Memorandum of Understanding (MOU)

Between VHA Central Office and Local VA

Facilities

Annette Anderson
VA Central IRB Administrator
Live Meeting Presentation
Objectives

• Review major provisions of Memorandum

of Understanding (MOU)
• Discuss how to process the MOU and
amend your facility’s Federalwide
Assurance (FWA) to list the VA Central
IRB as one of your IRBs of record

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Why an MOU?

• OHRP and ORO requirement if VA facility

having an FWA uses another entity’s IRB
as an IRB of record
• ORHP and ORO have guidance on the
types of responsibilities that need to be
detailed in the MOU
• Current template developed in accordance
with ORO checklists

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MOU Template

• Has gone through VHA concurrence and

approved by:
• ORO
• OGC
• Principal Under Secretary for Health – Dr. Cross
• Under Secretary for Health – Dr. Kussman
• Cannot be modified
• Any questions or concerns, call us

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MOU Template Sections

• Purpose
• General Provisions
• Responsibilities of VHA Central Office
HRPP and VA Central IRB
• Responsibilities of {Name of Local Facility}
• Termination Provisions

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MOU Template
Purpose
• Spells out the respective authorities, roles and
responsibilities of the VHACO Human Research
Protection Program (HRPP), the VA Central IRB,
and the local VA facility
• The MOU does not
• Preclude prior agreements (e.g., for use of an
affiliate’s IRB, or for use of another VA facility’s IRB
and/or R&D Committee)
• Include any other entity with which the local VA facility
may have an MOU for IRB and/or R&D Committee
services (e.g., an academic affiliate)

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MOU Template
General Provisions

• Both VHACO and the local VA facility will

• Be guided by The Belmont Report
• Adhere to all VA and other federal requirements for
the protection of human participants in research (e.g.,
the Common Rule & VHA Handbook 1200.5)
• Maintain a current Federalwide Assurance (FWA)
listing the VA Central IRB as an IRB of record
• Have AAHRPP accreditation of their respective
HRPPs

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MOU Template
General Provisions
• Both VA Central IRB and the local VA facility will
• Evaluate potential conflict of interest issues of all
members of the local research team

• VA Central IRB
• Will serve as a Privacy Board & may grant HIPAA
waivers of authorization for use or disclosure of protected
health information (PHI)
• Will not charge the local VA facility or investigators for its
services

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Responsibilities of VHACO HRPP
& VA Central IRB
• The VHACO Institutional Official will
provide resources for the VA Central IRB
• The VA Central IRB will
• Maintain current OHRP registration
• Ensure appropriate training for its members &
staff
• Manage conflicts of interest of IRB members

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Responsibilities of VHACO HRPP
& VA Central IRB
• VHACO HRPP will maintain SOPs that :
• Meet all VA & other federal requirements for
protection of human subjects
• Provide for adequate monitoring & audits
• Contain procedures for reporting results of
external monitoring or audits (e.g., FDA,
sponsors)
• SOPs contain the details, not the MOU

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Responsibilities of VHACO HRPP
& VA Central IRB
• VA Central IRB is a full-service IRB that
will:
• Meet at least monthly in person and via audio
or video conferencing
• Perform initial and continuing review of
selected multi-site projects

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Responsibilities of VHACO HRPP
& VA Central IRB
• Evaluate local context by one or more of the following:
• Reviewing the Local Site Application
• VA Central IRB member and/or staff knowledge of
local research context
• Using ad hoc advisors who have had direct
experience with the local site, its subject
populations and/or the local community
• Interacting regularly with the local
site liaison

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Responsibilities of VHACO HRPP
& VA Central IRB

• Provide written notice to the local VA facility within 10

working days of a VA Central IRB action that requires
the local VA facility’s response
• Work closely with the local VA facility to investigate
and take action on
• Complaints from subjects or others
• Incidents of investigator noncompliance
• Unanticipated problems and project deviations

• Coordinate required reporting to regulatory

agencies

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Responsibilities of VHACO HRPP
& VA Central IRB

• Determine if a project constitutes research

and if it does, if it is human research

• Determine if sites are engaged in research

• Determine if a project is exempt from IRB

review

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Responsibilities of VHACO HRPP
& VA Central IRB
• Maintain all relevant records
• Perform continuous quality improvement
• Seek feedback as part of continuous quality
improvement

• VHACO HRPP will provide access to VA

Central IRB records as required (e.g., for
AAHRPP)

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Responsibilities of VHACO HRPP
& VA Central IRB
• The VA Central IRB will maintain a website
containing:
• A list of current members
• SOPs, forms, and reviewer checklists
• Investigator Guide
• Meeting dates and application deadlines
• A list of VA Central IRB approved projects
• A list of local VA facilities that use the VA
Central IRB
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Responsibilities of Local VA Facility

• Retains ultimate responsibility for its HRPP

• Institutes appropriate local oversight
mechanisms to ensure compliance with
determinations of VA Central IRB (e.g., audits &
monitoring)
• Promptly informs VA Central IRB of any
• Complaints from subjects or others
• Unanticipated problems & serious adverse events
• Suspension or termination of research activities
• Serious and continuing noncompliance

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Responsibilities of Local VA Facility

• Modifies its existing FWA to add the VA Central IRB as an

IRB of Record and follow provisions of the MOU
• If the local VA facility uses its affiliate’s or another VA’s
IRB, it must review the MOU for that arrangement and, if
needed, modify that MOU to permit use of the VA Central
IRB as one of its IRBs of record (e.g., if the MOU states
that the affiliate IRB is the only IRB the VA facility will use)
• If the local VA facility uses the R&D Committee of another
VA facility, it must review the MOU and, if needed, modify
the MOU to permit use of the VA Central IRB

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Responsibilities of Local VA Facility

