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

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.