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Memorandum of Understanding (MOU)

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Title: Memorandum of Understanding (MOU)


1
Memorandum of Understanding (MOU)
  • Between VHA Central Office and Local VA
    Facilities
  • Annette Anderson
  • VA Central IRB Administrator
  • Live Meeting Presentation

2
Objectives
  • Review major provisions of Memorandum of
    Understanding (MOU)
  • Discuss how to process the MOU and amend your
    facilitys Federalwide Assurance (FWA) to list
    the VA Central IRB as one of your IRBs of record

3
Why an MOU?
  • OHRP and ORO requirement if VA facility having an
    FWA uses another entitys 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

4
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

5
MOU Template Sections
  • Purpose
  • General Provisions
  • Responsibilities of VHA Central Office HRPP and
    VA Central IRB
  • Responsibilities of Name of Local Facility
  • Termination Provisions

6
MOU TemplatePurpose
  • 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
    affiliates IRB, or for use of another VA
    facilitys IRB and/or RD Committee)
  • Include any other entity with which the local VA
    facility may have an MOU for IRB and/or RD
    Committee services (e.g., an academic affiliate)

7
MOU TemplateGeneral 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

8
MOU TemplateGeneral 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

9
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

10
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

11
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

12
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

13
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 facilitys 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

14
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

15
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)

16
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

17
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

18
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 affiliates or
    another VAs 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 RD Committee
    of another VA facility, it must review the MOU
    and, if needed, modify the MOU to permit use of
    the VA Central IRB

19
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 Investigators Section or
    Department Chief and
  • The ACOS/RD
  • Provides comments and/or suggestions in response
    to VA Central IRB initial review considerations
    within 30 calendar days of receipt

20
Responsibilities of Local VA Facility
  • Notifies Local Site Investigator and VA Central
    IRB of the local VA facilitys decision to
    participate, or decline to participate, within 10
    calendar days of receiving VA Central IRBs final
    decision
  • If local VA facility agrees to participate,
    ensures the project is reviewed at the next RD
    Committee meeting
  • Ensures project is not started until approved by
    both VA Central IRB and local VA facility RD
    Committee

21
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

22
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

23
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

24
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 facilitys participation
  • Submit an application to another IRB of record if
    the VA Central IRB has determined the facility
    should not participate

25
Responsibilities of Local VA Facility
  • Designate in writing one or more local officials
    (e.g., IRB Chair or Member, AO, ACOS/RD, RD
    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

26
MOU TemplateTermination 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

27
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)

28
Update of Local VA Facility FWA
  • Contact Priscilla Craig in ORO by phone
    (202-266-4572) or e-mail (priscilla.craig_at_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)

29
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

30
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_at_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

31
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

32
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

33
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/RD to do so

34
VA Central IRBContact Information
  • Annette Anderson Hector Ramirez
  • VA Central IRB Administrator VA Central IRB
    Coordinator
  • 202-461-1813 202-461-1819
  • annette.anderson3_at_va.gov hector.ramirez_at_va.gov
  • Lorna Kamber Lucindia Shouse
  • VA Central IRB Coordinator VA Central IRB
    Coordinator
  • 202-461-1812 202-461-1818
  • lorna.kamber_at_va.gov lucindia.shouse_at_va.gov
  • Website http//www.research.va.gov/programs/pride
    /cirb/default.cfm
  • Toll free number 1-877-254-3130
  • Email va.central.irb_at_va.gov
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