1. Chesapeake Research Review, Inc. Human Research Protection Experts IRB Services Consultation Education 1 Holding External IRBs Accountable: An Independent IRB Perspective Felix Gyi, PharmD, MBA, CIP, RAC CEO July 22, 2009 Secretary’s Advisory Committee on Human Research Protections

2. Chesapeake IRB History   Founded in 1993   Business lines:   IRB Services   HRPP Consulting, Training, and Program Support   Review all areas of Biomedical Research   In-patient and outpatient   All therapeutic areas; all phases   Social and Behavioral Research   International Research   AAHRPP Accredited   FDA Inspections (4 to date with NO FINDINGS) 2

3. 3 Web Based Platform: CIRBI  Provides real-time status tracking of IRB process 24 hours/7 days a week via secure web access  Fully electronic submission  IRB meetings in electronic environment  Approval documents posted online  21 CFR 11 Compliant/Validated  All actions auditable  Secure, encrypted, role-based access

4. Operational Metrics   Three standing meetings per week   Five business days from completed submission to IRB review   Expedited Reviews within one day   Verbal notification of IRB determination within one business day   Written documentation of IRB determination within 3 business days 4

5. Metrics  Oversight for:  530 protocols  1800 sites  2009 Performance Metrics:  Protocol: Complete submission to IRB determination is 4 days  Site: Complete submission to IRB determination is 0.9 days 5

6. Why Do Institutions Outsource IRB Oversight?   Quality Reviews   Timely Responses   Competition for Sites   Competitive Advantage   Efficiencies/Economies of Scale   Increase research portfolio size without increased overhead burden 6

7. Steps to Successful Collaboration   Evaluation/Due Diligence   Workflow and Communication Plan   Implementation   Well defined IAA (Contract)   Periodic Assessments 7

8. Evaluation   Accreditation   Institutional Expectations v Practices   Policies and Procedures   Training Requirements   Resources at both Institutions   “Flow” of information 8

9. Workflow   Establish institutional review process   Document the Process for Submissions   Who researches allegations of non- compliance   Planned Emergency Research and Emergency Use of Test Articles 9

10. Communication Plan   Identify the Communication Plan   How will the Institutional Officials be notified?   Routine Communications   “For Cause” Issues   Communications Requiring Immediate Attention 10

11. 11 Example of Robust Process

12. Implementation   Roll Out to Investigators and Study Coordinators – Town Hall Meeting   Notify IRB Members  Institutional requirements  Establishment of flow, processes, templates 12

13. Periodic Assessment   Review on an as needed basis by representatives of both Institutions   Evaluate:  Submissions to date  Communications process  Concerns   Modify workflow as necessary 13

14. Conclusions   Limits of “reach” into institution   Liability concerns:   Regulatory   Legal   Public Relations   (Financial)   Wisdom of outsourcing IRBs are one part of an institution’s HRPP and are not the only gatekeeper of protecting subjects’ rights and welfare. 14

15. On Behalf of CIRB...   The Consortium of Independent Review Boards (CIRB), a nonprofit organization, applauds this OHRP initiative to recognize the role of the IRB   CIRB mission statement: “ Assuring the protection and rights of human research subjects, while promoting the integrity, high quality and effectiveness of the independent IRB process”   All CIRB Members are either AAHRPP accredited or seeking accreditation   CIRB Metrics for all 12 CIRB members 15

16. CIRB Comments   Direct enforcement authority over IRBs by OHRP does not raise a concern:   IRBs are already subject to similar oversight by FDA   Assume that enforcement will be against IRB as organization, not IRB members   Supports a guidance versus a new regulation.   OHRP has authority to issue guidance   Guidance allows for changes   Recommends OHRP flexibility as to:   Setting guidance expectations   Allowing IRBs and institutions to establish the assignments of responsibilities   Communication with Independent IRBs as partners/entities 16

17. 17 Thank You Contact info: fgyi@irbinfo.com 443-283-1501 fgyi@irbinfo.com