Greater than minimal risk studies are reviewed by a fully-convened committee at an IRB meeting. The committee discusses the study and determines whether the Criteria of Approval for Human Subject Research are met, and makes a decision to approve, approve with stipulations, defer, or disapprove the study.
The OHR staff will advise you when the study is scheduled for full committee review. The ability to schedule a study for review is related to the pre-review response time, the IRB's meeting agenda, and expertise that may be required for the review. Once a study is reviewed by the IRB, the OHR staff will communicate any changes requested by the IRB and will work with you to resolve any issues
The Department of Health & Human Services (HHS), Office for Human Research Protections (OHRP), and the Food and Drug Administration (FDA) oversee the operations of the IRB.