VA Central IRB Overview (Annette R. Anderson)

							VA Central IRB


Annette R. Anderson, MS, RHIA, CIP
VA Central IRB Administrator




Local Accountability Meeting June 2011
VA Central IRB Purpose

 • Improve human research protection in
  VA multi-site studies by ensuring
  • Consistent expert ethical & scientific review
  • Local issues are addressed
 • Enhance efficiency and consistency of
  multi-site IRB reviews


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Projects Reviewed by VA Central IRB

• VA Office of Research and Development
  (ORD) funded studies only with some
  exceptions (SPRINT NHLBI-funded study)
• VA facilities that do not use the VA Central
  IRB will not be able to participate in projects
  reviewed by the VA Central IRB - there can
  be no IRB shopping



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 Local VA Facility Requirements

• Local VA facilities that plan to use the VA
  Central IRB must:
  • Amend their Federalwide Assurance (FWA) to include the
    VA Central IRB as one of their IRBs of record
  • Enter into a Memorandum of Understanding (MOU) with
    VHA Central Office
  • Develop standard operating procedures (SOPs) for using
    the VA Central IRB as an IRB of record
  • Modify affiliate MOU if appropriate

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Memorandum of Understanding

• Spells out the respective authorities, roles and
  responsibilities of the VHA Central Office Human
  Research Protection Program (HRPP), the VA
  Central IRB, and the local VA facility
• Requires the Medical Center Director (IO) to
  appoint the local site representatives to:
   • Provide comments to VA Central IRB on initial project
      review determinations
  •   Provide final local site participation decision
  •   Serve as local site liaison with VA Central IRB


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Local Accountability

• Every VA facility that performs human
 research has ultimate responsibility for its
 HRPP, even if it uses an external IRB
 (e.g., affiliate’s, another VA’s or the VA
 Central IRB)
  • Include the VA Central IRB as part of local
    VA facility annual review of its HRPP



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VA Central IRB Operations

• IO is Principal Deputy Under Secretary for
    Health
•   Staffed by Program for Research Integrity
    Development and Education (PRIDE)
•   No charge to the field for using the VA Central
    IRB
•   Monthly meetings or more frequently as needed
•   Ad hoc expert advisors
•   VA Central IRB website
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VA Central IRB is a Full Service IRB

• Convened Board and Expedited
• Continuing Reviews and Amendments
• Exempt Reviews
• Waivers of HIPAA-compliant authorization and
  Informed Consent
• SAE/UAP; Protocol Deviations; and Reports of
  Noncompliance
The VA Central IRB does not review the
  emergency use of test articles

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VA Central IRB Composition

• 17 voting members from across the country,
  including two Co-Chairs
• 5 nonvoting members
  •   Ethics
  •   Legal Affairs
  •   Regulatory Affairs
  •   Privacy & HIPAA
  •   Information Security Officer

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    Progress to Date
• 94 VA facilities have amended their FWA listing the
    VA Central IRB as an IRB of Record
•   46 studies reviewed involving over 400 sites since
    inception in August 2008
•   AARHPP site visit took place in February 2011 and
    results will be reviewed at June AAHRPP Council
•   First routine ORO site visit scheduled for end of
    August 2011



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Application Process -2 Processes

• Principal Investigator (PI) or Study Chair (SC)
  New Project Application
    • Co-PI and Coordinating Center Supplements
    • Protocol and other documentation (i.e., investigator
          drug brochure, surveys, scripts, case report forms)
      •   Waiver requests and Vulnerable Population
          Supplements
      •   Model Documents (i.e., recruitment materials,
          informed consent forms
• Local Site Investigator (LSI) Application
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Key Elements of the PI/SC Application

• Protocol must clearly differentiate clinical care
    from research activities
•   Protocol must be consistent with
     • The PI/SC Application
     • Informed consent form
     • HIPAA authorization form
•   Protocol must contain sufficient information for
    the IRB to evaluate all regulatory criteria for
    approval of research

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Key Elements of the PI/SC Application

• List of potential participating facilities
   • PI or SC enlists local VA facilities
      • Check VA Central IRB website to see if all potential
          participating sites have listed the VA Central IRB as an
          IRB of record
      •   If not listed, verify with the VA facility that it can perform
          human research (i.e., that it has a FWA)
      •   Notify VA Central IRB staff of all potential participating
          VA facilities that are not listed ASAP
• Signed by PI/SC, PI/SC’s supervisor, and
  ACOS/R&D at the PI/SC’s VA facility

