title: Compensation for clinical trial-related injury and death in India: challenges and the way forward.
abstract: Clinical research, including clinical trials, is the bedrock of evidence-based medicine and is the most reliable method of generating credible data. Over the last decade, India has been one of the preferred destinations for clinical research activities. However, a couple of trials generated widespread media coverage due to alleged ethical transgressions, which generated debate among various stakeholders and dented the overall image of clinical research activities in the country. One of the major issues which has emerged is of compensation to research participants for clinical trial-related injury or death. To address this question, the Government of India has come up with regulations regarding compensation for research participants. While these rules provide a robust framework for compensation, some concerns have been raised regarding interpretation and implementation of these guidelines. In this article, we have tried to raise some debatable issues that need to be addressed to bring more clarity to this subject. These issues need to be handled in a balanced manner so that they are able to address the concerns of all stakeholders. It is envisaged that once clarity emerges, confidence in the clinical research process will be restored.
authors.affiliation: Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India, yk.ykgupta@gmail.com.
authors.forename: Yogendra Kumar
authors.initials: YK
authors.lastname: Gupta
authors.forename: Arun Kumar
authors.initials: AK
authors.lastname: Pradhan
authors.forename: Aman
authors.initials: A
authors.lastname: Goyal
authors.forename: Prafull
authors.initials: P
authors.lastname: Mohan
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence / Q000592:standards; D002986:Clinical Trials as Topic; D035881:Compensation and Redress; D028744:Ethics Committees, Research / Q000592:standards; D033161:Government Regulation; D006801:Humans; D007194:India; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D014947:Wounds and Injuries / Q000191:economics*