time being considerate of patients'
anxieties. The reporting policy should be disclosed to patients, for
instance when tests are administered, so patients know what to expect.
Reporting policies should take into consideration under what
circumstances (eg, all results, only abnormal results, etc) and by whom
(eg, the laboratory or the physician) test results are appropriately
reported to the patient. Any anticipated inconsistencies should be
disclosed to patients as soon as they are discovered.
provide test results in language understandable to the patient and in
the manner deemed most appropriate by the physician. Any information
gathered from test results that would be necessary for patients to make
intelligent medical decisions and give informed consent on future
medical treatments must be disclosed to them.
take all appropriate precautions to ensure the confidentiality of test
results. Such precautions may include, but are not limited to, not
leaving test results on an answering machine, on voice mail, or with a
third party unless previously given permission to do so by the patient,
not delivering test results via electronic mail, and not sending test
results through the mail in any form other than a sealed envelope. (II,
IV, V) Issued December 1998 based on the report "Reporting Clinical Test
Results: General Guidelines," adopted June 1998.
E-8.10 Lien Laws.
In states where
there are lien laws, a physician may file a lien as a means of assuring
payment of his or her fee provided the fee is fixed in amount and not
contingent on the amount of settlement of the patient's claim against a
third party. (I, VI) Issued prior to April 1977.
E-8.11 Neglect of
Physicians are free
to choose whom they will serve. The physician should, however, respond
to the best of his or her ability in cases of emergency where first aid
treatment is essential. Once having undertaken a case, the physician
should not neglect the patient. (I, VI) Issued prior to April 1977;
Updated June 1996.
of the Physician-Patient Relationship.
Physicians have an
obligation to support continuity of care for their patients. While
physicians have the option of withdrawing from a case, they cannot do so
without giving notice to the patient, the relatives, or responsible
friends sufficiently long in advance of withdrawal to permit another
medical attendant to be secured. (I, VI) Issued June 1996 (formerly
included in Opinion 8.11).
It is a fundamental
ethical requirement that a physician should at all times deal honestly
and openly with patients. Patients have a right to know their past and
present medical status and to be free of any mistaken beliefs concerning
their conditions. Situations occasionally occur in which a patient
suffers significant medical complications that may have resulted from
the physician's mistake or judgment. In these situations, the physician
is ethically required to inform the patient of all the facts necessary
to ensure understanding of what has occurred. Only through full
disclosure is a patient able to make informed decisions regarding future
responsibility includes informing patients of changes in their diagnoses
resulting from retrospective review of test results or any other
information. This obligation holds even though the patient's medical
treatment or therapeutic options may not be altered by the new
information. Concern regarding legal liability which might result
following truthful disclosure should not affect the physician's honesty
with a patient. (I, II, III, IV) Issued March 1981; Updated June 1994.
E-8.13 Managed Care.
The expansion of
managed care has brought a variety of changes to medicine including new
and different reimbursement systems for physicians with complex referral
restrictions and benefits packages for patients. Some of these changes
have raised concerns that a physician's ability to practice ethical
medicine will be adversely affected by the modifications in the system.
In response to these concerns, the following points were developed to
provide physicians with general guidelines that will assist them in
fulfilling their ethical responsibilities to patients given the changes
heralded by managed care.
(1) The duty of
patient advocacy is a fundamental element of the patient-physician
relationship that should not be altered by the system of health care
delivery. Physicians must continue to place the interests of their
(2) When health care
plans place restrictions on the care that physicians in the plan may
provide to their patients, physicians should insist that the following
principles be followed:
(a) Any broad
allocation guidelines that restrict care and choices--which go beyond
the cost/benefit judgments made by physicians as a part of their normal
professional responsibilities--should be established at a policy making
level so that individual physicians are not asked to engage in bedside
(b) Regardless of
any allocation guidelines or gatekeeper directives, physicians must
advocate for any care they believe will materially benefit their
should be given an active role in contributing their expertise to any
allocation process and should advocate for guidelines that are sensitive
to differences among patients. Health care plans should create
structures similar to hospital medical staffs that allow physicians to
have meaningful input into the plan's development of allocation
guidelines. Guidelines for allocating health care should be reviewed on
a regular basis and updated to reflect advances in medical knowledge and
changes in relative costs.
appellate mechanisms for both patients and physicians should be in place
to address disputes regarding medically necessary care. In some
circumstances, physicians have an obligation to initiate appeals on
behalf of their patients. Cases may arise in which a health plan has an
allocation guideline that is generally fair but in particular
circumstances results in unfair denials of care, i.e., denial of care
that, in the physician's judgment, would materially benefit the patient.
In such cases, the physician's duty as patient advocate requires that
the physician challenge the denial and argue for the provision of
treatment in the specific case. Cases may also arise when a health plan
has an allocation guideline that is generally unfair in its operations.
In such cases, the physician's duty as patient advocate requires not
only a challenge to any denials of treatment from the guideline but also
advocacy at the health plan's policy-making level to seek an elimination
or modification of the guideline. Physicians should assist patients who
wish to seek additional, appropriate care outside the plan when the
physician believes the care is in the patient's best interests.
(e) Health care
plans must adhere to the requirement of informed consent that patients
be given full disclosure of material information. Full disclosure
requires that health care plans inform potential subscribers of
limitations or restrictions on the benefits package when they are
considering entering the plan.
(f) Physicians also
should continue to promote full disclosure to patients enrolled in
health care plans. The physician's obligation to disclose treatment
alternatives to patients is not altered by any limitations in the
coverage provided by the patient's health care plan. Full disclosure
includes informing patients of all of their treatment options, even
those that may not be covered under the terms of the health care plan.
Patients may then determine whether an appeal is appropriate, or whether
they wish to seek care outside the plan for treatment alternatives that
are not covered.
should not participate in any plan that encourages or requires care
below minimum professional standards.
(3) When physicians
are employed or reimbursed by health care plans that offer financial
incentives to limit care, serious potential conflicts are created
between the physicians' personal financial interests and the needs of
their patients. Efforts to contain health care costs should not place
patient welfare at risk. Thus, physicians should accept only those
financial incentives that promote the cost-effective delivery of health
care and not the withholding of medically necessary care.
should insist that any incentives to limit care be disclosed fully to
patients by plan administrators upon enrollment and at least annually
should advocate that limits be placed on the magnitude of fee withholds,
bonuses and other financial incentives to limit care and that incentive
payments be calculated according to the performance of a sizable group
of physicians rather than on an individual basis..79
should advocate that health care plans or other groups develop financial
incentives based on quality of care. Such incentives should complement
those based on the quantity of services used.
should encourage both that patients be aware of the benefits and
limitations of their health care coverage and that they exercise their
autonomy by public participation in the formulation of benefits packages
and by prudent selection of health care coverage that best suits their
needs. (I, II, III, V) Issued June 1996 based on the report "Ethical
Issues in Managed Care," adopted June 1994 (JAMA. 1995; 273: 330-35);
Updated June 2002.
E-8.132 Referral of
Patients: Disclosure of Limitations.
(1) When a physician
agrees to provide treatment, he or she thereby enters into a contractual
relationship and assumes an ethical obligation to treat the patient to
the best of his or her ability. Some health care plans contracts
restrict the participating physician's scope of referral to medical
specialists, diagnostic laboratories, and hospitals that have
contractual arrangements with the health plan. Some plans also restrict
the circumstances under which referrals may be made to contracting
medical specialists. If the health care plan does not permit referral to
a non-contracting medical specialist or to a diagnostic or treatment
facility when the physician believes that the patient's condition
requires such services, the physician should so inform the patient so
that the patient may decide whether to accept the outside referral at
his or her own expense or confine herself or himself to services
available within the health care plan. In determining whether treatment
or diagnosis requires referral to outside specialty services, the
physician should be guided by standards of good medical practice.
(2) Physicians must
not deny their patients access to appropriate medical services based
upon the promise of personal financial reward, or the avoidance of
financial penalties. Because patients must have the necessary
information to make informed decisions about their care, physicians have
an obligation to assure the disclosure of medically appropriate
treatment alternatives, regardless of cost.
(3) Physicians must
assure disclosure of any financial inducements that may tend to limit
the diagnostic and therapeutic alternatives that are offered to patients
or that may tend to limit patients' overall access to care. Physicians
may satisfy this obligation by assuring that the health care plan makes
adequate disclosure to enrolled patients. Physicians should also promote
an effective program of peer review to monitor and evaluate the quality
of the patient care services within their practice setting. (II, IV)
Issued June 1986; Updated June 1994 based on the report "Financial
Incentives to Limit Care: Ethical Implications for HMOs and IPAs,"
adopted June 1990; updated June 2002.
Containment Involving Prescription Drugs in Health Care Plans
When health care
plans, whether publicly or privately financed, establish drug formulary
systems, physicians are obligated to advocate for formularies that meet
the medical needs of their patients.
should maintain awareness of plan decisions about drug selection by
staying informed, where appropriate, about pharmacy and therapeutics
(P&T) committee actions and by ongoing personal review of formulary
composition. P&T committee members should include independent physician
representatives. Mechanisms should be established for ongoing peer
review of formulary policy. Physicians who perceive inappropriate
influences on formulary development should notify the proper regulatory
scientifically based evidence is available, physicians are ethically
required to advocate for changes to the formulary that would benefit the
patient. Physicians also should advocate for exceptions to the formulary
on a case-by-case basis when justified by the health care needs of
particular patients. Mechanisms to appeal formulary exclusions should be
established. Other cost-containment mechanisms, including prescription
caps and prior authorization, should not unduly burden physicians or
patients in accessing optimal drug therapy. Quality improvement rather
than cost containment should be the primary determinant for formulary
exclusions. In order to be cost efficient, however, physicians should
select the lowest cost medication of equal efficacy for their patients.
should advocate that limits be placed on the extent to which health care
plans use incentives or pressures to lower prescription drug costs.
Financial incentives are permissible when they promote
cost-effectiveness, not when they require withholding medically
necessary care. Physicians should not be made to feel that they
jeopardize their compensation or participation in a health care plan if
they prescribe drugs that are necessary for their patients but that may
also be costly. There should be limits on the magnitude of financial
incentives, which should be calculated according to the practices of a
sizeable group of physicians rather than on an individual basis, and
incentives based on quality of care rather than cost of care should be
used. Prescriptions should not be changed without the physician's
knowledge and authorization. This affords the physician the opportunity
to discuss the change with the patient.
should encourage health care plans to develop mechanisms to educate and
assist physicians in cost-effective prescribing practices, including the
availability of clinical pharmacists. Such initiatives are preferable to
financial incentives or pressures by health care plans or hospitals,
which can be ethically problematic.
should advocate that methods to limit prescription drug costs within
health care plans in which they participate be disclosed to patients. In
particular, they should encourage health care plans to inform patients
upon enrollment concerning:
(i) the existence of
(ii) provisions for
cases in which the physician prescribes a drug that is not included in
(iii) incentives or
other mechanisms used to encourage formulary compliance by physicians,
with pharmaceutical benefit management companies or pharmaceutical
companies that could influence the composition of the formulary.
(6) If physicians exhaust all avenues to secure a
formulary exception for a significantly advantageous drug, they are
still obligated to disclose the option of the more beneficial drug to
the patient, so that the patient can consider whether to obtain the
medication out-of-plan. Under circumstances in which the health care
program will not subsidize the drug, physicians should help patients by
identifying alternative forms of financial assistance, such as those
available through pharmaceutical companies' assistance programs. (III)
Issued June 1996
based on the report "Managed Care Cost Containment Involving
Prescription Drugs," adopted June 1995; updated June 2002.
on Disclosure in Managed Care Contracts.
The previous Opinion
8.137, issued June 1997, was deleted in June 2000 and combined with
Misconduct in the Practice of Medicine.
