A Critique and Some Recommendations on the ICMR Consultative Document

On Ethical Guidelines of Medical Research

Newsletter Jan 2000


For almost fifteen years now, we have been working in the area of women's health and have consistently raised questions about unethical practices in biomedical research by governmental and non-governmental agencies. We have drawn attention to the fact that ordinary (and most often, poor and unaware) women and men, have had to pay a steep price in terms of their health and well-being for the sake of such research. In fact, there is adequate evidence to show that in many such research studies, especially contraceptive research, basic requirements of Informed Consent have not been fulfilled, adequate information has not been satisfactorily communicated to trial subjects, sufficient precautions have not been taken to rule out contraindications and the follow-up, monitoring and/or treatment of side effects has been abysmal. In addition, coercion of trial subjects has also been a key area of concern.


In early December 1997, we were shocked to learn of a study conducted by the leading cancer research institute in the country, the Institute for Cytology and Preventive Oncology [ICPO]. During the study, conducted between 1976-1988, cervical dysplasia was left untreated in 1,100 women, in order to study the progress of the disease. Even after abnormal tissue growth was detected and the risk of cervical cancer identified, the doctors did not warn or treat these women, but chose instead, to use them as guinea pigs for their experiments. That such a study was conducted by an institute under the Indian Council for Medical Research [ICMR], the premier body which actually lays down the ethical guidelines for medical research in the country, raised many issues of concern relating to the ethics of conducting biomedical research on human subjects.


Consequent to our protest, we were invited for a meeting to discuss the matter with members of the ICMR and ICPO in December 1997. During this meeting, Dr BN Saxena, the then Addl. DG, ICMR, admitted that written, informed consent had not been obtained from participants in the study. Dr Dilip Das, Director of ICPO was also present during this meeting, and could not furnish any proof that requirements for written, informed consent had been complied with. Despite this public admission of flouting ethical norms by the premier medical research institution in the country, no action has been taken against the erring officials, no follow up ordered with women who were part of the study, and no compensation has been awarded to those who have been adversely affected.


The Draft Consultative Document on Ethical Guidelines on Biomedical Research Involving Human Subjects [referred to as ‘Draft Guidelines'] were circulated during the meeting, and comments were invited from the groups present. A consultative meeting was held this year to further the process of finalising the Draft Guidelines. Although Saheli never received the invitation for this meeting despite assurances to the contrary, we submitted our comments to the ICMR. We take this opportunity to share with all of you our critique of the Draft guidelines. It is essential to generate a wider public debate on medical ethics in order to bring different areas of concern into the ambit of the new ethical guidelines for biomedical research.


The following is an edited version of our comments submitted to the ICMR.


As compared to the brief, Policy Statement on the Ethical Considerations Involved in Research of Human Subjects issued by the ICMR in 1980, the Draft Guidelines released by the Council in 1997 have attempted to cover a lot of ground to address the extensive broadening in current research interests in the country and the widening horizons of research. Newer areas being covered include: Human genetics research, organ transplantation, epidemiological research and assisted reproductive technologies. Widening the scope of the document is an encouraging sign of the attempt to keep pace with the challenges posed by scientific and technological developments.


While the aims of the exercise have been laudable, several lacunae remain. The Draft Guidelines fail to acknowledge changing social trends, especially in the context of gender and class inequalities in Indian society. It is imperative that the new Draft Guidelines go beyond responding to the challenges posed by new technologies and new areas of research. Such guidelines must break new ground in building effective safeguards to protect the interests of research subjects, right from the stage of the research design to mandatory follow up. Basic principles of human rights must be used to ensure that the unequal power relationship between research subjects and researchers is neutralised, and that no new avenues of exploitation of research subjects open up. It is also crucial that the basic principles should be stated clearly and unambiguously.


