Abstract
Are trial participants adequately safeguarded by the ethics committees-the Indian scenario?
Highlights
Clinical trials are paramount for the development of medical science and advancement in therapeutics
The CDSCO considers and approves only those trials that have been approved by the Ethics Committees, thereby, making the Ethics Committees (EC) the most important link in safeguarding participant’s rights and safety
There have been many instances of unethical trials being conducted in India and globally (SOMO, 2008). One such example is the cervical cancer screening clinical trial conducted in India and sponsored by US National Cancer Institute (NCI) and the Bill and Melinda Gates Foundation
Summary
Clinical trials are paramount for the development of medical science and advancement in therapeutics. Since clinical trials involve human “participants,” their safety, and policies to protect their rights justly take precedence over scientific advancement. In India, the regulatory agency overseeing and approving clinical trials is the CDSCO, “Central Drugs Standard Control Organization” (Central Drugs Standard Control Organization, 2014).
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