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Multi-Institutional Facilitated IRB Review

Multi-Institutional Facilitated IRB Review. Third Annual Clinical Research Management Workshop June 22, 2010. Kathleen Lawry, MSSA, CIP, CIM, Assistant Director Research Administration MetroHealth Medical Center. Philip A. Cola , MA

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Multi-Institutional Facilitated IRB Review

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  1. Multi-Institutional Facilitated IRB Review Third Annual Clinical Research Management Workshop June 22, 2010 Kathleen Lawry, MSSA, CIP, CIM, Assistant Director Research Administration MetroHealth Medical Center Philip A. Cola, MA Vice President, Research and Technology University Hospitals Case Medical Center

  2. Multi-Institutional Facilitated IRB Review Background • The Clinical Translational Science Collaborative (CTSC) in Cleveland, Ohio has endorsed process improvement in clinical research management as a high priority • Initial process improvement initiative was the development and implementation of a “facilitated review” process (FR) • to facilitate the conduct of research within four legally separate institutions in a manner that reduces investigator burden while maintaining the integrity of the IRB review

  3. Multi-Institutional Facilitated IRB Review Background Continued… • Prior to this initiative, investigators at each of the separate legal entities were required to submit common research protocols to each site’s IRB for review and approval • A process was created to allow studies approved by one institution to receive FR via an newly created electronic “HUB” at the other participating institution(s) • Process relies on executed Inter-Institutional Agreements (IIAs) among separate institutions that share investigators and protocols

  4. Facilitated ReviewProcess Overview • The design allows Institution A to act as the IRB of record and review collaborative studies according to all applicable regulatory standards (federal, state & local) • IRB at Institution B (Named IRB) affirms the review by conducting a “local context” review of the protocol to ensure institutional “local” compliance • Approved study documentation including adverse event, unanticipated problem, and deviation reports, amendments and continuing reviews are uploaded and maintained in the HUB, accessible to all participating institutions.

  5. Leveraging Electronic Systems for Facilitated Review (FR) FR allows investigators to submit a single IRB submission for review by multiple institutions within the Cleveland CTSC utilizing an online electronic “HUB” The “HUB” Will permit all IRBs named in application a secure extranet platform from which to: • Exercise oversight • perform parallel reviews of projects by multiple Named IRBs • Communicate between IRBs and investigators

  6. Facilitated ReviewMethodology Key elements: • A single IRB submission to the IRB of record • A complete electronic file with all study documents, correspondence, reviews from IRB of Record and Named IRB updated for the life cycle of the study • Brief site specific application and review forms for all named IRB(s) • Online review by all named IRB(s) with the ability to request additional information and clarification • Site specific consent forms • Electronic notifications (i.e. study expires)

  7. Facilitated ReviewMethodology (continued…) Process Flow: • Each Named IRB decides whether or not to accept a protocol for Facilitated Review • Each Named IRB retains control over their own process for performing a local context review and the design of their own review forms • If there are no concerns about local context, the Chair (or designee) may decide to accept the review, of the IRB of Record • The IRB of record performs all future continuing reviews, amendment reviews and reviews of unanticipated problems for the life of the study

  8. Oversight by the Named IRB(s) Studies Approved Utilizing Facilitated Review: • The HUB is updated with all continuing reviews, amendment reviews and reviews of unanticipated problems and all named IRB(s) are notified electronically and can review these documents thus retaining continuous oversight • All unanticipated problems, complaints, expirations and or suspensions are reported to the named IRB(s) electronically via the HUB

  9. Flow Chart Facilitated Review Study is Approved By IRB of Record PI Requests Facilitated Review by Named IRB(s) PI Uploads Study Documents to HUB and Completes Site Specific forms; IRB of Record uploads reviews and approvals Named IRB Reviews Study Named IRB Approves Study Named IRB Disapproves Study for Facilitated Review PI Uploads all Continuing Reviews, Amendments, Un-anticipated Problems for the life of the study IRB of Record Reports to Named IRB(s) any Suspensions, Complaints or Compliance Issues PI Requests Full Board or Expedited Review by Named IRB

  10. Contact Information Kathleen Lawry, MSSA, CIP, CIM Institutional Review Board Manager Assistant Director, Research Administration-Compliance MetroHealth Medical Center 2500 MetroHealth Drive Cleveland, Ohio 44109-1998 216-778-2077 (Office) email: klawry@metrohealth.org Philip A. Cola, M.A.  Vice President, Research and Technology University Hospitals Case Medical Center 11100 Euclid Avenue Cleveland, Ohio 44106-7061 Phone: (216) 844-5576 Fax: (216) 844-1547 Philip.Cola@uhhospitals.org

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