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VA Central IRB. K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs September 6, 2006. VA Central IRB Purpose. Review VA-funded multi-site studies

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va central irb

VA Central IRB

K. Lynn Cates, MD

Assistant Chief Research & Development Officer

Office of Research & Development

Department of Veterans Affairs

September 6, 2006

va central irb purpose
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
va central irb examples of research projects
VA Central IRBExamples of Research Projects
  • Quality Improvement & Organizational Research
  • Database Research
  • Nursing Research
  • Cooperative Studies
  • Genomics Research
va central irb logistics
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
mou between local facility va central irb
MOU Between Local Facility& VA Central IRB
  • “Crisp” agreements with clear delineation of respective
      • Roles
      • Responsibilities
      • Authorities
va central irb process
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
va central irb roll out
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
va central irb advantages
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
va central irb challenges
VA Central IRBChallenges
  • Assurance of review quality
  • Local accountability
  • Ownership by local IRBs
  • Expectations that it will solve everyone’s problems
  • Local IRBs at a few small research programs may go out of business
  • Affiliate relationships
  • Conflict of interest
  • Communication
local accountability
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 facility’s IRB
  • Institutional Official must designate an entity (e.g., IRB or R&D Committee) or individual(s) to ensure accountability
local accountability who is responsible
Local AccountabilityWho is Responsible?
  • Who should be designated to provide local accountability?
    • Medical Center Director & ACOS/R&D have ultimate responsibility
  • Who should be designated to provide local comments to the VA Central IRB?
    • IRB or designee
    • R&D Committee or designee
    • IO designee
    • Combination of the above
local accountability local responsibilities
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
ownership by local irbs develop trust
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
why the va central irb will not solve everyone s problems
Why the VA Central IRB Will Not Solve Everyone’s Problems
  • Lots of other local responsibilities for HRP
  • Other approvals
  • (e.g., R&D 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
affiliate relationships
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
conflict of interest
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
communication strategy
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
va central irb timeline
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
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