Subject: Institutional Oversight of Mayo Clinic's Federalwide Assurance

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to uphold its Assurance with the Office for Human Research Protections (OHRP).

1. A copy of Mayo's Federalwide Assurance (FWA)^[1] will be maintained in the office of the Director, Mayo Clinic Office for Human Research Protection and will be available to the Mayo Clinic community via the Mayo Clinic Office for Human Research Protection – IRB website. Mayo Clinic's assurance ¹ is based on the following principles:
   1. Safeguarding the rights and welfare of human participants in research and other research activities. Mayo Clinic's policies and procedures are designed to protect the rights and welfare of human participants and are effectively applied in compliance with its FWA.¹
   2. Mayo Clinic staff and students, which comprise its schools, departments, divisions, and facilities at Mayo Clinic Rochester (MCR), Mayo Clinic Arizona (MCA), and Mayo Clinic Jacksonville (MCJ) are subject to the FWA ¹ and this policy. This includes any research for which an Assurance or another formal agreement (e.g., Authorization Agreement^[2] or Cooperative Research Project) ^[3], ^[4] identifies the Mayo Clinic Institutional Review Board (IRB) as the IRB of Record. ^[5]
   3. Mayo Clinic agrees to uphold the ethical principles of the Belmont Report ^[6] and apply DHHS regulations, including Subparts A, B, C, & D ^[7] to all proposed research involving human participants regardless of sponsorship. The ethical principles set forth in the Belmont Report ⁶ are:
   4. 1. Respect for Persons: Recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy;
      2. Beneficence: Obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risk of harm; and
      3. Justice: Fairness in the distribution of research benefits and burdens.
   5. Mayo Clinic further agrees to apply additional regulations such as, the U.S. Food and Drug Administration Human Subject Regulations, ^[8] and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) ^[9], when applicable, to research involving human participants under review.
2. Structure of the IRB.
   1. The IRB Committees are appointed as Mayo Clinic Committees. As such, the IRB Committees serve Mayo Clinic as a whole, rather than a particular school or department, and any institution for which the Mayo Clinic IRB is designated as the IRB of Record ⁷ in a FWA 1 filed with OHRP ^[10] with a corresponding Authorization Agreement.¹⁰
   2. Mayo Clinic's Assurance requires that each IRB Committee be approved and registered with OHRP. ¹⁰
3. IRB Authority
   1. Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.^[11],^[12]

^[1] Mayo Clinic's Federalwide Assurance

^[2] OHRP Website - Assurances

^[3] 45 CFR 46.114

^[4] 21 CFR 56.114

^[5] IRB Policy I.D

^[6] Belmont Report

^[7] 45 CFR 46

^[8] 21 CFR 50, 21 CFR 56, 21 CFR 312, 21 CFR 812

^[9] Health Insurance Portability and Accountability Act of 1996

^[10] HHS - Office for Human Research Protections

^[11] 45 CFR 46.112

^[12] 21 CFR 56.112