1. Project Manager Emily Sheffer: emily.sheffer@irbshare.orgemily.sheffer@irbshare.org IRBshare Liaison Training

2. IRBshare Liaison Training Overview Introductions IRBshare Refresher IRBshare Start Up Steps The IRBshare System

3. Why create another joint review model? Flexibility in federal regulations (OHRP 45 CFR 46.114 and FDA 21 CRF 56.114) Institutions can use a “joint review” arrangement and “rely upon the review of another qualified IRB…avoiding duplication of effort” Lessons learned from centralized models Disease-specific models are inherently restrictive Numerous contractual agreements (i.e., study-specific MOUs) can be burdensome CIRBs can have intensive startup costs and/or ongoing overhead CIRBs provide little flexibility for local IRBs Ongoing debate regarding external IRB’s ability to fully understand local context issues

4. Conference Series Grant Support Vanderbilt awarded R13: “Novel IRB Review Models for Efficient Multisite Review” Three meetings from 2011-2013 Goal was to develop, build, and pilot new model(s) of IRB review of multisite studies Multiple stakeholders Individuals from nearly 2/3s of the CTSAs, OHRP, FDA, NCATS Regulatory, legal, ethics, and clinical trial experts Iterative development Ongoing evaluation Start small: establish reliance for initial study review first, then expand

5. IRBshare: General Features Universal terms of use preclude lengthy negotiations All institutions sign a one-time master agreement without site- specific modifications or study-specific language Inclusive consortia broadens model utilization IRBshare network is open to any FWA-holding organization and any area of research Low cost strengthens sustainability IRBshare network is free to join and has little to no overhead or startup costs

6. IRBshare: Shared Review Model Local investigator submits study to local IRB; study reviewed by convened IRB upload Local investigator submits study to local IRB; study reviewed by local subcommittee (>1 IRB member) using IRBshare documents FULL BOARD REVIEW SITESHARED REVIEW SITE Committee Responsibility: Determine whether study meets all federal regulatory guidelines for approval of research (e.g., 45 CFR 46.111) Subcommittee Responsibility: Verify full board review site’s determination + review for site’s own local context issues IRB application Consent form(s) Protocol + IB/Device Manual Meeting minutes (redacted) Determination letter download

8. Local Context Checklist

9. IRBshare: Reliance Model Features Reliance model enables simultaneous IRB approval Once IRB approval uploaded to IRBshare, all study sites can seek approval Flexible reliance options support local autonomy “Lead” IRB established organically on study-by-study basis Studies may have more than one “lead” IRB IRBs always have the option to review study locally Local submission processes and forms do not have to change Dynamic IRB responsibilities address local IRB oversight concerns Local context review is always the responsibility of the local IRB Local IRB regains study oversight after relying on Full Board Review Site All study-related events are reported locally, with study-wide issues also reported broadly via the mechanism established for the study Shared IRB documents minimize submission requirements at local IRBs Once IRB approval documents uploaded to IRBshare, local IRBs can accept shortened IRB applications (e.g., local context only) from local investigators

10. IRBshare: Additional Features Transparency enables continuing education and dialogue Sharing IRB documentation enables continuing education and dialogue between IRBs Shared documents creates opportunity to utilize shared expertise, consult other IRBs, and promote consistency in the IRB review process

11. Who can use IRBshare? Any institution with a Federalwide Assurance with OHRP (i.e., most institutions) Any industry-sponsored or investigator-initiated multi-site study Any number of institutions (>1 up to ∞) Greater than minimal risk studies (i.e., full board review required)

12. Participating Institutions (n=36) *AAHRPP accredited; †CTSA institution or affiliate Baystate Health*University of Alabama Birmingham*† Boston University Medical Center*†University of Arkansas for Medical Sciences*† Children’s National Medical Center*†University of California San Diego† Duke University*†University of Illinois Chicago*† Maine Medical Center*University of Iowa*† Marshall University*University of Kansas*† Medical University of South Carolina*†University of Kentucky*† Meharry Medical College†University of Miami† Mississippi State University*University of Minnesota*† Mount Sinai Medical School*†University of North Carolina at Chapel Hill *† New York University School of Medicine*†University of Pittsburgh*† North Shore LIH Health SystemUniversity of Southern California*† Seattle Children’s HospitalUniversity of Texas HSC at San Antonio*† Stanford University*†University of Texas Southwestern Medical Center† The Scripps Research Institute†University of Washington† The University of Utah*†Vanderbilt University*† Tufts Medical Center†Virginia Commonwealth University*† Tufts University †Washington University (St. Louis) *†

13. Preliminary Results 4 active studies with shared reviews conducted o ISCHEMIA Trial: Duke relied on Vanderbilt o Days from Submission to Approval: 6 o MENDS II: Baystate relied on Vanderbilt o Days from Submission to Approval: 42 o Vitamin D & Type 2 Diabetes: MUSC relied on Tufts o Days from Submission to Approval: 27 o Neonatal Abstinence Syndrome Study: Vanderbilt relied on Tufts o Days from Submission to Approval: 16

14. Sites showing willingness to be transparent o 5 institutions have uploaded IRB approvals to IRBshare Process improvement o Sites are modifying their processes based on those of other sites o Institutions are thinking of how they can streamline their local submission processes Shared review process said to be simple and easy to implement The word is spreading! o PIs are approaching IRBshare regarding their awarded multisite studies and responses to RFAs o Funding agencies are recommending use of IRBshare (“or other centralized models”) in RFAs User Experience

15. Continue effort to include continuing reviews and amendments Include expedited studies Leverage the “IRBshare Network” to spread best practice and determine other ways to create efficiencies in IRB processes Share SOPs Streamline PI submission process Increase utilization: more institutions + more studies Evaluate IRBshare User Satisfaction Efficiency Implementation What’s Next for IRBshare

16. IRBshare Start Up Steps Inform local IRB staff and members (see checklist)see checklist Educate investigators and study teams Presentation, brochures, and PI checklist available herehere Modify IRB SOPs Determine how to facilitate the use of IRBshare Sample SOPs on Resource Page available herehere Encourage neighboring institutions to join IRBshare Project Manager can provide materials or a webinar Connect with other IRBshare Liaisons (here)here Set goals for your IRB IRBshare launch date Deadlines for educating staff Workgroups to discuss streamlining submission processes

17. IRBshare System IRBshare.org IRBshare Dashboard Common system actions Logging in Adding users Searching for projects Registering my site in a study Editing review information Uploading full board review documents

18. Screenshots of IRBshare System View in Slideshow mode to see animations

19. IRBshare System: Liaison Dashboard

20. IRBshare System: Logging In

21. IRBshare System: Adding Users

22. IRBshare System: Searching for Projects

23. IRBshare System: Registering My Site for a Study Federally-funded studies: Any institution in IRBshare can register for a federally-funded study. To register, search for the study and click on the title If your institution is not yet registered, you will see a popup when you click on the title. The popup asks you to verify that your institution is participating in the study.

24. IRBshare System: Registering My Site for a Study Consortium-Specific Studies If your institution belongs to the consortium related to the study you select, you will be prompted to register for the study—and acknowledge your institution is participating in the study— before you are able to access the project page. If your institution is not a member of the consortium related to the study, or this has not been noted in IRBshare by the Administrator, you will see the following popup if you click on the consortium- specific study.

25. IRBshare System: Editing Review Info

26. IRBshare System: Uploading Full Board Review Documents

27. IRBshare System: Create a New Project