IRB Metrics

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IRB Metrics

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

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IRB Metrics

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

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Typical IRB Approval Milestones
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• 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

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• 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

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UCSD Example

• Quantitative Analysis of HRPP WorkflowMichael
  Caligiuri, Ph.D.Director, HRPPUCSDJune, 2008

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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)

0surveys, chart reviews 1observational
2minimal risk, blood draw, vulnerable
population 3Phase III, investigational drug or
device 4Phase I or II safety trial
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Mean 37.2 days Median 27 days
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PI
Mean PI time 19.97 21.7 days
HRPP
Mean HRPP time 19.86 15.9 days
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3 weeks
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Predictive Models
Model 1 3 factors Committee, Funding,
Radiation Statistic F4.33 plt0.01 Test
1 C1 FC RNo 67 days C2 FC
RNo 59 days C3 FC RNo 51
days Conclusion Committee assignment accounts
for 8 days
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Predictive Models
Model 1 3 factors Committee, Funding,
Radiation Statistic F4.33 plt0.01 Test
2 C1 FC RNo 67 days C1 FNC
RNo 49 days Conclusion Funding source
accounts for 18 days
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Impact of Funding Source on Approval Delays for
each Biomedical IRB
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Impact of Radiation Exposure and PRMC Review on
Approval Delays for each Biomedical IRB
No PRMC review
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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
• [phone]
• tonyperez_at_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 [phone]
• mcaligiuri_at_ucsd.edu