What does the IRB/IEC conduct with regard to trials?

• A. Only initial review
• B. Initial and continuing review of trials
• C. Only ongoing monitoring after enrollment
• D. Procedural audits of the study sites

Answer: (B)

The main idea is that IRB/IEC oversight is ongoing, not a one-time check. Before a trial starts, the board reviews the protocol, informed consent form, recruitment plans, and the overall risk–benefit to decide if it can be conducted ethically. Once a study is underway, the IRB continues to oversee it through continuing review, evaluating safety data, any protocol or consent changes, and compliance with the approved plan at intervals (at least annually for most studies, and sooner for higher-risk research). This ongoing review ensures that new information or adverse events are promptly considered and participant rights and welfare remain protected. Procedural audits of study sites aren’t the IRB’s routine role; audits or inspections of sites are typically handled by sponsors or regulatory authorities.