VACCINE RESEARCH & ETHICAL CONCERNS

With the Indian government [through the Ministry of Health & Family Welfare and the Indian Council Of Medical Research (ICMR)] having entered into a Memorandum of Understanding with the International AIDS Vaccine Initiative (IAVI) in March 2001, it will not be long before India becomes the site for extensive research on vaccines for HIV/AIDS. The discovery of a vaccine would be a great boon in India’s fight against HIV/AIDS, but concerns also arise in testing potential vaccines on people, especially when vaccine efficacy remains in doubt. Yet, without research and trials in India for particular HIV/AIDS strains prevalent here, it will be difficult to develop an effective vaccine for the country.

IAVI plans to begin conducting clinical trials in India for the development of an effective vaccine in the near future. In light of these fast-emerging events, it is vital that Indians in general and those involved with HIV/AIDS in particular are presented with all the information necessary to understand the pros, cons and all other ramifications of such research and trials. This is because several complex ethical issues arise in the context of HIV/AIDS vaccine research due to HIV/AIDS itself being such a complex, multi-faceted and layered epidemic. This edition of Positive Dialogue attempts to highlight some of these ethical considerations that require to be addressed and monitored before research is commenced and while it is undertaken.

Indian law & policy on ethics of research

A matter of great concern in the Indian context is the lack of clarity regarding the regulations that govern issues of biomedical research. The rules that exist are archaic and need far greater clarity. The Drugs & Cosmetics Act, 1940 (DCA) and its Rules cover the issue of clinical trials for drugs but an examination of them shows that these provisions are completely out of touch with modern ethical practices. The ICMR is the government agency that oversees research studies in India. It appears to have the power to review, assess and approve those studies that involve either biomedical and/or behavioural research and have government participation. In 2000 ICMR formulated guidelines for biomedical research being the Ethical Guidelines for Biomedical Research on Human Subjects (available at ). Although it is unclear whether the DCA or the ICMR Guidelines have precedence in any given trial, it would appear that it is the guidelines that will govern the proposed trials for an HIV/AIDS vaccine planned by IAVI. These guidelines contain, inter alia, general principles of ethics, ethical review procedures and specific principles for clinical evaluation of vaccines, drugs, diagnostics etc.

Although it is often argued that HIV/AIDS receives undue focus and too much attention, it is frequently forgotten that the stigma this epidemic creates has, hitherto, rarely been seen in human history. Therefore, even a trial for an HIV/AIDS vaccine will throw up some complex and unique ethical questions that require close and special scrutiny before any approval is granted.

Informed Consent

Obtaining voluntary informed consent from the subjects of research is a stage that all legitimate and ethical research studies have to stringently satisfy before they commence. This is well recognised and a cardinal principle in the ICMR Guidelines. (Consent to participate in research also includes the right of the subject to abstain from further participation and the duty on the part of the researcher to obtain fresh consent if there are material changes in the conditions or procedure of the research.)

A primary issue that arises in this regard is that of the manner in which consent is taken. Firstly, there can be no doubt that the consent must be express and not implied. Secondly, it must be in writing and signed or acknowledged in some manner by the subject and supported by an independent witness. This means that a consent form would need to be formulated – one which is simple, clear and comprehensive in terms of information provided. This information should include, inter alia, the aims, methods and duration of research, the guarantee of confidentiality, entitlements of the subject in the event of harm/injury caused due to the trial and most importantly the risks (and benefits, if any) to the subject by embarking on the trial. The form may contain technical information in which case such information must be simplified and explained to the subject. In the event of a subject being unable to read, the form must be read out and explained. The quandary for a researcher will often arise when the information imparted in the form requires elucidation to the extent that the form could be viewed as an intimidating legal document. Should the researcher then compromise on full informed consent for the sake of brevity and convenience? Surely not. The right to give consent is viewed by law as a core and inalienable right that protects the self-autonomy and liberty of an individual.

