ICMR to frame clinical trial compensation guidelines

The Indian Council of Medical Research (ICMR) would lay down a framework to compensate clinical trial volunteers for injuries during clinical research programmes in the country.

The move follows increasing complaints from Parliamentarians and civil society groups against the absence of a proper mechanism to compensate clinical trial victims. According to industry estimates, the Indian clinical research sector is worth $300 million.

The proposal stipulates that all clinical trial victims be compensated, irrespective of the cause of injury and the individuals or agencies responsible. Also, the injured would have the right to claim compensation, irrespective of whether or not the injury was foreseeable/predictable. The fact that the participant had consented in writing to participate in the research would not have any bearing on the person’s rights for compensation.

 

A draft compensation guideline, prepared by ICMR’s bioethics group, an association of clinical research organisations and global research-based pharmaceutical companies, has been published by ICMR for public comments.

The Indian Society of Clinical Research, which authored the draft guideline, is an association of clinical research professionals engaged in research programmes in India. Corporate members of the society include 17 pharmaceutical majors, including Astrazeneca, Bristol Myers Squibb, Eli Lilly, Novartis and Pfizer.

The need for systematic tracking of clinical trial compensations was brought to the fore after a Parliamentary panel found the apex drug control authority, Central Drugs Standard Control Organisation (CDSCO), had no statistics on the number of clinical trial deaths and the subsequent compensation status. An inquiry revealed there were dozens of instances in which victims were not compensated. Following the CDSCO directive, 22 companies compensated the victims early this year. The compensation would include payments for the immediate medical/surgical management of research-related injuries, compensation for research-related injuries leading to temporary or permanent disabilities and payments to legal heirs/lawful guardians in case of death.

According to ICMR Ethical Guidelines for Biomedical Research on Human Participants (2006), research participants who suffer a physical injury as a result of their participation, are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability. However, there was no structured format on the implementation of this provision.

The compensation guideline would take final shape after the December 31 deadline for comments.