Questions on the FDA’s 30-Day IND Review Period and IRB Approval

Question:

Can an IRB issue an approval for a protocol before the protocol has completed the 30 days review period by the US FDA? If the IRB issued an approval prior to completion of the 30-day review period, is the IRB issued approval valid, if the US FDA required changes to be made to the protocol necessitating an updated protocol version?
– Director, Project Management, CRO

Response:

The requirements for a clinical investigation of an investigational new drug (21 CFR 312.40) include both the study has an IND and that it complies with 21 CFR 50 & 56. 

Therefore, the reviews are separate and individually required. The research may not proceed without both the IRB approval and review by the FDA. An IRB approval without also ensuring the IND review process from FDA does not allow the study to proceed.

If the FDA requires changes during the 30-day window, while the initial IRB approval would be valid at the time it was given, the protocol cannot be initiated until changes required by the FDA are addressed. Those changes would need to be submitted to the IRB approval prior to being implemented. Approval by both the IRB and FDA are both required prior to implementation of any change to the research. 

The requirements for a clinical investigation of a device (21 CFR 812.42) are similar and requires both the FDA and IRB to have approved the study.