What does this entail in the HIV/AIDS context? With the stigma and prejudice that continues to surround HIV/AIDS, the responsibility on researchers cannot be over-emphasised. (It is important to note that the ICMR Guidelines give special attention to vulnerable groups and those who are socially disadvantaged and therefore have reduced autonomy.) When testing for an HIV/AIDS vaccine (in Phases II/III of a trial), the first aim of a researcher would be to identify persons who are at high risk of getting HIV/AIDS – this would be the most efficient manner by which the efficacy of the vaccine could be tested. Once subjects are identified (possibly intravenous drug users, sex workers, prisoners or men who have sex with men) a researcher would then prefer that the subject continue to indulge in high risk behaviour after being given the potential vaccine in order to conclusively demonstrate its efficacy. This clearly raises great ethical dilemmas – at the time of obtaining consent should one not be providing prophylactic information to a subject at high risk of contracting a life-threatening medical condition? On the other hand, how can vaccine research proceed if prophylactic information is promoted among the subjects? What is the kind of information to be imparted to a subject in these circumstances, especially in key area of explaining risks and benefits? Obviously a fine balance needs to be arrived at in these circumstances.

(While informing the prospective subjects about risks involved in participating in the research it is necessary to state that in the case of ineffective vaccines the subjects run the risk of contracting the disease or not being able to inoculate themselves with a successful vaccine in the future.)

Disclosure of HIV+ status

Another issue that arises in the HIV/AIDS context is that of disclosure of HIV+ status to the subjects. Many persons who are HIV+ often do not know of their own status. In the case of subjects of vaccine research, in order to test the efficacy of the potential vaccine it would be necessary to periodically test the subjects to ensure that they do not become HIV+. In the event of becoming HIV+ a subject would not be able to continue on the trial and the researcher would be obliged to inform the subject of the reasons for discontinuation. This would necessarily involve disclosure of HIV+ status and the concomitant need to provide counselling. But is this where the obligation of the researcher ends? Is not the researcher obliged to provide all the necessary care, treatment and support to the subject on such disclosure? After all, the subject may have never known of his/her HIV+ status but for the fact s/he was included in the research trials. More importantly, the subject may not have been infected with HIV/AIDS if prophylactic information had been supplied to her/him.

The ICMR Guidelines envisage situations where subjects are assured free medical services as part of compensation for participation. However, it stipulates that the medical services should not be so extensive as to amount to inducement thereby vitiating consent. The question that arises in the HIV/AIDS context is whether providing anti-retroviral therapy would be seen as an inducement, especially in India where such treatment is a luxury for most? (The ICMR Guidelines refer to ‘provision for the best possible nationally available care’.)

Confidentiality

The ICMR Guidelines recognise the need to guarantee confidentiality to research subjects. They provide that confidentiality can only be breached under the orders of a court of law or where reporting to a health authority is necessary. They also provide that the researcher should not breach the subject’s confidentiality and if the research is sought to be published or photographed, specific consent for this purpose must be taken from the subject on two different occasions and not at the commencement of the study. At the same time, the Guidelines only make this a duty on the researcher ‘as far as possible’. In the HIV/AIDS context in particular this would not be a satisfactory level of assurance. In an area where the researcher is likely to be working with subjects who suffer the double stigma of being from marginalised communities and being at high risk of becoming HIV+, the guarantee of confidentiality has to be non-negotiable, absolute and fundamental.

There are several other important ethical issues and significant details that arise and must be examined before permitting a vaccine trial, especially for HIV/AIDS. However, some of the fundamental issues have been briefly encapsulated above. It is important to always remember that the research to be conducted must be relevant to the community and geographical area where it is performed and that the fruits of that research must be made available to all. It must also be conducted in a manner that is accountable and transparent. These are not principles and standards that are followed with regularity in the Indian polity. HIV/AIDS vaccine research is an opportunity to create a healthy precedent on these and several other ethical principles. It is up to civil society and those involved with HIV/AIDS to ensure that such principles are demanded and maintained.

The Indian Medical Council Regulations 2002 

The Indian Medical Council Regulations, passed in April 2002 reflect an abject lack of a human rights sensibility. The onslaught of HIV/AIDS in India should have made the medical fraternity acutely aware of the need to address and uphold human rights while dealing with patients generally and HIV+ persons in particular. HIV/AIDS had such an impact elsewhere after which the importance of consent before testing, confidentiality and non-discrimination were seen as essential components in effectively dealing with the epidemic and key to a good public health system. It appears to be an approach that the Indian Medical Council (IMC) is averse to.

