Before trial initiation, which body’s approval or favorable opinion is required for the protocol?

• A. Sponsor's internal review board
• B. Institutional Review Board approval or favorable opinion
• C. Regulatory authority approval
• D. Community advisory board approval

Answer: (B)

Before starting a trial, the protocol must undergo independent ethics review to protect participants. An Institutional Review Board (IRB) or Ethics Committee (EC) examines the study to ensure risks are minimized, potential benefits justify any risks, informed consent is adequate, and protections for confidentiality and participant rights are in place. A favorable opinion or approval from this body is the formal clearance needed to begin the trial at sites.

The sponsor’s internal review board isn’t a substitute for this formal ethics review, and regulatory authority approval, while important for regulatory compliance, does not replace the IRB/EC’s protocol approval. Community advisory boards do not have the formal authority to approve protocols.