Duke University Health System, Inc. Institutional Review Board

1. Duke University Health System, Inc.Institutional Review Board Recent Accomplishments And Future Goals Jody Power, MS, MBA, CIP Executive Director DUHS IRB August 11, 2010

2. Outline of Presentation • Department Structure and Function • Workload and Metrics • Recent Accomplishments • a. AAHRPP accreditation • b. eIRB implementation completed • c. Integration of institutional reviews • into eIRB process • IV. Future Goals

3. The Scope of the IRB’s Responsibility The DUHS IRB is responsible for the initial and continuing review and approval of all biomedical research involving human subjects* that is conducted by Duke employees, students, or fellows, regardless of location, or uses Duke facilities. Research at another site, if conducted by Duke employees, must be reviewed and approved by the DUHS IRB even if no study activities occur at Duke. The DUHS IRB serves as the IRB-of-Record for the Duke University Schools of Medicine and Nursing, Duke University Hospital and Medical Center, Duke Raleigh Hospital, Durham Regional Hospital, and Duke University Affiliated Physicians. * as defined by 45 CFR 46.102 and 21 CFR 56.102

4. The Scope of the IRB’s Authority • The federal regulations provide the IRB with the authority to: • ▪Approve* • ▪Disapprove • ▪Require modification of • ▪Suspend approval of • ▪Terminate approval of • any aspect of research involving human subjects, including an individual investigator’s right to conduct that research. • *Research studies approved by the IRB may be further reviewed by Institutional officials who may decide that the study cannot be conducted at the Institution. However, Institutional officials cannot approve research that has not been approved by the IRB. • (45 CFR 46.112)

5. The Regulations and External Oversight The IRB, and all DUHS investigators, are governed by the following regulations and policies: ● 45 CFR 46 (The Common Rule) ● 21 CFR 50/56 (FDA Regulations) ● 21 CFR 312 (IND Regulations) ● 21 CFR 812 (IDE Regulations) ● 45 CFR 160/164 (HIPAA) ● NC State Law ● DUHS Policy ● DUHS IRB Policy ● VA Regulations, when applicable as enforced by: OHRP, FDA, OCR, VA, local/state government and the institution.

6. DUHS IRB Facts ●The DUHS IRB office oversees 9 convened IRBs ● 8 IRBs meet monthly on the 1st, 2nd, 3rd, and 4th Wednesday/Thursday of each month for a total of 94 meetings annually (minus holidays) with ~24 agenda items at each meeting. ● IRB #9 is a Rapid Response IRB capable of meeting within 24 hours’ notice. It is comprised of experienced IRB members. ● Two-thirds of all IRB submissions are reviewed via the expedited process by an IRB Chair, Executive Director, or designee.

7. Facts about convened IRBs The 9 DUHS IRBs are comprised of representatives from: Anesthesiology Community & Family Medicine Cancer Center DCRU Dept. of Medicine Nursing School Nursing Administration Ophthalmology Obstetrics & Gynecology Pathology Pediatrics Radiation Oncology Pharmacy Radiology Psychiatry Medical School Students Surgery Duke University Departments and the surrounding Durham/Triangle community. There are currently ~200 members on the IRB’s rosters.

8. IRB Office Organization – FY11 1 Senior Chair 9 Chairs 4.2 FTEs 1 Executive Director 1 Director of Ed. Programs 6 Board Specialists 2 Compliance Specialists 2 Medical Writers 2 Support Staff 13.5 FTEs The Senior Chair and Executive Director report directly to the Associate Dean for Research Support Services, School of Medicine.

9. Trends in IRB Submissions FY08FY09FY10 New Studies 1255 1275 1676 Continuing Reviews 2124 2929 3120 Amendments 4097 4035 9362 Safety Events 2542 1629 5659 Other 970 - TOTAL 10988 9868 19817 # Active Studies 3379* 4204 5097 Operating Budget $2.19M $2.38M $2.30M *excluding exempts

10. External Reporting by the IRB in FY10 UPIRTSOs*S/C NC** OHRP 18 2 FDA 40 3 * Unanticipated Problems Involving Risks to Subjects or Others ** Serious and/or continuing noncompliance

11. Association for the Accreditation of Human Research Protections Programs (AAHRPP) is an international accreditation body for organizations that conduct research with human subjects. Full accreditation was awarded to Duke Medicine in March, 2009.

