1. Aligning IRBs and the Ethical Conduct of Research APS Annual Convention, May 2008 Felice J. Levine American Educational Research Association American Educational Research Association

2. Issues Misalignment of research practice and regulatory system at local level 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 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 To achieve legitimacy and work effectively, IRBs must be perceived as fair by investigators

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

4. Procedural Justice Decision-making processes seen as biased or unfair, misconduct and commitment declines 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 Process must be viewed as clear, fair, consistent, accurate, and provide an opportunity for appeal

5. Interactional Justice Insincere, or dismissive treatment of investigators lead to negative perceptions of decision-makers 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 Investigators should be treated with dignity and provided with sincere and complete explanations about protocol decisions

6. Historical Rationale Belmont Report: Belmont Report: Provides framework for balancing issues in human subjects research Provides framework for balancing issues in human subjects research National Commission National Commission Saw IRBs as “working closely” with investigators to ensure the participants are protected and the application of policies is fair to investigators Saw IRBs as “working closely” with investigators to ensure the participants are protected and the application of policies is fair to investigators

7. Four Models for Reform Decentralizing the IRB Decentralizing the IRB Expediting Expedited Review Expediting Expedited Review Limiting Review of Public Use Data Files Limiting Review of Public Use Data Files Enhancing Educative Function of IRBs Enhancing Educative Function of IRBs Can be accomplished under current regulatory framework!

8. Model 1: Decentralizing the IRB Establish decentralized departmental or research unit review committees Establish decentralized departmental or research unit review committees Transfer functions of central IRB to these units, at least for minimal risk research 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 Create agreements between central IRB and decentralized units to ensure accountability, quality, and any conflicts of interest addressed Example: Student research (minimal risk) Example: Student research (minimal risk)

9. Advantages of Decentralization Methodological expertise Methodological expertise Substantive knowledge Substantive knowledge Opportunities for education Opportunities for education Speed of review Speed of review Less complex system for investigators Less complex system for investigators

10. Model 2: Expediting Expedited Review Decentralized system: Decentralized system: Minimal risk research in identified categories is reviewed at departmental or research unit level Minimal risk research in identified categories is reviewed at departmental or research unit level Centralized system: 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) 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)

11. Advantages Speed of Processing Speed of Processing Large number of SBS protocols are minimal risk Large number of SBS protocols are minimal risk Addresses one of biggest complaints by SBS researchers Addresses one of biggest complaints by SBS researchers

12. 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 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 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 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 No additional IRB review needed unless data files are enhanced or merged

13. Advantages Wider use of anonymous or de-identified files by investigators to: Wider use of anonymous or de-identified files by investigators to: Verify findings Verify findings Test alternative hypotheses Test alternative hypotheses Ask new questions Ask new questions Maximum use of limited resources Maximum use of limited resources Less burdensome on research participants Less burdensome on research participants Avoid repeated review by multiple IRBs Avoid repeated review by multiple IRBs

14. Enhancing Educative Function of IRBs An IRB could assist investigators up front in developing protocols that meet ethical and regulatory standards 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) 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 Creates positive climate focused on education and prevention Consistent with procedural justice research literature Consistent with procedural justice research literature

15. Moving Forward Institutions can - and should - create a climate that is viewed as fair Institutions can - and should - create a climate that is viewed as fair Building trust, legitimacy, and transparency into process will improve human subjects protection Building trust, legitimacy, and transparency into process will improve human subjects protection Investigators should build broad support for change at the departmental level Investigators should build broad support for change at the departmental level OHRP can provide a supportive environment OHRP can provide a supportive environment Encourage reforms within the regulations Encourage reforms within the regulations Issue a call to test reform models Issue a call to test reform models