These Draft Guidelines fall short of such objectives on several counts. Contentious issues remain relating to newer technologies like genetic research, organ transplantation etc. which need to be publicly debated with groups working in these areas. As a women’s organisation, we shall here address the shortcomings in the Draft Guidelines in areas in which we have been directly engaged:




Informed consent is central to ethical biomedical research. In addition to the discussion on ‘informed consent' in the section of ‘General Principles’, the subject comes up repeatedly in various contexts. The Draft Guidelines undermine the cardinal principle of informed consent in the interest of "the overall purpose and importance of research". Sufficient attention has not been paid to building in the safeguards necessary in a country like ours, with such poor health facilities, low nutritional levels, and a high rate of illiteracy. In such a situation, it becomes all the more necessary to ensure that trialsubjects have adequate information about the trial study prior to giving truly ‘informed consent‘. Our recommendations on various aspects of ‘informed consent’ are stated below:


i.     The prejudice that adequate information cannot be imparted to illiterate people should be dispensed with.

ii.     Information about potential risks and benefits should be provided verbally and in writing in simple, comprehensible language without technical jargon and in vernacular language whenever necessary.

iii.   A social worker [not the doctor alone] should be involved in counselling. While giving written informed consent, the signature should be witnessed by a person not related with the trial.

iv.   For research involving the whole community large group, the consent of the village elder and/or community leader should not be considered adequate. Proxy consent (as is being proposed) should not be permitted.

v.    Where a new study proposes to use samples collected for a previous study, consent given for the earlier study cannot be deemed to apply to the new study.

vi.   Even when the research design involves minimal risk (e.g. only collecting data from subjects’ records) the Ethical Committee of the institution involved in conducting research should make a case-by-case judgement about waiving informed consent.

vii. Researchers should not be allowed to disclose the identity of the participants to those not associated with the trial, without seeking permission from the Ethical Committee.

viii. Health insurance should be mandatory for trial participants, and the details of the insurance cover should be communicated while obtaining informed consent.


With respect to ‘Essential information for Prospective Research Subjects‘ we believe that the scope of the information provided to the prospective research subjects needs to be widened. Hence it is our recommendation that the following information be mandatory:


·         The experimental nature of the drug/diagnostic procedure/vaccine/herbal remedy etc.

·         The goals of the study.

·         The nature of the drug/Formulation/vaccine used, including its significance in physiological and/or pathological processes.

·         The likely mode of action of the preparation under trial.

·         The results of prior studies of similar nature using the similar preparation, including adverse reactions.

·         Theoretical risks including adverse reactions not seen in previous studies.

·         Options of treatment for problems arising out of the testing of the formulation! Drug/ vaccine.

·         Compensation available for subjects who experience adverse reactions. This information may include the source of compensation and the spectrum of coverage (e.g. medical treatment, lostincome, pain and suffering). '

·         Real and theoretical benefits from participation in the study.

·         Reimbursement for lost earnings and legitimate expenses.

·         Study design, including: eligibility criteria for participation; number of participants and centres; duration of study; mode of administration of a formulation and route of administration: number and nature of visits, procedures potentially considered invasive should be outlined (e.g. blood drawing, HIV testing, physical examination, injections, skin tests).

·         The need to be re-contacted in the course of follow-up studies.

·         Provisions for confidentiality of patient records. (in general, patient information is restricted to study personnel, within the limits of the law. Data should be published in such a way that the identity of individual patients is protected.)

·         The name and telephone number of a person who may be contacted for further information pertaining to the trial or for reporting of adverse reactions.




Although this is the first time ethical guidelines in India are addressing ARTs, little attention has been devoted to the substantive questions involved. Intervention in reproduction is a sensitive issue which has a deep impact on relationships at a personal, familial and societal level. The current Draft merely skims over ethical dilemmas which could potentially crop up. Instead of guidelines for research, this section reads like promotional literature for such technologies.


The Draft Guidelines reveal clear biases which are likely to work against the interests of certain sections who are not within the narrowly defined confines of the family e.g. single parents, homosexuals etc. In general, ARTs should be made available to any consenting woman who desires to have a child using these technological innovations. The marital status of the woman - married, unmarried, single, divorced - as well as her sexual inclination - heterosexual, homosexual or bisexual - should not be used as decision-making criteria. Changing social trends the world over, should be kept in mind while setting up ethical guidelines and accordingly the words ‘husband‘ and 'wife‘ must also be substituted by 'male partner’ and ‘female partner’. The notion of "legitimacy" of children needs to be redefined keeping in minds the custodial rights of mothers.


Ethical guidelines should not accept social stigma attached to infertility as a norm. Societies have evolved social ways for childless couples to deal with infertility, for instance, adoption, foster-parenthood, etc.


