AMA CODE OF MEDICAL ETHICS
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AMA CODE OF MEDICAL
ETHICS
Preface
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.
The Reports--from
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
History
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
adopted.
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.
Principles of
Medical Ethics
Preamble:
The medical
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
appropriate entities.
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
public health.
VIII. A physician
shall, while caring for a patient, regard responsibility to the patient
as paramount.
IX. A physician
shall support access to medical care for all people.
Adopted June 1957;
revised June 1980; revised June 2001.4
E-1.00 Introduction
E-1.01 Terminology.
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.
The following
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
legal obligations.
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
E-2.01 Abortion.
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
April 1977.
E-2.015 Mandatory
Parental Consent to Abortion.
Physicians should
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
involvement.
Physicians should
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.
Public officials
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
June 1998.
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.
Decisions regarding
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
The treating
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.
E-2.037 Medical
Futility in End-of-Life Care.
When further
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.
Nevertheless,
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
futility; and
(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.
(b) Joint
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).
E-2.04 Artificial
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
conceived naturally.
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.
E-2.05 Artificial
Insemination by Anonymous Donor.
Thorough medical
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
Society of
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.
Physicians should
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.
E-2.055 Ethical
Conduct in Assisted Reproductive Technology.
The following
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.
(2) Fertility
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
promotional materials.
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.
E-2.06 Capital
Punishment.
An individual's
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
prisoner.
Physician
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.
The following
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.
Physicians should
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
Punishment:
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.
E-2.065
Court-Initiated Medical Treatments in Criminal Cases.
Physicians can
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
psychiatric evaluations.
A recognized,
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
1998.
E-2.067 Torture.
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
E-2.07 Clinical
Investigation.
The following
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
suitable subjects.
(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
subjects.
(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.
(b) Voluntary
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.
(ii) Ordinarily,
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:
(a) Adequate
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
individual.
(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.
E-2.071 Subject
Selection for Clinical Trials.
Ethical
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
protocols.
(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;
20(2-3): 12-15)..14
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.
(1) Investigators
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.
E-2.076 Surgical
"Placebo" Controls.
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.
The appropriateness
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
(1) Surgical
"placebo" controls should be used only when no other trial design will
yield the requisite data.
(2) Particular
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
study design.
(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)
E-2.077 Ethical
Considerations in International Research.
Physicians, either
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
guidelines:
(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.
E-2.079 Safeguards
in the Use of DNA Databanks in Genomic Research
The following
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
subjects.
(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
identifiers).
(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.
(c) Individuals
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
discarded.
(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.
E-2.08 Commercial
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
clinical research.
(2) Potential
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
material.
(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
June 1990.
E-2.09 Costs.
While physicians
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
1998.
E-2.095 The
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).
Ethical principles
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;
272: 1056-62).
E-2.10 Fetal
Research Guidelines.
The following
guidelines are offered as aids to physicians when they are engaged in
fetal research:
(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
significant.
(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
projects.
(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.
(b) Alternative
treatment or methods of care, if any, should be carefully evaluated and
fully explained. If simpler and safer treatment is available, it should
be pursued.
(9) In research
primarily for treatment of the gravid female:
(a) Voluntary and
informed consent, in writing, should be given by the patient.
(b) Alternative
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
scientific knowledge:
(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.
E-2.105 Patenting
Human Genes.
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.
Genetic research
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.
(2) Substance
patents on purified proteins present fewer ethical problems than patents
on genes or DNA sequences and are thus preferable.
(3) Patent
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
genetic sequences.
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.
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
therapies.
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.
Investigators must
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.
E-2.12 Genetic
Counseling.
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.
Genetic selection
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).
E-2.13 Genetic
Engineering.
The Federal
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.
(6) The
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
(8) These
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.
E-2.132 Genetic
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:
(a)The disease
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).
E-2.135 Insurance
Companies and Genetic Information..23
Physicians should
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
1996.
E-2.136 Genetic
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:
(1) Physicians
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.
(c) Searching
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
Postmortem").
(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).
E-2.137 Ethical
Issues in Carrier Screening of Genetic Disorders.
All carrier testing
must be voluntary, and informed consent from screened individuals is
required.
Confidentiality of
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
1991.
E-2.138 Genetic
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 | 