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Aligning IRBs and the Ethical Conduct of Research. APS Annual Convention, May 2008 Felice J. Levine American Educational Research Association. Issues. Misalignment of research practice and regulatory system at local level

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aligning irbs and the ethical conduct of research

Aligning IRBs and the Ethical Conduct of Research

APS Annual Convention, May 2008

Felice J. Levine

American Educational Research Association

issues
Issues
  • Misalignment of research practice and regulatory system at local level
  • Studies show an overall concern about fairness, especially in the review of minimal risk research
  • To achieve legitimacy and work effectively, IRBs must be perceived as fair by investigators
organizational justice extrapolations 101
Organizational Justice:Extrapolations 101

Perceptions of fairness lead to good conduct!

Perceptions that a process is

unfair leads to misconduct!

Institutions can create a climate that

engenders commitment and compliance

(See: Keith-Spiegal and Koocher, Ethics and Behavior, Jan. 2005)

procedural justice
Procedural Justice
  • Decision-making processes seen as biased or unfair, misconduct and commitment declines
  • Process must be viewed as clear, fair, consistent, accurate, and provide an opportunity for appeal
interactional justice
Interactional Justice
  • Insincere, or dismissive treatment of investigators lead to negative perceptions of decision-makers
  • Investigators should be treated with dignity and provided with sincere and complete explanations about protocol decisions
historical rationale
Historical Rationale
  • Belmont Report:
      • Provides framework for balancing issues in human subjects research
  • National Commission
      • Saw IRBs as “working closely” with investigators to ensure the participants are protected and the application of policies is fair to investigators
four models for reform
Four Models for Reform
  • Decentralizing the IRB
  • Expediting Expedited Review
  • Limiting Review of Public Use Data Files
  • Enhancing Educative Function of IRBs

Can be accomplished under

current regulatory framework!

model 1 decentralizing the irb
Model 1:Decentralizing the IRB
  • Establish decentralized departmental or research unit review committees
  • Transfer functions of central IRB to these units, at least for minimal risk research
  • Create agreements between central IRB and decentralized units to ensure accountability, quality, and any conflicts of interest addressed
  • Example: Student research (minimal risk)
advantages of decentralization
Advantages of Decentralization
  • Methodological expertise
  • Substantive knowledge
  • Opportunities for education
  • Speed of review
  • Less complex system for investigators
model 2 expediting expedited review
Model 2: Expediting Expedited Review
  • Decentralized system:
    • Minimal risk research in identified categories is reviewed at departmental or research unit level
  • Centralized system:
    • Through assurance process, OHRP could encourage mechanisms to track and report on the processing of protocols under expedited review (e.g., number submitted, approved under expedited, approved under full review, and processing time)
advantages
Advantages
  • Speed of Processing
  • Large number of SBS protocols are minimal risk
  • Addresses one of biggest complaints by SBS researchers
model 3 limiting review of public use data files
Model 3: Limiting Review of Public Use Data Files
  • IRB must determine that a data file has no direct or indirect identifiers before made available to the public
  • Once classified as de-identified, no further review by an IRB is required – 45CFR46 specifically exempts public use data files
  • OHRP could provide a certificate for data files that have been de-identified so that they are exempt from review as a matter of standard practice
  • No additional IRB review needed unless data files are enhanced or merged
advantages1
Advantages
  • Wider use of anonymous or de-identified files by investigators to:
    • Verify findings
    • Test alternative hypotheses
    • Ask new questions
  • Maximum use of limited resources
  • Less burdensome on research participants
  • Avoid repeated review by multiple IRBs
enhancing educative function of irbs
Enhancing Educative Function of IRBs
  • An IRB could assist investigators up front in developing protocols that meet ethical and regulatory standards
  • An IRB could hold monthly open meetings to address questions about regulations or specific protocols (e.g., procedures to enhance confidentiality)
  • Creates positive climate focused on education and prevention
  • Consistent with procedural justice research literature
moving forward
Moving Forward
  • Institutions can - and should - create a climate that is viewed as fair
    • Building trust, legitimacy, and transparency into process will improve human subjects protection
  • Investigators should build broad support for change at the departmental level
  • OHRP can provide a supportive environment
    • Encourage reforms within the regulations
    • Issue a call to test reform models