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




                                          2
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



                                                    3
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




                                                    4
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

                                                      5
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
   IRB)




                                                  6
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


                                                             7
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

                                            8
VA Central IRB Reviews

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



                                              9
VA Central IRB Composition

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


                                     10
Progress to Date

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



                                            11
Future Plans

• Implement wide use of SharePoint for document
  sharing
• 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
  increases
                                                  12
Application Process

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



                                                      13
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


                                                             14
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



                                                 15
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

                                                16
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


                                                   17
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

                                                  18
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


                                                19
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
                                               20
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)
                                                         21
LSI Application Process

• Each Local Site Investigator (LSI) prepares a
  Local Site Application based on 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

                                                      22
 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)




                                                    23
Review of Local Site Investigator
Applications
• 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
                                                 24
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
 facility

                                                          25
Continuing Review

• VA Central IRB staff notifies PI and LSIs of
  continuing review deadlines
• Each 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 study, not
  for each specific site so that all sites for a given
  study get on the same review cycle

                                                         26
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




                                                   27
Contact Information

Lynn Cates, MD
Assistant Chief Research & Development Officer
Director, PRIDE
202-461-1811; lynn.cates@va.gov

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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