The concept of consent is fundamental to our lives is recognised under a variety of laws and ethical codes of practice. It derives from the seminal notion that every human being of adult years and sound mind has the right to decide what should be done to her/his body. Any medical procedure would, therefore, require that information be imparted to a patient in order for the person to make an informed choice for agreeing to the treatment. Shockingly enough, the regulations virtually ignore this very fundamental ethic. Consent is only referred to in one clause (‘7.16: Before performing an operation the physician should obtain in writing the consent…’). Apart from the very unclear manner in which proxy consent has been dealt with in this clause, it fails to contemplate the myriad non-operative situations in medical practice. The regulations provide that pathological tests and other diagnostic lab investigations require to ‘…be done judiciously and not in a routine manner.’ This is just not sufficiently protective language that imposes a duty on the healthcare worker to obtain consent. In the HIV/AIDS context particularly, where testing for sero-status is a key issue, this provision gives much leeway to the physician to insist on an HIV test without obtaining consent and irrespective of the treatment required. Consent has been recognised as essential before testing in the National AIDS Prevention & Control Policy. Yet, it has been ignored in the IMC regulations.

The principle of confidentiality is sacrosanct in legal and human rights discourse. It should be sacrosanct in any sensible public health strategy too. After all, would anyone access the services of a physician with the knowledge that the information shared in the visit would be divulged outside the doctor-patient relationship? However, the IMC regulations fall short of protecting confidentiality in a precise and satisfactory manner. For instance, the regulations provide that a physician should ‘… ensure himself that the patient, his relatives or his responsible friends have such knowledge of the patient’s condition as will serve the best interests of the patient and the family.’ The regulations provide specific grounds under which a physician can disclose ‘the secrets of a patient that have been learnt in the exercise of his/her profession…’. These include disclosure under orders of a court of law, in cases of a notifiable disease and ‘in circumstances where there is a serious and identified risk to a specific person and/or community’. This appears to be an attempt by the IMC to factor in a leading judgement on medical confidentiality – Tarasoff v Regents of the University of California. It seems that the IMC got the framework laid down by the American court a little wrong. In the Tarasoff case the court sought to delicately balance the need to maintain confidentiality against the need for disclosure in very specific circumstances. It held that if a physician found that an identifiable third party was foreseeably endangered due to the conduct of the patient then the physician had a duty to warn the third party. The disclosure was to be to a specific third party and not generally. The regulations, however, conveniently permit the physician to violate confidentiality in cases of risk to a community, thereby permitting public disclosure. The implications of this in the HIV/AIDS context are worrisome. The regulations also fail to put sufficient onus on the private health sector to treat all patients without discrimination. For healthcare in India to reclaim its position as a key service provider, it is necessary for members of the community to understand the importance of the human rights of patients and assist in their realisation. The IMC Regulations fail to do so.

Kolkatta: In the case of P vs. Union of India, filed by Lawyers Collective HIV/AIDS Unit, the High Court of Calcutta passed a judgement on 28 January 2002 in terms of the offer made by the respondent to the petitioner. In this case the pregnant petitioner was admitted for delivering her child at a hospital under the administrative control of the Indian Navy. After delivery the petitioner required blood infusion. A sailor donated fresh blood to the petitioner, which did not come from the blood bank of the hospital as required under the Drugs & Cosmetics Act. The petitioner was later found to be HIV+. As the sailor’s blood was not tested for HIV and he was later found to be HIV+, it was clear that the petitioner became HIV+ on account of the transfusion. The Court felt that since the hospital was under administrative control of the Indian Navy the Indian Navy had a duty to compensate the petitioner. Correspondence was exchanged between the petitioner and respondent Indian Navy during the pendency of the petition. Finally the respondent made an offer. It included compensation amounting to a sum of Rs. 10 lakhs with interest at 18% from the date of filing of the petition (amounting to approximately Rs. 22 lakh), medical treatment at the cost of the Government and a government job with accommodation. The petitioner was agreeable to the offer and the Court passed the judgement in terms of the same.