Sexual contact that
occurs concurrent with the physician-patient relationship constitutes
sexual misconduct. Sexual or romantic interactions between physicians
and patients detract from the goals of the physician-patient
relationship, may exploit the vulnerability of the patient, may obscure
the physician's objective judgment concerning the patient's health care,
and ultimately may be detrimental to the patient's well-being. If a
physician has reason to believe that non-sexual contact with a patient
may be perceived as or may lead to sexual contact, then he or she should
avoid the non-sexual contact. At a minimum, a physician's ethical duties
include terminating the physician-patient relationship before initiating
a dating, romantic, or sexual relationship with a patient.
Sexual or romantic
relationships between a physician and a former patient may be unduly
influenced by the previous physician-patient relationship. Sexual or
romantic relationships with former patients are unethical if the
physician uses or exploits trust, knowledge, emotions, or influence
derived from the previous professional relationship. (I, II, IV) Issued
December 1989; Updated March 1992 based on the report "Sexual Misconduct
in the Practice of Medicine," adopted December 1990 (JAMA. 1991; 266:
E-8.145 Sexual or
Romantic Relations Between Physicians and Key Third Parties.
Patients are often
accompanied by third parties who play an integral role in the
patient-physician relationship. The physician interacts and communicates
with these individuals and often is in a position to offer them
information, advice, and emotional support. The more deeply involved the
individual is in the clinical encounter and in medical decision making,
the more troubling sexual or romantic contact with the physician would
be. This is especially true for individual whose decisions directly
impact on the health and welfare of the patient. Key third parties
include, but are not limited to, spouses or partners, parents,
guardians, and proxies.
refrain from sexual or romantic interactions with key third parties when
it is based on the use or exploitation of trust, knowledge, influence,
or emotions derived from a professional relationship. The following
factors should be considered when considering whether a relationship is
appropriate: the nature of the patient's medical problem, the length of
the professional relationship, the degree of the third party's emotional
dependence on the physician, and the importance of the clinical
encounter to the third party and the patient. (I, II) Issued December
1998 based on the report "Sexual or Romantic Relations between
Physicians and Key Third Parties," adopted June 1998.
It is unethical for
a physician to practice medicine while under the influence of a
controlled substance, alcohol, or other chemical agents which impair the
ability to practice medicine. (I) Issued December 1986.
of Surgeon without Patient's Knowledge or Consent.
A surgeon who allows
a substitute to operate on his or her patient without the patient's
knowledge and consent is deceitful. The patient is entitled to choose
his or her own physician and should be permitted to acquiesce to or
refuse the substitution..82
obligation to the patient requires the surgeon to perform the surgical
operation: (1) within the scope of authority granted by the consent to
the operation; (2) in accordance with the terms of the contractual
relationship; (3) with complete disclosure of facts relevant to the need
and the performance of the operation; and (4) utilizing best skill.
It should be noted
that it is the operating surgeon to whom the patient grants consent to
perform the operation. The patient is entitled to the services of the
particular surgeon with whom he or she contracts. The operating surgeon,
in accepting the patient, is obligated to utilize his or her personal
talents in the performance of the operation to the extent required by
the agreement creating the physician-patient relationship. The surgeon
cannot properly delegate to another the duties which he or she is
required to perform personally.
Under the normal and
customary arrangement with patients, and with reference to the usual
form of consent to operation, the operating surgeon is obligated to
perform the operation but may be assisted by residents or other
surgeons. With the consent of the patient, it is not unethical for the
operating surgeon to delegate the performance of certain aspects of the
operation to the assistant provided this is done under the surgeon's
participatory supervision, i.e., the surgeon must scrub. If a resident
or other physician is to perform the operation under non-participatory
supervision, it is necessary to make a full disclosure of this fact to
the patient, and this should be evidenced by an appropriate statement
contained in the consent. Under these circumstances, it is the resident
or other physician who becomes the operating surgeon. (I, II, IV, V)
Issued prior to April 1977; Updated June 1994.
E-8.17 Use of
All individuals have
a fundamental right to be free from unreasonable bodily restraint.
Physical and chemical restraints should therefore be used only in the
best interest of the patient and in accordance with the following
(1) The use of
restraints, except in emergencies, may be implemented only upon the
explicit order of a physician, in conformance with reasonable
(2) Judgment should
be exercised in issuing pro re nata (PRN) orders for the use of physical
or chemical restraints, and the implementation of such orders should be
frequently reviewed and documented by the physician.
(3) The use of
restraints should not be punitive, nor should they be used for
convenience or as an alternative to reasonable staffing.
should be used only in accordance with appropriate clinical indications.
(5) As with all
therapeutic interventions, informed consent by the patient or surrogate
decision maker is a key element in the application of physical and
chemical restraints, and should be incorporated into institutional
(6) In certain
limited situations, it may be appropriate to restrain a patient
involuntarily. For example, restraints may be needed for the safety of
the patient or others in the area. When restraints are used
involuntarily, the restraints should be removed when they are no longer
needed. (I, IV) Issued March 1992.83 based on the report "Guidelines for
the Use of Restraints in Long Term Care Facilities," adopted June 1989.
Families of a Patient's Death.
Disclosing the death
of a patient to the patient's family is a duty which goes to the very
heart of the physician-patient relationship and should not be readily
delegated to others by the attending physician. The emotional needs of
the family and the integrity of the physician-patient relationship must
at all times be given foremost consideration.
residency training may be asked to participate in the communication of
information about a patient's death, if that request is commensurate
with the physician's prior training or experience and previous close
personal relationship with the family. It would not be appropriate for
the attending physician or resident to request that a medical student
notify family members of a patient's death. Medical students should be
trained in issues of death and dying, and should be encouraged to
accompany attending physicians when news of a patient's death is
conveyed to the family members. (I, IV) Issued March 1992 based on the
report "Informing Families of a Patient's Death: Guidelines for the
Involvement of Medical Students," adopted December 1989; Updated June
Procedures on the Newly Deceased for Training Purposes
work to develop institutional policies that address the practice of
performing procedures on the newly deceased for purposes of training.
Any such policy should ensure that the interests of all the parties
involved are respected under established and clear ethical guidelines.
Such policies should consider rights of patients and their families,
benefits to trainees and society, as well as potential harm to the
ethical sensitivities of trainees, and risks to staff, the institution,
and the profession associated with performing procedures on the newly
deceased without consent. The following considerations should be
addressed before medical trainees perform procedures on the newly
(1) The teaching of
life-saving skills should be the culmination of a structured training
sequence, rather than relying on random opportunities. Training should
be performed under close supervision, in a manner and environment that
takes into account the wishes and values of all involved parties.
should inquire whether the deceased individual had expressed preferences
regarding handling of the body or procedures performed after death. In
the absence of previously expressed preferences, physicians should
obtain permission from the family before performing such procedures.
When reasonable efforts to discover previously expressed preferences of
the deceased or to find someone with authority to grant permission for
the procedure have failed, physicians must not perform procedures for
training purposes on the newly deceased patient. In the event
post-mortem procedures are undertaken on the newly deceased, they must
be recorded in the medical record. (I, V) Issued December 2001 based on
the report "Performing Procedures on the Newly Deceased for Training
Purposes," adopted June 2001.
Self-Treatment or Treatment of Immediate Family Members..84
should not treat themselves or members of their immediate families.
Professional objectivity may be compromised when an immediate family
member or the physician is the patient; the physician's personal
feelings may unduly influence his or her professional medical judgment,
thereby interfering with the care being delivered. Physicians may fail
to probe sensitive areas when taking the medical history or may fail to
perform intimate parts of the physical examination. Similarly, patients
may feel uncomfortable disclosing sensitive information or undergoing an
intimate examination when the physician is an immediate family member.
This discomfort is particularly the case when the patient is a minor
child, and sensitive or intimate care should especially be avoided for
such patients. When treating themselves or immediate family members,
physicians may be inclined to treat problems that are beyond their
expertise or training. If tensions develop in a physician's professional
relationship with a family member, perhaps as a result of a negative
medical outcome, such difficulties may be carried over into the family
member's personal relationship with the physician. Concerns regarding
patient autonomy and informed consent are also relevant when physicians
attempt to treat members of their immediate family. Family members may
be reluctant to state their preference for another physician or decline
a recommendation for fear of offending the physician. In particular,
minor children will generally not feel free to refuse care from their
parents. Likewise, physicians may feel obligated to provide care to
immediate family members even if they feel uncomfortable providing care.
It would not always
be inappropriate to undertake self-treatment or treatment of immediate
family members. In emergency settings or isolated settings where there
is no other qualified physician available, physicians should not
hesitate to treat themselves or family members until another physician
becomes available. In addition, while physicians should not serve as a
primary or regular care provider for immediate family members, there are
situations in which routine care is acceptable for short-term, minor
emergencies, it is not appropriate for physicians to write prescriptions
for controlled substances for themselves or immediate family members.
(I, II, IV) Issued June 1993.
general guidelines are offered to serve physicians when they are called
upon to decide among treatments:
(1) Treatments which
have no medical indication and offer no possible benefit to the patient
should not be used (Opinion 2.035).
(2) Treatments which
have been determined scientifically to be invalid should not be used
(3) Among the
treatments that are scientifically valid, medically indicated, and offer
a reasonable chance of benefit for patients, some are regulated or
prohibited by law; physicians should comply with these laws. If
physicians disagree with such laws, they should seek to change them.
(4) Among the
various treatments that are scientifically valid, medically indicated,
legal, and offer a reasonable chance of benefit for patients, the
decision of which treatment to use should be made between the physician
and patient. (I, III, IV) Issued June 1998 based on the report "Invalid
Medical Treatment," adopted December 1997..85
E-8.21 Use of
Chaperones During Physical Exams.
From the standpoint
of ethics and prudence, the protocol of having chaperones available on a
consistent basis for patient examinations is recommended. Physicians aim
to respect the patient's dignity and to make a positive effort to secure
a comfortable and considerate atmosphere for the patient--such actions
include the provision of appropriate gowns, private facilities for
undressing, sensitive use of draping, and clear explanations on various
components of the physical examination. A policy that patients are free
to make a request for a chaperone should be established in each health
care setting. This policy should be communicated to patients, either by
means of a well-displayed notice or preferably through a conversation
initiated by the intake nurse or the physician. The request by a patient
to have a chaperone should be honored.
An authorized health
professional should serve as a chaperone whenever possible. In their
practices, physicians should establish clear expectations about
respecting patient privacy and confidentiality to which chaperones must
If a chaperone is to
be provided, a separate opportunity for private conversation between the
patient and the physician should be allowed. The physician should keep
inquiries and history-taking, especially those of a sensitive nature, to
a minimum during the course of the chaperoned examination. (I, IV)
Issued December 1998 based on the report, "Use of Chaperones During
Physical Exams," adopted June 1998.
E-9.00 Opinions on
Professional Rights and Responsibilities
engage in activities that involve the accreditation, approval, or
certification of institutions, facilities, and programs that provide
patient care or medical education or certify the attainment of
specialized professional competence have the ethical responsibility to
apply standards that are relevant, fair, reasonable, and
nondiscriminatory. The accreditation of institutions and facilities that
provide patient care should be based upon standards that focus upon the
quality of patient care achieved. Standards used in the accreditation of
patient care and medical education, or the certification of specialized
professional attainment should not be adopted or used as a means of
economic regulation. (II, IV, VII) Issued December 1982.
strive to further their medical education throughout their careers, for
only by participating in continuing medical education (CME) can they
continue to serve patients to the best of their abilities and live up to
professional standards of excellence. Fulfillment of mandatory state CME
requirements does not necessarily fulfill the physician's ethical
obligation to maintain his or her medical expertise.
