What is the IRB/IEC's role in a trial?

• A. To review/approve the protocol and consent process and protect participants’ rights and safety
• B. To manage trial finances
• C. To select sites
• D. To perform data analysis

Answer: (A)

The IRB/IEC serves as the ethics guardian of a trial, focusing on protecting participants’ rights and safety throughout the study. They review and approve the study protocol and the informed consent process, ensuring that risks are minimized, benefits are favorable, and participant selection is fair. They verify that the consent form is understandable and that informed consent is genuinely voluntary, and they conduct ongoing oversight through continuing review and monitoring of safety events.

They do not handle trial finances, choose sites, or perform data analysis. Those tasks fall to sponsors, site management teams, or statisticians, while the IRB/IEC’s primary duty is to safeguard participants and ensure ethical and regulatory compliance.