Q – Why does the IRB need to review my grant?
A – In the past, numerous instances have been identified in which human subject research described in a grant application differed significantly from how it was described in an IRB application/protocol. The grant included important elements (e.g., targeting of vulnerable subjects, additional arms, different doses, etc.) that were ultimately implemented without IRB review and approval. Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(f) require that each grant application or proposal for HHS-supported human subject research be reviewed and approved by the IRB.