Guidelines for physicians attending a CME conference or activity are as
(1) The physician
choosing among CME activities should assess their educational value and
select only those activities which are of high quality and appropriate
for the physician's educational needs. When selecting formal CME
activities, the physician should, at a minimum, choose only those
activities that (a) are offered by sponsors accredited by the
Accreditation Council for Continuing Medical Education.86 (ACCME), the
American Academy of Family Physicians (AAFP), or a state medical
society; (b) contain information on subjects relevant to the physician's
needs; (c) are responsibly conducted by qualified faculty; (d) conform
to Opinion 8.061, Gifts to Physicians from Industry.
(2) The educational
value of the CME conference or activity must be the primary
consideration in the physician's decision to attend or participate.
Though amenities unrelated to the educational purpose of the activity
may play a role in the physician's decision to participate, this role
should be secondary to the educational content of the conference.
should claim credit commensurate with only the actual time spent
attending a CME activity or in studying a CME enduring material.
promotional activities put on by industry or their designees is not
unethical as long as the conference conforms to Opinion 8.061, Gifts to
Physicians from Industry, and is clearly identified as promotional to
for physicians serving as presenters, moderators, or other faculty at a
CME conference are as follows:
serving as presenters, moderators, or other faculty at a CME conference
should ensure that (a) research findings and therapeutic recommendations
are based on scientifically accurate, up-to-date information and are
presented in a balanced, objective manner; (b) the content of their
presentation is not modified or influenced by representatives of
industry or other financial contributors, and they do not employ
materials whose content is shaped by industry. Faculty may, however, use
scientific data generated from industry-sponsored research, and they may
also accept technical assistance from industry in preparing slides or
other presentation materials, as long as this assistance is of only
nominal monetary value and the company has no input in the actual
content of the material.
(2) When invited to
present at non-CME activities that are primarily promotional, faculty
should avoid participation unless the activity is clearly identified as
promotional in its program announcements and other advertising.
(3) All conflicts of
interest or biases, such as a financial connection to a particular
commercial firm or product, should be disclosed by faculty members to
the activity's sponsor and to the audience. Faculty may accept
reasonable honoraria and reimbursement for expenses in accordance with
Opinion 8.061, Gifts to Physicians from Industry.
for physicians involved in the sponsorship of CME activities are as
involved in the sponsorship of CME activities should ensure that (a) the
program is balanced, with faculty members presenting a broad range of
scientifically supportable viewpoints related to the topic at hand; (b)
representatives of industry or other financial contributors do not exert
control over the choice of moderators, presenters, or other faculty, or
modify the content of faculty presentations. Funding from industry or
others may be accepted in accordance with Opinion 8.061, Gifts to
Physicians from Industry.
(2) Sponsors should
not promote CME activities in a way that encourages attendees to violate
the guidelines of the Council on Ethical and Judicial Affairs, including
Opinion 8.061, Gifts to Physicians from.87 Industry, or the principles
established for the American Medical Association's Physician Recognition
Award. CME activities should be developed and promoted consistent with
guideline (2) for Attendees.
(3) Any non-CME
activity that is primarily promotional must be identified as such to
faculty and participants, both in its advertising and at the conference
(4) The entity
presenting the program should not profit unfairly or charge a fee which
is excessive for the content and length of the program.
(5) The program,
content, duration, and ancillary activities should be consistent with
the ideals of the AMA CME program. (I, V) Issued December 1993; Updated
Political Communications with Patients and Their Families
Physicians enjoy the
rights and privileges of free political speech shared by all Americans.
It is laudable for physicians to run for political office; to lobby for
political positions, parties or candidates; and in every other way to
exercise the full scope of their political rights as citizens. These
rights may be exercised individually or through involvement with
organizations such as professional societies and political action
physicians have a responsibility to work for the reform of, and to press
for the proper administration of, laws that are related to health care.
Physicians should keep themselves well-informed as to current political
questions regarding needed and proposed changes to laws concerning such
issues as access to health care, quality of health care services, scope
of medical research, and promotion of public health.
It is natural that
in fulfilling these political responsibilities, physicians will express
their views to patients or their families. However, communications by
telephone or other modalities with patients and their families about
political matters must be conducted with the utmost sensitivity to
patients' vulnerability and desire for privacy. Conversations about
political matters are not appropriate at times when patients or families
are emotionally pressured by significant medical circumstances.
Physicians are best able to judge both the intrusiveness of the
discussion and the patient's level of comfort. In general, when
conversation with the patient or family concerning social, civic, or
recreational matters is acceptable, discussion of items of political
import may be appropriate.
circumstances should physicians allow their differences with patients or
their families about political matters to interfere with the delivery of
high-quality professional care. (I, VII) Issued June 1999 based on the
report "Physicians' Political Communications with Patients and Their
Families," adopted December 1998.
Covenants and the Practice of Medicine.
Covenants-not-to-compete restrict competition, disrupt continuity of
care, and potentially deprive the public of medical services. The
Council on Ethical and Judicial Affairs discourages any agreement which
restricts the right of a physician to practice medicine for a specified
period of time or in a specified area upon termination of an employment,
partnership, or corporate agreement. Restrictive covenants are unethical
if they are excessive in geographic scope or duration in the
circumstances presented, or if they fail to make.88 reasonable
accommodation of patients' choice of physician. (VI, VII) Issued prior
to April 1977; Updated June 1994 and June 1998.
Covenants-Not-to-Compete for Physicians-in-Training.
It is unethical for
a teaching institution to seek a non-competition guarantee in return for
fulfilling its educational obligations. Physicians-in-training
(residents in programs approved by the Accreditation Council for
Graduate Medical Education [ACGME], fellows in ACGME-approved fellowship
programs, and fellows in programs approved by one of the American Board
of Medical Specialties specialty boards) should not be asked to sign
covenants-not-to-compete as a condition of their entry into any
residency or fellowship program. (III, IV, VI) Issued December 1997
based on the report "Covenants-Not-to-Compete for
Physicians-in-Training," adopted June 1997 (JAMA. 1997; 278: 530).
Action and Patient Advocacy.
should not be conducted in a manner that jeopardizes the health and
interests of patients. Formal unionization of physicians and
physicians-in-training may tie physicians' interests to the interests of
workers who may not share physicians' primary and overriding commitment
to patients and the public health. Physicians should not form workplace
alliances with those who do not share these ethical priorities. Strikes
reduce access to care, eliminate or delay necessary care, and interfere
with continuity of care. Each of these consequences is contrary to the
physician's ethic. Physicians should refrain from the use of the strike
as a bargaining tactic.
There are some
measures of collective action that may not impinge on essential patient
care. Collective activities aimed at ultimately improving patient care
may be warranted in some circumstances, even if they create
inconvenience for the management.
physicians-in-training should take full advantage of the tools of
collective action through which to press for needed reforms.
Informational campaigns, non-disruptive public demonstrations, lobbying
and publicity campaigns, and collective negotiation are among the
options available which do not limit services to patients.
collective activities should be in conformance with the law. (I, III)
Issued December 1998 based on the report "Collective Action and Patient
Advocacy," adopted June 1998.
E-9.03 Civil Rights
and Professional Responsibility.
medical society activities or membership, medical education and
training, employment, and all other aspects of professional endeavors
should not be denied to any duly licensed physician because of race,
color, religion, creed, ethnic affiliation, national origin, sex, sexual
orientation, age, or handicap. (IV) Issued prior to April 1977; Updated
Impaired, Incompetent, or Unethical Colleagues.
Physicians have an
ethical obligation to report impaired, incompetent, and unethical
colleagues in accordance with the legal requirements in each state and
assisted by the following guidelines:.89 Impairment. Impairment should
be reported to the hospital's in-house impairment program, if available.
Otherwise, either the chief of an appropriate clinical service or the
chief of the hospital staff should be alerted. Reports may also be made
directly to an external impaired physician program. Practicing
physicians who do not have hospital privileges should be reported
directly to an impaired physician program, such as those run by medical
societies, when appropriate. If none of these steps would facilitate the
entrance of the impaired physician into an impairment program, then the
impaired physician should be reported directly to the state licensing
Initial reports of incompetence should be made to the appropriate
clinical authority who would be empowered to assess the potential impact
on patient welfare and to facilitate remedial action. The hospital peer
review body should be notified where appropriate. Incompetence which
poses an immediate threat to the health of patients should be reported
directly to the state licensing board. Incompetence by physicians
without a hospital affiliation should be reported to the local or state
medical society and/or the state licensing or disciplinary board.
With the exception of incompetence or impairment, unethical behavior
should be reported in accordance with the following guidelines:
that threatens patient care or welfare should be reported to the
appropriate authority for a particular clinical service. Unethical
behavior which violates state licensing provisions should be reported to
the state licensing board or impaired physician programs, when
appropriate. Unethical conduct which violates criminal statutes must be
reported to the appropriate law enforcement authorities. All other
unethical conduct should be reported to the local or state medical
inappropriate behavior of a physician continues despite the initial
report(s), the reporting physician should report to a higher or
additional authority. The person or body receiving the initial report
should notify the reporting physician when appropriate action has been
taken. Physicians who receive reports of inappropriate behavior have an
ethical duty to critically and objectively evaluate the reported
information and to assure that identified deficiencies are either
remedied or further reported to a higher or additional authority.
Anonymous reports should receive appropriate review and confidential
investigation. Physicians who are under scrutiny or charge should be
protected by the rules of confidentiality until such charges are proven
or until the physician is exonerated. (II) Issued March 1992 based on
the report "Reporting Impaired, Incompetent, or Unethical Colleagues,"
adopted December 1991 (J Miss St Med Assoc. 1992; 33: 176-77); Updated
June 1994 and June 1996.
Adverse Drug or Device Events.
A physician who
suspects the occurrence of an adverse reaction to a drug or medical
device has an obligation to communicate that information to the broader
medical community, (eg, through submitting a report or letter to a
medical journal or informing the manufacturer of the suspect drug or
device). In the case of a serious adverse event, the event should be
reported to the Food and Drug Administration (FDA). Spontaneous reports
of adverse events are irreplaceable as a source of valuable information
about drugs and medical devices, particularly their rare or delayed
effects, as well as their safety in vulnerable patient populations.
Although premarketing and mandated postmarketing studies provide basic
safeguards for the public health, they suffer from inherent deficiencies
that limit their ability to detect rare or unexpected consequences of
drug or medical device use. Physicians who prescribe and monitor the use
of drugs and medical devices constitute the group best able to observe
and communicate information about resulting adverse events..90
events, such as those resulting in death, hospitalization, or medical or
surgical intervention, are the most important to report and are the only
adverse events for which the FDA desires a report. Certainty, or even
reasonable likelihood, of a causal relationship between the drug or
medical device and the serious adverse event will rarely exist and is
not required before reporting the event to the FDA. Suspicion of such a
relationship is sufficient to give rise to an obligation to participate
in the reporting system. (I, V, VII) Issued June 1993 based on the
report "Reporting Adverse Drug and Medical Device Events," adopted June
1993; Updated June 1994 (Food & Drug Law J. 1994; 49: 359-66).
Discrimination in the Medical Profession.
Physician leaders in
medical schools and other medical institutions should take immediate
steps to increase the number of women in leadership positions as such
positions become open. There is already a large enough pool of female
physicians to provide strong candidates for such positions. Also,
adjustments should be made to ensure that all physicians are equitably
compensated for their work. Women and men in the same specialty with the
same experience and doing the same work should be paid the same
compensation. Physicians in the workplace should actively develop the
following: (1) retraining or other programs which facilitate the
re-entry of physicians who take time away from their careers to have a
family; (2) on-site child care services for dependent children; and (3)
policies providing job security for physicians who are temporarily not
in practice due to pregnancy or family obligations.
