Who is responsible for safeguarding participant rights and welfare?

• A. The Ethics Committee/IRB.
• B. The sponsor.
• C. The trial monitor.
• D. The site pharmacist.

Answer: (C)

Protecting participants’ rights and welfare is the responsibility of the Ethics Committee/IRB. They independently review the study protocol and consent materials to ensure risks are minimized and that informed consent is truly informed. The investigator at the site then has the ongoing duty to protect participants—obtaining consent, monitoring safety, and maintaining confidentiality under IRB oversight. The sponsor provides overall trial oversight and resources for safety, but the primary guardian of rights and welfare is the IRB/ethical oversight, with the investigator carrying the day-to-day protection at the site. A trial monitor ensures adherence to the protocol and proper safety reporting, but does not replace the IRB’s authority or the investigator’s duty to protect participants.