IRBshare Overview: IRBs Emily Sheffer, MPA Vanderbilt University Medical Center IRBshare Project Manager |

IRBshare Overview Background The Shared Review Model Process for Using IRBshare Benefits of IRBshare Current Progress Next Steps

IRBshare Background Developed with funds from NCRR/NCATS conference series grant (PI – Bernard) Involved diverse experts from across the US Developed over three years ( ) Based on lessons learned from other streamlining models (central IRBs, independent IRBs, ceded reliance agreements) Institutional Representatives CTSA Leadership, IRB Directors, Lawyers, Clinical Trial Experts Sponsors Eli Lily, NIH, VA Regulatory Expertise OHRP, AAHRPP, WIRB

The Shared Review Model

IRBshare Shared Review Model 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 OVERSIGHT IRB Committee Responsibility: 1.Determine whether study meets all federal regulatory guidelines for approval of research (e.g., 45 CFR ) Subcommittee Responsibility: 1.Verify Lead IRB’s determination, AND 2.Review for site’s own local context issues 3.Document reliance on Lead IRB’s review via IRBshare System. IRB application Consent form(s) Protocol + IB/Device Manual Meeting minutes (redacted) Determination letter download

Local Context Checklist

After using the Shared Review Local Oversight IRB inherits expiration date of Lead IRB Local Oversight IRB is the IRB of record for their site until the next review All events and protocol deviations are reported locally Study-wide issues are reported across sites as stipulated by the protocol/sponsor

IRBshare-related Process Changes (in red) Pre-SubmissionPre-ReviewReviewPost-Review Lead IRBLead site determined by sponsor + investigators + IRB Follow local policies and procedures Follow local IRB policies Redact meeting minutes (if not written in redacted fashion) Upload approval documents to IRBshare Local Oversight IRB (relying site) Discuss appropriate submission process when using IRBshare (modified submission possible!) Shortened pre-review: Verify approved application of Lead IRB Check for local context information Optional: Add “flag” to study in internal database to show (1) IRBshare study + (2) Lead IRB (e.g., “IRBshare – UCSD”) Download Lead IRB’s approval documents accessed via IRBshare Reviewer Completes Review Document comments/concerns Verify agreement with Lead IRB determination Document approval of local context Document risk, review cycle, and expiration if approved Enter determination + approval status + risk level + approval and expiration dates Send letter documenting use of IRBshare

Benefits of IRBshare Streamline IRB review while maintaining local oversight Minimal process change and burden for the Lead IRB Reduce analyst time in pre-review by utilizing a local abbreviated application and the full, approved IRB application for Lead IRB Avoid duplicative IRB reviews AND maintaining local oversight IRBshare involves MINIMAL CHANGES to current processes

Benefits of IRBshare Promote transparency, consistency and education among IRBs IRBs share their approval documents with other IRBs (only) that may increase review quality Promotes consistency in IRB determinations Encourages communication and education between IRBs Mechanism for receiving collaborative, non-punitive feedback on reviews

Benefits of IRBshare Scalability 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 Minimize the number of external agreements each IRB has to maintain Available to studies at any level of review (expedited or full committee)

Benefits of IRBshare Mechanism to streamline submission for investigators Full applications are submitted to the Lead IRB Local IRB only needs to submit local context issues + local consent form

Current Progress IRBshare Pilot Phase (February December 2014)

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 Shreveport*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† 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)

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 9 studies have had at least 1 reliance 13 reliances to date (4 in Year 1; 9 in Year 2) 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