Physicians in the
academic medical setting should strive to promote the following: (1)
extension of tenure decisions through "stop the clock" programs,
relaxation of the seven year rule, or part-time appointments that would
give faculty members longer to achieve standards for promotion and
tenure; (2) more reasonable guidelines regarding the appropriate
quantity and timing of published material needed for promotion or tenure
that would emphasize quality over quantity and that would encourage the
pursuit of careers based on individual talent rather than tenure
standards that undervalue teaching ability and overvalue research; and
(3) fair distribution of teaching, clinical, research, administrative
responsibilities, and access to tenure tracks between men and women.
Also, physicians in academic institutions should consider formally
structuring the mentoring process, possibly matching students or faculty
with advisors through a fair and visible system. Where such policies do
not exist or have not been followed, all medical workplaces and
institutions should create strict policies to deal with sexual
harassment. Grievance committees should have broad representation of
both sexes and other groups. Such committees should have the power to
enforce harassment policies and be accessible to those persons they are
meant to serve. Grantors of research funds and editors of scientific or
medical journals should consider blind peer review of grant proposals
and articles for publication to help prevent bias. However, grantors and
editors will be able to consider the author's identity and give it
appropriate weight. (II, VII) Issued June 1994 based on the report
"Gender Discrimination in the Medical Profession," adopted June 1993
(Women's Health Issues. 1994; 4: 1-11).
Bonuses to Attract Graduates of U.S. Medical Schools
Signing bonuses or
compensation should not be offered or denied to a resident based on the
country where the resident attended or graduated from medical school.
(III, IV, VI) Issued June 2000 based on the report, "Signing Bonuses to
Attract Graduates of U.S. Medical School," adopted December 1999..91
corruption, or dishonest or unethical conduct on the part of members of
the medical profession is reprehensible. In addition to posing a real or
potential threat to patients, such conduct undermines the public's
confidence in the profession. A physician should expose, without fear or
loss of favor, incompetent or corrupt, dishonest, or unethical conduct
on the part of members of the profession. Questions of such conduct
should be reported and reviewed in accordance with Opinion 9.031,
"Reporting Impaired, Incompetent, or Unethical Colleagues."
governmental laws may subject the physician to civil or criminal
liability. Expulsion from membership is the maximum penalty that may be
imposed by a medical society upon a physician who violates the ethical
standards involving a breach of moral duty or principle. However,
medical societies have a civic and professional obligation to report to
the appropriate governmental body or state board of medical examiners
credible evidence that may come to their attention involving the alleged
criminal conduct of any physician relating to the practice of medicine.
Although a physician charged with allegedly illegal conduct may be
acquitted or exonerated in civil or criminal proceedings, this does not
discharge a medical society from its obligation to initiate a
disciplinary proceeding against a member with reference to the same
conduct where there is credible evidence tending to establish unethical
The Council cannot
pass judgment in advance on a situation that may later come before it on
appeal. The Council cannot be an attorney for a society or a member
thereof and later judge in the same factual situation. The local medical
society has the initial obligation of determining all the facts and
whether or not disciplinary action is indicated. Questions asking for a
review of a proposed course of action or an evaluation of an existing
factual situation should be presented to the appropriate official of the
physician's local society. (II, III, VII) Issued prior to April 1977;
Updated June 1994.
with Disruptive Behavior
This Opinion is
limited to the conduct of individual physicians and does not refer to
physicians acting as a collective, which is considered separately in
Opinion 9.025, "Collective Action and Patient Advocacy."
conduct, whether verbal or physical, that negatively affects or that
potentially may negatively affect patient care constitutes disruptive
behavior. (This includes but is not limited to conduct that interferes
with one's ability to work with other members of the health care team.)
However, criticism that is offered in good faith with the aim of
improving patient care should not be construed as disruptive behavior.
(2) Each medical
staff should develop and adopt bylaw provisions or policies for
intervening in situations where a physician's behavior is identified as
disruptive. The medical staff bylaw provisions or policies should
contain procedural safeguards that protect due process. Physicians
exhibiting disruptive behavior should be referred to a medical staff
(3) In developing
policies that address physicians with disruptive behavior, attention
should be paid to the following elements:
(a) Clearly stating
principal objectives in terms that ensure high standards of patient care
and promote a professional practice and work environment.
(b) Describing the
behavior or types of behavior that will prompt intervention..92
(c) Providing a
channel through which disruptive behavior can be reported and
appropriately recorded. A single incident may not be sufficient for
action, but each individual report may help identify a pattern that
(d) Establishing a
process to review or verify reports of disruptive behavior.
(e) Establishing a
process to notify a physician whose behavior is disruptive that a report
has been made, and providing the physician with an opportunity to
respond to the report.
(f) Including means
of monitoring whether a physician's disruptive conduct improves after
(g) Providing for
evaluative and corrective actions that are commensurate with the
behavior, such as self-correction and structured rehabilitation.
Suspension of responsibilities or privileges should be a mechanism of
final resort. Additionally, institutions should consider whether the
reporting requirements of Opinion 9.031, "Reporting Impaired,
Incompetent, or Unethical Colleagues," apply in particular cases.
which individuals will be involved in the various stages of the process,
from reviewing reports to notifying physicians and monitoring conduct
(i) Providing clear
guidelines for the protection of confidentiality.
(j) Ensuring that
individuals who report physicians with disruptive behavior are duly
protected. (I, II, VIII) Issued December 2000 based on the report
"Physicians With Disruptive Behavior," adopted June 2000.
E-9.05 Due Process.
The basic principles
of a fair and objective hearing should always be accorded to the
physician or medical student whose professional conduct is being
reviewed. The fundamental aspects of a fair hearing are a listing of
specific charges, adequate notice of the right of a hearing, the
opportunity to be present and to rebut the evidence, and the opportunity
to present a defense. These principles apply when the hearing body is a
medical society tribunal, medical staff committee, or other similar body
composed of peers. The composition of committees sitting in judgment of
medical students, residents, or fellows should include a significant
number of persons at a similar level of training.
These principles of
fair play apply in all disciplinary hearings and in any other type of
hearing in which the reputation, professional status, or livelihood of
the physician or medical student may be negatively impacted. All
physicians and medical students are urged to observe diligently these
fundamental safeguards of due process whenever they are called upon to
serve on a committee, which will pass judgment on a peer. All medical
societies and institutions are urged to review their constitutions and
bylaws and/or policies to make sure that these instruments provide for
such procedural safeguards. (II, III, VII) Issued prior to April 1977;
Updated June 1994.
Between Medical Supervisors and Trainees.
Clear policies for
handling complaints from medical students, resident physicians, and
other staff should be established. These policies should include
adequate provisions for protecting the confidentiality of complainants
whenever possible. Confidentiality of complainants should be protected
when doing so does not hinder the subject's ability to respond to the
complaint. Access to employment and evaluation files should be carefully
monitored to remove the possibility of tampering. Resident physicians
should be permitted access to their employment files and also the right
to copy the contents thereof, within the provisions of applicable
federal and state laws..93
resident physicians, and other staff should refuse to participate in
patient care ordered by their supervisors in those rare cases in which
they believe the orders reflect serious errors in clinical or ethical
judgment, or physician impairment, that could result in a threat of
imminent harm to the patient or to others. In these rare cases, the
complainant may withdraw from the care ordered by the supervisor,
provided withdrawal does not itself threaten the patient's immediate
welfare. The complainant should communicate his or her concerns to the
physician issuing the orders and, if necessary, to the appropriate
persons for mediating such disputes. Mechanisms for resolving these
disputes, which require immediate resolution, should be in place.
Third-party mediators of such disputes may include the chief of staff of
the involved service, the chief resident, a designated member of the
institutional grievance committee, or, in large institutions, an
institutional ombudsperson largely outside of the established hospital
punitive actions against those who raise complaints are unethical and
are a legitimate cause for filing a grievance with the appropriate
institutional committee. (II, III, VII) Issued June 1994 based on the
report "Disputes Between Medical Supervisors and Trainees," adopted
December 1993 (JAMA. 1994; 272: 1861-65).
E-9.06 Free Choice.
Free choice of
physicians is the right of every individual. One may select and change
at will one's physicians, or one may choose a medical care plan such as
that provided by a closed panel or group practice or health maintenance
or service organization. The individual's freedom to select a preferred
system of health care and free competition among physicians and
alternative systems of care are prerequisites of ethical practice and
optimal patient care. In choosing to subscribe to a health maintenance
or service organization or in choosing or accepting treatment in a
particular hospital, the patient is thereby accepting limitations upon
free choice of medical services.
The need of an
individual for emergency treatment in cases of accident or sudden
illness may, as a practical matter, preclude free choice of a physician,
particularly where there is loss of consciousness. Although the concept
of free choice assures that an individual can generally choose a
physician, likewise a physician may decline to accept that individual as
a patient. In selecting the physician of choice, the patient may
sometimes be obliged to pay for medical services which might otherwise
be paid by a third party. (IV) Issued prior to April 1977.
E-9.065 Caring for
Each physician has
an obligation to share in providing care to the indigent. The measure of
what constitutes an appropriate contribution may vary with circumstances
such as community characteristics, geographic location, the nature of
the physician's practice and specialty, and other conditions. All
physicians should work to ensure that the needs of the poor in their
communities are met. Caring for the poor should be a regular part of the
physician's practice schedule.
In the poorest
communities, it may not be possible to meet the needs of the indigent
for physicians' services by relying solely on local physicians. The
local physicians should be able to turn for assistance to their
colleagues in prosperous communities, particularly those in close
proximity..94 Physicians are meeting their obligation, and are
encouraged to continue to do so, in a number of ways such as seeing
indigent patients in their offices at no cost or at reduced cost,
serving at freestanding or hospital clinics that treat the poor, and
participating in government programs that provide health care to the
poor. Physicians can also volunteer their services at weekend clinics
for the poor and at shelters for battered women or the homeless.
In addition to
meeting their obligation to care for the indigent, physicians can devote
their energy, knowledge, and prestige to designing and lobbying at all
levels for better programs to provide care for the poor. (I, VII) Issued
June 1994 based on the report "Caring for the Poor," adopted December
1992 (JAMA. 1993; 269: 2533-2537).
As a citizen and as
a professional with special training and experience, the physician has
an ethical obligation to assist in the administration of justice. If a
patient who has a legal claim requests a physician's assistance, the
physician should furnish medical evidence, with the patient's consent,
in order to secure the patient's legal rights.
should have recent and substantive experience in the area in which they
testify and should limit testimony to their sphere of medical expertise.
Medical witnesses should be adequately prepared and should testify
honestly and truthfully to the best of their medical knowledge. The
medical witness must not become an advocate or a partisan in the legal
proceeding. The medical witness should be adequately prepared and should
testify honestly and truthfully. The attorney for the party who calls
the physician as a witness should be informed of all favorable and
unfavorable information developed by the physician's evaluation of the
case. It is unethical for a physician to accept compensation that is
contingent upon the outcome of litigation. (II, IV, V, VII) Issued June
1986; Updated June 1996 based on the report "Ethical Guidelines for
Medical Experts," adopted December 1995.
E-9.08 New Medical
In the ethical
tradition expressed by Hippocrates and continuously affirmed thereafter,
the role of the physician has been that of a healer who serves patients,
a teacher who imparts knowledge of skills and techniques to colleagues,
and a student who constantly seeks to keep abreast of new medical
Physicians have an
obligation to share their knowledge and skills and to report the results
of clinical and laboratory research. Both positive and negative studies
should be included even though they may not support the author's
hypothesis. This tradition enhances patient care, leads to the early
evaluation of new technologies, and permits the rapid dissemination of
withholding of new medical knowledge, skills, and techniques from
colleagues for reasons of personal gain is detrimental to the medical
profession and to society and is to be condemned. Prompt presentation
before scientific organizations and timely publication of clinical and
laboratory research in scientific journals are essential elements in the
foundation of good medical care. (I, II, V, VII) Issued December 1984;
Updated June 1994..95
E-9.09 Patent for
Surgical or Diagnostic Instrument.
