Office of Research Oversight

1. MOUs in Human Research Tom Puglisi, PhD, CIP ORD COACH Conference on Local Accountability for Human Research Protection Fall 2006 Office of Research Oversight

2. All of the Institution’s human subjects research … will be guided by the ethical principles in … the Belmont Report This Institution assures that … the Institution will comply with the Terms of the Federalwide Assurance … Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution’s responsibilities under this Assurance, I assure protections for human subjects … Responsibility for Protecting Human SubjectsFederalwide Assurance (FWA)

3. Protecting the rights and welfare of research participants must be an organization's first priority. An organization should promote a research environment where ethical, productive investigation is valued. Responsibility for Protecting Human SubjectsAAHRPP Accreditation Principles

4. Protecting Human Research Participants: Responsibility of everyone within an organization Not limited to the Institutional Review Board (IRB) Policies and procedures of the organization as a must result in a coherent, effective system to protect research participants All individuals must know their roles and responsibilities. Responsibility for Protecting Human SubjectsAAHRPP Accreditation Principles

5. Required when a VA Facility Uses another entity’s IRB as its IRB of Record Documents roles and responsibilities of: The VA Facility The IRB The Entity Operating the IRB In lieu of the OHRP “Authorization Agreement” Memorandum of Understanding (MOU)

6. Signed by Facility Director, VISN Director, Entity IO Kept on file for 5 years after expiration Submitted to ORO with FWA At initial submission and with each renewal Reviewed periodically and at FWA renewal Revised promptly whenever conditions change Submitted to ORO whenever revised Memorandum of Understanding (MOU)Required Process

7. The IRB(s) will comply with all relevant VA requirements including VHA Handbook 1200.5 The IRB entity will provide the VA Facility and ORO with any records, documents, or reports related to compliance reviews of research: Conducted or supported by VA Approved by the VA facility’s R&D Committee, or Involving individuals with VA appointments Memorandum of Understanding (MOU)Minimum Content

8. The parties provide for specific communication and cooperation mechanisms to ensure: Adequate protections for human research subjects; Compliance with federal and VA requirements (including VHA Handbook 1058.1) for reporting: Adverse events; Unanticipated problems involving risks to subjects or others; Serious or continuing noncompliance; and For-cause suspensions and terminations of research Memorandum of Understanding (MOU)Minimum Content

9. The parties provide for specific mechanisms: Consistent with all Federal and VA requirements, including VHA Handbook 1058.2, To address allegations of research misconduct involving: VA human subject research, or Individuals acting as VA employees or agents in VA human subject research Memorandum of Understanding (MOU)Minimum Content

10. Suggested elements are available on the ORD and ORO websites. VA facilities are strongly encouraged to contact ORD and the ORO Central Office as early as possible for assistance in developing or revising MOUs. Memorandum of Understanding (MOU)

11. http://www.1.va.gov/oro/ 811 Vermont Avenue, N.W., Suite 574 (10R) Washington, D.C. 20420 PHONE: (202) 565-5184 FAX: (202) 565-9194 Office of Research Oversight