It is only recently that the issue of institutionalising ethics in social science research has received more attention. Among the many reasons for this, is the widening of the scope of such research. One the one hand, the research has moved out of the confines of the university and involves non-governmental organisations, activists groups, funding agencies as well as market research organisations. On the other hand, research is also probing into more complex and intimate areas of life, such as sexuality and violence.

In order to initiate debate and reflection within the larger research community, The Centre for Enquiry into Health and Allied Themes (CEHAT) started a process of documentation and dialogue on this subject. A drafting committee consisting of eminent social science practitioners (Prof. Ghanshyam Shah, Dr. Ashok Dayalchand, Dr. Thelma Narayan, Dr. V. Muraleedharan, Dr. Sarojini Thakur, Ms. Radhika Chandiramani, Ms. Geeta Misra, Ms. Padma Prakash and Dr. Lakshmi Lingam; Coordination and research was done by Dr Amar Jesani and Ms Tejal Barai.) reviewed the existing literature on ethics in social science research from all over the world and drafted guidelines that took into consideration the specific problems facing social scientists working in the Indian context. These guidelines were then circulated widely among researchers and institutions involved in social science research.

A national level meeting was organised in Mumbai. Among those who attended the meeting were researchers working in research institutes, universities, non governmental organisations, hospitals and treatment centres. The two-day meeting aimed at a thorough review and revision of the draft guidelines and planning for the manner in which wider support for ethics in research could be sought and devising institutional mechanisms for making guidelines effective.

The meeting was initiated by an introductory address on the need and scope of ethics in social science research by Dr. Ghanshyam Shah, Jawaharlal Nehru University. This was followed by a presentation by Ms. Tejal Barai, CEHAT, on the draft guidelines and feedback received on them . The group was Divided into three and each sub group discussed the guidelines, issues emerging from it and suggested changes. The rapporteurs’ reports were then combined and a presentation on the discussion was made by Dr. Anand Zachariah, CMC Vellore, on the morning of the subsequent day.

The discussions covered a wide range of issues starting from the title of the document. Some felt that scope of the document should be limited to research with human subjects and not cover the entire range of social science research. The need for a specific focus on health in the title was also discussed. There was a general feeling that the document should contain the word ‘guidelines’ rather than ‘code’. Apart from this, specific doubts related to conceptualising privacy and informed consent in the Indian setting were also discussed. However, it was felt that the principles on which these concepts are based are universal and researchers must respect the validity of these concepts. Several changes in the wording of the text were also suggested. In general, there was a feeling that the guidelines must be as broad as possible so that researchers in different situations could adapt it for their own use.

Following this session, Dr. Amar Jesani, CEHAT, made a presentation, on the implementation mechanism and the feedback received on this issue. The sub groups then discussed this section of the guidelines.

Among the issues that emerged was the practicality of prescribing a particular type of institutional mechanism, when research was being conducted in such a wide range of settings and institutions. There was also a feeling that one must guard against the guidelines becoming another formality that researchers may follow in the letter while violating its spirit. It was also felt that formalising this process through a central body such as ICSSR could lead to such a scenario. It was also felt that a formal mechanism could give undue powers to the authorities, while undermining the autonomy of the researchers. On the other hand, a need was also articulated to institutionalise ethics, so that ethical conduct of research becomes the norm and attention is aid to the ethical aspects of research as a rule rather than an exception. The general feeling was that there should be sufficient flexibility to allow the use of the guidelines in different settings. It was also suggested that different types of models of the implementation mechanism could be developed which would be applicable to various settings.

Certain commitments were made. The assembly, in general, agreed to share their own experiences and dilemmas with the group. Thus, some documentation of actual field experiences could be developed and it would be educative for others facing similar situations. It was also decided that the Drafting Committee would function as a peer group, which would deliberate, on decisions/problems referred to them by anyone in the group at any later time. Those who were in charge of research projects or heads of institutions committed that they would use the guidelines immediately in their work. Those who were part of larger organisations and institutions committed that they would discuss the guidelines with their superiors and their colleagues and initiate a discussion on them in their own institutions. It was also decided that the guidelines would be finalised as soon as possible and disseminated widely. The secretariat would remain at CEHAT.