A physician may
patent a surgical or diagnostic instrument he or she has discovered or
developed. The laws governing patents are based on the sound doctrine
that one is entitled to protect one's discovery. (V, VII) Issued prior
to April 1977.
E-9.095 Patenting of
A physician has the
ethical responsibility not only to learn from but also to contribute to
the total store of scientific knowledge when possible. Physicians should
strive to advance medical science and make their advances known to
patients, colleagues, and the public. This obligation provides not
merely incentive but imperative to innovate and share the ensuing
advances. The patenting of medical procedures poses substantial risks to
the effective practice of medicine by limiting the availability of new
procedures to patients and should be condemned on this basis.
Accordingly, it is unethical for physicians to seek, secure, or enforce
patents on medical procedures. (V, VII) Issued June 1996 based on the
report "Ethical Issues in the Patenting of Medical Procedures," adopted
June 1995 (Food & Drug Law J. 1998; 53: 341-57).
E-9.10 Peer Review.
ethics committees, hospital credentials and utilization committees, and
other forms of peer review have been long established by organized
medicine to scrutinize physicians' professional conduct. At least to
some extent, each of these types of peer review can be said to impinge
upon the absolute professional freedom of physicians. They are,
nonetheless, recognized and accepted. They are necessary, and committees
performing such work act ethically as long as principles of due process
(Opinion 9.05, "Due Process") are observed. They balance the physician's
right to exercise medical judgment freely with the obligation to do so
wisely and temperately. (II, III, VII) Issued prior to April 1977;
Updated June 1994.
Committees in Health Care Institutions.
guidelines have been developed to aid in the establishment and
functioning of ethics committees in hospitals and other health care
institutions that may choose to form such committees.
committees in health care institutions should be educational and
advisory in purpose. Generally, the function of the ethics committee
should be to consider and assist in resolving unusual, complicated
ethical problems involving issues that affect the care and treatment of
patients within the health care institution. Recommendations of the
ethics committee should impose no obligation for acceptance on the part
of the institution, its governing board, medical staff, attending
physician, or other persons. However, it should be expected that the
recommendations of a dedicated ethics committee will receive serious
consideration by decision makers.
(2) The size of the
committee should be consistent with the needs of the institution but not
so large as to be unwieldy. Committee members should be selected on the
basis of their concern for the welfare of the sick and infirm, their
interest in ethical matters, and their reputation in the community and
among their peers for integrity and mature judgment. Experience as a
member of hospital or medical society committees concerned with ethical
conduct or quality assurance should be considered in selecting ethics
committee members. Committee members should not have other
responsibilities that are likely to prove incompatible with their duties
as members of the ethics committee. Preferably, a majority of the
committee should consist.96 of physicians, nurses, and other health care
providers. In hospitals, medical staff bylaws should delineate the
functions of the committee, general qualifications for membership, and
manner of selection of members, in accordance with these guidelines.
(3) The functions of
the ethics committee should be confined exclusively to _ethical matters.
The Code of Medical Ethics of the American Medical Association is
recommended for the guidance of ethics committees in making their own
recommendations. The matters to be considered by the committee should
consist of ethical subjects that a majority of its members may choose to
discuss on its own initiative, matters referred to it by the executive
commitee of the organized medical staff or by the governing board of the
institution, or appropriate requests from patients, families, or health
denominational health care institutions or those operated by religious
orders, the recommendations of the ethics committee may be anticipated
to be consistent with published religious tenets and principles. Where
particular religious beliefs are to be taken into consideration in the
committee's recommendations, this fact should be publicized to
physicians, patients, and others concerned with the committee's
(5) In its
deliberations and communication of recommendations, the procedures
followed by the ethics committee should comply with institutional and
ethical policies for preserving the confidentiality of information
members should be prepared to meet on short notice and to render their
recommendations in a timely and prompt fashion in accordance with the
demands of the situation and the issues involved. (II, IV, VII) Issued
June 1994 based on the report "Guidelines for Ethics Committees in
Health Care Institutions," adopted December 1984 (JAMA. 1985; 253:
may be called to clarify ethical issues without reference to a
particular case, facilitate discussion of an ethical dilemma in a
particular case, or resolve an ethical dispute. The consultation
mechanism may be through an ethics committee, a subset of the committee,
individual consultants, or consultation teams. The following guidelines
are offered with respect to these services:
(1) All hospitals
and other health care institutions should provide access to ethics
consultation services. Health care facilities without ethics committees
or consultation services should develop flexible, efficient mechanisms
of ethics review that divide the burden of committee functioning among
collaborating health care facilities.
offering ethics consultation services must appreciate the complexity of
the task, recognizing the potential for harm as well as benefit, and act
responsibly. This includes true institutional support for the service.
consultation services require a serious investment of time and effort by
the individuals involved. Members should include either individuals with
extensive formal training and experience in clinical ethics or
individuals who have made a substantial commitment over several years to
gain sufficient knowledge, skills, and understanding of the complexity
of clinical ethics. A wide variety of background training is preferable,
including such fields as philosophy, religion, medicine, and law.
structural standards should be developed and consistently followed.
These should include developing a clear description of the consultation
service's role and determining which types of cases will be addressed,
how the cases will be referred to the service, whether the service will
provide recommendations or simply function as a forum for discussion,
and whether recommendations are binding or advisory..97
procedural standards should be developed and consistently followed.
These should include establishing who must be involved in the
consultation process and how notification, informed consent,
confidentiality and case write-ups will be handled.
(6) In general,
patient and staff informed consent may be presumed for ethics
consultation. However, patients and families should be given the
opportunity, not to participate in discussions either formally, through
the institutional process, or informally.
(7) In those cases
where the patient or family has chosen not to participate in the
consultation process, the final recommendations of the consultant(s)
should be tempered.
(8) In general,
ethics consultation services, like social services, should be financed
by the institution.
(9) A consultation
service should be careful not to take on more than it can handle, ie,
the complexity of the role should correspond to the level of
sophistication of the service and the resources it has available. As a
result, some services may offer only information and education, others a
forum for discussion but not advice, others might serve a mediation
role, and some might handle even administrative or organizational ethics
issues. (IV, V) Issued June 1998 based on the report "Ethics
Consultation," adopted December 1997.
Patient-Physician Relationship: Respect for Law and Human Rights.
The creation of the
patient-physician relationship is contractual in nature. Generally, both
the physician and the patient are free to enter into or decline the
relationship. A physician may decline to undertake the care of a patient
whose medical condition is not within the physician's current
competence. However, physicians who offer their services to the public
may not decline to accept patients because of race, color, religion,
national origin, sexual orientation, or any other basis that would
constitute invidious discrimination. Furthermore, physicians who are
obligated under pre-existing contractual arrangements may not decline to
accept patients as provided by those arrangements. (I, III, V, VI)
Issued July 1986; Updated June 1994.
Disparities in Health Care.
medical care based on immutable characteristics such as race must be
avoided. Whether such disparities in health care are caused by treatment
decisions, differences in income and education, sociocultural factors,
or failures by the medical profession, they are unjustifiable and must
be eliminated. Physicians should examine their own practices to ensure
that racial prejudice does not affect clinical judgment in medical care.
(I, IV) Issued March 1992 based on the report "Black-White Disparities
in Health Care," adopted December 1989 (JAMA. 1990; 263: 2344-2346);
Updated June 1994.
Disparities in Health Care.
A patient's gender
plays an appropriate role in medical decision making when biological
differences between the sexes are considered. However, some data suggest
that gender bias may be playing a role in medical decision making.
Social attitudes, including stereotypes, prejudices, and other
evaluations based on gender role expectations, may play themselves out
in a variety of subtle ways. Physicians must ensure that gender is not
used inappropriately as a consideration in clinical decision making.
Physicians should examine their practices and attitudes for influence of
social or cultural biases which could be inadvertently affecting the
delivery of medical care.
Research on health
problems that affect both genders should include male and female
subjects, and results of medical research done solely on males should
not be generalized to females without evidence that results apply to
both sexes. Medicine and society in general should ensure that resources
for medical research.98 should be distributed in a manner which promotes
the health of both sexes to the greatest extent possible. (I, IV) Issued
March 1992 based on the report "Gender Disparities in Clinical Decision
Making," adopted December 1990 (JAMA. 1991; 266: 559-62); Updated June
and Infectious Diseases.
A physician who
knows that he or she has an infectious disease, which if contracted by
the patient would pose a significant risk to the patient, should not
engage in any activity that creates a significant risk of transmission
of that disease to the patient. The precautions taken to prevent the
transmission of a contagious disease to a patient should be appropriate
to the seriousness of the disease and must be particularly stringent in
the case of a disease that is potentially fatal. (I, IV) Issued August
1989; Updated June 1996 and June 1999.
Patients and Physicians.
A physician may not
ethically refuse to treat a patient whose condition is within the
physician's current realm of competence solely because the patient is
seropositive for HIV. Persons who are seropositive should not be
subjected to discrimination based on fear or prejudice. When physicians
are unable to provide the services required by an HIV-infected patient,
they should make appropriate referrals to those physicians or facilities
equipped to provide such services. A physician who knows that he or she
is seropositive should not engage in any activity that creates a
significant risk of transmission of the disease to others. A physician
who has HIV disease or who is seropositive should consult colleagues as
to which activities the physician can pursue without creating a risk to
patients. (I, II, IV) Issued March 1992 based on the report "Ethical
Issues in the Growing AIDS Crisis," adopted December 1987 (JAMA. 1988;
259: 1360-1361); Updated June 1996 and June 1998.
E-9.132 Health Care
Fraud and Abuse.
guidelines encourage physicians to play a key role in identifying and
(1) Physicians must
renew their commitment to Principle II of the American Medical
Association's Principles of Medical Ethics which states that "a
physician shall deal honestly with patients and colleagues, and strive
to expose those physicians deficient in character, competence, or who
engage in fraud or deception."
should make no intentional misrepresentations to increase the level of
payment they receive or to secure non-covered health benefits for their
patients. (II) Issued June 1998 based on the report "Health Care Fraud
and Abuse," adopted December 1997 (J. Okla. St. Med. Assoc. 1998; 91:
E-10.00 Opinions on
the Patient-Physician Relationship
Elements of the Patient-Physician Relationship
From ancient times,
physicians have recognized that the health and well-being of patients
depends upon a collaborative effort between physician and patient.
Patients share with physicians the responsibility for their own health
care. The patient-physician relationship is of greatest benefit to
patients when they bring medical problems to the attention of their
physicians in a timely fashion, provide information about their medical
condition to the best of their ability, and work with their physicians
in a mutually respectful.99 alliance. Physicians can best contribute to
this alliance by serving as their patients' advocate and by fostering
(1) The patient has
the right to receive information from physicians and to discuss the
benefits, risks, and costs of appropriate treatment alternatives.
Patients should receive guidance from their physicians as to the optimal
course of action. Patients are also entitled to obtain copies or
summaries of their medical records, to have their questions answered, to
be advised of potential conflicts of interest that their physicians
might have, and to receive independent professional opinions.
(2) The patient has
the right to make decisions regarding the health care that is
recommended by his or her physician. Accordingly, patients may accept or
refuse any recommended medical treatment.
(3) The patient has
the right to courtesy, respect, dignity, responsiveness, and timely
attention to his or her needs.
