11/12/20151 IRBs from Both Sides Now Bennett I. Bertenthal Indiana University.

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IRBs from Both Sides Now

Bennett I. Bertenthal

Indiana University

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Professional Experience

Survivor of Shutdownof Research at UVA

Chair, SBS IRB, University of Chicago

PI, Social InformaticsData Grid

Dean, College of Arts & SciencesIndiana University

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Brief History

• By early 2000, IRBs intimidated by recent penalties imposed by OPRR– University of Pennsylvania

– Johns Hopkins University

– University of Illinois at Chicago (UIC)

• Impact: IRBs interpreted regulations very narrowly & literally– Unnecessarily preventing or delaying research

– Impairing integrity of research designs

– Adversarial relationship with researchers

• By spring, 2001, University of Chicago IRB had become dysfunctional– External committee recommended restructuring IRB

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Recommendations

• IRB should be facilitative, educational, and collegial– Not adversarial and burdensome

• IRB Chair should be experienced, senior researcher• IRB should be comprised of senior researchers from

departments and academic units• IRB manager and staff should report to IRB Chair, and

not to Associate Provost for Research Administration– Necessary for chair to maintain facilitative orientation

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Implementation

• Initial conditions: IRB Chair and secretary• Importance of appointing right IRB manager

– New manager was veteran of the UIC shutdown – Graduate student in bioethics who appreciated facilitating

research while maintaining compliance– Serendipitous to find someone experienced, knowledgeable,

and connected

• Importance of appointing right faculty to IRB committee– Prerequisites: Conscientious, informed, dedicated, and

committed to improving turn-around-time for reviewing protocols– Principal responsibilities

• Assist in review of expedited protocols• Participate in monthly review of protocols by full committee

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Scorecard

• IRB Manager

• Faculty on IRB Committee

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Institutional Commitment

• Administrative commitment for sufficient space, staffing and resources is necessary for facilitative, collegial orientation– Commitment is directly a function of time and energy required by

Administration• Bert’s Law Resources = f(Complaints to Dean)

– Fewer complaints and problems resulted in less attention and resources from Dean’s Office

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Consultation with Staff

• Feedback was not limited to informing PIs about unacceptable protocol answers– PIs no longer had to play 20 questions to complete protocol

• Staff available to answer questions and assist with filling out protocol– Staff functioned as a resource to help solve problems

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Review of Protocols

• Significantly reduce number of protocols requiring review by Full Committee– Most research involving children no longer required full review

• Protocols involving special populations (e.g., prisoners) or sensitive issues (e.g., wife abuse in China)– PIs invited to attend committee review: answer questions, provide

clarifications, receive immediate first-hand feedback

• Significantly increase number of protocols requiring Expedited review– Chair and one committee member

• Significantly increase number of Exempt reviews– Special guidance for research involving public use data sets

• IRB director and co-director appointed to IRB Committee to complete standard Continuation Reviews

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User-Friendly Website

• Getting Started

• Decision Trees

• FAQs

• Links to web-based tutorials and tests (e.g., NIH, CITI)

• Comprehensive IRB manual

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Online Protocol Submission System

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Online Templates

• Easy-to-use models of responses– Protocol– Informed consent– Recruitment ads

• Minimizes omissions and commissions• Recommendation: Assist new investigators with

departmental advisory committee– Teach ‘tricks of the trade’

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Customer Satisfaction Survey

• Survey should be designed by professional survey researcher

• Analysis should enable disaggregating responses as a function of discipline and respondent (e.g., student vs. faculty)

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Myth #1

• Online protocol submission system will significantly improve efficiency and reliability of review process

• Experience with IRBWise– Improved reliability and record keeping– Minimized redundancy for researchers and staff– But, review time did not change significantly

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Myth #2

• If FWA is limited to federally funded research, then review of remaining protocols by IRB is unnecessary– Faculty are ethical and can ensure that the rights of human

participants are protected– If true, IRB protocols would not require any modification to

assure protection of human participants• Sensitivity to informed consent and risks vs benefits varies with

knowledge, experience, and motivation by the investigator

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Myth #3

• IRB Committee members are well-trained and knowledgeable about the regulations contained in

45 CFR 46

Not Always!

• Initial training and continuing education is necessary, but commitment by faculty is most important

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Questions

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The University of Chicago Social and Behavioral Sciences (SBS) Institutional Review Board (IRB) recently reviewed its policies and procedures for reviewing research involving existing data sets and data archives. The IRB recognizes that some research involving existing data sets and archives may not meet the definition of “human subjects” research requiring IRB review; some may meet definitions of research that is exempt from the HHS regulations at 45 CFR 46; and some may require IRB review.  This document is intended to provide guidance on IRB review policies and review procedures and to reduce burdens associated with IRB review for investigators whose research involves only the analysis of existing data sets and archives.

The IRB considers most research involving existing data sets and archives to fall within the following categories: Analysis of de-identified, publicly available data Analysis of non-publicly available data with restricted access to participant identifiers (coded private information) Analysis of publicly available data with private identifiable information or of non-publicly available data with private identifiable information where researchers will not record individual identifiers Analysis of non-publicly available data containing private identifiable information

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