The Indian Council for Medical Research (ICMR) will soon finalise the guidelines for compensation to participants for research related injury in India. The ICMR earlier in October 2008 had issued draft guidelines in this regard and had invited comments from the experts and others. As per the draft guideline, it applies to all clinical research, whether sponsored by the pharmaceutical or medical device industry, government or academia or individual investigators. However, the draft guideline does not apply to post-marketing surveillance and ancillary care.

"We have received a number of suggestions and comments from the experts and others on the draft guidelines. The committee on this issue will meet soon and will discuss on incorporating the suggestions and comments before finalising the guidelines," senior ICMR officials said.

Once the committee takes a decision on incorporating the suggestions and comments received from the experts and others, the ICMR will issue the final guidelines on the issue. Though the guideline is not mandatory, it is significant as in the event of any dispute it will play a crucial role in deciding the matter.

At present, laws governing the clinical trials in the country are vague on the issue of giving proper compensation to the trial participants. Though the 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. The new ICMR guideline proposes to bring uniformity in giving compensation to the participants.

As per the draft guideline, compensation should be provided to the research participants when temporary or permanent injury occurs due to participation in the clinical research and also when injury is caused by a procedure which has been undertaken to manage an adverse reaction occurring during the research. The guideline proposes compensation to the participants irrespective of whether injury was foreseeable or predictable or not, the fact that the research participant had freely consented in writing to participate in the research and irrespective of the fact that the injury was caused through a departure from the agreed protocol, scientific misconduct or negligence by the investigator.

Under the guidelines, compensation should be paid to a child injured in-utero through the participation of the parent in clinical research and all research related injuries be compensated irrespective of their causes and individuals or agencies responsible.