Subject: IRB Review of Human Subjects Research – Full Committee

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to review all human subjects research activities according to applicable criteria, as defined by Federal regulations.

1. Full Committee Eligibility
   1. Studies not qualifying for IRB review through an expedited review procedure will be reviewed by a fully convened IRB.
2. Full Committee Review
   1. Research will be reviewed at convened meetings at which the majority of IRB members are present, including at least one member whose primary concerns are in non-scientific areas. In order for the research to be approved, it will receive the approval of the majority of those members present at the meeting. ^[1], ^[2]

^[1] 45 CFR 46.108 (b)

^[2] 21 CFR 56.108 (c)