Subject: IRB Review of Human Subjects Research - Expedited

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to permit the use of expedited review procedures for eligible human subjects research activities, as defined by Federal regulations.

1. Eligibility for Expedited Review
   1. The IRB may use an expedited review procedure to review either or both of the following:
   2. 1. Research that involves no more than minimal risk, and which appears on the following list: Expedited Review Categories ^[1]
      2. Minor changes in previously approved research during the period (of one year or less) for which approval is authorized. ^[2], ^[3]
2. Expedited Review
   1. The review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among the members of the IRB.
   2. The reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research.
   3. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in IRB Policy III.E. ^[4], ^[5], ^[6]
3. IRB Oversight of Expedited Review.
   1. All IRB members shall be advised of research proposals which have been approved under expedited review. ^[7], ^[8]

^[1] Expedited Review Categories

^[2] 45 CFR 46.110(a), (b)

^[3] 21 CFR 56.110(a), (b)

^[4] 45 CFR 46.110(b)

^[5] 21 CFR 56.110(b)

^[6] IRB Policy III.E

^[7] 45 CFR 46.110(c)

^[8] 21 CFR 56.110(c)