The Draft Guidelines reinforce conservative attitudes by recommending matching of religious and ethnic background for donor insemination. issues like religion and educational level have no bearing ongenetic inheritance and should not be considerations during donor selection.


The Draft Guidelines focus only on risks to the subject and do not touch upon other ethical issues involved with ARTs which arise out of changes in family structures e.g. who gets custody of frozen embryos after a divorce? Can a woman be inseminated with her partner's sperm after his death? In case of serious/life threatening illness which needs the biological parents or siblings e.g. bone- marrow transplant, kidney transplant etc., should the identity of a sperm or egg donor be revealed? What are the legal aspects of these situations, relating to inheritance, custody etc.? Though it is difficult to envisage changes in laws right away, dilemmas and conflicts are bound to arise and a document on ethical considerations should take into account the changing societal trends.




We found to our amazement that the Draft Guidelines have not given this area of research separate attention. This is a serious lacuna. The world over, women's right to safe and effective contraception is increasingly being recognised, as is their right to safety during the research, development and testing of contraceptive methods.  At the same time, women's groups and social organisations are also beginning to play an important role in the development and monitoring of contraceptive research to ensure the safety of women's health and well being.


The bulk of Contraceptive Research is targeted towards women, a section of society that already has lower nutritional levels and poor access to health facilities. Secondly, most of the emerging contraceptive technologies have multi-systemic effects, and require more careful studies in order to ensure their long term safety vis-a-vis women's health and their future progeny.


All aspects of contraceptive research must respect the diverse knowledge and needs of women, as defined by women. Further, fertility and pregnancy are not diseases, but a normal part of a woman's life and must be understood as such. Since contraceptives are used by healthy women and men in the prime of their lives, the risks-benefit evaluation has to be different from that used on drugs/procedures for treatment of diseases. Contraceptive research must follow ethical principles which pay heed to the bodily integrity of women, as well as their self-respect and dignity.


We suggest the following broad guidelines [based on the Canadian Women's Committee on Population and Development entitled 'Bill of Rights for Contraceptive Research, Development and Use, 1996] within which contraceptive research must be conducted:


A) Contraceptive Research and Development


1.    Hazardous contraceptives, and contraceptives with potential for abuse should not be promoted. Instead, such methods should be promoted which:

·                      enhance women's health and well-being;

·                      are user-controlled;

·                      are reversible in the case of spacing methods;

·                      meet women's needs at various points in their life cycle;

·                      exhibit demonstrable advantages over existing contraceptives.

2.   Research must assess the degree of risk to children conceived as a result of contraceptive failure.

3.   More resources must be allocated to the development of safer methods of contraception, such as barrier methods, that offer protection from sexually transmitted diseases, especially HIV; and also to the development of male contraceptives.

4.   As part of formal research processes, mechanisms must be introduced which facilitate equal participation of women's health activists and potential contraceptive users in decision-making and advisory bodies involved in:

·                          setting research priorities

·                          monitoring ongoing research

·                          defining the criteria for safety reviewing research findings and assessing

·                          the acceptability of a method to proceed from one research stage to another.

5.    Contraceptive research must be subject to review by multidisciplinary ethics committees.

6.    There should be transparency in contraceptive research, including:

·                          criteria for determining research priorities;

·                          information on research protocols;

·                          findings of the previous research;

·                          criteria for determining safety;

·                          funding and patent information.


B) Contraceptive Testing, Evaluation, Approval and Monitoring


1.    Written informed consent must be obtained from all the participants of research trials in accordance with the guidelines laid out in Point (I) above on ‘informed consent'.

2.    Researchers, government and funding institutions are responsible for ensuring the safety of trial participants, and liable in case of damage to health/life of the trial participants or their future progeny.

3.    Participants must be informed of their right to withdraw from trials at any time. Voluntary withdrawals must get due weightage during trial evaluations.

4.    To determine whether a contraceptive is appropriate for a particular country trials must take place within that country. Participants in these trials must reflect the make-up of women who will be using the contraceptives.

5.    Long-term monitoring and follow-up of trial participants and children born to them during or after trials must be undertaken to determine the effects of the contraceptive technologies over time.

6.    Contraceptive trials should immediately cease if the potential arises for serious risk to trial participants.

7.    Users' responses to and assessment of the contraceptive method under review must be recognised as valid research findings and incorporated into the evaluation process.

