Review of policies for injuries to research participants in India.

BACKGROUND As there is little Indian data about severity, frequency and types of research related injuries, costs involved and policies regarding compensation, this study was conducted to review the present Indian scenario. METHODS The study was carried out in three parts; a questionnaire-based survey, in-depth interviews, and a review of informed consent and insurance documents of projects submitted to three ethics committees. RESULTS 47% of investigators were either unaware of, or had not understood, the legal requirements and depended on sponsors to manage these issues, whereas 74% of ethics committee members were aware of the requirements. Although 40% of investigators, 30% of ethics committee members and all sponsors had policies to manage compensation issues, these were mainly to provide immediate free medical care or reimbursement of expenses incurred for the acute management of an adverse event. Compensation for loss of time/wages, death, physical disability or long term incapacitation was not included. A review of informed consent and insurance documents showed that compensation issues were inadequately discussed, with only insurance certificates submitted to ethics committees. CONCLUSION In India, there are no uniform policies and investigators are largely unaware of their responsibilities. Therefore, there is an urgent need to draft national guidelines regarding compensation for research injuries of research participants and highlight the responsibilities of each stakeholder. Potential research injuries should be categorised based on risk assessment, severity and seriousness of the injury. Further, it would be necessary to have arbitration committees to determine the extent of compensation. Training and awareness workshops for those involved in clinical research, including research participants, is also needed.