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IRB Purview

This document describes the purview of UW-Madison IRBs.

  1. This document describes the purview of UW-Madison IRBs. The UW-Madison has established multiple IRBs in order to ensure appropriate expertise is available to review the range and complexity of research conducted by its faculty, staff, and students.

    1. The UW-Madison may use external IRBs to review human subjects research, such as when required by federal regulations, as a condition of participating in the research, or for studies that require certain resources (e.g., for studies subject to the single IRB requirement that involve a significant number of sites) or particular expertise to conduct the review (e.g., knowledge of other states’ laws that may apply to research for a multi-site study).

    2. The Education and Social/Behavioral Science IRB (ED/SBS IRB) specializes in education, social and behavioral science research

      1. It does not review FDA-regulated research or research that falls under Madison VA Hospital purview.

      2. It does not have appropriate expertise for review of medical research, but may review minimal risk health-related studies, such as those involving exercise, tape sensors, and single venipuncture, where medical training is not necessary for the evaluation of risk to research participants.

      3. The ED/SBS IRB reviews some social and behavioral research involving genetic testing.

    3. The Health Sciences (HS) IRB reviews studies involving medical interventions or procedures where medical expertise is required for evaluation, but also can review studies generally under the purview of the Health Sciences Minimal Risk IRB, such as when the review timeline is a factor.

      1. Generally, FDA-regulated research is reviewed by this board.

    4. The Health Sciences Minimal Risk (MR) IRB primarily reviews studies that present minimal risk to subjects and that involve medical interventions or procedures requiring medical expertise or that require knowledge of the health care setting (e.g., medical records research, research database and tissue banking projects, exempt human subjects research that occurs in the health care setting or involves health care records).

      1. The MR IRB can review more than minimal risk studies, when the committee consists of members with the appropriate expertise or ad hoc consultant(s) are appointed, should additional expertise be necessary.

  2. All IRBs may review federally and non-federally funded prisoner research.

  3. Research teams are required to submit applications through an electronic system, ARROW, to trigger a request for IRB review.

    1. As part of the ARROW application, research teams identify whether they are requesting review by an internal or external IRB (i.e., ceded review).

    2. When requesting review by an internal IRB, the research team provides input on which IRB they propose to review the research.

    3. The IRB Offices review the application and may determine that the research falls under the purview of another internal IRB or may consider a ceded review.

      1. When questions about appropriate IRB purview arise, the IRB Offices will confer with one another and the research team to come to an agreement on which IRB will oversee the research.

    4. After a research team submits an application and the review process begins, which may include review by a campus scientific review committee, if the research team thinks that a more appropriate review would be conducted by a different IRB, the research team can contact the IRB Director or IRB chair of the committee to which the study was originally submitted to discuss potential transfer and the basis of the request.

      1. The IRB Director, Chair, or Designee receiving the request will assess its rationale and may confer with others, including the proposed IRB, to determine whether a transfer to a different IRB is appropriate (i.e., the other IRB has more appropriate expertise to assess the research) and permissible based on the type of research (e.g., VA and FDA research can only be reviewed by certain internal IRBs).

      2. If an IRB Director or Chair has concerns about the basis of or they decline the request, they will consult with the institutional official regarding an appropriate course of action as necessary.

      3. If the IRB Director or Chair agrees to the transfer, they will confirm the transfer with the proposed reviewing IRB and instruct the research team how to proceed.

Adopted By: Cross-Campus Human Research Protection Program (HRPP) Advisory Committee
Adoption Date: December 11, 2014
Revised: 7/16/2019

Copyright © 2014 University of Wisconsin System Board of Regents

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Keywords:IRB, Purview, Education, Social, Behavioral, Health Sciences, medical intervention, IRB review, minimal risk, health research, FDA, prisoner research   Doc ID:42273
Owner:Travis D.Group:VCRGE and Graduate School
Created:2014-07-29 09:47 CDTUpdated:2019-08-23 15:31 CDT
Sites:VCRGE and Graduate School
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