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 facility’s 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 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

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 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)

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 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

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 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

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 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

20. 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

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 facility’s 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/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

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@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 notdo 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 toORO 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

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/R&D 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@va.govhector.ramirez@va.gov Lorna Kamber Lucindia Shouse VA Central IRB Coordinator VA Central IRB Coordinator 202-461-1812 202-461-1818 lorna.kamber@va.govlucindia.shouse@va.gov Websitehttp://www.research.va.gov/programs/pride/cirb/default.cfm Toll free number 1-877-254-3130 Email va.central.irb@va.gov