Almost three years after issuing a draft guidelines for 'Compensation to participants for research related injuries', the union health ministry is yet to come out with the final document which would have set the standard for this highly unregulated area in the burgeoning clinical trial industry in the country.

A document in this regard is significant in the country as the laws governing the clinical trials in the country are vague on the issue of giving proper compensation to the trial participants. Though the Indian Council for Medical Research (ICMR) Ethical Guidelines for Biomedical Research on Human participants, 2006 have specified the need for provision of compensation of participants for research related injuries, in the absence of clear guidelines in this regard, the sponsors of the trials very often exploit the participants by simply providing some treatments.

To ensure better compensation to the clinical trial subjects in an organized manner, the ICMR had in November 2008 issued a draft guidelines for compensation to participants for research related injury in India. The new ICMR draft guideline proposes to bring uniformity in giving compensation to the participants. As per the draft document, the guidelines would apply to all clinical research, whether sponsored by the pharmaceutical or medical device industry, government or academia or individual investigators. It did not apply to post-marketing surveillance and ancillary care.

However, even almost three years after coming out with the draft document, the ICMR could not finalise this important document which would have gone a long way in providing the rightful compensation to the participants of the clinical trials in case of injuries related to the trials. Sources said that the delay in finalising the document is due to the indifferent attitude of the senior officials in the ICMR. “After the retirement of senior scientist Dr Vasantha Muthuswamy, things are not moving fast in the premier research organisation in the country,” sources said.

The issue of compensation to participants for research related injury is variably addressed globally. In the United States, it is not mandatory by law for sponsors and institutions to provide either free medical care or compensation for research related injuries to trial participants, apart from general tort law principles that apply to everyone. In contrast, many European countries mandate the provision of clinical trials insurance, through which participants are often covered regardless of fault. The Association of the British Pharmaceutical Industry (ABPI) guidelines recommend that subjects suffering from research related injuries be compensated.