Human Subject Research Town Hall Georgia Regents University

1. Human Subject Research Town Hall Georgia Regents University January 16, 2013 Michael P. Diamond,  MD Associate Dean for Research, Medical College of Georgia Vice President for Clinical and Translational Sciences

2. Agenda • GRU IRB Development & Highlights • Human Subject Research – Challenges • Human Subject Research Vision • Human Subject Research Initiatives - 2014 • WIRB-Copernicus Group - • Dr. Stuart Horowitz, MBA, PhD • President Institutions and Institutional Services • GRU WIRB & IRBNET Highlights • GRU IRB Office – Improvements & Highlights – • Ivy Tillman, Director, GRU IRB Office • New GRU IRB Policies • Contact Information

3. Human Subject Research - Past Changes • eIRB

4. Human Subject Research - Past Changes • eIRB NEW IRB C - Cancer

5. Human Subject Research– “Present” Changes • eIRB NEW IRB C - Cancer • IRB B – Social Behavioral • Office of Human Research Protection Renamed to IRB Office • IRB Office - Staff Restructure • Creation of Division of Clinical and Translational Sciences • Selection of new IRB electronic portal • WIRB-Copernicus Agreement • IRB Policies & Procedures • Administrative Changes • Pre-review process • Many New & Revised Policies

6. Human Subject Research – Challenges

7. Human Subject Research – Challenges • IRB • eIRB – • Early version product - manufacturer marketed new product within 10 months of GRU’s purchase • Not metric driven • Submission process is burdensome & time consuming • Rigorous” Policies • Ancillary Approvals • Unclear Research Initiation Process • Clinical Trial Oversight, Budget Development, and Billing

8. Human Subject Research – Future

9. Human Subject Research – Future To Foster a Culture Conducive to, and Supportive of, Research

10. Human Subject Research - Future WIRB IRBNet IRB Policies & Procedures Expedited Review Process Consent Language Streamlined Research Initiation Process Locations for Research Clinical Trial Data Management System, Registry System Billing Research Website

11. WIRB & IRBNET Stuart Horowitz, PhD MBA President, Institutions & Institutional Services

12. WIRB– Highlights • GRU has joined the National Research Network through the WIRB-Copernicus Group (WCG) • Western Institutional Review Board (WIRB) • Copernicus Group IRB (CGIRB), • IRBNet, the top research compliance software supporting institutions. • WCG is the world's largest provider of regulatory and ethical review services for human research. • 8 individual AAHRPP-accredited panels • 100+ experienced board members • 60+ years of combined experience in protocol and study-related review • Only ISO 9001:2008 Certified IRB • WCG can serve as the GRU IRB of record for commercially sponsored trials. • The nation's leading independent institutional review boards

13. More than an IRB…A comprehensive ethical review solution World-Class IRB Review Services

14. WIRB – At a Glance • Founded in 1968 (first independent IRB) • Network of nearly 750 leading research institutions that rely on WIRB review • Currently managing over 10,000 protocols • Over 125,000 protocols reviewed to date • Only independent IRB with an international fellows program—trained over 120 fellows in 16 countries in partnership with WHO • Ethical Review Clearinghouse for ex-US Research • First independent IRB to earn AAHRPP accreditation • Industry leading expertise – On staff - 40 Certified IRB Professionals (CIP) - 14 Regulatory Attorneys & Analysts - 13 Physicians

15. “Single Review Solution”Providing the Industry’s Only Single Review Solution (SRS) The Usual Approach CRO/ Sponsor CRO Coordination Central IRB Central IRB Sites Local IRB Sites Our Approach – “SRS” CRO/ Sponsor Central IRB Local IRB Sites Central IRB Sites WIRB – Copernicus Group

16. WIRB– Value Added • GRU has committed to utilize WIRB exclusively for Industry-sponsored clinical trials • Efficiency • Innovative “Single Review Solution” • Approximate 5 day approval time when full complete submission provided • Access • GRU will be provided the opportunity to connect with the world’s leading sponsors and CROs and to expand our repertoire of industry sponsored clinical trials. • Access to private funding through the top industry sponsors and CRO’s • Oversight • 1 IRB-portal for managing, reviewing, submitting human subject research for WIRB (industry sponsored clinical trials) and IRB A, IRB B, and IRB C.

