ETHICAL GUIDELINES FOR
SOCIAL SCIENCE RESEARCH IN HEALTH

• Introduction
  • Section I --Preamble
  • Section II --Ethical Principles for Research
  • Section III --Rights and Responsibilities of Researchers and Institutions
    • Relationship between researchers and institutions
    • Protection and promotion of integrity in research
    • Relationship among researchers
    • Data Sharing
    • Reporting and publication of research
  • Section IV --Rights of Participants
    • Relationship with the participants
    • Informed consent
    • Privacy, anonymity and confidentiality
  • Section V --Rights and Responsibilities of Peer Reviewers/Referees
  • Section VI --Rights and Responsibilities of Editors and Publishers
  • Section VII --Rights and Responsibilities of Funders and Sponsors
  • Section VIII --Organisational Mechanism for Ethics

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INTRODUCTION


Amar Jesani
Tejal Barai


Ethics is concerned with the conduct of human beings. All scientific activities, including those by the social scientists, are conducted with the participation of human beings or have an impact on human beings or on the wider society and environment. Therefore, it is essential that scientists/researchers understand ethical issues and the implications of their scientific work and act accordingly. For making ethical judgement, the scientists/researchers rely upon various standards of ethics, which could be universal or specific to the culture(s) or localities. Indeed, it is essential that researchers share and discuss the ethical issues in their work and evolve collective standards of their own.


Self-regulation and ethics have been issues for debate within research more often in medicine than in social sciences. The Second World War and the Nuremberg trials of doctor-researchers exposed the horrors of the fascist politics as well as unethical biomedical research. In the post World War period, therefore, the scientists paid increased attention to ethics in biomedical research. In the process, the quality and validity of unethical research was questioned, the human rights of participants recognised and ethical codes formulated. The Nuremberg Code (1947) was followed by the Declaration of Helsinki in 1964, which was amended subsequently (WMA, 1989). The Council for International Organisations of Medical Sciences (CIOMS) and the World Health Organisation (WHO) (1993) also proposed guidelines in 1983 and adopted them in 1992. These international developments followed as well as inspired several such initiatives at the national level and in various specific fields of biomedical research. India, too, did not remain unaffected. In 1980, the Indian Council of Medical Research formulated "Policy statement on ethical considerations involved in research on human subjects" and in 1997, it brought out the draft of "Consultative Document on Ethical Guidelines on Biomedical Research Involving Human Subjects".


The issue of ethics in social sciences, unlike in medical research, has been given less prominence in India. Although many social scientists have paid serious attention to the appropriate conduct of research and set personal examples, they are often not discussed as ethics and no efforts are made to formalise some guidelines based on such experience(s). Our national councils for social science research and their institutions have many guidelines either as administrative orders or for improving the quality of research but enough efforts have not been made to bring them together as comprehensive ethical guidelines. Besides, in the absence of such comprehensive guidelines, ethics are hardly there in the social science education curriculum.


But this situation in India is definitely not due to lack of attention to ethics in social sciences in other countries. In fact, In the post World War period, there has been growing pressure on social science professionals to self regulate and evolve their own codes of conduct. There has been a continuing debate between the view of making the social sciences "value free" and "objective" and the view that social scientists could not remain value free simply because they deal with contemporary society and because there is an explicit connection between research and social action or political viewpoint. The former tries to make social scientists attain a status of professionals and often puts them in ivory tower situations, while the latter tries to make them aware of the impact of their activities on the society. However, in both cases the ethics of the social inquiry and the application of the expertise of social science to current social problem need to be dealt with.


Internationally, the associations of applied anthropology and the psychologists formulated their codes as early as in 1940s and 1950s. The controversy around the Project Camelot and its cancellation in 1965 led to increased discussion on ethics among the social scientists and eventually prompted most of the major social science associations to formulate their guidelines (Barnes 1979). The universities have also tried to establish formal guidelines to protect student research and their exploitation by the teachers. Our survey of ethical guidelines in the social sciences in different developed countries showed, to our surprise, that most associations of sociologists, anthropologists, political scientists, psychologists, etc. have formulated and refined their ethical guidelines in last three decades. Besides, in last one and half decades there have been attempts by the associations of different science and social science disciplines to combine their efforts and evolve joint guidelines. The most important effort made so far has been the joint efforts for evolving common ethical guidelines by medical, social science and natural science disciplines. For instance, the Medical Research Council of Canada, the Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council of Canada appointed a joint committee (called Tri-Council Working Group) to formulate "The Code of Ethical Conduct for Research Involving Humans". In 1997, these three councils adopted the Tri-Council report as a common code of ethics. Apparently some similar processes are also on the USA. In essence, these developments emphasise that the principles governing all research on humans by all disciplines of sciences have many things in common. And the researchers need to respect and protect human rights of the participants of research.


