A 12-Step Model for Ethical and Regulatory Governance in Clinical Research

Description

Paramita Choudhuri¹, Ritu Tiwari², Maithili Janye³, Harshita Koli⁴, Sneha A. Bhat⁵, and Srishti Gupta⁶ (Ethics Committee Secretariat, Fortis Hospital Limited, Bannerghatta RoadBangalore & Fortis Healthcare Research Foundation, Gurugram Haryana¹, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh², Assistant Manager, Clinical Research, Fortis Hospital Mumbai & Fortis Healthcare Research Foundation, Gurugram Haryana³, Trainee Clinical Research Associate, Fortis Healthcare Research Foundation, Gurugram Haryana^4,5,6)

Ethical oversight is the foundation of responsible Clinical Research. The Good Clinical Practice (GCP) Guidelines outline a comprehensive framework to ensure participant safety, scientific integrity, and transparency on conduct of research. This paper reviews the ethical, scientific, and procedural requirements for protocol submission to Ethics Committees (ECs), as suggested under the Indian GCP Guidelines and as per applicable regulatory requirements. Key elements include defining research objectives, study rationale, detailed methodology, inclusion and exclusion criteria, informed consent procedures, statistical plans, and safety monitoring measures. In addition, the guidelines emphasize unbiased participant recruitment, confidentiality, and appropriate compensation for study-related injuries. Compliance to these principles ensures that research is ethically and scientifically sound, and socially beneficial. By adhering to these guidelines, investigators, institutions, and sponsors can maintain the integrity of clinical trials while ensuring the safety, well-being of participants. This paper focuses on identifying the critical ethical and procedural checkpoints that promote compliance, transparency, and trust in clinical research in India.