The Indian Council of Medical research brought out the 'Policy Statement on Ethical Considerations involved in Research on Human Subjects' in 1980 and revised these guidelines in 2000 as the 'Ethical guidelines for Biomedical Research on Human Subjects'. Due to further rapid developments in science and technology in India after the release of the second version, it became necessary to update these guidelines to make adequate specific provision to meet ethical challenges posed by these advances. Necessitated by the globalization leading to increasing research in the developing world, the international guidelines released in 2002 by the developed countries including the revised CIOMS guidelines focused on observance of ethical norms relevant to different pluralistic cultural environment in these countries for the protection of the research participants in these regions. In India the challenge faced is to apply universal ethical principles to biomedical research in the multicultural Indian society with a multiplicity of health-care systems of considerably varying standards. The scope of this third version of the Council's guidelines takes note of these changes, and in keeping with the national policies and the demands of Indian culture, addresses ethical issues in specific situations to the extent possible. While on one hand, research involving human participants must not violate any universally applicable ethical standards, on the other hand, a researcher needs to consider local cultural values when it comes to the application of the ethical principles to individual autonomy and informed consent. In India, one will have to consider autonomy versus harmony of the environment of the research participant. In research on sensitive issues, this will have to be properly addressed in the research protocol to safeguard the human rights of the dependent or vulnerable persons and populations.
