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New regulations on compensation for injury and death in drug trials

Neha Madhiwalla

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.

About the Authors

Neha Madhiwalla ([email protected])

B 3 Fariyas, 143 August Kranti Marg, Mumbai 400 036




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