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VA Central IRB MOU Webinar

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... research protection in ORD multi-site studies by ensuring ... PI enlists sites ... not providing all materials required for IRB review in a timely fashion ... – PowerPoint PPT presentation

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Title: VA Central IRB MOU Webinar


1
VA Central IRBMOU Webinar
  • K. Lynn Cates, MD
  • Assistant Chief Research Development Officer
  • Office of Research Development
  • Department of Veterans Affairs

2
Human Research Has Changed
  • New opportunities
  • Electronic age
  • Larger, more complex studies
  • Faster translation to clinical care
  • New risks
  • Database Research (e.g., Medicare, PTSD, TBI,
    Diabetes, etc.)
  • Genomics Research
  • Health Services Research
  • Cooperative Studies

3
VA Central IRBPurpose
  • Improve human research protection in ORD
    multi-site studies by ensuring
  • Expert ethical scientific review
  • Local issues are addressed
  • Enhance efficiency of IRB reviews

4
VA Central IRBLogistics
  • ORD studies only
  • ORD Service (e.g., CSP, RRD, HSRD, QUERI) will
    determine if a study should be reviewed by the VA
    Central IRB
  • VA facilities that do not use the VA Central IRB
    will not be able to participate in projects
    reviewed by the VA Central IRB

5
VA Central IRBLogistics
  • No charge to the field for using the VA Central
    IRB
  • Staffed by PRIDE in ORD
  • Monthly meetings
  • Ad hoc expert advisors
  • VA Central IRB website

6
VA Central IRB Reviews
  • Full
  • Expedited
  • Exempt
  • Continuing
  • Waiver of HIPAA-compliant authorization

7
Geographical Distribution of VA Central IRB
Voting Members
Updated 07/01/08
8
IRB Composition
  • 20 members
  • 2 co-chairs
  • Mostly VA appointments
  • Without compensation (WOC) appointments for
    non-affiliated members
  • Compensation
  • _at_ 1/8 for members
  • _at_ 2/8 for co-chairs

9
Nonvoting Members
  • Ethics
  • Legal
  • Regulatory Affairs
  • Privacy HIPAA
  • Information Security Officer
  • Chief Information Officer

10
VA Central IRBProcess
  • PI enlists sites
  • PI submits PI Application to VA Central IRB,
    including list of participating VA facilities
  • Each Local Site Investigator (LSI) submits a
    Local Site Application based on PI Application
  • Signatures
  • Service Chief/Director
  • ACOS/RD

11
VA Central IRBProcess
  • VA Central IRB performs review
  • Local VA facilities have 30 days to provide
    comments
  • VA Central IRB is final arbiter
  • Local VA facilities decide whether or not to
    participate
  • Local RD Committee must approve before research
    is initiated at that facility
  • Other sites may be added later

12
Federalwide Assurance (FWA)
  • VHA has an FWA for the VHACO Human Research
    Protection Program (HRPP)
  • Institutional Official (IO) PDUSH
  • Human Protections Administrator (HPA) CRADO

13
Local VA Facilities
  • 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 VHACO
  • Develop SOPs for using the VA Central IRB as an
    IRB of record

14
MOU Between Local VA Facility VHACO
  • Memoranda of Understanding (MOUs) will be crisp
    agreements with clear delineation of respective
  • Roles
  • Responsibilities
  • Authorities

15
VA Central IRBLocal 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., affiliates,
    another VAs or the VA Central IRB)

16
Local AccountabilityWho is Responsible?
  • The local Institutional Official (IO) is the
    medical center director (MCD)
  • MCD ACOS/RD have ultimate responsibility

17
Local AccountabilityWho is Responsible?
  • Who should be designated to provide local
    accountability to provide local comments to the
    VA Central IRB?
  • IRB or designee
  • RD Committee or designee
  • Other IO designee

18
MOU Template
  • Cannot be modified
  • Webinars to guide local VA facilities

19
Local AccountabilityLocal Roles
Responsibilities
  • Local knowledge of
  • Research culture (e.g., depth breadth of local
    research program)
  • Research infrastructure (e.g., space, equipment,
    etc.)
  • Community culture attitudes (e.g., ethnicity,
    race, language, etc.)
  • State local laws (e.g., who can be legally
    authorized representative)

20
Local AccountabilityLocal Roles
Responsibilities
  • Resources for local Research Office HRPP
  • Investigator oversight
  • Investigator responsibilities (e.g., hiring
    qualified research personnel)
  • Research misconduct/impropriety (e.g.,
    investigations of misconduct)
  • Local RD Committee Review

21
Local AccountabilityLocal Roles
Responsibilities
  • Training, credentialing privileging, and
    conflict of interest (must keep documentation on
    file)
  • Monitoring auditing of projects
  • Local handling of adverse events unanticipated
    problems
  • Other reviews (e.g., local RD Committee, IACUC,
    Radiation Safety, etc.)

22
Investigator Training Webinars
  • To review
  • How the VA Central IRB will work
  • Principal Investigator (PI) Application Form
  • Local Site Investigator (LSI) Application Form

23
VA Central IRBMeasures to Ensure High Quality
  • Well-trained staff
  • Qualified IRB co-chair members
  • Expert ad hoc advisors
  • Formal peer-reviewed evaluation
  • Routine ORO auditing monitoring
  • AAHRPP accreditation

24
VA Central IRBMeasures to Ensure High Quality
  • Work closely with
  • 4 ORD Services
  • ORO
  • OGC
  • Ethics
  • Privacy
  • OIT
  • Input from other Federal agencies
  • (e.g., OHRP, NCI)

25
VA Central IRBAdvantages
  • Consistent expert ethical scientific review
  • More training experience for IRB in reviewing
    multi-site studies
  • Centralized investigator accountability
  • Earlier identification of trends in adverse
    events
  • Eliminates local conflict of interest
  • Model for local VA IRBs
  • More efficient IRB review of multi-site studies
  • Potential to facilitate translation of research

26
Why the VA Central IRB Will Not Solve Everyones
Problems
  • Lots of other local responsibilities for HRPP (as
    spelled out in MOU)
  • Other approvals
  • (e.g., RD Committee, animal, biosafety,
    radiation safety, unions, OMB)
  • Many current delays are caused by investigators
    not providing all materials required for IRB
    review in a timely fashion

27
Affiliate Relationships
  • VA Central IRB should not affect affiliate
    relationships
  • Current VA policy does not permit a VA IRB to
    serve as the IRB of record for the affiliate
  • Duplicative review
  • Dual appointment investigators

28
Contact Information
  • Lynn Cates, MD
  • Assistant Chief Research Development Officer
  • Director, PRIDE
  • 202-461-1811 lynn.cates_at_va.gov
  • Marisue Cody, PhD
  • Deputy Director, PRIDE
  • 202-461-1814 marisue.cody_at_va.gov
  • Annette Anderson
  • VA Central IRB Administrator
  • 202-461-1813 annette.anderson3_at_va.gov
  • Lorna Kamber
  • VA Central IRB Coordinator
  • 202-461-1812 lorna.kamber_at_va.gov
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