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India Revises Guidelines to Protect Human Subjects

Volume 9, No. 1, December 2000

Revised guidelines for the conduct of biomedical research involving humans adopted by the Indian Council of Medical Research (ICMR) in September 2000, assert that all such proposals "should be reviewed by an appropriately constituted Institutional Ethics Committee (IEC)."

Besides conducting the initial review, the guidelines assign IECs "a continuing responsibility of regular monitoring for the compliance of the ethics of the approved programmes till the same are completed. Such an ongoing review is in accordance with the Declaration of Helsinki and all the international guidelines for biomedical research."

The guidelines stipulate that the scientific evaluation of the proposal must be completed before the ethical review begins and recommends that ethical reviews be done in formal meetings rather than through the circulation of proposals. The guidelines further recommend that IEC records be retained for at least 15 years.

Independence and competence are cited as the criteria for IEC membership. A person from outside the institution is preferred as the IEC chair. Membership should be a mix of medical, non-medical, scientific and non-scientific persons.

The guidelines outline the obligations of investigators regarding informed consent and the essential information that must be provided to prospective research subjects. Compensation to participants and the treatment of special populations such as pregnant or nursing women, children, mentally challenged individuals, prisoners, and economically or socially disadvantaged persons are addressed. Other topics covered include clinical trials; epidemiological, human genetics and transplantation research; and reproductive technologies.

The ICMR document "Ethical Guidelines for Biomedical Research on Human Subjects" is available at http://icmr.nic.in/vsicmr/wel.htm.