1. IRBshare Liaison Connections Call What are the data saying? What resources are available? What’s about IRBchoice?

2. What are the data saying?

3. Who’s IN IRBshare? Baystate Health*Ohio UniversityUniversity of Cincinnati*† Boston University Medical Center*†Oregon Health & Science University†University of Illinois Chicago*† Children’s National Medical Center*†Pennington Biomedical Research Center*University of Iowa*† Cincinnati Children’s Hospital Medical Center*†St. Claire Regional Medical CenterUniversity of Kansas*† Columbia University*†Seattle Children’s HospitalUniversity of Kentucky*† Duke University*†Stanford University*†University of Miami† Louisiana State University A & M*Texas A&M UniversityUniversity of New Mexico Health Sciences Center*† Louisiana State University HSC New Orleans*The Rockefeller University*†University of North Carolina at Chapel Hill *† Louisiana State University HSC Shreveport*The Scripps Research Institute†University of Pennsylvania*† Maine Medical Center*The University of Arizona*University of Pittsburgh*† Marshall University*The University of Texas HSC at Houston*†University of Southern California*† Medical University of South Carolina*†The University of Utah*†University of Texas HSC at San Antonio*† Mayo Clinic*†Tufts Medical Center†University of Texas Southwestern Medical Center† Meharry Medical College†Tufts University †University of Washington† Michigan State University*Tulane University*Vanderbilt University*† Mississippi State University*University of Alabama Birmingham*†Virginia Commonwealth University*† Mount Sinai Medical School*†University of Arkansas for Medical Sciences*†Wake Forest University Health Sciences* New York University School of Medicine*†University of California, Los Angeles†*Washington University (St. Louis) *† North Shore LIH Health SystemUniversity of California, San Diego†West Virginia University* Northwestern University †University of California, San Francisco*†Xavier University (Louisiana) States (n=28): Alabama Arizona Arkansas California Florida Illinois Iowa Kansas Kentucky Louisiana Maine Massachusetts Michigan Mississippi Minnesota New Mexico New York North Carolina Ohio Oregon Pennsylvania South Carolina Tennessee Texas Utah Virginia West Virginia Washington (Washington DC) *AAHRPP accredited (n=45); †CTSA institution (n=38)

4. Site Accrual Overtime

5. Who’s USED IRBshare? Institution IRB of RecordUsed Shared ReviewSubmission to Approval Baystate Health * 342, 91, 14 Duke University * † 136, 20, 23 Louisiana State University Health Science Center New Orleans * 525, 19 Maine Medical Center * 1 Marshall University * 1 Medical University of South Carolina * † 2127 Northwestern University † 248, 1 Oregon Health & Science University † 137 Pennington Biomedical Research Center * 2 The University of Texas Health Science Center at Houston * † 347, 12, 1, 2 Tufts Medical Center † (only count one as a CTSA) 2 Tulane University * 4 University of Alabama Birmingham * † 221, 61 University of California, Los Angeles * † 1 University of California, San Diego † 1 University of Iowa * † 3 University of Kansas Medical Center * † 113 University of Kentucky * † 2123 University of Miami * † 1 University of North Carolina at Chapel Hill * † 3 University of Pittsburgh * † 48, 22, 38, 31 Vanderbilt University * † 111014, 20, 22, 7, 11, 8, 3, 17, 5, 5

6. Reliances Overtime (n=34) Y1 (Feb ‘13-Jan ‘14): 4 reliancesY2 (Feb ’14-Jan ‘15): 10 reliancesY3 (Feb ’15-present): 20 reliances

