1 / 18

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. Review VA-funded multi-site studies

elsa
Download Presentation

VA Central IRB

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript


  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

  5. 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

  7. 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 everyone’s 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 facility’s IRB • Institutional Official must designate an entity (e.g., IRB or R&D Committee) or individual(s) to ensure accountability

  11. 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

  12. 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

  13. 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

  14. 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

  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

  16. 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

  17. 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

  18. 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

More Related