VA Central IRB MOU Webinar

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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

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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

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VA Central IRB Reviews

• Full
• Expedited
• Exempt
• Continuing
• Waiver of HIPAA-compliant authorization

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Geographical Distribution of VA Central IRB
Voting Members
Updated 07/01/08
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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

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Nonvoting Members

• Ethics
• Legal
• Regulatory Affairs
• Privacy HIPAA
• Information Security Officer
• Chief Information Officer

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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

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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

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Federalwide Assurance (FWA)

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

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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

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MOU Between Local VA Facility VHACO

• Memoranda of Understanding (MOUs) will be crisp
  agreements with clear delineation of respective
• Roles
• Responsibilities
• Authorities

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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)

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Local AccountabilityWho is Responsible?

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

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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

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MOU Template

• Cannot be modified
• Webinars to guide local VA facilities

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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)

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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

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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.)

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Investigator Training Webinars

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

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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

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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)

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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

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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

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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

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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