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ICMR Initiates Public Consultation on Ethical Framework for Non-Regulatory Clinical Trials

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The Indian Council of Medical Research (ICMR) has released draft guidelines for Non-Regulatory Clinical Trials (NRCTs) to ensure ethical standards in biomedical research that fall outside standard regulatory oversight.

The Indian Council of Medical Research (ICMR) has taken a significant step toward strengthening the ethical landscape of Indian biomedical research by inviting public feedback on its 'Draft Ethical Guidance for Non-Regulatory Clinical Trials (NRCTs).' While standard clinical trials for drugs and medical devices are governed by the Central Drugs Standard Control Organization (CDSCO) under the New Drugs and Clinical Trials Rules, 2019, a vast segment of biomedical research—such as observational studies, public health research, and academic clinical trials—often operates in a regulatory grey area. These non-regulatory trials are essential for understanding disease patterns, social determinants of health, and the efficacy of public health interventions. However, the absence of a standardized ethical framework for such studies has historically raised concerns regarding participant safety, informed consent, and data privacy. By formalizing these guidelines, the ICMR aims to bridge this gap, ensuring that research conducted by academic institutions, NGOs, and public health bodies adheres to the same high ethical standards as commercial clinical trials.

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