8.    Independent mechanisms must be established to monitor research trials to ensure compliance with international ethical standards.




In this age of liberalisation, it is surprising that the Draft Guidelines make only a passing mention of Post Marketing Surveillance (PMS). Our experience with PMS of contraceptives demonstrates the problems inherent in the concept. PMS being conducted by the pharmaceutical company which stands to gain directly, defies scientific objectivity. There is an urgent need to provide stringent guidelines to govern PMS. Some recommendations:


    I.        Monitoring mechanisms should be an integral part of the licensing agreement.

  II.         PMS should be time bound.

 III.        Information should be provided on the package of the drug/device clearly stating that it is undergoing PMS.

 IV.        Adequate information must include all potential side-effects, however rare,

  V.        Treatment plan for side effects /complications must be part of the ethical clearance prior to commencement of marketing/PMS,

 VI.        Mechanisms to award damages in case of complications, serious side-effects, long term problems, etc. must be set into motion.

VII.        License/registration should be provisional until results of PMS are available.

VIII.        Results of PMS should be subject to independent expert analysis. New ethical guidelines, in addition to keeping pace with scientific developments, must prioritise safeguarding the rights, health and well-being of research subjects. The manner in which political ideology permeates medical research makes it imperative to develop a pro-people, pro-woman definition of "overall purpose" of research.


We hope that the ICMR begins finalising the Draft Guidelines by taking cognisance of recommendations by women's groups like Saheli and other health activists. Only the collective pressure of groupsworking in different areas of health can ensure accountability within medical research.




The billionth Indian is supposed to have been born. According to estimates released by the Population Division of the Department of Economic and Social Affairs of the United Nations, this occurrence took place on 15th of August this year. The announcement was received with considerable surprise, since the "event" was supposed to occur sometime in May 2000. In fact, officials at the Ministry of Health and Family Welfare insist that India is still short of the billion mark by about 12 million. On October 12, 1999, according to United Nations Population Fund (UNFPA) estimates, world population reached the 6 billion mark. Was it mere coincidence that the day falls on Columbus Day, with Christopher Columbus representing imperialism, exploitation and the beginning of Native American genocide in the Americas? Projecting the "event" in terms of demographic alarmism, organisations like the Zero Population Growth have popularised the expression "Y6B",  likening it to the impending computer chaos / digital doomsday predicted to occur at the turn of the century in Y2K.


In any case, how relevant is the precise date of crossing either the billion mark or that of six billion? In such a vast country, exact projections are near impossible, and estimates may be way off the mark. Fixing exact dates on these events may prove to be of mere statistical interest, and only serve to whip up a collective frenzy about the population "explosion".


The truism that "all people use resources and create waste", and large families use more resources and create more waste, gained currency among governments and most international development agencies like World Bank, IMF etc. which put the population ‘problem’ high on their agenda. The consumption component of the debate is entirely ignored. The highest polluting industrial processes that provide consumer goods for the wealthiest fifth of humanity are controlled almost entirely by men in the most powerful, transnational corporations, governments and industrial giants who manufacture chemicals and weapons of mass destruction, with the main goal of maximising economic growth and profit. Yet, policies of ‘population control' are targeted at the ‘poorest of the poor' women whose main goal is survival, are institutionally powerless, and have larger numbers of children for complex reasons that range from immediate survival and necessity, to high infant mortality, lack of access to health services and patriarchal control over reproduction. In the absence of social security, children are the only security in illness and old age, and are viewed as additional working hands and family support, rather than extra consumers who will drain the family resources.


With one of the oldest population programmes in the world, Indian women, especially from the poorer sections, have been subjected to a population reduction programme garbed in euphemisms that have historically ranged from ‘family planning', to ‘family welfare' and now ‘reproductive health'. From a policy-makers perspective, long—acting hormonal contraceptives like injectables (Net En and Depo Provera) and implants like Norplant are "ideal" because they are provider-controlled. Women need not be ‘relied upon' to remember taking the pill, or keep IUDs in place, and men need not be persuaded to use condoms. The shift to long-acting, hazardous contraceptives is sought to be justified on the plea that birth rates have to be brought down in a hurry - the price that women pay with their health is irrelevant. In the "war" against population, ethics of medical research are also another casualty.