What is the role of IRBs/IECs concerning trial-related agreements?

• A. They must be allowed to review agreements to protect participants.
• B. They enforce regulatory penalties.
• C. They select service providers.
• D. They sign the protocol.

Answer: (A)

The protective role of IRBs/IECs includes reviewing trial-related agreements to ensure they won’t compromise participant rights or safety. Before contracts with sites, sponsors, vendors, or CROs are finalized, the IRB/IEC should be allowed to review those agreements to confirm that responsibilities for safety monitoring, reporting, data access, confidentiality, indemnification, and insurance are adequately addressed. If contract terms could affect participant welfare, the IRB/IEC can require changes to enhance protection. They don’t enforce penalties, select service providers, or sign the protocol; their function is to review and approve the protocol and related agreements to safeguard participants.