Comprehensive Approach to Ethics Committee Functions: Safeguarding Patients and SAE Reporting in Clinical Trials

Description

Shweta Rai¹, Ritu Tiwari², Maithili Janye³, Srishti Gupta⁴, Sneha A Bhat⁵, and Kuldeep Kumar⁶ (Fortis Healthcare Research Foundation, Gurugram Haryana^1,4,5,6, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh², and Fortis Hospital Mumbai & Fortis Healthcare Research Foundation, Gurugram Haryana³)

This study examines the critical role of Ethics Committees (ECs) in safeguarding participants’ rights, safety, and well-being in clinical trials. It outlines the institutional framework for ECs, emphasizing their independent and multidisciplinary composition, which includes both medical and non-medical members. The report details the committee’s responsibilities, including review and approval of trial protocols, ensuring compliance with regulatory guidelines such as the NDCT Rules 2019 and Good Clinical Practice (GCP), and oversight of serious adverse event reporting. It also highlights the necessity of ongoing training for EC members and the importance of timely communication with regulatory authorities. Through these mechanisms, ECs maintain ethical standards, promote participant protection, and foster public trust in clinical research.