Will the proposed compensation guidelines for research-related injury spell the death knell for clinical research in India?
The Indian Council of Medical Research and the Central Drugs Standards Control Organization of the Directorate General of Health Services of the Ministry of Health and Family Welfare' draft guidelines for compensation of research-related injury have evoked strong responses from the clinical research community. All stakeholders, including academic researchers, teachers in medical colleges, the pharmaceutical industry and even members of Institutional Review Boards and Ethics Committees have expressed grave reservations about several clauses in the guidelines. Moreover, these two guidelines differ from each other in important areas, reiterating that more thought and discussion is necessary to refine the guidelines. We present an academic researcher's perspective of the guidelines and our views on how they will affect clinical research in the country. The paper covers the types of research-related injury that are entitled for compensation, controversies on whether injury resulting from standard care should be entitled for compensation, whether causality needs to be established as a prerequisite for eligibility for compensation and whether all forms of research should have mandatory provision for compensation. We also put forward the potential dangers of such recommendations, which could potentially be inducement for patients to participate in clinical research. Finally, we raise the philosophical issue of infringement of an individual's fundamental rights regarding what research he/she wishes to participate in. While these points are based on several formal and informal discussions with stakeholders from various fields of clinical research, the views expressed are the authors' own personal thoughts.
Department of Clinical Research Secretariat and TMC Research Administrative Council, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India.
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CS
Pramesh
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RA
Badwe
D035843:Biomedical Research / Q000191:economics / Q000592:standards; D002986:Clinical Trials as Topic / Q000191:economics / Q000592:standards; D035881:Compensation and Redress; D004345:Drug Industry; D028744:Ethics Committees, Research / Q000592:standards*; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007194:India; D007258:Informed Consent / Q000941:ethics; D012108:Research Personnel