Title: VA Central IRB MOU Webinar
1VA Central IRBMOU Webinar
- K. Lynn Cates, MD
- Assistant Chief Research Development Officer
- Office of Research Development
- Department of Veterans Affairs
2Human 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
3VA Central IRBPurpose
- Improve human research protection in ORD
multi-site studies by ensuring - Expert ethical scientific review
- Local issues are addressed
- Enhance efficiency of IRB reviews
4VA Central IRBLogistics
- ORD studies only
- ORD Service (e.g., CSP, RRD, HSRD, 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
5VA Central IRBLogistics
- 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
6VA Central IRB Reviews
- Full
- Expedited
- Exempt
- Continuing
- Waiver of HIPAA-compliant authorization
7Geographical Distribution of VA Central IRB
Voting Members
Updated 07/01/08
8IRB Composition
- 20 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
9Nonvoting Members
- Ethics
- Legal
- Regulatory Affairs
- Privacy HIPAA
- Information Security Officer
- Chief Information Officer
10VA Central IRBProcess
- 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/RD
11VA Central IRBProcess
- 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 RD Committee must approve before research
is initiated at that facility - Other sites may be added later
12Federalwide Assurance (FWA)
- VHA has an FWA for the VHACO Human Research
Protection Program (HRPP) - Institutional Official (IO) PDUSH
- Human Protections Administrator (HPA) CRADO
13Local 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
14MOU Between Local VA Facility VHACO
- Memoranda of Understanding (MOUs) will be crisp
agreements with clear delineation of respective - Roles
- Responsibilities
- Authorities
15VA 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)
16Local AccountabilityWho is Responsible?
- The local Institutional Official (IO) is the
medical center director (MCD) - MCD ACOS/RD have ultimate responsibility
17Local 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
18MOU Template
- Cannot be modified
- Webinars to guide local VA facilities
19Local AccountabilityLocal 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)
20Local 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
21Local AccountabilityLocal 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 RD Committee, IACUC,
Radiation Safety, etc.)
22Investigator Training Webinars
- To review
- How the VA Central IRB will work
- Principal Investigator (PI) Application Form
- Local Site Investigator (LSI) Application Form
23VA Central IRBMeasures 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
24VA 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, NCI)
25VA 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
- Potential to facilitate translation of research
26Why the VA Central IRB Will Not Solve Everyones
Problems
- Lots of other local responsibilities for HRPP (as
spelled out in MOU) - Other approvals
- (e.g., RD 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
27Affiliate 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
28Contact Information
- Lynn Cates, MD
- Assistant Chief Research Development Officer
- Director, PRIDE
- 202-461-1811 lynn.cates_at_va.gov
- Marisue Cody, PhD
- Deputy Director, PRIDE
- 202-461-1814 marisue.cody_at_va.gov
- Annette Anderson
- VA Central IRB Administrator
- 202-461-1813 annette.anderson3_at_va.gov
- Lorna Kamber
- VA Central IRB Coordinator
- 202-461-1812 lorna.kamber_at_va.gov