The Mayo Foundation Institutional Review Board (IRB)

Institutional Review Boards (IRB) are used to ensure the rights and welfare of people participating in clinical trials both before and during their trial participation. These impartial review panels perform the job of risk and benefit assessment ensuring that the risks are both minimized and fairly disclosed to study participants when testing drugs, vaccines, or medical devices. IRBs are monitored by the FDA to protect and ensure the safety of participants in medical research.

The Mayo IRB is free standing. That is, it is not regulated by any other group within Mayo. The Mayo IRB reviews all human subject research conducted at Mayo Clinic Jacksonville, Mayo Clinic Rochester, and Mayo Clinic Scottsdale.

The Mayo Foundation has five fully convened Institutional Review Boards (collectively the “IRB”).

IRB members are appointed by the Board of Governors of Mayo Foundation. Members include staff from Rochester, Jacksonville, and Scottsdale, and their respective communities. The members are chosen to ensure that the IRB:

• is sufficiently qualified to safeguard the rights and welfare of human research subjects; and
• has the professional competence to review specific research activity and to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

Mayo has guaranteed to the United States Department of Health and Human Services in it’s Federal Wide Assurance (FWA) that all human subject research regardless of funding source will be reviewed by the Mayo Foundation IRB.

The Federal Wide Assurance is the written agreement Mayo has with the federal government to comply with applicable rules governing research involving humans. The FWA generally describes the operating procedures for Mayo’s IRB and also states Mayo’s obligation to safeguard the rights and welfare of human research subjects under Mayo’s auspices. Under the FWA, Mayo’s IRB has the authority to review human subject research at Mayo Clinic Rochester, Mayo Clinic Jacksonville, and Mayo Clinic Scottsdale.

The Mayo IRB serves three primary functions:

1. The IRB must have knowledge of, make recommendations regarding, and implement institutional and extra-institutional policies concerning studies of human subjects.
2. The IRB serves as an ethical review board for investigations involving human subjects to insure that:
   • The rights and welfare of subjects at risk are adequately protected.
   • The risks to subjects are outweighed by the sum of the benefit to the subject and the importance of the knowledge to be gained.
   • The informed consent of subjects is obtained in accordance with published guidelines and regulations.
3. The IRB may disapprove a protocol for human studies or require modifications, limitations, or conditions. Contingencies regarding protocols must be satisfied and approved by the IRB before the study can begin. The decisions of the IRB in this regard are final. Even though the human studies aspects of a protocol may be approved by the IRB, the protocol itself may be rejected by the Research Committee, by the Board of Governors, or by any other body having power of review.