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IRB Metrics

IRB Metrics

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IRB Metrics

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  1. IRB Metrics Tony Perez Chief Health Sciences Counsel University of California, San Diego (formerly Director, IRB Administration University of California, Davis)

  2. IRB Metrics • Measure IRB Approval Process • Establish Common Milestones • Define Milestones • When has milestone been achieved? • Measurement • Understanding of Variables Affecting Milestone Achievement

  3. Typical IRB Approval Milestones

  4. Variables Influencing Achievement • Complexity of Protocol • Receipt of Documents From Sponsor • Complexity of IRB Application Form • Assistance from IRB or Other Office • Clinical Trials Office • IRB Administration Office • PI Staffing • Competence • Amount

  5. Variables Influencing Achievement • Administrative Approval • Administration Sign-off • Resource Sign-off • Other Required Approvals • Scientific Review Committee • Radiation Use Committee

  6. Variables Influencing Achievement • Workload of IRB Administration • Administrative Pre-Review for Completeness • Substantive Pre-Review • Response of PI to Correct Submission Deficiencies • Response of Sponsor to Correct Submission Deficiencies • Workload of IRB • Overworked IRB Members • Lack of IRB Members

  7. Variables Influencing Achievement • Workload of IRB Members • Large Volume of Protocols to Review • Large Volume of Revisions to Review • Workload of IRB Committees • Limitations on Meeting Agenda Items • Other Items to Review • Substantive Modifications • Unanticipated Problems

  8. Variables Influencing Achievement • Workload in IRB Administration Office • Expertise of IRB Administration Staff • Clarity of Requests by IRB Members • Method of Transmission

  9. Variables Influencing Achievement • Volume of Required Revisions • Complexity of Required Revisions • Communication with and Approval from Sponsor

  10. Variables Influencing Achievement • Workload of IRB Administration Office • Method of Transmission

  11. UCSD Example Quantitative Analysis of HRPP WorkflowMichael Caligiuri, Ph.D.Director, HRPPUCSDJune, 2008

  12. Analysis of the 1st 100 Biomedical IRB Applications for 2008 • Time Period: IRB Review to Final Approval • 4 biomedical committees; randomly assigned a code number • Independent variables (project characteristics): *0=surveys, chart reviews; 1=observational; 2=minimal risk, blood draw, vulnerable population; 3=Phase III, investigational drug or device; 4=Phase I or II safety trial

  13. Mean = 37.2 days Median = 27 days

  14. PI Mean PI time: 19.97 ± 21.7 days HRPP Mean HRPP time: 19.86 ± 15.9 days

  15. 3 weeks

  16. Predictive Models Model 1: 3 factors Committee, Funding, Radiation Statistic: F=4.33; p<0.01 Test 1: C=1; F=C; R=No 67 days C=2; F=C; R=No 59 days C=3; F=C; R=No 51 days Conclusion: Committee assignment accounts for 8 days

  17. Predictive Models Model 1: 3 factors Committee, Funding, Radiation Statistic: F=4.33; p<0.01 Test 2: C=1; F=C; R=No 67 days C=1; F=NC; R=No 49 days Conclusion: Funding source accounts for 18 days

  18. Impact of Funding Source on Approval Delays for each Biomedical IRB

  19. Impact of Radiation Exposure and PRMC Review on Approval Delays for each Biomedical IRB No PRMC review

  20. Thank You Tony Perez, J.D. Chief Health Sciences Counsel University of California, San Diego University Center 201 9500 Gilman Drive #0097 La Jolla, California 92093-0097 (858) 246-0222 tonyperez@ucsd.edu Michael Caligiuri, Ph.D. Director, Human Research Protections Program University of California, San Diego La Jolla Village Professional Center Suite A208 8950 Villa La Jolla La Jolla, California 92037 Phone: 858-455-5050 mcaligiuri@ucsd.edu