Administrative Review and Approval

Section 1005.120  Administrative Review and Approval a)         In accordance with 45 CFR 46, research proposals and requests for health data that have been approved by the IRB are also subject to administrative review and approval by the Department. b)         After administrative review of the administrative impact, technical feasibility and human subject protection as described in 45 CFR 46, the Director may disapprove research that has been approved by the IRB; however, the Director will not approve a request if it has not been approved by the IRB.