An Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is an independent body comprising medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial.
An IRB/IEC should carry out the following activities to guarantee the rights and safety of trial subjects:
- Review and approval of trial protocols and amendments
- The review and approval of methods and materials used to obtain and document informed consent of trial subjects.
