1. SMARTIRB.org Conceived at Hubs Hubs Coalesced Into Regions UC Braid New England Ohio Consortium U New Mexico U Texas Vanderbilt Wisconsin/MARCH IRBrely (n=115) SMART IRB (n=64+750)

2. SMARTIRB.org Added Value of IRB Reliance Patients and Those At Risk Investigators and Institutions CTSA Consortium

3. Enabling IRB Reliance on a national scale Funded by NCATS: July 2016-April 2018 Harvard University, University of Wisconsin-Madison & Dartmouth College A team of SMART IRB Ambassadors from CTSAs across the nation Implement NIH Policy on the Use of a Single IRB for Multi-Site Research JOIN ENABLEHARMONIZE Aims

4. Advancing Research Together Supporting Local Implementation Single IRB Authorization Agreement Guidance & Standard Operating Procedures (SOPs) A team of SMART IRB Ambassadors Online sharing through open-source platforms

5. Access Expertise Across the Nation Columbia University Duke University Harvard University Medical University of South Carolina Metro Health Oregon Health & Science University Pennsylvania State University Stanford University University of California San Francisco University of Kansas Medical Center University of Kentucky University of New Mexico University of Texas Health Science Center at San Antonio University of Wisconsin-Madison smartirb.org/ambassadors Ambassadors from CTSAs across the nation are available to assist institutions in joining and implementing SMART IRB.

6. Timeline for Adoption and Implementation 2018 Sep Oct Dec 2017 JanApr Dec2018Feb MarMay SMART IRB Website and Joinder Tool Release Sept 15, 2016 2016 May 64 CTSA hubs join SMART IRB V1.0 of Web-based Compendium to enable studies using SMART IRB Jan 31, 2017 May 1, 2017 25% of CTSA affiliates join SMART IRB V2.0 of Web-based Compendium Pilot SMART IRB Process 50% of CTSA affiliates join SMART IRB V3.0 of Web-based Compendium Evaluate pilot studies of 2-4 Harmonization projects December 1, 2017 May 1, 2018 75% of CTSA affiliates Signed On with SMART IRB V4.0 of Web-based Compendium Adoption of common policy, method, process by CTSA Program hubs Ambassador Kick Off Sept 13-14, 2016 Join, Enable, Harmonize October 25 th, 2017 To-date, 23 institutions have joined SMART IRB

7. 23 Institutions Have Signed On Already Broad Institute Cambridge Health Alliance Forsyth Institute Harvard T.H. Chan School of Public Health Harvard University Harvard University Faculty of Medicine Icahn School of Medicine at Mount Sinai Johns Hopkins University School of Medicine Medical University of South Carolina Stanford University Trustees of Dartmouth College Tufts Medical Center University Hospitals Cleveland Medical Center University of Kansas Medical Center University of Kentucky University of New Mexico Health Sciences Center University of Rochester University of Southern California University of Southern California - Health Science Campus University of Texas Health Science Center at San Antonio University of Utah University Wisconsin-Madison Vanderbilt University Medical Center 17 CTSA Hubs 8 As of Oct 24th

8. Join SMART IRB Today 9 Review the SMART IRB Agreement Connect with a SMART IRB Ambassador to address questions Join Online. IRB administrator or other research compliance personnel should initiate the process. Get Started: smartirb.org/joinsmartirb.org/join QUESTIONS? CONTACT US AT HELP@SMARTIRB.ORGHELP@SMARTIRB.ORG 1 1 2 2 3 3