The University and Medical Center Institutional Review Board (UMCIRB) is duly constituted, allows only those IRB members who are independent of the investigators and the sponsor of the research study to vote, has written procedures for initial and continuing review of research studies, prepares written minutes of convened meetings, and retains records pertaining to the review and approval process; all in compliance with requirements define in 45 CFR 46, Subparts A-D, 21 CFR 50 and 21 CFR 56 (applied to all research studies under the Food and Drug Administration regulation) and the International Conference on Harmonisation Good Clinical Practice guidelines.
