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ICMR moves to cut clinical trial delays with single ethics review system

ICMR moves to cut clinical trial delays with single ethics review system

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NEW DELHI: In a move aimed at speeding up medical research and reducing delays in clinical trials, the Indian Council of Medical Research (ICMR) has introduced new guidelines allowing a single ethics committee to clear multicentre health studies conducted across different hospitals and institutions in India.At present, every hospital or institution participating in a multicentre study separately reviews the same research proposal, often leading to months of delays, repeated paperwork and inconsistent decisions.Under the new framework, one designated “Single Ethics Committee” will review the study on behalf of all participating sites, while continuing to monitor participant safety, informed consent and adverse events across centres.ICMR said the system is expected to improve coordination, reduce duplication and help generate faster evidence for public health policy and treatment strategies.The guidelines apply to a wide range of biomedical and health research, including clinical trials involving drugs, vaccines, biologics and medical devices, as well as public health, genetic and epidemiological studies.The document stressed that participant protection would remain central to the process despite the centralised review mechanism. Ethics committees will still be required to examine local cultural sensitivities, participant safety, informed consent procedures and site-specific risks before approving studies.The guidelines also call for stronger systems to monitor serious adverse events, protocol violations and participant safety during trials.The new framework was released during the 1st ICMR Annual Clinical Trial Meet 2026, where experts also discussed reforms needed to strengthen India’s clinical research ecosystem and expand evidence-based integrative medicine research.One of the highlights of the meeting was the presentation of findings from an ICMR-CCRAS clinical trial on iron deficiency anaemia involving nearly 4,000 women aged 18-49 years.The study compared Ayurvedic formulations — Punarnavadi Mandura alone and in combination with Drakshavaleha — with standard iron-folic acid therapy over 90 days. Researchers said the Ayurvedic formulations showed therapeutic equivalence in improving haemoglobin levels and clinical outcomes.Experts at the meeting said faster and more harmonised ethical approvals could help India improve large-scale multicentre research, including studies involving underserved and geographically dispersed populations.

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