Who is primarily responsible for safeguarding participant rights and welfare?

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

Answer: (B)

The main idea here is that the sponsor holds the overarching obligation to protect participants throughout the trial. Because the sponsor designs the study, funds it, and provides the resources and oversight needed to run it safely, they’re responsible for putting in place the protections that safeguard rights and welfare. This includes ensuring the protocol minimizes risks, that the informed consent process is robust and properly documented, and that systems are in place for safety monitoring and prompt reporting of adverse events. The sponsor also ensures that investigators and sites are qualified and trained to protect participants and that there are adequate monitoring mechanisms to maintain compliance with ethical and regulatory standards.

The Ethics Committee/IRB reviews and approves the protocol and consent forms and continues to monitor safety, which is essential to protection, but the sponsor is the entity responsible for implementing and maintaining those protections across the entire trial. The trial monitor and site pharmacist support safety and compliance, but their roles are more about oversight and day-to-day operations rather than being the primary owners of participant rights.