Which term refers to an independent body responsible for protecting rights, safety, and well-being of human subjects by reviewing, approving, and providing continuing review of trial protocols and informed consent documents?

• A. Institutional Review Board (IRB)
• B. Monitoring
• C. Investigator
• D. Legally Acceptable Representative

Answer: (A)

An Institutional Review Board is an independent body responsible for protecting the rights, safety, and well-being of research participants by reviewing and approving trial protocols and informed consent documents, and providing ongoing review throughout the study. The IRB evaluates the risk-benefit balance, ensures informed consent is appropriate and documented, and protects participant privacy and vulnerable populations. It operates before the study begins and continues to monitor ongoing conduct, requiring modifications or disapproval if protections are not adequate. This role is distinct from monitoring (oversight of trial conduct), the investigator (the researcher conducting the study), and a legally acceptable representative (a surrogate who consents on behalf of someone unable to consent).