Types of IRB Panels

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IRB: Types of IRB Panels
Policy number:
102
References:
45 CFR 46.103(b)(2), 45 CFR 46.103(d), 45 CFR 46.114
21 CFR 56.114
FDA Info Sheets: Non-Local IRB Review
Date: 2/17/2014
Policy Owner: Executive
Director HRPP
AAHRPP Standard I-2.
Cross References:
200A Role, Composition of Executive Committee
Definitions:
None
1.0 Reason for Policy
To describe the roles of established University of Minnesota IRBs.
2.0 Scope of Policy
The scope of this policy is the University community and its healthcare components.
3.0 Policy Statement
The University of Minnesota convenes the following duly constituted, registered IRB panels to review
research involving human subjects conducted by faculty, staff and students of the University of
Minnesota and representatives from Fairview Health Systems and Gillette Children’s Specialty
Healthcare: Health & Biological Sciences, Social and Behavioral Sciences, Student Social and
Behavioral Sciences, and Executive Committee. Each IRB performs separately and independently from
one another.
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Health & Biological Sciences IRBs
Any research project involving human participants, irrespective of the source of funding is reviewed by
a medical IRB if, in the opinion of HRPP staff, the intervention proposed is medical or clinical in nature
and cannot be reviewed by Expedited review or screened as Exempt. One committee convenes to review
the continuing review of the Health and Biological Sciences protocols.
Social and Behavioral Sciences IRB
Any research project involving human participants, regardless of the source of funding is reviewed by
this panel if, in the opinion of HRPP staff, the intervention proposed is social or behavioral in nature and
cannot be reviewed by Expedited review or screened as Exempt.
Student Social and Behavioral Sciences (SSBS) IRB
Any research project involving human participants, regardless of the source of funding is reviewed by
the SSBS if the Principal Investigator is a student with an advisor (including PhD. dissertation)
proposing to study subjects without medical intervention that cannot be reviewed by Expedited review
or screened as Exempt.
Executive Committee IRB
This IRB panel, while designed as an Executive Committee can, when needed, review any research
project involving human participants regardless of the source of funding in areas either medical or social
in nature that cannot be reviewed by Expedited review or screened as Exempt, when acting as a duly
constituted IRB. The Executive Committee meets as necessary but at least quarterly to consider policies
and occurring trends seen by the committees. The Committee conducts continuous, real time, quality
monitoring and works on improvements in the process and review of research activity by HRPP.
4.0 Required approvals for this document
Title
Executive Director, HRPP
5.0 Revision History
Revision
02/16/14
10/01/09
04/10/09
09/26/06
Reason for change
Administrative changes
Revise AAHRPP reference
Reformat
Date of release
09/02/14
10/01/09
04/27/09
To obtain a copy of a historical policy, e-mail IRB at irb@umn.edu or call 612-626-5654
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