Mumbai: On 6 June 2002, in another case filed by the Lawyers Collective HIV/AIDS Unit, the High Court of Bombay passed an interim order in J vs. A’ in which the plaintiffs had sought declaration that they are entitled to 2/3 share in a flat which was part of the assets of the 1^st plaintiff’s husband who died due to HIV-related complications. The plaintiffs (the wife and child of the deceased) are HIV+. The defendants denied that the 1^st plaintiff was ever married to the deceased. The Court appointed a Court Receiver for the said flat and ordered that it should be given out on leave and license by the Receiver and awarded the plaintiff 2/3 of the proceeds therefrom. The Court also said that the plaintiff should be entitled to make an application before the deceased’s principal employer/authority for payment of widow’s compensation.

On 5 July 2002, the Constitutional Court of South Africa directed the government to make Nevirapine available to all HIV+ pregnant women availing of public health facilities, in an appeal from the judgement of the South African High Court in December 2001 (Minister of Health & ors. v Treatment Action Campaign & ors.). Nevirapine is a drug, which when administered to the woman in labour along with a single dose to the newborn, reduces the risk of HIV infection transmitting to the baby from 25-30% to 2-8%.

The High Court had ruled in favour of the petitioners (Treatment Action Campaign and others) directing government in similar terms. Till the filing of the petition, the government had devised a programme to make Nevirapine available to a restricted number of pilot sites in the country. This meant that Nevirapine was not made available for all pregnant women availing of public health care facilities.

The Constitutional Court rejected the government’s defence (one of many) that it could not afford the treatment package, holding that this was possible as the total budget to be allocated for health had been increased to Rand 1 billion and would go up to Rand 1.8 billion by 2004 - 2005. However, the Constitutional Court watered down the judgement of the High Court insofar as the latter required the submission of the revised policy by the government to the Court.

In keeping with the objective of creating awareness and building capacity on HIV/AIDS-related legal and ethical issues, Lawyers Collective HIV/AIDS Unit organised a two-day workshop on Women, Law and HIV/AIDS on 27-28 July 2002 in Mumbai. The workshop was an effort to interact with those working in and with women’s groups on the need for a human rights based approach to HIV/AIDS especially in the context of women’s vulnerability to it. The workshop participants consisted of NGOs looking at women’s issues other than HIV related issues and also NGOs working specifically in the HIV field. Discussions and presentations covered a variety of topics including basic science and sexual health, sexuality and gender, violence against women and laws relating to women.

Contributions: Vivek Divan and Shehzad Mansuri

Monthly Drop-in meeting

Lawyers Collective HIV/AIDS Unit holds monthly drop in meetings on the first Thursday of each month. The meetings start at 4.30 pm at the Delhi Office and at 5.00 pm at the Mumbai Office. The objective of the meeting is to share experiences, information and discuss issues of concern. We invite your active participation in these meetings.

Lawyers Collective HIV/AIDS Unit provides legal aid and allied services for people affected by HIV/AIDS. The main objective of the Unit is to protect and promote the fundamental rights of persons living with HIV/AIDS, who have been denied their rights in areas such as:

· Health care
·Employment
·Terminal dues like gratuity, pension
·Marital rights relating to maintenance, custody etc
·Housing

The Unit is involved in initiating public interest litigation on issues like the right to marry, confidentiality, access to health care, safe blood supply, quacks, etc. Lawyers Collective HIV/AIDS Unit also conducts workshops on legal and ethical issues relating to HIV/AIDS for people living with HIV/AIDS, lawyers, judges, health care providers, NGOs etc.

Please send your comments and queries to the addresses given below. Those affected by HIV/AIDS seeking legal aid, advice and support are welcome to contact us at:

Lawyers Collective HIV/AIDS Unit
Programme Management Unit
7/10, BOTAWALLA BUILDING, 2^ND FLOOR
HORNIMAN CIRLCE, FORT
MUMBAI - 400 023

TEL: 022 267 6213/9 FAX: 022 270 2563
E-MAIL: aidslaw@vsnl.com
 

63/2 MASJID ROAD, 1^st FLOOR, JANGPURA
NEW DELHI – 110014

TEL/FAX: 011 4321101/2 or 011 4316925
E-MAIL: aidslaw1@ndb.vsnl.net.in
Hours: Monday – Friday: 10:00 a.m. – 7:00 p.m.
Saturday: 10:00 a.m. – 4:00 p.m.