Clinical Trials (Ethics Committee) Accreditation Programme
This programme is targeted at Institutional Ethics Committees that review clinical trials and research protocols involving human participants. It ensures these committees follow ethical guidelines, protect participant rights, maintain transparency, and perform reviews with scientific and moral rigour. Accreditation enhances institutional accountability, boosts credibility in the research ecosystem, and promotes public trust in healthcare research. It is especially important for institutions involved in biomedical research, clinical trials, or drug development.
a. Safety and well-being of research participants
b. Protection of rights and research participants
c. Robust consent process to ensure patient safety
d. Improves efficiency, effectiveness, and overall clinical trial process
e. Commitment to quality and accountability and accreditation
f. Ensures public trust and confidence
CDSCO-registered Institutional and Independent Ethics Committees involved in the review and approval of clinical trials (including new investigational products).
Eligible Ethics Committees can apply online by registering on the NABH website. Kindly refer to the General Information Brochure available on the Ethics Committee Accreditation page.
Hospitals Accreditation Programme (5th Edition April 2020)
Revised Fee w.e.f. 01.04.2024
| Ethics Committee having 0-10 ongoing trials | Ethics Committee having more than 10 ongoing trials |
|---|---|
| Application Fee: 5,000/- Annual Fee: 30,000/- Virtual Assessment Fee: 2,000/- |
Application Fee: 20,000/- Annual Fee: 30,000/- Virtual Assessment Fee: 2,000/- |
18% GST applicable extra.
NABH organises Programme on Implementation (POI) for Ethics Committees to help understand and implement accreditation standards. These sessions are delivered by experienced NABH faculty.
- Trainings on Good Clinical Practice (GCP) and awareness sessions on Ethics Committee standards are also conducted.
- NABH is also introducing training programmes on the New Drugs and Clinical Trials Rules.
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