It is an independent, multidisciplinary body that reviews clinical trial protocols to ensure the protection of the rights, safety, and well-being of human participants.
Key Responsibilities and Functions
- Pre-study Approval: Evaluates clinical trial protocols, informed consent documents, investigator qualifications, and recruitment materials before a study starts.
- Risk/Benefit Analysis: Determines if the potential risks to subjects are minimized and justified by the potential benefits.
- Ongoing Monitoring: Performs continuous assessment of ongoing trials, reviewing amendments, and safety updates to ensure safety.
- Compliance: Ensures research adheres to international standards like Good Clinical Practice (GCP) and local regulatory laws.
It is also known as an Independent Ethics Committee (IEC), Institutional Review Board (IRB), or Research Ethics Committee (REC),
- Italian Committee for Bioethics. Guidelines for Ethics Committees in Italy https://bioetica.governo.it/en/opinions/opinions-responses/guidelines-for-ethics-committees-in-italy/#:~:text=We%20recommend%20also%20to%20define,insurance%20cover%20for%20their%20roles.
- https://www.advarra.com/learn/clinical-trials-acronyms/independent-ethics-committee/#:~:text=Definition,ethics%20approval%20across%20participating%20regions.
