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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

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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

  • Login