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Both IRB committees for the UHCMC IRB (IRB00000684 and IRB00001691) are registered per the new Food and Drug Administration (FDA)'s registration requirements as reviewing FDA regulated research. Confirmation of this registration can be found by searching the UHCMC IRB Organizational Information number (IORG0004088) on the HHS Office of Human Research Protections (OHRP) registration system and clicking on the link for "U Hosps Case Med Ctr." Please note that both committees of the UHCMC IRB also review federally funded research and are also registered as such.
The “Activity Determination Form” (DET) has been revised to clarify the Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) definition of “research” and to remove the stipulation that information gathered from the non-research activity may not be published (to take into account information presented and published from quality improvement projects and case reports, per UHCMC policy).
In addition, clarifications were made to the form’s instructions to state that an investigator must select applicability from all three categories on the form: DHHS (Section A and/or B), Food and Drug Administration (FDA, section C) and HIPAA (Section D) in order for the Center for Clinical Research and Technology to make a determination as to the applicability of the federal regulations pertaining to human subject research.
In January, 2009, the Food and Drug Administration (FDA) posted a final rule (effective July 14, 2009) that will require institutional review boards (IRBs) to register through a system maintained by the Department of Health and Human Services (HHS). This registration system is the same system utilized by the HHS Office of Human Research Protections (OHRP) to maintain a list of IRBs which review federally funded research. Any IRBs reviewing clinical investigations regulated by the FDA must be registered in this system by September 14, 2009.
Please note that UHCMC IRB has two IRB committees, both of which are registered in this system. Anyone who requires documentation of this registration may search the OHRP website to confirm current registration status.
The IRB registrations numbers (IRB00000684 and IRB00001691), as well as the HHS Federal Wide Assurance of Compliance number (FWA00003937) can be found on the IRB FAQ webpage, the IRB Statement of Compliance letter, the IRB rosters and the IRB protocol approval letter.
The following administrative revisions have been made to the New Protocol Checklist (N):
A policy has been developed to provide an explanation about “quality improvement/assurance” activities and when IRB review and/or approval is needed. This policy reflects current Federal regulatory guidance disseminated by the Office of Human Research Protections (OHRP).