(4) The patient has
the right to confidentiality. The physician should not reveal
information without the consent of the patient, unless provided for by
law or by the need to protect the welfare of the individual or the
(5) The patient has
the right to continuity of health care. The physician has an obligation
to cooperate in the coordination of medically indicated care with other
health care providers treating the patient. The physician may not
discontinue treatment of a patient as long as further treatment is
medically indicated, without giving the patient reasonable assistance
and sufficient opportunity to make alternative arrangements for care.
(6) The patient has
a basic right to have available adequate health care. Physicians, along
with the rest of society, should continue to work toward this goal.
Fulfillment of this right is dependent on society providing resources so
that no patient is deprived of necessary care because of an inability to
pay for the care. Physicians should continue their traditional
assumption of a part of the responsibility for the medical care of those
who cannot afford essential health care. Physicians should advocate for
patients in dealing with third parties when appropriate. (I, IV, V,
VIII, IX) Issued June 1992 based on the report, "Fundamental Elements of
the Patient-Physician Relationship," adopted June 1990; Updated 1993.
The practice of
medicine, and its embodiment in the clinical encounter between a patient
and a physician, is fundamentally a moral activity that arises from the
imperative to care for patients and to alleviate suffering. A
patient-physician relationship exists when a physician serves a
patient's medical needs, generally by mutual consent between physician
and patient (or surrogate). In some instances the agreement is implied,
such as in emergency care or when physicians provide services at the
request of the treating physician. In rare instances, treatment without
consent may be provided under court order (see Opinion 2.065).
Nevertheless, the physician's obligations to the patient remain intact.
The relationship between patient and physician is based on trust and
gives rise to physicians' ethical obligations to place patients' welfare
above their own self-interest and above obligations to other groups, and
to advocate for their patients' welfare.
patient-physician relationship, a physician is ethically required to use
sound medical judgment, holding the best interests of the patient as
paramount. (I, II, VI, VIII) Issued December 2001 based on the report
"The Patient-Physician Relationship," adopted June 2001..100
It has long been
recognized that successful medical care requires an ongoing
collaborative effort between patients and physicians. Physician and
patient are bound in a partnership that requires both individuals to
take an active role in the healing process. Such a partnership does not
imply that both partners have identical responsibilities or equal power.
While physicians have the responsibility to provide health care services
to patients to the best of their ability, patients have the
responsibility to communicate openly, to participate in decisions about
the diagnostic and treatment recommendations, and to comply with the
agreed-upon treatment program.
rights, patients' responsibilities are derived from the principle of
autonomy. The principle of patient autonomy holds that an individual's
physical, emotional, and psychological integrity should be respected and
upheld. This principle also recognizes the human capacity to self-govern
and choose a course of action from among different alternative options.
Autonomous, competent patients assert some control over the decisions
which direct their health care. With that exercise of self-governance
and free choice comes a number of responsibilities.
communication is essential to a successful patient-physician
relationship. To the extent possible, patients have a responsibility to
be truthful and to express their concerns clearly to their physicians.
(2) Patients have a
responsibility to provide a complete medical history, to the extent
possible, including information about past illnesses, medications,
hospitalizations, family history of illness, and other matters relating
to present health.
(3) Patients have a
responsibility to request information or clarification about their
health status or treatment when they do not fully understand what has
(4) Once patients
and physicians agree upon the goals of therapy and a treatment plan,
patients have a responsibility to cooperate with that treatment plan and
to keep their agreed-upon appointments. Compliance with physician
instructions is often essential to public and individual safety.
Patients also have a responsibility to disclose whether previously
agreed upon treatments are being followed and to indicate when they
would like to reconsider the treatment plan.
generally have a responsibility to meet their financial obligations with
regard to medical care or to discuss financial hardships with their
physicians. Patients should be cognizant of the costs associated with
using a limited resource like health care and try to use medical
(6) Patients should
discuss end-of-life decisions with their physicians and make their
wishes known. Such a discussion might also include writing an advance
(7) Patients should
be committed to health maintenance through health-enhancing behavior.
Illness can often be prevented by a healthy lifestyle, and patients
should take personal responsibility when they are able to avert the
development of disease.
(8) Patients should
also have an active interest in the effects of their conduct on others
and refrain from behavior that unreasonably places the health of others
at risk. Patients should inquire as to the means and likelihood of
infectious disease transmission and act upon that information which can
best prevent further transmission.
(9) Participation in
medical education is to the mutual benefit of patients and the health
care system. Patients are encouraged to participate in medical education
by accepting care, under appropriate supervision, from medical students,
residents, and other trainees. Consistent with the process of informed
consent, the patient or the patient's surrogate decision maker is always
free to refuse care from any member of the health care team.
(10) Patients should
discuss organ donation with their physicians and, if donation is
desired, make applicable provisions. Patients who are part of an organ
allocation system and await needed transplant.101 should not try to go
outside of or manipulate the system. A fair system of allocation should
be answered with public trust and an awareness of limited resources.
(11) Patients should
not initiate or participate in fraudulent health care and should report
illegal or unethical behavior by physicians and other providers to the
appropriate medical societies, licensing boards, or law enforcement
authorities. (I, IV, VI) Issued June 1994 based on the report "Patient
Responsibilities", adopted June 1993; Updated June 1998, December 2000,
and June 2001.
Patient-Physician Relationship in the Context of Work-Related and
When a physician is
responsible for performing an isolated assessment of an individual's
health or disability for an employer, business, or insurer, a limited
patient-physician relationship should be considered to exist. Both
"Industry Employed Physicians" (IEPs), who are employed by businesses or
insurance companies for the purpose of conducting medical examinations,
and "Independent Medical Examiners" (IMEs), who are independent
contractors providing medical examinations within the realm of their
specialty, may perform such medical examinations.
Despite their ties
to a third party, the responsibilities of IEPs and IMEs are in some
basic respects very similar to those of other physicians. IEPs and IMEs
have the same obligations as physicians in other contexts to:
objectively the patient's health or disability. In order to maintain
objectivity, IEPs and IMEs should not be influenced by the preferences
of the patient-employee, employer, or insurance company when making a
diagnosis during a work-related or independent medical examination.
(2) Maintain patient
confidentiality as outlined by Opinion 5.09, Industry Employed
Physicians and Independent Medical Examiners.
(3) Disclose fully
potential or perceived conflicts of interest. The physician should
inform the patient about the terms of the agreement between himself or
herself and the third party as well as the fact that he or she is acting
as an agent of that entity. This should be done at the outset of the
examination, before health information is gathered from the
patient-employee. Before the physician proceeds with the exam, he or she
should ensure to the extent possible that the patient understands the
physician's unaltered ethical obligations, as well as the differences
that exist between the physician's role in this context and the
physician's traditional fiduciary role.
IEPs and IMEs are
responsible for administering an objective medical evaluation but not
for monitoring patients' health over time, treating patients, or
fulfilling many other duties traditionally held by physicians.
Consequently, a limited patient-physician relationship should be
considered to exist during isolated assessments of an individual's
health or disability for an employer, business, or insurer.
The physician has a
responsibility to inform the patient about important health information
or abnormalities that he or she discovers during the course of the
examination. In addition, the physician should ensure to the extent
possible that the patient understands the problem or diagnosis.
Furthermore, when appropriate, the physician should suggest that the
patient seek care from a qualified physician and, if requested, provide
reasonable assistance in securing follow-up care. (I) Issued December
1999 based on the report "Patient-Physician Relationship in the Context
of Work-Related and Independent Medical Examinations," adopted June
(1) Physicians must
keep their professional obligations to provide care to patients in
accord with their prerogative to choose whether to enter into a
(2) The following
instances identify the limits on physicians' prerogative:
should respond to the best of their ability in cases of medical
emergency (Opinion 8.11, "Neglect of Patient").
cannot refuse to care for patients based on race, gender, sexual
orientation, or any other criteria that would constitute invidious
discrimination (Opinion 9.12, "Patient-Physician Relationship: Respect
for Law and Human Rights"), nor can they discriminate against patients
with infectious diseases (Opinion 2.23, "HIV Testing").
(c) Physicians may
not refuse to care for patients when operating under a contractual
arrangement that requires them to treat (Opinion 9.12,
"Patient-Physician Relationship: Respect for Law and Human Rights").
Exceptions to this requirement may exist when patient care is ultimately
compromised by the contractual arrangement.
(3) In situations
not covered above, it may be ethically permissible for physicians to
decline a potential patient when:
(a) The treatment
request is beyond the physician's current competence (Opinion 9.12,
"Patient-Physician Relationship: Respect for Law and Human Rights").
(b) The treatment
request is known to be scientifically invalid, has no medical
indication, and offers no possible benefit to the patient (Opinion 8.20,
"Invalid Medical Treatment").
(c) A specific
treatment sought by an individual is incompatible with the physician's
personal, religious, or moral beliefs.
(4) Physicians, as
professionals and members of society, should work to assure access to
adequate health care (Fundamental Element VI).* Accordingly, physicians
have an obligation to share in providing charity care (Opinion 9.065,
"Caring for the Poor") but not to the degree that would seriously
compromise the care provided to existing patients. When deciding whether
to take on a new patient, physicians should consider the individual's
need for medical service along with the needs of their current patients.
Treatments range along a continuum from necessary to sustain life, to
necessary to sustain functioning health, to useful to sustain
functioning health, to discretionary. Clearly, greater individual need
for a service corresponds with a stronger obligation to treat. (I, VI,
VIII, IX) Issued December 2000 based on the report "Potential
Considerations," adopted June 2000.
determining an adequate level of health care are outlined in Opinion
2.095: "The Provision of Adequate Health Care."
(1) If physicians
who share office space want to share a clinical lab, may they refer
The Council does not
view self-referral to a shared clinical lab as inappropriate when the
facility is a true extension of the physician's practice. Thus, the
Council's guidelines permit two or more solo practicing physicians to
share a clinical laboratory to avoid duplication and limit overhead
costs, as long as several conditions are met: (a) the physicians have
office space in the same building or complex where the laboratory is
located, (b) the laboratory is not a separate corporate entity, (c) the
physicians actively supervise the testing provided by the laboratory,
(d) the physicians are equally responsible for the actions of the
laboratory or are responsible for the services to their patients, (e)
the laboratory provides services only for patients of the physicians,
(f) all testing is performed on site, and (g) all services are billed by
the ordering physician under that physician's provider number. While
self-referral to shared clinical laboratories is permissible, there is
still an obligation to comply with the Council's guidelines in Opinion
8.032, "Conflicts of Interest: Health Facility Ownership by a
(2) May a physician
refer patients to an outside pharmacy if the physician has a financial
A pharmacy is a
health care facility for the purposes of the Council's guidelines.
Hence, when a physician has a financial interest in a pharmacy, it is
inappropriate to refer patients to the pharmacy unless the demonstrated
need or direct provision of care requirements of the Council's
guidelines are met. (The Council's Opinion 8.06, "Drugs and Devices:
Prescribing states in part that "a physician may own or operate a
pharmacy...if there is no resulting exploitation of patient." That
position was superseded by Opinion 8.032, "Conflicts of Interest: Health
Facility Ownership by a Physician.") According to Opinions 8.06 and
6.04, it is not inappropriate to dispense drugs within one's own office
practice, as long as the drugs are medically indicated for the patient
and the quantity of the drug prescribed is no greater than is reasonably
required for the patient's condition.
(3) May physicians
self-refer patients to outside physical therapy facilities, optical
shops, or other
health care facilities if they directly provide or supervise the care
or services provided there?
self-refer to an outside facility if they directly provide care at that
facility. For instance, a surgeon may operate at an ambulatory surgical
facility in which the surgeon has an investment interest. In general,
the provision of care is "direct" only if it entails the personal,
hands-on involvement of the physician on site when care is being
provided to the patient. The physician need not be present the entire
time on every visit of a patient's care. However, the physician must be
participating in the patient's care on site for a significant percentage
of visits and a significant portion of the time during which services
are rendered. The appropriate degree of physician involvement is a
medical decision that will vary according to patients' needs, making it
difficult to give explicit guidelines in this area. Sometimes, physician
participation will be required every third episode of patient care; for
other cases, every sixth visit would be adequate. However, the Council
feels that physicians who directly provide care to the patient on site
at least every fourth patient visit may confidently be considered to
have fulfilled the direct provision of care requirement, though there
will be many patients for whom more or less on-site physician care will
be medically indicated.