The present effort to formulate ethical guidelines for research in social sciences and health in India began in 1998. After a rigorous documentation of the guidelines for medical as well as social science research in India and outside, a multi-disciplinary national committee was constituted in 1999. As is evident from their backgrounds (see Appendix for brief outline on each member of the committee), they brought together vast experience of last few decades in social science and health research and activism. The committee met twice to prepare the drafts of the guidelines and the final draft was mailed to over 100 researchers and institutions in different parts of the country to get their feed back. Besides, it was directly presented at six institutions to teachers, researchers and students. The feedback thus obtained from all over the country was summarised in a paper, which, along with the draft of the guidelines were then thoroughly discussed in a national meeting of researchers and activists from social science and health fields in May 2000. (See Appendix for the list of participants at the May 2000 meeting.) The draft of the guidelines discussed at this meeting was again revised, discussed and adopted by the committee after the meeting. The final guidelines thus formulated are given in this document.

In brief, we have made all possible efforts to consult the social scientists and health researchers from different parts of the country. Our objective was to incorporate available experience, expertise and concerns on ethics in the guidelines so that, they could be used by more and more researchers across the country in their work. We are aware that any effort (more so if it is voluntary effort) in formulating comprehensive guidelines for such a vast field of research in such a vast country like ours is not going to be adequate. However, the feedback received from the community of researchers suggests that this is a good beginning and we hope that as more researchers and institutions use these guidelines, they will get further refined and become more comprehensive. Perhaps it is true that real improvement in the standards of quality of and ethics in research in our country need more effort than the mere drafting of ethical guidelines. But at the same time the very process of drafting, discussing, adopting and ultimately using guidelines have not only an educational value, but they also contribute the larger process of improvement. The guidelines would also provide a means to individual researchers and institutions to resist pressures to undertake research that might compromise their ethics.

The guidelines presented here provide an ethical framework based on four moral or normative principles and ten principles relevant for ethics in research in India. The ethics are after all arrived at on the basis of the context of the situation, and the principle-based framework assists the researchers in developing their moral arguments for choosing the most appropriate and ethical action in the given situation. In that sense, the guidelines are not administrative rules, but they are approximate standards informing the choice of action in a concrete situation. Fundamental to understanding and applying ethical principles and guidelines is the concern for and protection of the human rights of the participants. Further, the guidelines formulate rights and responsibilities of the four major actors in research endeavour; namely, the researchers, the institutions, the sponsors and funders, and the gatekeepers.

Lastly, the development of organisational mechanism for ethics in social science research in health has been kept as an open process to be evolved by the community of researchers and institutions. The national meeting of researchers in May 2000 correctly felt that such a mechanism could be different for different types of institutions and projects; and that only by practising ethics within institutions could we arrive at appropriate models for the organisational mechanism. Indeed, such a process would also create a critical mass of individuals and institutions having experience in integrating ethics and guidelines in their institutional environment and the research process. Of course, this is a collective endeavour of networking, sharing, discussing and providing assistance to each other. We hope that the publication of this document will help in consolidating the process started while formulating it.

REFERENCES

Barnes J. A. (1979), "Who should know what? Social science, privacy and ethics", Cambridge: Cambridge University Press. Pages. 158-168).

CIOMS (Council for International Organisations of Medical Sciences) and (WHO) World Health Organisation (1993), "International Ethical Guidelines for Biomedical Research Involving Human Subjects". Proposed Guidelines, 1983. Revised and adopted, 1992. Geneva: CIOMS/WHO.

International Tribunal of Nuremberg (1947), "The Nuremberg Code". In Scholle Connor Suzan, Fuenzalida-Puelma Herman L. (Ed.), "Bioethics: Issues and Perspectives". See Appendices, Pages 217-8. Washington DC: Pan American Health Organisation.

WMA (World Medical Assembly) (1989), "Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects". Adopted, June 1964 (Helsinki) and amended, October 1975 (Tokyo), October 1983 (Venice) and 1989 (Hong Kong. In Scholle Connor Suzan, Fuenzalida-Puelma Herman L. (Ed.), "Bioethics: Issues and Perspectives". See Appendices, Pages 218-20. Washington DC: Pan American Health Organisation.

ICMR (Indian Council of Medical Research) (1980), "Policy Statement on Ethical Considerations Involved in Research on Human Subjects". New Delhi: ICMR.

ICMR (Indian Council of Medical Research) (1997), "Consultative Document on Ethical Guidelines on Biomedical Research Involving Human Subjects". (Draft). New Delhi: ICMR.


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