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Administrative and Designated Reviews

• Administrative Review by assigned VA Central
    IRB Coordinator and Regulatory Advisor
•   Primary Reviewer System with extensive use of
    reviewer checklists
•   Privacy Officer and Information Security Officer
    Reviews
•   Any reviewer can contact investigators for
    response to questions or they can go through
    VA Central IRB staff
•   Ad hoc reviewers as needed
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Potential VA Central IRB Actions

• Approve the study
• Approve the study contingent upon required
    minor modifications (Convened Board)
•   Approve contingent upon local site comment
• Require modifications (Expedited Review)
• Defer the study pending major modifications
    (Convened Board)
• Disapprove
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Local Site Initial Review

• After the PI/SC application is approved
  contingent upon local site comment, or
  approved contingent upon required minor
  modifications
   • A copy of the approved PI/SC Application packet is
      sent to each local site for review, along with a copy of
      the VA Central IRB approval letter
  •   Local Site Investigators (LSIs) can begin preparing LSI
      applications


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Local Site Initial Review

• Each local site has 30 days to provide comments
    to the VA Central IRB
     • A form has been developed for this purpose
•   Comments must be provided to the VA Central
    IRB by the individual designated by the Medical
    Center Director; usually one of the following:
     • R&D Chair
     • Local IRB Chair
     • ACOS or AO for R&D

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LSI Application Process

• Each LSI prepares a LSI Application based
  on the approved PI/SC Application
• The PI/SC reviews all LSI Applications for
  consistency
  • The VA Central IRB will require a justification
    for any differences among the LSI Applications
    including the informed consent forms



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 Review of Local Site Comments

• VA Central IRB reviews all local site comments
  and decides if changes are needed as follows:
   • No changes needed; comments or questions of an
    administration nature only were received, or a no
    further comments response provided
  • Changes required in PI/SC Application (may or may
    not affect LSI Applications;)
  • Changes required in specific LSI Application only
    (affects only local site making comment)


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Review of Local Site Investigator
Applications
• Usually reviewed in conjunction with local site
    comments but can be reviewed after depending
    upon timing of receipt
•   Reviewed by convened IRB or expedited review
    procedures and:
     • Approved
     • Approved contingent on required minor modifications
     • Deferred for major modifications
     • Disapproved

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Local Facility Participation Decision

• Once a LSI Application is approved, local
 VA facilities have 10 work days to decide
 whether or not to participate
 • If a facility decides to participate, a copy of the
      applicable VA Central IRB minutes is posted to
      its SharePoint site
  •   A facility can still suggest changes but if the VA
      Central IRB, PI, or LSI do not accept the
      changes, the facility can decide not to
      participate in the study


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 Local Facility Approval

• Local VA facility must approve the research in accordance
  with VHA Handbook 1200.01 (R&D Committee) and local
  procedures before research can be initiated at that facility
• Copy of Local VA facility approval must be forwarded to
  VA Central IRB and to LSI
• Sites added after a study is approved are not given 30-
  day comment period; however, a site can always provide
  comments




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Continuing Review

• VA Central IRB staff notifies PI and LSIs of
  continuing review deadlines
• Each local participating site submits a continuing
  review report to PI/SC
• PI/SC prepares summary report and submits to
  VA Central IRB, along with copies of LSI reports
• Continuing review date is set for the overall
  study, not for each site; all sites for a given study
  are on the same IRB review cycle

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Adverse Events, Unanticipated Problems,
Protocol Deviations, and Complaints

• Reported to VA Central IRB, not the local IRB
• Table of Reporting Requirements is posted on the VA
    Central IRB website and is referenced in each final
    approval letter
•   Specific Reporting forms for Adverse Events,
    Unanticipated Problems, and Protocol Deviations are
    posted on VA Central IRB website
•   Other reports of noncompliance or complaints must be
    reported as they occur



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Future Plans

• Improve communications with sites by improving website
  content
• Instituting periodic webinars for new site liaisons and for
  when changes occur
   • New Handout for Liaisons
• Revise Memorandum of Understanding to incorporate
  changes and improve communications
• Transition to a fully electronic system




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Contact Information

Annette Anderson, MS, RHIA, CIP
VA Central IRB Administrator
202-461-1813; annette.anderson3@va.gov

Website http://www.research.va.gov/programs/pride/cirb/default.cfm
Toll free number 1-877-254-3130
Email va.central.irb@va.gov




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