chesapeake research review, inc. human research protection experts irb services consultation...
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Chesapeake Research Review, Chesapeake Research Review, IncInc..
Human Research Protection ExpertsHuman Research Protection ExpertsIRB Services • Consultation • EducationIRB Services • Consultation • Education
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Holding External IRBs Accountable:
An Independent IRB Perspective
Felix Gyi, PharmD, MBA, CIP, RACCEO
July 22, 2009Secretary’s Advisory Committee on
Human Research Protections
Chesapeake IRB History
Founded in 1993 Business lines:
IRB Services HRPP Consulting, Training, and Program Support
Review all areas of Biomedical ResearchIn-patient and outpatientAll therapeutic areas; all phases
Social and Behavioral Research International Research AAHRPP Accredited FDA Inspections (4 to date with NO FINDINGS)
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Web Based Platform: CIRBIWeb Based Platform: CIRBI
Provides real-time status tracking of IRB Provides real-time status tracking of IRB process 24 hours/7 days a week via secure process 24 hours/7 days a week via secure web accessweb access
Fully electronic submissionFully electronic submission IRB meetings in electronic environmentIRB meetings in electronic environment Approval documents posted onlineApproval documents posted online 21 CFR 11 Compliant/Validated21 CFR 11 Compliant/Validated All actions auditableAll actions auditable Secure, encrypted, role-based accessSecure, encrypted, role-based access
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
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MetricsMetrics
Oversight for:Oversight for: 530 protocols530 protocols1800 sites1800 sites
2009 Performance Metrics:2009 Performance Metrics:Protocol: Complete submission to IRB Protocol: Complete submission to IRB
determination is 4 days determination is 4 days Site: Complete submission to IRB Site: Complete submission to IRB
determination is 0.9 daysdetermination is 0.9 days
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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
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Steps to Successful Collaboration
Evaluation/Due Diligence Workflow and Communication Plan Implementation Well defined IAA (Contract) Periodic Assessments
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Evaluation
Accreditation Institutional Expectations v Practices Policies and Procedures Training Requirements Resources at both Institutions “Flow” of information
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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
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Communication Plan
Identify the Communication Plan How will the Institutional Officials be
notified? Routine Communications “For Cause” Issues Communications Requiring Immediate
Attention
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Example of Robust Process
Implementation
Roll Out to Investigators and Study Coordinators – Town Hall Meeting
Notify IRB Members Institutional requirementsInstitutional requirements Establishment of flow, processes, Establishment of flow, processes,
templatestemplates
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Periodic Assessment
Review on an as needed basis by representatives of both Institutions
Evaluate: Submissions to dateSubmissions to date Communications processCommunications process ConcernsConcerns
Modify workflow as necessary
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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.
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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
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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
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