VA Central IRB From Concept to Reality

1
VA Central IRBFrom Concept to Reality

• K. Lynn Cates, MD
• Assistant Chief Research Development Officer
• Director, PRIDE
• October 7, 2009

2
Human Research Has Changed

• More multi-site than single site studies
• New opportunities
• Electronic age
• Larger, more complex studies
• Faster translation to clinical care
• New risks
• Information security with large databases
• (e.g., Medicare genomics research)

3
VA Central IRBPurpose

• Improve human research protection in ORD
  multi-site studies by ensuring
• Consistent expert ethical scientific review
• Local issues are addressed
• Enhance efficiency of IRB reviews

4
VA Central IRBAdvantages

• Consistent expert ethical scientific review
• More training experience for IRB in reviewing
  complex multi-site studies
• Centralized investigator accountability
• Earlier identification of trends in adverse
  events
• Model for local VA IRBs
• More efficient IRB review of multi-site studies
• Potential to facilitate translation of research
  to clinical care

5
VA Central IRBLogistics

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

6
VHA Central Office HRPPReporting Relationships

• Institutional Official Principal Deputy Under
  Secretary for Health
• Human Protections Administrator Chief
  RD Officer
• Director PRIDE
• VA Central IRB Administrative Staff

7
VA Central IRBLogistics

• ORD studies only
• All CSP studies will go to the VA Central IRB
• Other ORD Services (e.g., RRD, HSRD, QUERI),
  not investigators, will refer studies to 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

8
VA Central IRB Composition

• 20 voting members
• 5 nonvoting members
• Ethics
• Legal Affairs
• Regulatory Affairs
• Privacy HIPAA
• Information Security Officer

9
VA Central IRB Reviews

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

10
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)

11
Local VA Facilities That Plan to Use the VA
Central IRB as an IRB of Record

• Amend their FWAs to include the VA Central IRB as
  one of their IRBs of record
• Enter into a Memorandum of Understanding (MOU)
  with VHA Central Office
• Develop SOPs for using the VA Central IRB
• When applicable, revise MOU with affiliate

12
VA Central IRBApplication Process

• 2 kinds of applications
• Principal Investigator (PI) or Study Chair (SC)
  Application
• Local Site Investigator (LSI) Application

13
VA Central IRBPI/SC Application Process

• PI or SC enlists local VA facilities
• Check VA Central IRB web site to see if all
  potential participating sites have completed the
  process of listing the VA Central IRB as an IRB
  of record (http//www.research.va.gov/programs/pri
  de/cirb/facilities.pdf)
• If not listed, verify with the VA facility that
  it can perform human research (i.e., that it has
  a Federalwide Assurance (FWA))
• Notify VA Central IRB staff of all potential
  participating VA facilities ASAP

14
VA Central IRBKey Elements of Application

• Protocol must clearly differentiate clinical from
  research activities
• Protocol must be consistent with
• Local Site Investigator (LSI) Application
• Informed consent form
• HIPAA authorization

15
VA Central IRBKey Elements of Applications

• Protocol must contain sufficient information for
  the IRB to evaluate all regulatory criteria for
  approval of research
• FDA issues must be addressed (e.g., IND or IDE
  status)
• Potential future use of data or specimens must be
  clearly described in protocol, informed consent,
  HIPAA authorization

16
VA Central IRB Potential Actions on PI/SC
Application

• Approve the study
• Approve the study contingent upon minor
  modifications
• Table the study pending major modifications

17
VA Central IRBApplication Process

• After the PI/SC application is approved by the VA
  Central IRB, or approved contingent upon minor
  modifications
• A copy of the approved PI/SC Application packet
  is sent to each local site
• Each local site has 30 days to provide comments
  to the VA Central IRB

18
VA Central IRBLSI Application Process

• Each Local Site Investigator (LSI) prepares a LSI
  Application based on PI/SC Application
• The PI/SC reviews all LSI Applications for
  consistency
• The VA Central IRB will require a justification
  for any differences among the LSI Applications
  including the informed consent forms

19
VA Central IRBProcess

• VA Central IRB reviews all LSI applications
  comments from local sites
• VA Central IRB is final arbiter of
• Changes to the PI/SC LSI Applications
• Global changes in protocol (affect all sites)
• Local changes in protocol (affect local site)

20
VA Central IRBProcess

• Local VA facilities have 10 days to decide
  whether or not to participate
• Local VA facility must approve the research in
  accordance with VHA Handbook 1200.01 (RD
  Committee) and local procedures before research
  can be initiated at that facility
• Other sites may be added later (but only have a
  10 day comment period, and can only make local
  modifications)

21
VA Central IRB First Year of Operation

• August 2008 - reviewed first study
• September 2009
• 70 VA facilities have signed up
• 19 studies received for review involving _at_ 150 VA
  facilities
• 9 studies approved
• Streamlining process to make it more efficient
  user friendly

22
VA Central IRBPlans for Second Year and Beyond

• March 2010 - apply for AAHRPP accreditation
• Ongoing formal peer-reviewed evaluation
• Split the IRB into 2 or more IRBs

23
VA Central IRBContact Information

• Lynn Cates, MD
• [phone]
• lynn.cates_at_va.gov
• Annette Anderson
• VA Central IRB Administrator
• [phone]
• annette.anderson3_at_va.gov