(4) May physicians
self-refer patients to an outside home infusion company or dialysis
center if they
continue to be responsible for the management of the patient's case?.104
responsibility for the patient's overall course of treatment does not
necessarily mean that the physician is actively involved in the care
provided to the patient by the home infusion company or dialysis center.
In home infusion, for instance, the physician directly provides care
only if he or she regularly travels to the patients' homes and is
personally involved in the patient's care. In a dialysis center, the
physician directly provides care only if he or she is personally
involved in the dialysis treatment. As discussed in question (3), the
physician need not be on site during the entire time that care is being
delivered or during every administration of care. However, there has to
be significant on-site involvement.
(5) If physicians
are part owners of a hospital, may they refer patients to a physical
laboratory, or MRI located within that hospital?
A physician may
refer an inpatient to needed hospital-based facilities, as long as the
physician is providing care to the patient in the hospital. However, for
outpatients seen in the physician's office practice, hospital-based
facilities are no different from the other outside facilities the
physician may own. Thus, referral of outpatients to a hospital-based
facility in which the physician has an ownership interest is
inappropriate self-referral, unless it meets the demonstrated need or
direct provision of care requirements. Furthermore, physicians with an
ownership interest in a hospital may admit their own patients there, but
only if they continue to directly provide care to those patients while
the patients are in the hospital. Physicians may not admit patients to a
hospital in which they have an ownership interest if the patients' care
will be turned over to other members of the hospital's staff, unless the
hospital meets a demonstrated need in the community.
(6) May physicians
refer patients to physical therapists or opticians they employ if they
next door to the physicians' offices, or within the same office
If physicians employ
therapists, opticians, or other allied professionals as part of their
practice, then they can have their patients see the allied
professionals, regardless of the allied professions' physical location.
However, if the allied professional is employed by a physical therapy
facility, optical shop, or other health care facility in which the
physician has an investment interest, but which is legally separate from
the physician's practice, then self-referral is generally not
appropriate unless the facility meets the demonstrated need or direct
provision of care requirements.
(7) If a group of
physicians owns some vacant office space next door to their own group
they lease that space to an independent physical therapist or
optician and refer their patients there?
This would be
acceptable as long as the office space is leased at its fair market
value, and the amount of rent paid is not tied to the profits of the
(8) If a physician
serves as the medical director of his or her own outside health care
facility, does this
constitute the direct provision of care at that facility?
The position of
"Medical Director" of a facility does not in itself necessarily mean
that the physician is directly involved in the care or services there.
For instance, providing only administrative duties or serving as a
figurehead or spokesperson for the facility would not constitute the
direct provision of care or services. The relevant factor is the
physician's activity, not his or her title.
(9) If the
physician-owned facility can provide higher quality services to patients
at a lower price than
competitors, does this indicate that the facility meets a
demonstrated need in the community, thereby allowing the
physician-owners to refer their own patients there?.105
facilities do not provide medically appropriate services, this
demonstrates a need for the facility in the community that is strong
enough to justify self-referral. For instance, if the quality of
services provided by competing facilities is so poor that they cannot be
considered adequate, or competitors charge substantially higher fees
than the physician-owned facility, then a demonstrated need for the
physician-owned facility may exist. However, the advantages of the
physician-owned facility for patients must be truly substantial; a
demonstrated need would not exist if the differences in quality and
price were only marginal. Moreover, the builder of the facility would
still have to show that alternative financing for the facility was
(10) If physicians
start their own outside facility in response to a demonstrated need in
community, and then some years later a few competitors enter the market,
are the physicians obligated to divest from their own facility?
Yes. The risks
inherent in self-referral require divestment when the need for
self-referral no longer exists. However, physicians who invested in
facilities to meet a demonstrated need in the community should not be
damaged by the requirement to later divest. If the investor were able to
recover his or her original investment, plus a reasonable rate of
return, there would appear to be no loss or hardship. The Council
expects that, generally, physicians can fully divest within three years
after the entry of competitors into the market. In the meantime, there
is still an obligation to comply with the Council's guidelines in
Opinion 8.032, "Conflicts of Interest: Health Facility Ownership by a
Physician." Adopted December 2000 as "Addendum I: Council on Ethical and
Judicial Affairs Clarification of Self-Referral (E-8.032)."
"Gifts to Physicians from Industry," is intended to provide ethical
guidance to physicians. Other parties involved in the health care
sector, including the pharmaceutical, devices, and medical equipment
industries and related entities or business partners, should view the
guidelines as indicative of standards of conduct for the medical
profession. Ultimately, it is the responsibility of individual
physicians to minimize conflicts of interest that may be at odds with
the best interest of patients and to access the necessary information to
inform medical recommendations. The guidelines apply to all forms of
gifts, whether they are offered in person, through intermediaries, or
through the Internet. Similarly, limitations on subsidies for
educational activities should apply regardless of the setting in which,
or the medium through which, the educational activity is offered.
(a) Do the
guidelines apply only to pharmaceutical, device, and equipment
manufacturers? "Industry" includes all "proprietary health-related
entities that might create a conflict of interest."
GUIDELINE 1. Any
gifts accepted by physicians individually should primarily entail a
patients and should not be of substantial value. Accordingly,
textbooks, modest meals, and other gifts are appropriate if they
serve a genuine educational function. Cash payments should not be
accepted..106 The use of drug samples for personal or family use
is permissible as long as these practices do not interfere with
patient access to drug samples. It would not be acceptable for
non-retired physicians to request free pharmaceuticals for
personal use or for use by family members.
(a) May physicians
accept gram stain test kits, stethoscopes, or other diagnostic
equipment? Diagnostic equipment primarily benefits the patient. Hence,
such gifts are permissible as long as they are not of substantial value.
In considering the value of the gift, the relevant measure is not the
cost to the company of providing the gift. Rather, the relevant measure
is the cost to the physician if the physician purchased the gift on the
(b) May companies
invite physicians to a dinner with a speaker and donate $100 to a
charity or medical school on behalf of the physician?
There are positive
aspects to the proposal. The donations would be used for a worthy cause,
and the physicians would receive important information about patient
care. There is a direct personal benefit to the physician as well,
however. An organization that is important to the physician--and one
that the physician might have ordinarily felt obligated to make a
contribution to--receives financial support as a result of the
physician's decision to attend the meeting. On balance, physicians
should make their own judgment about these inducements. If the charity
is predetermined without the physician's input, there would seem to be
little problem with the arrangement.
contributions to a professional society's general fund be accepted from
industry? The guidelines are designed to deal with gifts from industry
which affect, or could appear to affect, the judgment of individual
practicing physicians. In general, a professional society should make
its own judgment about gifts from industry to the society itself.
(d) When companies
invite physicians to a dinner with a speaker, what are the relevant
guidelines? First, the dinner must be a modest meal. Second, the
guideline does allow gifts that primarily benefit patients and that are
not of substantial value. Accordingly, textbooks and other gifts that
primarily benefit patient care and that have a value to the physician in
the general range of $100 are permissible. When educational meetings
occur in conjunction with a social event such as a meal, the educational
component must have independent value, such as a presentation by an
authoritative speaker other than a sales representative of the company.
Also, the meal should be a modest one similar to what a physician
routinely might have when dining at his or her own expense. In an office
or hospital encounter with a company representative, it is permissible
to accept a meal of nominal value, such as a sandwich or snack.
(e) May physicians
accept vouchers that reimburse them for uncompensated care they have
provided? No. Such a voucher would result directly in increased income
for the physician.
(f) May physicians
accumulate "points" by attending several educational or promotional
meetings and then choose a gift from a catalogue of education options?
This guideline permits gifts only if they are not of substantial value.
If accumulation of points would result in physicians receiving a
substantial gift by combining insubstantial gifts over a relatively
short period of time, it would be inappropriate..107
(g) May physicians
accept gift certificates for educational materials when attending
promotional or educational events? The Council views gift certificates
as a grey area which is not per se prohibited by the guidelines. Medical
text books are explicitly approved as gifts under the guidelines. A gift
certificate for educational materials, ie, for the selection by the
physician from an exclusively medical text book catalogue, would not
seem to be materially different. The issue is whether the gift
certificate gives the recipient such control as to make the certificate
similar to cash. As with charitable donations, pre-selection by the
sponsor removes any question. It is up to the individual physician to
make the final judgment.
(h) May physicians
accept drug samples or other free pharmaceuticals for personal use or
use by family members? The Council's guidelines permit personal or
family use of free pharmaceuticals (i) in emergencies and other cases
where the immediate use of a drug is indicated, (ii) on a trial basis to
assess tolerance, and (iii) for the treatment of acute conditions
requiring short courses of inexpensive therapy, as permitted by Opinion
8.19, "Self-Treatment or Treatment of Immediate Family Members." It
would not be acceptable for physicians to accept free pharmaceuticals
for the long-term treatment of chronic conditions.
(i) May companies
invite physicians to a dinner with a speaker and offer them a large
number of gifts from which to choose one? In general, the greater the
freedom of choice given to the physician, the more the offer seems like
cash. A large number of gifts presented to physicians who attend a
dinner would therefore be inappropriate. There is no precise way of
deciding an appropriate upper limit on the amount of choice that is
acceptable. However, it is important that a specific limit be chosen to
ensure clarity in the guidelines. A limit of eight has been chosen
because it permits flexibility but prevents undue freedom of choice.
Each of the choices must have a value to the physicians of no more than
(j) May physicians
charge for their time with industry representatives or otherwise receive
material compensation for participation in a detail visit? Guideline 1
states that gifts in the form of cash payments should not be accepted.
Also, Guideline 6 makes clear that, in the context of the
industry-physician relationship, only physicians who provide genuine
services may receive reasonable compensation. When considering the time
a physician spends with an industry representative, it is the
representative who offers a service, namely the presentation of
information. The physician is a beneficiary of the service. Overall,
these guidelines do not view that physicians should be compensated for
the time spent participating in educational activities, nor for time
spent receiving detail information from an industry representative.
Individual gifts of minimal value are permissible as long as the gifts
are related to the
physician's work (eg, pens and notepads).
(a) May physicians,
individually or through their practice group, accept electronic
equipment, such as hand held devices or computers, intended to
facilitate their ability to receive detail information
electronically?.108 Although Guideline 2 recognizes that gifts related
to a physician's practice may be appropriate, it also makes clear that
these gifts must remain of minimal value. It is not appropriate for
physicians to accept expensive hardware or software even though one
purpose only may pertain to industry-related activities of a modest
GUIDELINE 3. The
Council on Ethical and Judicial Affairs defines a legitimate
"meeting" as any activity, held at an appropriate location, where (a)
the gathering is primarily dedicated, in both time and effort, to
promoting objective scientific and educational activities and
discourse (one or more educational presentation(s) should be the
highlight of the gathering), and (b) the main incentive for
bringing attendees together is to further their knowledge on the
topic(s) being presented. An appropriate disclosure of financial
support or conflict of interest should be made.
Subsidies to underwrite the costs of continuing medical education
professional meetings can contribute to the improvement of patient
care and therefore are permissible. Since the giving of a subsidy
directly to a physician by a company's sales representative may
create a relationship which could influence the use of the company's
products, any subsidy should be accepted by the conference's
sponsor who in turn can use the money to reduce the conference's
registration fee. Payments to defray the costs of a conference should
not be accepted directly from the company by the physicians
attending the conference.
