After dilly-dallying on the issue for several years, the Indian Council for Medical Research (ICMR) has come out with a new set of Draft Guidelines on Compensation for Research Related Injury in India.
Indian Society for Clinical Research (ISCR) and Forum for Ethic Committees in India (FERCI) have prepared the new draft guidelines which apply to all clinical research, whether sponsored by the pharmaceutical or medical device industry, government or academia or individual investigators. These guidelines do not apply to post marketing surveillance and ancillary care.
As per the new guidelines, compensation should be provided to the research participants for temporary or permanent injury; when injury is caused by a procedure which has been undertaken to manage an adverse reaction occurring during the research; and to a child injured in-utero through the participation of the parent in clinical research.
Besides, compensation should be paid irrespective of the fact that the injury was foreseeable/predictable or not; or the research participant had freely consented in writing to participate in the research; or the injury was caused by the comparator product(s) under investigation in the clinical research; irrespective of the cause of injury and individuals/agencies responsible; and irrespective of the fact that the injury was caused through a departure from the agreed protocol, scientific misconduct or negligence by the investigator.
On the issue of quantum of compensation, the draft guidelines say that compensation could be in the form of payment for immediate medical or surgical management of research related injuries or for research related injuries leading to temporary or permanent disabilities. In case of death, compensation should be paid to the legal heir/lawful guardian.
The guidelines specify that the Informed Consent Document (ICD) should clearly state that the research participant has a right to claim compensation in case of research related injuries and whom to contact in the IEC for their rights as research participants, including the exclusions/limitations in simple and clear language which can be understood by the research participant.
However, compensation may not be provided if it is determined (by the Investigator and the IEC) that the injury has arisen through wrongful act or default of a third party and contributory negligence by the research participant (e.g. willful or reckless nonadherence to protocol procedures/instructions by the research participants as described in the ICDs).
Compensation will not be available: for failure of an investigational product to have its intended effect; for receiving placebo in consideration of its failure to provide a therapeutic benefit; for natural progression of an underlying disease; and for adverse effects due to concomitant medications allowed as per protocol / routine procedures as part of standard of care.
In fact the ICMR, way back in November 2008, had issued a draft guidelines in this regard, but could not finalise this important document which would have set the standard for this highly unregulated area in the burgeoning clinical trial industry in the country.
However, after almost three years, the ICMR has come out with a new set of guidelines on this issue and has invited comments from the stakeholders till the end of this year.