Ethical issues in international health research
The programme for this five-day meeting on the ethical dimensions of international health research, in Durban, South Africa, described it as a forum to address various ethical controversies arising from the growth in collaborative health research in developing countries.

“As more and more health research is being conducted in developing countries, practitioners, funders, and overseers are increasingly forced to deal with ethical controversies and conflicts arising from the differences in cultures, politics, wealth, standards of care, inPidual and group rights, and priorities.”

Sixty-five participants (from medicine, research, community health organisations, journalism, ethical review boards, and the pharmaceutical industry) and 12 faculty members gathered at a resort near Durban for the period of the seminar. The participants from India came from the All India Institute for Medical Sciences in Delhi, the National AIDS Research Institute in Pune, and Mumbai.

Solomon Benatar, director of the Bioethics Centre at the Faculty of Health Sciences, University of Cape Town, South Africa, spoke on the general principles of health research ethics.

The recent interest in ethics stems partly from controversies in AIDS research. Also, the quantum of medical research has gone up sharply, as have reports of violations of existing ethical guidelines for health research. There is the question of access to research, and to the products of research. At resent, 90 per cent of the world’s research is done on 10 per cent of the world’s problems.

The principle-based approach to bioethics — using the principles of beneficence, non-maleficence, autonomy and justice — was presented as providing a framework within which these problems could be addressed.

A discussion on professional ethics was led by Kenneth Winston of the Kennedy School of Government. The purpose was to explore the conflict between one’s moral responsibilities as a member of the human community, and one’s professional obligations.

Robert Levine, Chair, Human Investigation Committee Yale-New Haven Medical Centre, outlined the history of research ethics, from the protectionism of the 1960s, to viewing the benefits of participating in research. He argued that the Helsinki document’s distinction between therapeutic and non-therapeutic research is illogical, out of touch with current ethical thinking, and widely disregarded. He proposed two changes to existing international ethical guidelines: that the distinction between therapy and research be removed, and that the standard of care for participants be based on the “highest attainable and sustainable care available in the host country”.

The proposals sparked off extended debate with strong views expressed against and for the proposed revisions.
H. M. Coovadia, investigator in childhood HIV in Africa and member of the Institutional Review Board at the University of Natal, presented the history of the standard-of-care controversy.

This debate dates back to 1995 when the New England Journal of Medicine challenged on-going research on short courses of anti-retroviral drugs to reduce vertical transmission of HIV. A longer course, known as the 076 regimen, had already been proved effective, but was felt to be too expensive and logistically unsuitable for developing countries. These trials, conducted on over 15,000 women in Asia and Africa, were called unethical because the control group received a placebo, even though an effective treatment existed. The NEJM argued that the trials violated the researchers’ primary responsibility to the study population (asserted in international ethics guidelines) as health provider.

Professor Coovadia mentioned ethical, logistical and economic arguments to support placebo-control trials in specific situations. The longer course was neither affordable nor implementable. Its efficacy was unproven in a breast-feeding population. Finally, local institutional review boards could make autonomous decisions. Finally, this research eventually led to the development of successively cheaper alternatives to the 076 regimen. This presentation, too, provoked a good deal of discussion.

To the suggestion that economics was used to drive science and the ethics of scientific research, Professor Coovadia responded that the placebo-control trials concerned both scientific and economic issues. He did concede that decision-making had sometimes been blurred in what had become an emotion-charged debate.

Other sessions discussed issues in policy setting on health research, researchers’ obligations to the community, ethical review processes and the functioning of institutional review boards, international research and the law, informed consent in the cross-cultural context, ethical issues in randomised clinical trials, conflict of interest, scientific misconduct and the regulatory process.
Many of the issues discussed at the workshop concern Indians greatly. Collaborative research is increasing in India. There is a need for greater awareness of and discussion on medical research ethics, translating into better, more ethical research in India.

The meeting was sponsored by the Africa Centre for Population Studies and Reproductive Health, the South African Medical Research Council, and the University of Natal (in South Africa); the Harvard School of Public Health, the Kennedy School of Government, the Tufts University School of Medicine, and the United States National Institutes of Health (US); and the Wellcome Trust, UK.
Ms Srinivasan’s participation was sponsored by the organisers. Travel and related costs were funded by the Institute for International Education, USA (through the Ford Foundation, India), and the Adenwalla Trust, Mumbai.