January 15, 2012

New clinical trial norms on anvil

The Indian Council of Medical Research ( ICMR) has sought proposals from doctors and health activists to advise on the new draft guidelines for compensation to people undertaking drug trails. The subjects will be compensated if they are injured during the trails.

Proposals will be invited till December 31. As per the new guidelines, mothers undergoing clinical trials which harm their unborn child will be able to demand compensation from researchers. The guidelines apply to all clinical research, whether sponsored by the pharmaceutical or medical device industry, government or academia or individual investigators.

The guidelines say compensation could be in the form of payment for immediate medical/ surgical management of research-related injuries or for permanent disabilities. It says the Informed Consent Document (ICD) should state that the research participant has a right to claim compensation in case of research-related injuries and whom to contact for their rights as research participants. If guidelines are finalised then compensation has to be paid, irrespective of whether the injury was foreseeable/predictable and that the research participant had given his consent in writing about participating in the research study.

However, the new ethical draft guidelines for biomedical research on human participants have churned out mixed reactions in the medical fraternity and health activists. According to them, some issues have been left out in the guidelines to make them firm. Kalpana Mehta, a health activist who have been working on the issues of clinical trials since few years said, "If points related to continuing medical care to trial subjects, sharing the profits of the approved drug with trial subjects and points to equalise legal representation are added then guidelines will be better to deal with clinical trial issues." Dr Anand Rai, a whistle blower in clinical trials issues said, "The role of independent ethics committees is marred so some strong actions are needed on this front. Compensation must be paid to research participants receiving placebo or otherwise sponsor will misuse the guidelines."

On the other hand, doctors too feel there is a little scope of addition in the draft guidelines. Dr Sanjay Dixit, Head community medicine, MGM College says, "There should be systematic tracking of adverse events. In addition need of structured format for reporting and compensation must be included in the guidelines." Proposing continuing medical care to trials subject he further said all research institution should make it public about the ongoing trials at their notice boards.

Link: Original Article

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