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 and 21 CFR

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 )

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 (IND Regulations)
● 21 CFR (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
FY08 FY09 FY10
New Studies
Continuing Reviews
Amendments
Safety Events
Other
TOTAL
# Active Studies 3379*
Operating Budget $2.19M $2.38M $2.30M
*excluding exempts

10. External Reporting by the IRB in FY10
UPIRTSOs* S/C NC**
OHRP
FDA
* 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 
 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) 
 Customization of software by Click engineers
 Creation of in-house eIRB team to interact with Click 
 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
Convened IRB
Amendments
Expedited
Convened IRB
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 Office as 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: