The Institutional Review Board (IRB) or Independent Ethics Committee (IEC) is an independent body responsible for reviewing clinical trial protocols to ensure the protection of human subjects. Under ICH E6, the IRB/IEC must safeguard the rights, safety, and well-being of all trial participants.
What Is an IRB or Ethics Committee?
An IRB or IEC is composed of qualified individuals with diverse backgrounds, including at least one member whose primary expertise is in a scientific area and at least one member whose primary interest is in a nonscientific area. The committee must include both men and women and at least one member who is independent of the institution conducting the trial. Its primary function is to review the trial protocol, the informed consent documents, the investigator’s brochure, and subject recruitment materials before a trial may commence.
Regulatory Framework
The authority and operating procedures of IRBs/IECs are defined in 21 CFR Part 56 in the United States and in the EU Clinical Trials Regulation (536/2014) in Europe. ICH E6 Section 3 dedicates specific provisions to IRB/IEC composition, functions, and record-keeping requirements. The committee must document its review and decisions in written meeting minutes and retain these records for at least three years after trial completion.
Key Requirements
The IRB/IEC must conduct initial and continuing review of trials at intervals appropriate to the degree of risk, but at least once per year. It has the authority to approve, require modifications to, or reject a trial protocol and must receive prompt notification of any serious adverse events or protocol deviations. The committee must review the method and amount of compensation for subjects to ensure no undue influence or coercion exists.
Documentation
The IRB/IEC must maintain written Standard Operating Procedures (SOPs) and keep records of all meeting minutes, correspondence with investigators, and documentation of review decisions. Essential documents include the approved protocol, informed consent form versions, recruitment advertisements, and annual continuing review reports. These records must be available for regulatory inspection upon request.
Conclusion
The IRB/IEC serves as a critical safeguard in clinical research by providing independent ethical oversight. Effective functioning of the committee depends on diverse membership, robust SOPs, and diligent documentation of all reviews. Compliance with IRB/IEC requirements is a prerequisite for regulatory approval of any clinical trial.
