Process of Submission of Application to the Ethics Committee in Clinical Research

Description

DOI: https://doi.org/10.5281/zenodo.18427375

Rehan Rub¹, Maithili Janye², Ritu Tiwari³, Shwetangana Singh⁴, Moksha Ponnamma P G⁵, Harshal Thakur⁶, and Kuldeep Kumar⁷ (Quality Assurance-Clinical Research, Fortis Healthcare, Gurugram & Fortis Healthcare Research Foundation, Gurugram Haryana¹, Clinical Research, Fortis Hospital, Mumbai & Fortis Healthcare Research Foundation, Gurugram Haryana², Indian Pharmacopoeia Commission Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh³, Fortis Healthcare Research Foundation, Gurugram Haryana, India^4,5,6,7)

Ethics Committee (EC) review is a mandatory prerequisite for initiating clinical research involving human participants. The submission of a research proposal to an EC follows a defined process that ensures adequate scientific validity, participant protection, and regulatory compliance. The paper describes the step-by-step process of submitting an application to the Ethics Committee, explaining essential documents, regulatory requirements, evaluation procedures, and post-approval responsibilities. The discussion integrates principles from ICH-GCP, Indian GCP, and India’s New Drugs and Clinical Trials (NDCT) Rules, 2019.