Duke University Health System, Inc.Institutional Review Board

Recent Accomplishments

And

Future Goals

Jody Power, MS, MBA, CIPExecutive Director

DUHS IRB

August 11, 2010

Outline of Presentation

I. Department Structure and Function

II. Workload and Metrics

III. Recent Accomplishmentsa. AAHRPP accreditationb. eIRB implementation completedc. Integration of institutional reviews into eIRB process

IV. Future Goals

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

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)

The Scope of the IRB’s Authority

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.

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.

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.

IRB Office Organization – FY11

1 Senior Chair9 Chairs4.2 FTEs

1 Executive Director1 Director of Ed. Programs6 Board Specialists2 Compliance Specialists2 Medical Writers2 Support Staff13.5 FTEs

The Senior Chair and Executive Director report directly to the Associate Dean for Research Support Services, School of Medicine.

Trends in IRB SubmissionsTrends in IRB Submissions

FY08 FY09 FY10New Studies 1255 1275 1676Continuing Reviews 2124 2929 3120Amendments 4097 4035 9362Safety Events 2542 1629 5659Other 970 -

TOTAL 10988 9868 19817# Active Studies 3379* 4204 5097

Operating Budget $2.19M $2.38M $2.30M

*excluding exempts

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

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 toDuke Medicine in March, 2009.

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)

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

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

eIRB and Information SharingeIRB and Information Sharing

CTQAAudit requests/reports, trending, meeting attendance,noncompliance issues

Internal AuditsQuarterly risk reports

Research AdministrationBiweekly UPIRTSO reports

PRMO/DTMI regulatory groupMonthly IND/IDE reports

Research Departmental reports upon request

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

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”.

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

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

Institutional Review Incorporated into eIRB

Cancer Protocol CommitteeRadiation SafetyPediatric Risk AssessmentOffice of Corporate Research CollaborationsOffice of Research AdministrationClinical Research Support OfficeSBR

Coming Soon:Pathology/BiorepositoryStem Cell Committee

Data Feed to eResearch

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)

Goals for the IRB

I. Complete integration of the Primary Reviewer Checklists into the eIRB

II. Integrate meeting minutes into eIRB and, if possible, individual study records

III. Formulate with Research Administration a definitive policy for use of external IRBs

IV. 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)

“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

In Closing . . . .

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