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