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Investigator Certification

The Institutional Review Board (IRB) of University Hospitals works with the other related Case Western Reserve University institutional review boards in a common program for human subjects certification. This program meets the requirements for human subjects certification for both the National Institutes of Health (NIH) and the UH IRB.

Case Western Reserve University’s policy on human subjects certification requires certification of the Principal Investigator and all key personnel, as defined by NIH, on all grants funded through Case Western Reserve University. The UH IRB strongly encourages all investigators and study personnel who interact with subjects to be certified, but requires certification of the Principal Investigator as well as anyone who obtains written consent from subjects. This requirement applies to individuals who obtain consent, but are not necessarily listed as protocol investigators. For an individual protocol classified as minimal risk, the UH IRB may waive the requirement for certification of individuals obtaining consent if obtaining certification would be impractical. Certification requirements do not apply to investigators on protocols that the UH IRB classifies as exempt studies.

For the full text of the UH IRB’s policy please see Certification in Human Subject Protection.

Once certified, investigators must maintain valid certification by participating in ongoing continuing research education credit (CREC) programs. The UH IRB follows the Case Western Reserve University requirements for re-certification.

Protocols can be submitted to the UH IRB pending investigator certification(s); however, approvals will not be issued until investigator certification is complete. If certification lapses, re-certification must be completed before the protocol’s continuing review approval will be issued.

For additional information regarding human subjects certification please see Case Western Reserve University’s Office of Research Compliance CREC website at https://research.case.edu/Education/CREC.cfm.

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