Which statement best describes IRB/IEC responsibilities?

• A. They are responsible only for safety, not rights.
• B. They should safeguard the rights, safety, and well-being of all trial subjects.
• C. They are not responsible for participant welfare.
• D. They should supervise sponsor activities.

Answer: (B)

The core idea is that IRBs/IECs exist to protect people who participate in research by providing independent ethical oversight. They review the study protocol and the informed consent process before the study starts and continue to monitor during the trial to safeguard participants throughout the research.

By evaluating the protocol, they ensure risks are minimized and reasonable in relation to anticipated benefits, and that subject selection is fair and just. They verify that informed consent is obtained and documented in a way that is understandable and voluntary, and they guard privacy and confidentiality. They also pay attention to protections for vulnerable populations and require ongoing safety monitoring, including review of adverse events and any new information that could affect risk, which may lead to modifications, approval suspensions, or termination of the study if needed.

They do not supervise sponsor activities or manage day-to-day trial operations; their role is ethical and regulatory oversight to protect participants, not sponsor execution. This combination of safeguarding rights, safety, and welfare through independent review is why this statement best describes IRB/IEC responsibilities.