R495-820-7. Pre-Review

(1) Each research proposals submitted for DHHS IRB review must first be reviewed by the division gatekeeper and have all concerns addressed and resolved to the satisfaction of the division gatekeeper no later than the last business day of the month preceding the DHHS IRB meeting. (2) Some research may be exempt from DHHS IRB review as provided in 45 CFR 46.101(b). Division gatekeepers, alone or in consultation with the IRB chair, shall determine if the proposed research is exempt from DHHS IRB review. If proposed research is exempt, the division gatekeeper or chair will issue an exempt letter to the researcher. If the research is not exempt, the research proposal will be submitted for either expedited review or full board review by the DHHS IRB.