7. Site accrual + Reliances

8. What’s the turnaround time? Study TitleRisk CategorySubmittedReviewedApprovedSub--ApprReview to Appr ISCHEMIAGTMR2/14/20132/19/20132/20/201361 MENDS IIGTMR4/10/20135/16/20135/22/2013426 Vitamin D and type 2 diabetes NIDDKGTMR9/26/201310/22/201310/23/2013271 Neonatal AbstinenceGTMR11/26/201312/10/2013 140 A5315GTMR2/25/20143/17/2014 200 A5326GTMR5/7/20145/21/20145/29/2014228 Novel actions of metformin to augment resistance training adaptations in older adultsGTMR7/22/20147/23/2014 10 TCAPGTMR8/12/20148/15/20149/4/20142320 CHAPGTMR9/2/20149/5/20149/9/201474 TCAPGTMR7/2/20149/24/201410/1/2014917 TCAPGTMR9/18/201410/2/201411/5/20144834 TCAPGTMR11/26/201412/8/2014 120 CHAPGTMR12/8/201412/15/201412/16/201481 CHAPGTMR12/2/201412/19/201412/22/2014203 TCAP CRGTMR2/3/20152/4/2015 10 Understanding the Influence of Pregnancy on Breast MilkGTMR2/6/20152/11/2015 50 Behavioral Inflexibility in IDD: Outcome Measurement MR3/26/20154/2/2015 70 Eculizumab use in pediatric practiceGTMR4/9/20154/20/2015 110 TCAPGTMR3/16/20154/22/2015 370 A5324GTMR4/22/20154/24/20154/30/201586 A5332GTMR4/23/20155/1/20155/15/20152214 CPVTMR4/2/20156/2/2015 610 CHAP Amend + CRGTMR6/2/20156/3/2015 10 A5342GTMR4/27/20155/22/20156/4/20153813 A5342GTMR6/7/20156/8/20156/9/201521 A5332GTMR5/29/20156/12/2015 140 CHAP Amend + CRGTMR5/29/20156/19/20156/29/20153110 Southern Area Patient Oriented Research Organization SurveyMR6/12/2015 7/1/201519 U54--PhenotypingGTMR6/23/20157/2/20157/6/2015134 CHAP Amend + CRGTMR6/17/20157/10/2015 230 RETT Syndrome StudyGTMR7/17/20157/20/2015 30 Behavioral Inflexibility in IDD: Outcome Measurement --AmendmentMR7/16/20158/2/2015 170

9. Turnaround Time Trends IRB submission to approval: 14 day median Range: 1-91 days IRB review to approval: 1 day median Range: 0-34

10. Reasons Sites Haven’t Used IRBshare Already had IRB approval for study IRB policy requires certain type of study be taken to full board (stem cell) Lead IRB was not AAHRPP accredited Investigators have not requested it Did not agree with Lead IRB determination (2x—to our knowledge) Competing priorities within the IRB Not enough demand Do not understand responsibilities, Did not see advantage Others...

11. HELP: Need Resources!

12. What resources are available to help you? Documents, slides, and more: https://IRBshare.org/p/resources Launching IRBshare Quick Guide: herehere IRBshare Pros: admin@IRBshare.org Jenni Beadles, Nicollette Davis, and Emily Sheffer Your colleagues: members@irbsharenetwork.org liaisons@irbsharenetwork.org

13. What’s about IRBchoice?

14. IRBchoice WHAT IS IT? NHLBI-funded R01 to expand IRBshare’s master agreement and system to support multiple reliance models (full/ceded + shared) Goal: to enable IRBs to identify the reliance model that works best for their PI and institution on a study-by-study basis WHAT’S THE TIMELINE? Release in Fall 2015 WHAT ABOUT IRBshare? It will still be available and function as it does now

15. How is IRBchoice different? Multiple reliance models under one agreement, one system Provide more guidance to investigators when using an alternative IRB arrangement Collect data on why Lead IRBs decide to be IRB of Record, Sharing IRB, or both Collect data on why relying IRBs choose a review model (ceded, shared, or local)

16. Tracking Flexibility in Ceded Reliance Provide mechanism to document a study-specific plan for handling a limited number of issues, if needed and as accepted by the Lead IRB: HIPAA Privacy Board Filing reports Auditing Agreements generally have some squishy language around these issues: When an authorization will be used the language required under the HIPAA Privacy Rule…will be incorporated into informed consent documents, unless the Relying Institution obtains agreement from the Reviewing IRB to use a separate authorization form. Unless by separate agreement an alternate reporting arrangement has been agreed upon, the Reviewing IRB will provide the involved Relying Institution(s) the opportunity to review and comment on the report before it is sent to state or federal authorities, or others. The Reviewing IRB and Relying Institution(s) may agree to make a single or joint report to state or federal authorities. CIRB agreements have language stating that IRBs will work with each other to determine a plan of action if an audit is necessary Any required reporting to regulatory agencies or oversight authorities will be coordinated based on a process of discussion and consensus with the reporting sites and institutional officials.