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Ethical guidelines for biomedical research on human subjects

In 2000, the Indian Council of Medical Research (ICMR) published national guidance on research on human subjects following a revision of its 1980 policy statement on ethical considerations involved in research on human subjects. The 2000 guidance sets out general ethical issues and ethical principles applying to research on human subjects and well as the procedures that should be used for ethical review of research.

The 12 ethical principles cover topics such as the need for voluntariness and informed consent, the minimisation of risk to research subjects, and privacy and confidentiality. The discussion of general ethical issues covers topics such as what information should be provided to participants, inducements to participate, compensation for research-related injury, and international collaboration in research. The second half of the guidance focuses on five specific areas of research: clinical trials, epidemiological studies, genetic research, transplantation (including fetal tissue), and research into assisted reproduction.