VA Central IRB K Lynn Cates MD Assistant

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 • Continue to promote highest quality human subject protection by ensuring • • • Appropriate ethical & scientific review Sensitivity to community attitudes Enhance efficiency of reviews 2

VA Central IRB Examples of Research Projects • Quality Improvement & Organizational Research • Database Research • Nursing Research • Cooperative Studies • Genomics Research 3

VA Central IRB Logistics • 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 4

MOU Between Local Facility & VA Central IRB “Crisp” agreements with clear delineation of respective • • • Roles Responsibilities Authorities 5

VA Central IRB Process • 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 6

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 7

VA Central IRB Advantages • 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 8

VA Central IRB Challenges • 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 9

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 10

Local Accountability Who 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 11

Local Accountability Local 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 12

Ownership by Local IRBs Develop Trust • Ensure quality review • Leverage the respect for, & networking capabilities of, local IRBs by working closely together • Create a transparent process • • Establish close communications • • Provide complete information, not just an approval letter 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 13

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 14

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 15

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 16

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 17

VA Central IRB Timeline 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 18