VA Central IRB

1
VA Central IRB

• K. Lynn Cates, MD
• Assistant Chief Research Development Officer
• Office of Research Development
• Department of Veterans Affairs

2
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)
• Genomics Research
• Health Services Research

3
VA Central IRBPurpose

• Improving veterans lives
• Enhancing the quality of human research
  protection in VA-funded multi-site studies by
  ensuring
• Expert ethical scientific review
• Local issues are addressed
• Enhancing efficiency of IRB reviews

4
VA Central IRBLogistics

• Office of Research Development (ORD)-funded
  studies only
• ORD funding Service will determine if a study
  should
• be reviewed by the VA Central IRB
• No charge to the field for using the VA Central
  IRB
• Staffed by PRIDE in ORD
• IRB members from all over the country
• Expert ad hoc advisors
• Monthly meetings
• VA Central IRB Web site

5
VA Central IRB Reviews

• Full
• Expedited
• Exempt
• Continuing
• Waiver of HIPAA-compliant authorization

6
IRB Composition

• _at_ 18 members
• 2 Co-chairs
• Mostly VA appointments
• Without compensation (WOC) appointments for
  non-affiliated members
• Compensation
• _at_ 1/8 for members
• _at_ 2/8 for co-chairs

7
Nonvoting Members

• Regulatory affairs
• Legal
• Privacy HIPAA
• Information security

8
VA Central IRBProcess

• PI enlists sites
• PI submits protocol to VA Central IRB, including
  list of participating VA facilities
• Each participating VA facility submits a local
  site application
• VA Central IRB performs review
• Local VA facilities provide comments

9
VA Central IRBProcess

• VA Central IRB is final arbiter
• Local VA facilities decide whether or not to
  participate
• Local RD Committee must approve before research
  is initiated at that facility
• Other sites may be added later

10
Federalwide Assurance (FWA)

• VHA Central Office (VHACO) will seek an FWA for
  the VHACO Human Research Protection Program
  (HRPP)
• Institutional Official (IO) PDUSH
• Human Protections Administrator (HPA) CRADO
• Local VA facilities that plan to use the VA
  Central IRB will amend their FWAs to include it
  as one of their IRBs of record

11
MOU Between Local Facility VHACO HRPP

• Memoranda of Understanding (MOUs) will be crisp
  agreements with clear delineation of respective
• Roles
• Responsibilities
• Authorities

12
VA Central IRBLocal 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., affiliates,
  another VAs or the VA Central IRB)

13
Local AccountabilityWho is Responsible?

• The local Institutional Official (IO) is the
  medical center director (MCD)
• MCD ACOS/RD have ultimate responsibility

14
Local AccountabilityWho is Responsible?

• Who should be designated to provide local
  accountability to provide local comments to the
  VA Central IRB?
• IRB or designee
• RD Committee or designee
• Other IO designee
• Combination of the above

15
Local AccountabilityLocal Roles
Responsibilities

• Knowledge of local research context
• Community culture attitudes (e.g., ethnicity,
  race, language, etc.)
• Needs of differing subject populations
• Research culture (e.g., depth breadth of local
  research program)
• Professional community standards
• Research infrastructure (e.g., space, equipment,
  etc.)
• State local laws (e.g., who can be legally
  authorized representative)

16
Local AccountabilityLocal 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 RD Committee Review

17
Local AccountabilityLocal Roles
Responsibilities

• Training credentialing (must keep documentation
  on file)
• Monitoring auditing of projects
• Local handling of adverse events unanticipated
  problems
• Other reviews (e.g., local RD Committee, IACUC,
  Radiation Safety, etc.)

18
VA Central IRBMeasures to Ensure High Quality

• Well-trained staff
• Qualified IRB chair members
• Expert ad hoc advisors
• Formal peer-reviewed evaluation
• Routine ORO auditing monitoring
• AAHRPP accreditation

19
VA Central IRBMeasures to Ensure High Quality

• Work closely with
• 4 ORD Services
• ORO
• OGC
• Ethics
• Privacy
• OIT
• Input from other Federal agencies (e.g., OHRP)

20
VA Central IRBAdvantages

• 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
• Gets research results to veterans faster

21
VA Central IRBChallenges

• Ownership by local IRBs
• Assurance of review quality
• Expectations that it will solve everyones
  problems
• Affiliate relationships
• Conflict of interest
• Communication

22
Contact Information

• Lynn Cates, MD
• Assistant Chief Research Development Officer
• Director, PRIDE
• 202-254-0282 lynn.cates_at_va.gov
• Marisue Cody, PhD
• Director, COACH
• 202-254-0271 marisue.cody_at_va.gov
• Annette Anderson
• VA Central IRB Administrator
• 202-254-0204 annette.anderson3_at_va.gov
• Lorna Kamber
• VA Central IRB Coordinator
• 202-254-0291 lorna.kamber_at_va.gov