(a) Are conference
subsidies from the educational division of a company covered by the
guidelines? Yes. When the Council says "any subsidy," it would not
matter whether the subsidy comes from the sales division, the
educational division, or some other section of the company.
(b) May a company or
its intermediary send physicians a check or voucher to offset the
registration fee at a specific conference or a conference of the
physician's choice? Physicians should not directly accept checks or
certificates which would be used to offset registration fees. The gift
of a reduced registration should be made across the board and through
the accredited sponsor.
Subsidies from industry should not be accepted directly or indirectly to
pay for the
costs of travel, lodging, or other personal expenses of physicians
attending conferences or meetings, nor should subsidies be
accepted to compensate for the physicians' time. Subsidies for
hospitality should not be accepted outside of modest meals or
social events held as a part of a conference or meeting. It is
appropriate for faculty at conferences or meetings to accept reasonable
honoraria and to accept reimbursement for reasonable travel,
lodging, and meal expenses. It is also appropriate for
consultants who provide genuine services to receive reasonable
compensation and to accept reimbursement for reasonable travel,
lodging, and meal expenses. Token consulting or advisory
arrangements cannot be used to justify the compensation of physicians
for their time or their travel, lodging, and other out-of-pocket
(a) If a company
invites physicians to visit its facilities for a tour or to become
educated about one of its products, may the company pay travel expenses
and honoraria? This question has come up in the context of a
rehabilitation facility that wants physicians to know of its existence
so that they may refer their patients to the facility. It has also come
up in the context of surgical device or equipment manufacturers who want
physicians to become familiar with their products..109 In general,
travel expenses should not be reimbursed, nor should honoraria be paid
for the visiting physician's time since the presentations are analogous
to a pharmaceutical company's educational or promotional meetings. The
Council recognizes that medical devices, equipment, and other
technologies may require, in some circumstances, special evaluation or
training in proper usage which can not practicably be provided except on
site. Medical specialties are in a better position to advise physicians
regarding the appropriateness of reimbursement with regard to these
trips. In cases where the company insists on such visits as a means of
protection from liability for improper usage, physicians and their
specialties should make the judgment. In no case would honoraria be
appropriate and any travel expenses should be only those strictly
(b) If the company
invites physicians to visit its facilities for review and comment on a
product, to discuss their independent research projects, or to explore
the potential for collaborative research, may the company pay travel
expenses and an honorarium? If the physician is providing genuine
services, reasonable compensation for time and travel expenses can be
given. However, token advisory or consulting arrangements cannot be used
to justify compensation.
(c) May a company
hold a sweepstakes for physicians in which five entrants receive a trip
to the Virgin Islands or airfare to the medical meeting of their choice?
No. The use of a sweepstakes or raffle to deliver a gift does not affect
the permissibility of the gift. Since the sweepstakes is not open to the
public, the guidelines apply in full force.
(d) If a company
convenes a group of physicians to recruit clinical investigators or
convenes a group of clinical investigators for a meeting to discuss
their results, may the company pay for their travel expenses? Expenses
may be paid if the meetings serve a genuine research purpose. One guide
to their propriety would be whether the National Institutes of Health
conducts similar meetings when it sponsors multi-center clinical trials.
When travel subsidies are acceptable, the guidelines emphasize that they
be used to pay only for "reasonable" expenses. The reasonableness of
expenses would depend on a number of considerations. For example,
meetings are likely to be problematic if overseas locations are used for
exclusively domestic investigators. It would be inappropriate to pay for
recreation or entertainment beyond the kind of modest hospitality
described in this guideline.
(e) How can a
physician tell whether there is a "genuine research purpose?" A number
of factors can be considered. Signs that a genuine research purpose
exists include the facts that there are (1) a valid study protocol, (2)
recruitment of physicians with appropriate qualifications or expertise,
and (3) recruitment of an appropriate number of physicians in light of
the number of study participants needed for statistical evaluation.
(f) May a company
compensate physicians for their time and travel expenses when they
participate in focus groups? Yes. As long as the focus groups serve a
genuine and exclusive research purpose and are not used for promotional
purposes, physicians may be compensated for time and travel expenses.
The number of
physicians used in a
particular focus group or in multiple focus groups should be an
appropriate size to accomplish the research purpose, but no larger..110
(g) Do the
restrictions on travel, lodging, and meals apply to educational programs
run by medical schools, professional societies, or other accredited
organizations which are funded by industry, or do they apply only to
programs developed and run by industry? The restrictions apply to all
conferences or meetings which are funded by industry. The Council drew
no distinction on the basis of the organizer of the conference or
meeting. The Council felt that the gift of travel expenses is too
substantial even when the conference is run by a non-industry sponsor.
(Industry includes all "proprietary health-related entities that might
create a conflict of interest.")
(h) May company
funds be used for travel expenses and honoraria for bona fide faculty at
educational meetings? This guideline draws a distinction between
attendees and faculty. As was stated, "[i]t is appropriate for faculty
at conferences or meetings to accept reasonable honoraria and to accept
reimbursement for reasonable travel, lodging, and meal expenses."
Companies need to be mindful of the guidelines of the Accreditation
Council on Continuing Medical Education. According to those guidelines,
"[f]unds from a commercial source should be in the form of an
educational grant made payable to the CME sponsor for the support of
(i) May travel
expenses be reimbursed for physicians presenting a poster or a "free
paper" at a scientific conference? Reimbursement may be accepted only by
bona fide faculty. The presentation of a poster or a free paper does not
by itself qualify a person as a member of the conference faculty for
purposes of these guidelines.
(j) When a
professional association schedules a long-range planning meeting, is it
appropriate for industry to subsidize the travel expenses of the meeting
participants? The guidelines are designed to deal with gifts from
industry which affect, or could appear to affect, the judgment of
individual practicing physicians. In general, a professional society
should make its own judgment about gifts from industry to the society
(k) May continuing
medical education conferences be held in the Bahamas, Europe, or South
America? There are no restrictions on the location of conferences as
long as the attendees are paying their own travel expenses.
(l) May travel
expenses be accepted by physicians who are being trained as speakers or
faculty for educational conferences and meetings? In general, no. If a
physician is presenting as an independent expert at a CME event, both
the training and its reimbursement raise questions about independence.
In addition, the training is a gift because the physician's role is
generally more analogous to that of an attendee than a participant.
Speaker training sessions can be distinguished from meetings (See 5b)
with leading researchers, sponsored by a company, designed primarily for
an exchange of information about important developments or treatments,
including the sponsor's own research, for which reimbursement for travel
may be appropriate.
(m) What kinds of
social events during conferences and meetings may be subsidized by
industry?.111 Social events should satisfy three criteria. First, the
value of the event to the physician should be modest. Second, the event
should facilitate discussion among attendees and/or discussion between
attendees and faculty. Third, the educational part of the conference
should account for a substantial majority of the total time accounted
for by the educational activities and social events together. Events
that would be viewed (as in the succeeding question) as lavish or
expensive should be avoided. But modest social activities that are not
elaborate or unusual are permissible, e.g., inexpensive boat rides,
barbecues, entertainment that draws on the local performers. In general,
any such events which are a part of the conference program should be
open to all registrants.
(n) May a company
rent an expensive entertainment complex for a evening during a medical
conference and invite the physicians attending the conference? No. The
guidelines permit only modest hospitality.
(o) If physicians
attending a conference engage in interactive exchange, may their travel
expenses be paid by industry? No. Mere interactive exchange would not
constitute genuine consulting services.
(p) If a company
schedules a conference and provides meals for the attendees that fall
within the guidelines, may the company also pay for the costs of the
meals for spouses? If a meal falls within the guidelines, then the
physician's spouse may be included.
(q) May companies
donate funds to sponsor a professional society's charity golf
tournament? Yes. But it is sensible if physicians who play in the
tournament make some contribution themselves to the event.
(r) If a company
invites a group of consultants to a meeting and a consultant brings a
spouse, may the company pay the costs of lodging or meals of the spouse?
Does it matter if the meal is part of the program for the consultants?
Since the costs of having a spouse share a hotel room or join a modest
meal are nominal, it is permissible for the company to subsidize those
costs. However, if the total subsidies become substantial, then they
Scholarship or other special funds to permit medical students,
residents, and fellows
to attend carefully selected educational conferences may be
permissible as long as the selection of students, residents, or
fellows who will receive the funds is made by the academic or training
institution. Carefully selected educational conferences are generally
defined as the major educational, scientific, or policy-making
meetings of national, regional, or specialty medical associations.
(a) When a company
subsidizes the travel expenses of residents to an appropriately selected
conference, may the residents receive the subsidy directly from the
company?.112 Funds for scholarships or other special funds should be
given to the academic departments or the accredited sponsor of the
conference. The disbursement of funds can then be made by the
departments or the conference sponsor.
(b) What is meant by
"carefully selected educational conferences?" The intent of Guideline 6
is to ensure that financial hardship does not prevent students,
residents, and fellows from attending major educational conferences. For
example, we did not want to deny cardiology fellows the opportunity to
attend the annual scientific meeting of the American College of
Cardiology or orthopedic surgery residents the opportunity to attend the
annual scientific meeting of the American Academy of Orthopedic
Surgeons. However, it was not the intent of the guideline to permit
reimbursement of travel expenses in other circumstances, such as when
conferences or symposia are designed specifically for students,
residents, or fellows. Accordingly, "carefully selected educational
conferences" should be interpreted as follows: funds may be used for the
reasonable travel and lodging expenses of students, residents, and
fellows to attend the major educational, scientific, or policy-making
meetings of national, regional, or specialty medical associations. The
Council recognizes that there may be some exceptional conferences for
all physicians or even for just students, residents, or fellows that do
not fall within this definition of carefully selected educational
conferences but that meet the spirit of Guideline 6. Accordingly, the
Council will consider proposals for travel and lodging subsidies for
such conferences on a case-by-case basis and grant approval to those
that meet the spirit of the guidelines.
GUIDELINE 7. No
gifts should be accepted if there are strings attached. For example,
should not accept gifts if they are given in relation to the
physician's prescribing practices. In addition, when companies
underwrite medical conferences or lectures other than their own,
responsibility for and control over the selection of content, faculty,
educational methods, and materials should belong to the
organizers of the conferences or lectures.
(a) May companies
send their top prescribers, purchasers, or referrers on cruises? No.
There can be no link between prescribing or referring patterns and
gifts. In addition, travel expenses, including cruises, are not
(b) May the funding
company itself develop the complete educational program that is
sponsored by an accredited continuing medical education sponsor? No. The
funding company may finance the development of the program through its
grant to the sponsor, but the accredited sponsor must have
responsibility and control over the content and faculty of conferences,
meetings, or lectures. Neither the funding company nor an independent
consulting firm should develop the complete educational program for
approval by the accredited sponsor.
(c) How much input
may a funding company have in the development of a conference, meeting,
or lectures? The guidelines of the Accreditation Council on Continuing
Medical Education on commercial support of continuing medical education
address this question..113 Issued June 1992. Revised December 2000 as
"Addendum II: Council on Ethical and Judicial Affairs Clarification on
Gifts to Physicians from Industry (E-8.061)" and June 2002 (Food and
Drug Law J. 1992; 47:445-59, and re-published Food & Drug Law J. 2001;
Opinions 8.062 and 8.063
Do the guidelines
discussing the sale of health-related products (E-8.063) and the sale of
non-health-related goods (E-8.062) apply to physicians' practice
Yes. The physician
who provides or sells products to patients must follow the above
guidelines regardless of whether the products are provided in the
physician's office or through a practice website. Adopted December 2000
as "Addendum III: Council on Ethical and Judicial Affairs Clarification
on Sale of Products from Physicians' Offices (E-8.062 and E-8.063)