Ethics committees and clinical trials registration in India: opportunities, obligations, challenges and solutions.
Registering clinical trials is considered an ethical and moral imperative. The launch of the Clinical Trials Registry-India provides opportunities to all in India to fulfil this imperative. The CTRI requires prospective registration, disclosure of all 20 items in the WHO Trial Registration Data Set and proof of ethics and regulatory clearances. Registration in the CTRI is voluntary. However, institutional research ethics committees have obligations. This article reviews these obligations and provides an example of how this can be achieved.
Tharyan
Prathap
P
South Asian Cochrane Network, Christian Medical College, Vellore 632 002, Tamil Nadu, India. prathap@cmcvellore.ac.in
D000068:Accreditation / Q000458:organization & administration; D002986:Clinical Trials as Topic / Q000941:ethics / Q000592:standards; D004345:Drug Industry / Q000941:ethics / Q000458:organization & administration; D028744:Ethics Committees, Research / Q000941:ethics / Q000458:organization & administration; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000941:ethics / Q000592:standards; D006801:Humans; D007194:India; D009937:Organizational Objectives; D012042:Registries / Q000941:ethics / Q000592:standards; D014944:World Health Organization