17. GRU TRANSITION TO WIRB & IRBNET

18. WIRB - External IRB Existing/ActiveIndustry Sponsored Trials • Existing and Active Studies for which Chesapeake IRB (CIRB) is the IRB of record will be transferred to WIRB unless: • The study is schedule to close within the next ~3 months • The sponsor explicitly refuses to transfer the protocol

19. WIRB - External IRB Existing/ Active Industry Sponsored Trials • Process for Transferring Studies • Telephone contact with Sponsor/CRO to discuss this change • Letter to Sponsor/CRO to notify of change and requesting response • - Telephone scripts, and letter templates are available, please contact EXTERNAL_IRB@GRU.EDU for templates and support with process. • Individual training / support to the Study Team to assist with transfer • Individual Protocol Submission Form • WIRB Multi-site application – 51 studies • WIRB New Study application – 8 studies • IRB submission and current status informationsubmitted to Chesapeake IRB Support staff are available to support and facilitate transition!

20. WIRB - External IRB New Industry Sponsored Trials • All New IRB Submissions for Industry Sponsored Clinical Trials will be submitted to WIRB via IRBNet • Training on WIRB Processes • Commenced Jan 15th • January 22nd 3:00 p.m. – 5:00 p.m. – Greenblatt Library • January 29th 3:00 p.m. – 5:00 p.m. – Greenblatt Library • Individual training will be offered on a continuing basis by contacting GRU IRB Office at EXTERNAL_IRB@GRU.EDU

21. WIRB - External IRB New Industry Sponsored Trials • WIRB Fees • New fee structure • Sponsor will be billed directly from WIRB • Competitive and may be cheaper particularly for multi-center trials. • GRU IRB Office • Will continue to provide Education, Training and Compliance services. • Fee for this service is being reviewed • On-site resource for WIRB

22. GRU IRB Office - IRB A, B, C • IRBNet • Will replace eIRB - Goal: March Go Live! • Training commencing in February 2014 • Single portal for submitting to WIRB & GRU IRB A, B, and C • Single Sign-On • Website hosted – accessible anywhere! – www.irbnet.org • Simple for external collaborators and new users via • -“Create your account” • Integrated tracking of CITI training • Streamlined submission process • Same “look and feel” for GRU IRB Submissions and WIRB submissions • Metrics Friendly • Existing protocols will be migrated into IRBNET

23. GRU IRB Office - IRB A, B, C • GRU IRB Office will continue to provide • Education • Training • Compliance services • Support for IRB Committees A, B, and C • New - Expedited Review Process

24. GRU IRB Office - IRB A, B, C Submission Dates

25. GRU IRB Office - IRB A, B, C Submission Dates • Last Day for access toeIRB– • Wednesday in February/March at 5 pm. • First Day for access to IRBNET– • following Monday, March at 8 am. • Specific transition dates will be communicated. • Emergency issues during the transition time sent directly to the IRB Office at: • email: IRB@GRU.EDU • phone: 706-721-3110

26. GRU IRB OFFICE Policy Updates Ivy Tillman,MS Director Institutional Review Board (IRB) Office Georgia Regents University

27. GRU IRB Office - Changes to IRB Office Changes to IRB Office IRB A (Biomedical) Administrator- Rebecca Miller IRB B (Social/Behavioral) Administrator- Casey Glover  IRB C (Cancer) Senior Administrator- Angela Toole  External IRB and VA IRB Administrator- Michelle Harper- Meriwether

28. GRU IRB Office - Changes to Submission Process • Changes to IRB Submission Process • Administrative Changes • Misspellings • Punctuation • Formatting • Witness/LAR signature line removal • Enterprise name changes • Pre-review process simplified • Expedited Review Process

29. GRU IRB Office - New Policies New Policies Guideline for Roles of Non-Faculty, Non-Georgia Licensed Physicians Clinical Trials Registration GRU Research Studies Involving Investigational Agents at Non- Georgia Regents Medical Center Sites Department Chair Responsibilities

30. GRU IRB Office - Revised Policies • Revised Policies • Reportable Events • Engagement in Human Subjects Research • IRB Operations • Investigational Drugs • Exempt protocols • Research Conducted at the Charlie Norwood VA Medical Center • Study Coordinator Responsibilities • Continuing Review 

31. Questions? Ivy Tillman,MS Director Institutional Review Board (IRB) Office 706-721-3110 itillman@gru.eduorIRB@GRU.EDU Michael P. Diamond,  MD Associate Dean for Research, Medical College of Georgia Vice President for Clinical and Translational Sciences michael.diamond@gru.eduor CTS@gru.edu 706-721-6395 Michelle Harper-Meriwether External IRB and VA IRB Administrator mharpermeriwethe@gru.edu 706-721-1478