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. Page 1 of 2 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 Page 2 of 2