1. IRBshare: Streamlining IRB Review of Multisite Studies EMILY SHEFFER, MPA | VANDERBILT UNIVERSITY MEDICAL CENTER | EMILY.SHEFFER@IRBSHARE.ORG

2. Brief History of IRBshare Funded by National Center for Research Resources (NCRR) (2011-2014) *New* model envisioned because use of IRB reliance was rare due to ◦Significant lack of trust between IRBs ◦Institutional/IRB policies against transferring oversight (still true for some institutions) Initial Project Goals ◦Maintain high level of protection for human subjects in multicenter trials ◦Accelerate study start Up ◦Create a scalable IRB reliance model (minimal funding required; open to all institutions) ◦Create transparency between IRBs to promote shared expertise and practices >30 Institutions CTSA Leadership, IRB Directors, Lawyers, Clinical Trial Experts Sponsors Sponsors Eli Lily, NIH, VA Regulatory Expertise Regulatory Expertise OHRP, AAHRPP, WIRB

3. IRBshare NATIONAL IRB RELIANCE MODEL TO STREAMLINE IRB REVIEW—WITHOUT TRANSFERRING IRB OVERSIGHT— WITH NO ADDITIONAL RESOURCES

4. Shared Review Model 1.Local investigator submits study to local IRB 2.Study reviewed according to risk level (expedited or full committee review) upload 1.Local investigator submits study to local IRB (abbrev application recommended) 2.Study reviewed by local subcommittee (>1 IRB member) using IRBshare documents LEAD IRB LOCAL OVERSIGHT 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 (not re-review) Lead IRB’s determination, AND 2.Review for site’s own local context issues IRB application Consent form(s) (become model consent(s)) Protocol + IB/Device Manual Meeting minutes (redacted) Determination letter download LOCAL IRB MAINTAINS OVERSIGHT BUSINESS AS USUAL Initial Study Review Continuing Review Study-wide amendments

5. Expected Benefits ◦National reliance model: no additional funding required ◦Inclusivity: open to any institution with an FWA ◦Minimal paperwork: single master agreement to join (no study-specific paperwork) ◦Minimal process change: ◦Lead IRB reviews for their site only ◦Subcommittee at Local Oversight IRB ◦Investigators only submit and report to their local IRB ◦Transparency: share expertise + best practices

6. Preliminary Results and Lessons Learned IRBSHARE MASTER AGREEMENT FINALIZED: OCTOBER 2012 FIRST RELIANCE: FEBRUARY 2013

7. IRBshare Scope and Eligibility Institutions ◦Any institution with an FWA and federally constituted IRB ◦AAHRPP not required, but captured for relying sites’ decision making Studies ◦All studies requiring IRB review (not applicable to exempt studies) ◦All diseases and conditions ◦All funders: Federal, industry, and investigator-initiated IRB Reviews Included ◦All Phase of Review: Initial study review, continuing review, and reviews of amendments

8. IRBshare Successes National Reliance Model: ◦67 institutions in 31 states ◦67 institutions in 31 states have executed single master reliance agreement ◦No funding required to support use Median of 14 days Accelerating Study Start Up: Median of 14 days from submission to approval (n=50 reliances; 76% studies are greater than minimal risk) Transparency ◦Shared Expertise—Institutions unable to transfer oversight can streamline their review ◦Shared Practices—IRBs communicating and sharing documents/templates

9. *AAHRPP accredited (n=51); †CTSA institution (n=43) States (n=31): Alabama Arizona Arkansas California Florida Georgia Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Massachusetts Michigan Minnesota Mississippi Missouri New Mexico New York North Carolina Ohio Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia West Virginia Washington (Washington DC) Baylor Research Institute*Northwestern University †University of California, San Diego† Baystate Health*Ohio UniversityUniversity of California, San Francisco*† Boston University Medical Center*†Oregon Health & Science University†University of Cincinnati*† Children’s National Medical Center*†Ochsner Health System*University of Illinois Chicago*† Cincinnati Children’s Hospital Medical Center*†Pennington Biomedical Research Center*University of Iowa*† Clinical Directors NetworkSt. Claire Regional Medical CenterUniversity of Kansas*† Columbia University*†Seattle Children’s HospitalUniversity of Kentucky*† Duke University*†Stanford University*†University of Miami*† Georgia Regents University*Sutter West Bay HospitalsUniversity of New Mexico Health Sciences Center*† Indiana University*†Texas A&M University*University of North Carolina at Chapel Hill *† Louisiana State University A & M*The Rockefeller University*†University of Pennsylvania*† Louisiana State University HSC New Orleans*The Scripps Research Institute†University of Pittsburgh*† Louisiana State University HSC Shreveport*The University of Arizona*University of Southern California*† Maine Medical Center*The University of Texas HSC at Houston*†University of Texas HSC at San Antonio*† Marshall University*The University of Utah*†University of Texas Southwestern Medical Center† Medical University of South Carolina*†Tufts Medical Center†University of Washington† Mayo Clinic*†Tufts University †Vanderbilt University*† Meharry Medical College†Tulane University*Virginia Commonwealth University*† Michigan State University*University of Alabama Birmingham*†Wake Forest University Health Sciences* Mississippi State University*University of Arkansas for Medical Sciences*†Washington University (St. Louis) *† Mount Sinai Medical School*†University of California, Davis*†West Virginia University* New York University School of Medicine*†University of California, Los Angeles†*Xavier University (Louisiana) North Shore LIH Health System

10. IRBchoice NHLBI-funded R01 to expand IRBshare’s master agreement and system to support multiple reliance models (full/ceded + shared) Goal: enable IRBs to identify the reliance model that works best for their PI and institution on a study-by-study basis Timeline: Release in Fall 2015