Putting patients first: draft guidelines for compensation for research-related injury in clinical trials in India

Gagandeep Kang | Indian Journal of Medical Ethics | Vol iX No 2 | April – June 2012

With the recent highlighting of ethical issues in several clinical trials, and the increase in awareness among parliamentarians, there has been some concern about the conduct of trials in india. The areas of concern include ensuring that consent is truly informed, and monitoring participant safety, the occurrence of deaths, and the payment of compensation. On November 18, 2011, the draft of the Drugs and cosmetics (3rd Amendment) rule, 2011, was published (1) in the Gazette of india, with a plan for implementation 45 days after publication. in addition, the draft guidelines for compensation were posted for comment by the indian council of Medical Research (icMR), where bioethicists have been responsible for developing and updating the Ethical guidelines for biomedical research on human participants, last revised in 2006. These guidelines state that research participants who suffer an injury as a result of participation in research are entitled to compensation for impairment or disability (2). it is commendable that the Government of india through the Ministry of Health and Family Welfare is taking steps to safeguard the rights of research participants and emphasise the responsibility of sponsors, investigators and institutional ethics committees engaged in conducting or reviewing clinical research in india. The proposed rules include several provisions for ensuring that study participants who suffer injury, permanent injury, or their heirs in case of the participants death, will be entitled to timely and just compensation. These rules highlight the need to ensure that research participants’ needs in case of injury, are given primacy, as they should be.

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