21 CFR 312.66 - Assurance of IRB Review

What it says

An investigator must assure that an institutional review board that complies with the requirements of Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation. The investigator must also promise to report promptly to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and must not make any change in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to subjects.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• A study cannot start before IRB approval, and it cannot continue past the approval period without continuing review.
• Protocol amendments and consent form changes go to the IRB before they are used.
• Unanticipated problems should be reported by the site according to the IRB's own timelines.

What FDA inspectors look for

• Whether the study was approved before enrollment.
• Whether continuing review was current throughout the study.
• Whether changes and problems were reported to the IRB.

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