12. AAHRPP Accreditation - Timeline  2004  Decision to apply for AAHRPP Accreditation  2004-2008  Policy/procedure creation & revision  Position creation and re-definition  Internal Audit processes enacted  2008  September – pre-submission review of application  November – formal application  September -December – IRB member & research staff training  2009  January - site visit  March - full AAHRPP accreditation awarded (3 years)

13. Simultaneous Events at Duke  Implementation of an electronic IRB system ▪ Improved efficiencies/re-distributed workloads ▪ Provided platform for interdepartmental interactions  CTSA grant award to Duke ▪ Reshaped the organizational units of research ▪ Made funding available for education/training ▪ Made funding available for community outreach programs Development of new IRB website ▪ Distribution of IRB policies to research community ▪ Communication with researchers and subjects

14. eIRB Implementation - Timeline •  2003 •  Execution of software license with Webridge (now Click Commerce) •  2004-2005 Customization of software by Click engineers Creation of in-house eIRB team to interact with Click 2006-2007 Testing and refinement of review process Training and roll-out by department •  Mandatory submission of new studies and their amendments, plus conversion of existing studies initiated • 2008 Conversion of all renewals to eIRB complete  Electronic presentation of eIRB studies at convened IRBs • 2009 Roll-out of eIRB complete; reporting implemented

15. eIRB and Information Sharing  CTQA Audit requests/reports, trending, meeting attendance, noncompliance issues  Internal Audits Quarterly risk reports  Research Administration Biweekly UPIRTSO reports  PRMO/DTMI regulatory group Monthly IND/IDE reports  Research Departmental reports upon request

16. Effects of Accreditation & eIRB Implementation  Standardization  Creation and revision of policies/procedures  Standardized training for IRB staff, members, & research staff  Workflow Efficiencies  Flat or decreased budget vs. increased submissions  Blended positions and elimination of redundancies  Interdepartmental Interfaces  Information sharing with research departments  Trending for educational purposes

17. Effect of eIRB on IRB Review Times FY05 FY10 New Studies Expedited 31 9 Convened IRB 39 29 Amendments Expedited 29 8 Convened IRB 40 22 Note: eIRB implementation eliminated ~$75K in copy costs from the IRB’s annual operating budget. Numbers represent calendar days from “rec’d in IRB” to “Review Complete”.

18. New Processes in DUHS IRB Officeas a Result of Accreditation & eIRB Expired IRB Approval  Formal notifications to PI, study team, SBRs, Financial Managers  Follow-up by Chairs, Associate Deans UPIRTSO Reporting  Biweekly reports - internal and external Internal Audits  Minutes – content and timing  Consent forms – required elements

19. Specific Changes within DUHS as a Result of Accreditation & eIRB  Improved system of UPIRTSO reporting  Standardized external reports  Internal reports to DUHS compliance groups  Coordinated effort to prevent expiration of IRB approval  Site Based Research Units  Department Chairs  Associate Deans  Financial Units  Coordinated education efforts  Trending  IRB, CRSO, DTMI, Compliance Training

20. Institutional Review Incorporated into eIRB Cancer Protocol Committee Radiation Safety Pediatric Risk Assessment Office of Corporate Research Collaborations Office of Research Administration Clinical Research Support Office SBR Coming Soon: Pathology/Biorepository Stem Cell Committee Data Feed to eResearch

21. Challenges for the Future  Constrained budgets and increasing workloads  Pressure (internal and external) to decrease process times vs. quality review  Development of appropriate external IRB models (“IRB-shopping” & institutional liability)

22. Goals for the IRB • Complete integration of the Primary Reviewer Checklists into the eIRB • Integrate meeting minutes into eIRB and, if possible, individual study records • Formulate with Research Administration a definitive policy for use of external IRBs • Enhance IRB’s participation in education of the research community within DUHS • (meetings with SBR Lead Coordinators) • V. Further refine review processes and enhance support for IRB members (eg, workshops, website materials)

23. In Closing . . . . “Research has to be based on the highest standards of responsible conduct, based on ethical principles by each and every individual taking part. Let me make it unmistakably clear, in case anyone has doubts. If institutions and individuals fail to truly accept their responsibilities and in good faith work to achieve them, then they simply should not be permitted to engage in this endeavor.” - Dr. Greg Koski Director, DHHS, OHRP August, 2000

24. For more information about the DUHS IRB, its policies, procedures, IRB member rosters, and staff/Chair contacts, please go to the IRB website at: http://irb.duhs.duke.edu