VA Central IRB

1
VA Central IRB

• K. Lynn Cates, MD
• Assistant Chief Research Development Officer
• Office of Research Development
• Department of Veterans Affairs
• September 6, 2006

2
VA Central IRBPurpose

• Review VA-funded multi-site studies
• Continue to promote highest quality human subject
  protection by ensuring
• Appropriate ethical scientific review
• Sensitivity to community attitudes
• Enhance efficiency of reviews

3
VA Central IRBExamples of Research Projects

• Quality Improvement Organizational Research
• Database Research
• Nursing Research
• Cooperative Studies
• Genomics Research

4
VA Central IRBLogistics

• No charge to the field for using the VA Central
  IRB
• Staffed by PRIDE in ORD
• IRB members from all over the country
• One IRB with panels
• Monthly meetings (at minimum)
• Electronic submission
• Evaluation tool
• MOU with local facilities

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MOU Between Local Facility VA Central IRB

• Crisp agreements with clear delineation of
  respective
• Roles
• Responsibilities
• Authorities

6
VA Central IRBProcess

• Investigator submits protocol to VA Central IRB
  including list of participating VA facilities
• VA Central IRB performs review
• Local VA facilities provide comments
• (e.g., local issues state local language)
• VA Central IRB is final arbiter
• Local VA facilities decide whether to opt in
• Investigator may independently pursue approval
  from sites that did not opt in after final VA
  Central IRB approval

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VA Central IRB Roll-out

• VA-funded research only
• First - Multi-site VA Health Services Research
  Cooperative Studies
• Then - Will consider the possibility of serving
  as IRB of record for small research programs
• More panels

8
VA Central IRBAdvantages

• More consistent expert ethical scientific
  review
• More training experience for IRB
• Centralized investigator accountability
• Earlier identification of trends in adverse
  events
• Elimination of local institutional conflict of
  interest
• Improved veterans access to multi-center trials
• Improved efficiency
• More consistent process with templates for
  submissions informed consent forms
• Transparent process/model for local IRBs

9
VA Central IRBChallenges

• Assurance of review quality
• Local accountability
• Ownership by local IRBs
• Expectations that it will solve everyones
  problems
• Local IRBs at a few small research programs may
  go out of business
• Affiliate relationships
• Conflict of interest
• Communication

10
Local Accountability

• Concept of Human Research Protection Program
  (HRPP) vs. IRB
• Every facility that performs human research has
  ultimate responsibility for its HRPP, even if it
  uses another facilitys IRB
• Institutional Official must designate an entity
  (e.g., IRB or RD Committee) or individual(s) to
  ensure accountability

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Local AccountabilityWho is Responsible?

• Who should be designated to provide local
  accountability?
• Medical Center Director ACOS/RD have ultimate
  responsibility
• Who should be designated to provide local
  comments to the VA Central IRB?
• IRB or designee
• RD Committee or designee
• IO designee
• Combination of the above

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Local AccountabilityLocal Responsibilities

• Providing local knowledge of
• Research culture
• Community culture attitudes
• State local laws
• Investigator oversight
• Investigator responsibilities
• Research misconduct/impropriety
• Training credentialing
• Monitoring auditing
• Handling of adverse events

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Ownership by Local IRBsDevelop Trust

• Ensure quality review
• Leverage the respect for, networking
  capabilities of, local IRBs by working closely
  together
• Create a transparent process
• Provide complete information, not just an
  approval letter
• Establish close communications
• Not just letters emails
• Provide opportunities for IRB chairs members to
  network, share experiences get help from one
  another
• Local IRBs involved in multi-site studies need to
  be able to talk to each other

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Why the VA Central IRB Will Not Solve Everyones
Problems

• Lots of other local responsibilities for HRP
• 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
• Potential for some loss of local compliance
  resources

15
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
• Non-VA-funded studies (e.g., some CSP studies)
• Communication will be key

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Conflict of Interest

• Less local institutional COI
• Potential COI by having VA Central IRB in ORD
• COI cannot be completely eliminated
• No matter where VA Central IRB is housed (ORD,
  separate office reporting to USH, independent
  IRB), VHA will be paying for it
• Is it worse for an IRB to by housed by
• An entity that funds research?
• An entity that gets funds for research?
• Must be aware of potential COI manage it
  effectively

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Communication Strategy

• Purpose
• Prepare for new VA Central IRB
• Ongoing communications after it is operational
• Targets
• Leadership (VACO, VISN Medical Center
  Directors)
• Administrative officials
• Investigators
• IRB staff members
• Affiliates
• Subjects
• Public
• Other agencies

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VA Central IRBTimeline

• Fall Winter 2005-6
• Site visits to NCI CIRB Independent IRBs
• National IRB Workshop, November 2005
• Draft policies procedures
• Communications
• NLB Health Systems Committee, ORO, Ethics,
  Nursing, Patient Care Services, etc.
• NRAC FRAC
• Spring Summer 2006
• Field Focus Group Meeting
• Recruit IRB Administrator IRB Coordinator
• Fall Winter 2006
• Local Accountability meetings
• VA IRB Chairs meeting, November 15, 2006
• National IRB Meeting, November 20-21, 2006
• Identify train IRB members