VA Central IRB MOU Webinar K. Lynn Cates, MD Assistant Chief Research & Development Officer Office of Research & Development Department of Veterans Affairs

Human Research Has Changed New opportunities Electronic age Larger, more complex studies Faster translation to clinical care New risks Database Research (e.g., Medicare, PTSD, TBI, Diabetes, etc.) Genomics Research Health Services Research Cooperative Studies

VA Central IRB Purpose Improve human research protection in ORD multi-site studies by ensuring Expert ethical & scientific review Local issues are addressed Enhance efficiency of IRB reviews

VA Central IRB Logistics ORD studies only ORD Service (e.g., CSP, RR&D, HSR&D, QUERI) will determine if a study should be reviewed by the VA Central IRB VA facilities that do not use the VA Central IRB will not be able to participate in projects reviewed by the VA Central IRB

VA Central IRB Logistics No charge to the field for using the VA Central IRB Staffed by PRIDE in ORD Monthly meetings Ad hoc expert advisors VA Central IRB website

VA Central IRB Reviews Full Expedited Exempt Continuing Waiver of HIPAA-compliant authorization

Geographical Distribution of VA Central IRB Voting Members Updated 07/01/08

IRB Composition 20 members 2 co-chairs Mostly VA appointments Without compensation (WOC) appointments for non-affiliated members 1/8 for 2/8 for co-chairs

Nonvoting Members Ethics Legal Regulatory Affairs Privacy & HIPAA Information Security Officer Chief Information Officer

VA Central IRB Process PI enlists sites PI submits PI Application to VA Central IRB, including list of participating VA facilities Each Local Site Investigator (LSI) submits a Local Site Application based on PI Application Signatures Service Chief/Director ACOS/R&D

VA Central IRB Process VA Central IRB performs review Local VA facilities have 30 days to provide comments VA Central IRB is final arbiter Local VA facilities decide whether or not to participate Local R&D Committee must approve before research is initiated at that facility Other sites may be added later

Federalwide Assurance (FWA) VHA has an FWA for the VHACO Human Research Protection Program (HRPP) Institutional Official (IO) – PDUSH Human Protections Administrator (HPA) – CRADO

Local VA Facilities Local VA facilities that plan to use the VA Central IRB must Amend their FWAs to include the VA Central IRB as one of their IRBs of record Enter into a Memorandum of Understanding (MOU) with VHACO Develop SOPs for using the VA Central IRB as an IRB of record

MOU Between Local VA Facility & VHACO Memoranda of Understanding (MOUs) will be “crisp” agreements with clear delineation of respective Roles Responsibilities Authorities

VA Central IRB Local Accountability Concept of Human Research Protection Program (HRPP) vs. IRB Every VA facility that performs human research has ultimate responsibility for its HRPP, even if it uses an external IRB (e.g., affiliate’s, another VA’s or the VA Central IRB)

Local Accountability Who is Responsible? The local Institutional Official (IO) is the medical center director (MCD) MCD & ACOS/R&D have ultimate responsibility

Local Accountability Who is Responsible? Who should be designated to provide local accountability & to provide local comments to the VA Central IRB? IRB or designee R&D Committee or designee Other IO designee

MOU Template Cannot be modified Webinars to guide local VA facilities

Local Accountability Local Roles & Responsibilities Local knowledge of Research culture (e.g., depth & breadth of local research program) Research infrastructure (e.g., space, equipment, etc.) Community culture & attitudes (e.g., ethnicity, race, language, etc.) State & local laws (e.g., who can be legally authorized representative)

Local Accountability Local Roles & Responsibilities Resources for local Research Office & HRPP Investigator oversight Investigator responsibilities (e.g., hiring qualified research personnel) Research misconduct/impropriety (e.g., investigations of misconduct) Local R&D Committee Review

Local Accountability Local Roles & Responsibilities Training, credentialing & privileging, and conflict of interest (must keep documentation on file) Monitoring & auditing of projects Local handling of adverse events & unanticipated problems Other reviews (e.g., local R&D Committee, IACUC, Radiation Safety, etc.)

Investigator Training Webinars To review How the VA Central IRB will work Principal Investigator (PI) Application Form Local Site Investigator (LSI) Application Form

VA Central IRB Measures to Ensure High Quality Well-trained staff Qualified IRB co-chair & members Expert ad hoc advisors Formal peer-reviewed evaluation Routine ORO auditing & monitoring AAHRPP accreditation

VA Central IRB Measures to Ensure High Quality Work closely with 4 ORD Services ORO OGC Ethics Privacy OI&T Input from other Federal agencies (e.g., OHRP, NCI)

VA Central IRB Advantages Consistent expert ethical & scientific review More training & experience for IRB in reviewing multi-site studies Centralized investigator accountability Earlier identification of trends in adverse events Eliminates local conflict of interest Model for local VA IRBs More efficient IRB review of multi-site studies Potential to facilitate translation of research

Why the VA Central IRB Will Not Solve Everyone’s Problems Lots of other local responsibilities for HRPP (as spelled out in MOU) 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

Affiliate Relationships VA Central IRB should not affect 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

Contact Information Lynn Cates, MD Assistant Chief Research & Development Officer Director, PRIDE ; Marisue Cody, PhD Deputy Director, PRIDE ; Annette Anderson VA Central IRB Administrator ; Lorna Kamber VA Central IRB Coordinator ;