• Maintains documentation that required training,

credentialing, and privileging is current for all local HRPP
staff and all local research team members of VA Central
IRB approved projects
• Works with the Local Site Investigator (LSI) in preparing
the Local Site Application which will be reviewed and
signed by both
• The Local Site Investigator’s Section or Department Chief and
• The ACOS/R&D
• Provides comments and/or suggestions in response to
VA Central IRB initial review considerations within 30
calendar days of receipt

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Responsibilities of Local VA Facility

• Notifies Local Site Investigator and VA Central

IRB of the local VA facility’s decision to
participate, or decline to participate, within 10
calendar days of receiving VA Central IRB’s final
decision
• If local VA facility agrees to participate, ensures
the project is reviewed at the next R&D
Committee meeting
• Ensures project is not started until approved by
both VA Central IRB and local VA facility R&D
Committee

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Responsibilities of Local VA Facility

• Forwards FOIA requests for any VA Central IRB

documents to VHACO FOIA Officer
• Does not independently modify any VA Central
IRB approved project except where necessary to
eliminate apparent immediate hazards to the
subjects
• Notifies VA Central IRB immediately of potential
research impropriety, misconduct, suspension,
debarment, or restriction of any local research
team member associated with a VA Central IRB
approved project

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Responsibilities of Local VA Facility

• Provides VA Central IRB access to research

subjects’ clinical records and/or case files if
required as part of oversight or monitoring
activities
• Participates in the annual review of the VHA
Central Office HRPP
• Maintains compliance with any additional state,
local or institutional requirements

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Responsibilities of Local VA Facility

• Promptly notifies VA Central IRB and the PI of

any changes in the local project team
• Coordinates approval of other local committees
• Conducts routine compliance audits and
monitoring and reports findings as required
• Maintains a file on each VA Central IRB-
approved project
• Maintains current SOPs that incorporate policies
and procedures of VA Central IRB
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Responsibilities of Local VA Facility

• The local VA facility will not:

• Submit a Local Site Investigator Application to
the VA Central IRB if another IRB of record
has already disapproved the facility’s
participation
• Submit an application to another IRB of record
if the VA Central IRB has determined the
facility should not participate

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Responsibilities of Local VA Facility

• Designate in writing one or more local officials

(e.g., IRB Chair or Member, AO, ACOS/R&D,
R&D Committee Chair) to perform the following:
• Provide comments/suggestions to VA Central IRB in
response to initial review considerations
• Respond to VA Central IRB final determination
• Serve as liaison among VA Central IRB, Local Site
Investigator, and local VA facility for oversight,
compliance and monitoring purposes

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MOU Template
Termination Provisions
• May be terminated without cause by either party
by giving a 60-day written notice to other party
• May be terminated for cause only under the
direction and guidance of ORO
• MOU in effect upon signature of VHACO
Institutional Official until terminated or
amended/revised per mutual agreement
• Renewed every three years upon renewal of
local facility FWA

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Update of Local VA Facility FWA

• Amend FWA on line at

http://ohrp.cit.nih.gov/efile/ using the FWA
update function and follow instructions
• Add VA Central IRB as an additional IRB of
Record
(NOTE: VA Central IRB is registered as
“IRB00006332 Veterans Health Administration
Central Office IRB #1”)

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Update of Local VA Facility FWA

• Contact Priscilla Craig in ORO by phone (202-

266-4572) or e-mail (priscilla.craig@va.gov) to
let her know it is ready for review
• After ORO review, she will notify local VA facility
to go online to “verify and submit” – do not do
this before ORO review
• After submitting update, print hard copy for
signature of local Institutional Official (i.e.,
Medical Center Director)

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Update of Local VA Facility FWA

• Prepare Memorandum of Understanding for

local VA IO signature to include preparing
signature blocks
• Use “Find and Replace” function of Microsoft
Word to substitute {Name of local VA facility}
with local VA facility name
• Send updated FWA, VA Addendum (found on
ORO website) and MOU to local VA facility IO
for signature

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Update of Local VA Facility FWA

• Obtain Network Director signature on all

documents
• Send signed FWA and VA Addendum to ORO
by fax (202-266-4572) or email PDF to
priscilla.craig@va.gov
• Send signed MOU via express mail (not U.S.
Postal Service) to
VA Central IRB
Office of Research and Development (12)
810 Vermont Ave, NW
Washington, DC 20420

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Update of Local VA Facility FWA

• VA Central IRB staff will send the MOU to the

Chief Research & Development Officer
(CRADO) for signature (per delegated authority
from VHACO Institutional Official)
• After CRADO signature, copies of MOU will be
sent to ORO and local VA facility
• ORO staff will monitor OHRP approval date of
FWA update and keep VA Central IRB staff
informed

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Renewal of MOU

• At least every 3 years when the FWA is

renewed, & sooner if
• The FWA is updated (e.g., appointment of
new Institutional Official)
• A substantive change is made to the MOU
template

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Publication of Active MOUs

• A list of active MOUs will be maintained on

the VA Central IRB website
• Currently we are releasing to investigators
the names of VA facilities expressing an
interest in the VA Central IRB only after
we obtain written permission from the
ACOS/R&D to do so

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VA Central IRB
Contact Information
Annette Anderson Hector Ramirez
VA Central IRB Administrator VA Central IRB Coordinator
202-461-1813 202-461-1819
annette.anderson3@va.gov hector.ramirez@va.gov

Lorna Kamber Lucindia Shouse

VA Central IRB Coordinator VA Central IRB Coordinator
202-461-1812 202-461-1818
lorna.kamber@va.gov lucindia.shouse@va.gov

Website http://www.research.va.gov/programs/pride/cirb/default.cfm
Toll free number 1-877-254-3130
Email va.central.irb@va.gov

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