Clarifications on Multiple Protocol Deviations Requiring IRB Approval

Deviations and violations that have the potential to impact patient safety or trial integrity, including eligibility exceptions, require IRB review. Generally, the DFCI IRB will not approve blanket requests to deviate from a protocol.

Deviation requests should be specific to a single patient and detail the event and plan for that patient. However, if needed, the IRB can review deviation requests that would apply to multiple patients on a single protocol. Study teams should consider that these requests may require full board IRB review and may not always be approved. Sponsor approval is required as part of any deviation submission.