Chesapeake IRB History

1. Holding External IRBs Accountable:An Independent IRB PerspectiveFelix Gyi, PharmD, MBA, CIP, RACCEO July 22, 2009Secretary’s Advisory Committee on Human Research Protections

2. 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) Chesapeake IRB History

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

5. 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 Metrics

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

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

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

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

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

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

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

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.

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. Thank YouContact info:fgyi@irbinfo.com443-283-1501