Safeguarding Standards: The Ethics Committee’s Role in Clinical Research Oversight

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Maithili Janye¹, Thilakesh², Mohamed Natheem³, Tarunima Singh Parihar⁴, Monika⁵, and Kuldeep Kumar⁶ (Clinical Research- Fortis CSR Foundation and Fortis Hospitals Limited, Mumbai¹ Fortis CSR Foundation & Fortis Hospitals Limited, Bannerghatta Road, Bangalore²,³, Fortis Memorial Research Institute, Gurugram, Haryana⁴,⁵, (Clinical Research Division) Fortis Healthcare Limited⁵)

The Ethics Committee is a multidisciplinary and autonomous body, plays a pivotal role in ensuring participant safety and benefits in clinical research. Comprising scientific and non-scientific professionals, this committee reviews study proposals to guarantee compliance with legal and ethical requirements. With over 1500 registered ethics committees in India alone, their primary responsibility is to examine and authorize research proposals, ensuring adherence to national regulatory bodies’ guidelines. This review focuses on the dual categorization of ethics committees – Institutional Ethics Committee (IEC) and Independent Ethics Committee (IEC) – and their distinct roles in upholding standards in clinical research. Through a comprehensive analysis, this project aims to explore the effectiveness of ethics committees in promoting ethical conduct, protecting human subjects, and maintaining research integrity. By examining the strengths and weaknesses of existing ethics committees, this review seeks to inform policy and practice reforms, ultimately enhancing the quality and credibility of clinical research.