| Policy | IRB Review of Human Subjects Research– Full Committee |
| DEPARTMENT: | OFFICE FOR HUMAN RESEARCH PROTECTION |
| POLICY NUMBER: | III.E |
| SECTION: | IRB REVIEW PROCEDURES |
| REVIEW: | IRB POLICY AND PROCEDURE COMMITTEES |
| ORIGINAL CREATION DATE: | March 19, 2007 |
| REVISION DATES: | |
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.
- Full Committee Eligibility
- Studies not qualifying for IRB review through an expedited review procedure will be reviewed by a fully convened IRB.
- Full Committee Review
- 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)
