| Policy | IRB Committee Determinations/Motions |
| DEPARTMENT: | OFFICE FOR HUMAN RESEARCH PROTECTION |
| POLICY NUMBER: | III.B |
| SECTION: | IRB REVIEW PROCEDURES |
| REVIEW: | IRB POLICY AND PROCEDURE COMMITTEES |
| ORIGINAL CREATION DATE: | March 19, 2007 |
| REVISION DATES: | |
Subject: IRB Committee Determinations/Motions
Policy:
It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – to render determinations as defined by Federal regulations.
- Approved
An approval is granted if the research activity meets the criteria for approval as defined in IRB Policy III.F [1] and no changes to the research application are recommended.
- Deferred
A deferral is granted if the research activity does not meet the criteria for approval as defined in IRB Policy III.F, 1 and the Board requires modifications in the research to secure approval. The application may subsequently be approved if the modifications have been made by the Investigator or the Investigator has justified to the satisfaction of the IRB that the modifications do not need to be made.
- New Studies: The application may be reconsidered upon re-submission after the requested changes have been made to the study or the Investigator has justified to the satisfaction of the IRB why the changes do not need to be made.
- Modifications: The change cannot be implemented, and the Board expects the research will continue as previously approved.
- Disapproved
A disapproval is granted if the research activity does not meet the criteria for approval as defined in IRB Policy III.F. 1 If the IRB disapproves a research activity, it will include in its written notification a statement of the reasons for its decision and give the Investigator an opportunity to respond in person or in writing, at the discretion of the IRB.
- New Studies: The application may be reconsidered as a new submission after substantial changes have been made to the study.
- Modifications: The change cannot be implemented, and the Board expects the research will continue as previously approved. [2], [3]
- Tabled Due to Lack of Time.
A study will be tabled if the Committee is unable to review it due to lack of time. The study will then be placed on a future agenda.
[1] IRB Policy III.F
[2] 45 CFR 46.109(a)
[3] 21 CFR 56.109(a)
