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Continuous review for ethical conduct of clinical trial-are the ethics committees complying?
Mrunalini Vinay Kalikar1, Ganesh Dakhale2
1Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, India.
Abstract:
Ethics committees (ECs) play a crucial role in safeguarding clinical trial participants through ongoing review beyond initial protocol approval. Although regulations require periodic monitoring of study progress, risk, protocol adherence, and informed consent processes, evidence from India indicates significant gaps in implementation.. Challenges such as limited resources, insufficient training, and lack of structured monitoring hinder effective continuous review. Strengthening EC capacity and accountability is essential to ensure ethical conduct and participant safety in ongoing clinical research.
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