1. IRBshare Overview: Investigators Emily Sheffer, MPA Vanderbilt University Medical Center IRBshare Project Manager EMILY.SHEFFER@VANDERBILT.EDUEMILY.SHEFFER@VANDERBILT.EDU | 615-343-2384

2. IRBshare Background Developed with funds from NCRR/NCATS conference series grant (R13; PI – Bernard) Developed over three years (2011- 2014) based on lessons learned from other streamlining models (central IRBs, independent IRBs, ceded reliance agreements) Involved diverse experts from different organizations (see image) Institutional Representatives CTSA Leadership, IRB Directors, Lawyers, Clinical Trial Experts Sponsors Eli Lily, NIH, VA Regulatory Expertise OHRP, AAHRPP, WIRB

3. What is IRBshare? reduces duplicative IRB reviews Joint IRB review model (45 CFR 46.114) that reduces duplicative IRB reviews of multisite studies for faster study start up Mechanism to streamline study submissions for investigators Mechanism to streamline study submissions for investigators increase transparency between IRBs facilitate more consistent IRB reviews, high quality reviews, and promote best practices Mechanism to increase transparency between IRBs by facilitating the sharing of approval documents to facilitate more consistent IRB reviews, high quality reviews, and promote best practices.

4. IRBshare Shared Review Model: IRBs 1.Local investigator submits study to local IRB 2.Study reviewed by convened IRB upload 1.Local investigator submits study to local IRB (perhaps abbrev forms) 2.Study reviewed by local subcommittee (>1 IRB member) using IRBshare documents LEAD IRB LOCAL/RELYING IRB Committee Responsibility: 1.Determine whether study meets all federal regulatory guidelines for approval of research (e.g., 45 CFR 46.111) Subcommittee Responsibility: 1.Verify Lead IRB’s determination, AND 2.Review for site’s own local context issues IRB application Consent form(s) Protocol + IB/Device Manual Meeting minutes (redacted) Determination letter download

5. Why IRBshare? Increase Reliance Opportunities Nationwide Free to join and use Open to any institution with a Federalwide Assurance (FWA) with OHRP Single reliance agreement allows use with any multisite study regardless of disease type and funding support Available to studies at any level of review (expedited or full committee) IRBshare can facilitate consortium-specific groups and studies

6. Using the Shared Review Model

7. Prior to Study Initiation Investigators at non- IRBshare sites should request that their institution join IRBshare Investigators at IRBshare sites should inquire about modified IRB submissions when their site is relying on another IRB via IRBshare Identify Potential Lead IRBs based on discussions with sponsor/funder + investigators + IRB

8. IRB Process: 1. Investigator Seeks Approval from Lead IRB Investigator at “Lead IRB” site submits study to local IRB per local IRB policies Lead IRB processes study according to level of review required (expedited/full) Lead IRB approves based on the federal regulatory guidelines for approval of research Lead IRB approves based on the federal regulatory guidelines for approval of research Lead IRB uploads approved documents to IRBshare for other IRBs to access Lead IRB uploads approved documents to IRBshare for other IRBs to access

9. 2. Disseminate Study Documents for Local Submission Coordinating center, lead PI, or sponsor disseminates study documents, including consents, to aid local IRB submission

10. IRB Process: 3. Local Investigators Submit Study to Local IRBs Local investigators request use of modified IRB submission (local context info + consent form) because a full IRB Application was completed by the investigator at the Lead IRB site. Local IRB accesses shared approval documents via the IRBshare System Local IRB subcommittee uses Shared Review to verify 1) agreement with Lead IRB’s determination + 2) local context issues If approved, local site inherits expiration date of Lead IRB + resumes study oversight. If not approved, study reviewed according to local policy.

11. After Using the Shared Review IRB: Lead IRBs and Relying IRBs are each responsible for their own local oversight Relying IRB inherits expiration date of Lead IRB Study Teams: All events and protocol deviations are reported to local IRB Study-wide issues are reported across sites as stipulated by the protocol/sponsor Submit amendments and continuing reviews to local IRB per local IRB policies (local IRB will use IRBshare as applicable)

12. IRBshare Progress to Date

13. IRBshare Network (n=52) *AAHRPP accredited †CTSA institution States (n=26): Alabama Arizona Arkansas California Florida Illinois Iowa Kansas Kentucky Louisiana Maine Massachusetts Michigan Mississippi Minnesota New Mexico New York North Carolina Pennsylvania South Carolina Tennessee Texas Utah Virginia West Virginia Washington (Washington DC) Baystate Health*The University of Utah*† Boston University Medical Center*†Tufts Medical Center† Children’s National Medical Center*†Tufts University † Columbia University*†Tulane University* Duke University*†University of Alabama Birmingham*† Louisiana State University A & M*University of Arkansas for Medical Sciences*† Louisiana State University HSC New Orleans*University of California San Diego† Louisiana State University HSC ShreveportUniversity 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† Michigan State University*University of Minnesota*† Mississippi State University* University of New Mexico Health Sciences Center*† Mount Sinai Medical School*†University of North Carolina at Chapel Hill *† New York University School of Medicine*† University of Pennsylvania*† North Shore LIH Health SystemUniversity of Pittsburgh*† Northwestern University †University of Southern California*† Pennington Biomedical Research Center*University of Texas HSC at San Antonio*† St. Claire Regional Medical CenterUniversity of Texas Southwestern Medical Center† Seattle Children’s HospitalUniversity of Washington† Stanford University*†Vanderbilt University*† The Rockefeller University*†Virginia Commonwealth University*† The Scripps Research Institute†Wake Forest University Health Sciences* The University of Arizona*Washington University (St. Louis) *† The University of Texas HSC at Houston*†Xavier University (Louisiana)

14. Preliminary Results First reliance: February 2013 Site Usage: 11 sites have uploaded their approval 8 sites have relied upon another IRB’s review Studies in IRBshare 13 studies added to IRBshare (4 added in Y1; 9 added in Y2) 9 studies have had at least 1 reliance 13 reliances to date (4 in Y1; 9 in Y2) Turnaround Time Median of 20 days from IRB submission to approval Median of 1 day from IRB review to approval * MUSC, Iowa, and UK also uploaded approvals

15. Contact Information IRBshare Project Manager Emily Sheffer | Vanderbilt University | EMILY.SHEFFER@IRBshare.org | 615- 343-2384EMILY.SHEFFER@IRBshare.org Local IRBshare Liaisons Found on the IRBshare website (https://IRBshare.org) under “Participating Institutions”https://IRBshare.org