MOUs in Human Research

1
Office of Research Oversight

• MOUs in Human Research
• Tom Puglisi, PhD, CIP
• ORD COACH Conference on
• Local Accountability for Human Research
  Protection
• Fall 2006

2
Responsibility for Protecting Human
SubjectsFederalwide Assurance (FWA)

• All of the Institutions 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 Institutions
  responsibilities under this Assurance, I assure
  protections for human subjects

3
Responsibility for Protecting Human
SubjectsAAHRPP Accreditation Principles

• 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.

4
Responsibility for Protecting Human
SubjectsAAHRPP Accreditation Principles

• 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.

5
Memorandum of Understanding (MOU)

• Required when a VA Facility
• Uses another entitys 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

6
Memorandum of Understanding (MOU) Required
Process

• 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

7
Memorandum of Understanding (MOU)Minimum Content

• 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 facilitys RD Committee, or
• Involving individuals with VA appointments

8
Memorandum of Understanding (MOU)Minimum Content

• 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

9
Memorandum of Understanding (MOU)Minimum Content

• 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

10
Memorandum of Understanding (MOU)

• 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.

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Office of Research Oversight

• http//www.1.va.gov/oro/
• 811 Vermont Avenue, N.W., Suite 574 (10R)
• Washington, D.C. 20420
• PHONE [phone]
• FAX [phone]