Health department seeks probe into ‘unethical' clinical trials at HCG
The department acted after Justice P Krishna Bhat, former chairperson of the Institutional Ethics Committee (IEC) at HCG, raised serious concerns and resigned earlier this year. His resignation followed complaints about how clinical trials were being handled, especially patient safety, ethical violations and conflicts of interest.
In a letter dated June 30, the health commissioner noted that the allegations raised questions about compliance with rules and integrity of clinical research.
'These lapses, if proven, will undermine the strict ethical principles laid down by DGCI, ICMR, DHR, and bodies like WHO,' the commissioner said. Justice Bhat had written on March 5 outlining several concerns. One of the main issues was a conflict of interest — Dr Sathish, director of clinical trials at HCG, was also acting as principal investigator (PI) or co-PI in many of the clinical trials he was supposed to oversee.
This, according to medical research rules, is not allowed. ICMR states members of an ethics committee should not act as investigators in the same studies, as it affects independent judgement and patient safety.
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