Frequently Asked Questions

Are research sponsors obligated to determine IRB compliance with regulations?

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Compliance & Regulatory: Biopharma
Compliance & Regulatory: MedTech
IRB: General

No. Sponsors should rely on the clinical investigator, who assures the sponsor on form FDA 1572 for drugs and biologics or the investigator agreement for devices, that the study will be reviewed by an IRB. Because clinical investigators work directly with IRBs, it is appropriate that they assure the sponsor that the IRB is functioning incompliance with the regulations.

An IRB must notify an investigator in writing of its decision to approve, disapprove or request modifications in a proposed research activity. This correspondence should be made available to the sponsor by the clinical investigator. In the Agency's view, this required documentation provides the sponsor with reasonable assurance that an IRB complies with 21 CFR part 56 and that it will be responsible for initial and continuing review of the study.