VA Central IRB

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					VA Central IRB

K. Lynn Cates, MD
Assistant Chief Research & Development Officer

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

PRIM&R November 15, 2009
Human Research Has Changed

• New opportunities
  • Electronic age
  • Larger, more complex studies
  • Faster translation to clinical care
• New risks
  • Database Research (e.g., Medicare)
  • Genomics Research

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 of IRB reviews

Projects Reviewed by VA Central IRB

• VA-funded studies only
• VA facilities that do not use the VA Central
  IRB will not be able to participate in projects
  reviewed by the VA Central IRB

Local VA Facility Requirements

• Local VA facilities that plan to use the VA
  Central IRB must:
  • Amend their FWAs 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

Local Accountability

• Concept of Human Research Protection
 Program (HRPP) vs. IRB
 • 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

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 IO to appoint the local site
  representatives to do the following:
   • 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

VA Central IRB Operations

• No charge to the field for using the VA
  Central IRB
• Staffed by PRIDE
• Monthly meetings
• Ad hoc expert advisors
• VA Central IRB website

VA Central IRB Reviews

•   Convened Board
•   Expedited
•   Exempt
•   Continuing
•   Waiver of HIPAA-compliant authorization

VA Central IRB Composition

• 20 voting members
• 5 nonvoting members
  •   Ethics
  •   Legal Affairs
  •   Regulatory Affairs
  •   Privacy & HIPAA
  •   Information Security Officer

Progress to Date

• 73 VA facilities have signed up
• 22 studies reviewed involving 150 sites
• 4 continuing reviews performed
• Implementation of new model – more

Future Plans

• Implement wide use of SharePoint for document
• Develop electronic system for submissions and
  document management
• Submit AAHRP application in March 2010
• Ongoing formal peer-reviewed evaluation
• Create a second VA Central IRB as workload
Application Process

• 2 kinds of applications
  • Principal Investigator (PI) or Study Chair (SC)
     • Co-PI Supplement
     • Coordinating Center Supplement
  • Local Site Investigator (LSI) Application

PI/SC Application Process

• PI or SC enlists local VA facilities
  • Check VA Central IRB web site 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
    Federalwide Assurance (FWA))
  • Notify VA Central IRB staff of all potential
    participating VA facilities that are not listed ASAP

Key Elements of the PI/SC Application

• Protocol must clearly differentiate clinical
  from research activities
• Protocol must be consistent with
  • The PI/SC Application
  • Informed consent form
  • HIPAA authorization

Key Elements of the PI/SC Application

• Protocol must contain sufficient
 information for the IRB to evaluate all
 regulatory criteria for approval of research
• Model informed consent documents and
 recruitment materials
• Waiver requests
• Signed by PI/SC, PI/SC’s supervisor, and
 ACOS/R&D of PI/SC local site

Administrative Pre-Review

• Not required but highly recommended,
 especially for studies requiring review by
 the convened IRB
  • Can identify problems with informed consent
   forms, recruitment materials, waiver requests
   or lack thereof; and missing or incorrectly
   completed documents; selection of sites; and
   other issues

Administrative Review

• Administrative Review by assigned VA Central
  IRB Coordinator
• Primary Reviewer System with extensive use of
  reviewer checklists
• Any reviewer can contact investigator for
  response to questions or they can go through
  VA Central IRB staff
• Ad hoc reviewers as needed

Potential VA Central IRB Actions

• Approve the study
• Approve the study contingent upon minor
  modifications (Convened Board)
• Require Modifications (Expedited Review)
• Defer the study pending major modifications
• Disapprove

Local Site Initial Review

• After the PI/SC application is approved by
 the VA Central IRB, or approved
 contingent upon minor modifications
  1. A copy of the approved PI/SC Application
     packet is sent to each local site for
     review while
  2. Local Site Investigators (LSIs) prepare
     LSI applications
Local Site Initial Review

• After the PI/SC application is approved by the
  VA Central IRB, or approved contingent upon
  minor modifications
  • Each local site has 30 days to provide comments to
    the VA Central IRB
  • Comments are provided to the VA Central IRB by the
    liaison designated by the medical center director
    (NOTE: the local IRB of record does not have perform
    a review or provide the comments unless
    designated by the medical center director)
LSI Application Process

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

 Review of Local Site Comments

• VA Central IRB reviews all local site
 comments & is final arbiter of:
  • Changes to the PI/SC Application
  • Global changes in protocol (affect all sites)
  • Local changes in protocol (affect local site)

Review of Local Site Investigator
• Usually reviewed in conjunction with local
 site comments but can be reviewed after
 depending upon timing of receipt
• Review by convened IRB or by expedited
 review procedures with review outcomes:
  • Approved Contingent on minor modifications
  • Deferred for Major Modifications
  • Disapproved
Local Facility Participation Decision

• 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 sent to
    the site
• 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

Continuing Review

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

Adverse Events, Unanticipated
Problems, and Protocol Deviations
• Table of Reporting Requirements is on the VA
  Central IRB website and is forwarded with each
  final approval letter
• Specific Reporting forms for Adverse
  Events/Unanticipated Problems and for Protocol
  Deviations on website

Contact Information

Lynn Cates, MD
Assistant Chief Research & Development Officer
Director, PRIDE

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

Toll free number 1-877-254-3130


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