IRB Authority and Independence
This document describes the authority of UW-Madison IRBs and the process for maintaining IRB independence.
This document describes the authority of UW-Madison IRBs and the process for maintaining IRB independence.
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Authority of IRBs
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The Chancellor of the UW-Madison grants, recognizes and maintains the UW-Madison IRBs' authority, as stated in the federal regulations.
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All UW-Madison faculty, staff and students are required to obtain UW IRB approval or exemption when they engage in human participants research unless a UW IRB has determined that IRB review of those activities can be deferred to another institution.
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As part of their review process, IRBs may require revisions to the IRB application or related materials in order for IRB approval or an exemption determination to be secured.
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All UW IRBs also have the authority to:
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Disapprove a research study
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Disapprove particular research activities
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Suspend IRB approval of enrollment
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Suspend IRB approval of a study
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Terminate IRB approval of a study
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Independence of IRBs
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If an IRB disapproves a protocol, defers a protocol application or requires protocol modifications as a condition for approval, no other UW-Madison official or committee may overturn the IRB’s decision.
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Research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution.
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An application that has been reviewed by a UW-Madison IRB may not be resubmitted by the study team to another UW-Madison IRB unless the IRB to which the research was originally submitted refers the application to the other IRB.
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Attempts to Unduly Influence IRB Chairs, Members and Staff
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Any attempt to unduly influence IRB members and/or staff in the performance of their duties should be reported to the reviewing IRB chair or IRB Director who consults with the Institutional Official (IO).
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Any attempts to unduly influence an IRB chair in the performance of his or her IRB duties should be reported to the IO.
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Any attempts by the IO to unduly influence an IRB chair, members and/or staff should be reported to the Vice Chancellor for Research and Graduate Education (VCRGE).
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Attempts to unduly influence IRB chairs, members, or staff will be handled by the IRB Chair, IRB Director IO, and/or VCRGE as follows:
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A prompt and thorough investigation of all allegations will be conducted.
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A written report describing the incident, the investigation and actions taken will be submitted to the VCRGE.
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If appropriate, corrective action will be taken to ensure that decisions of IRB chairs, members and/or staff are not or have not been unduly influenced.
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The IRB Chair, IRB Director, IO and/or VCRGE will communicate to IRB chair, members, staff and researchers the inappropriateness of attempts to unduly influence IRB members and/or staff in the performance of their IRB duties.
Adopted By: Chancellor, UW-Madison
Adoption Date: December 8, 2005
Revised: June 7, 2007
Revised By: HRPP Advisory Committee
Revised: March 1, 2012
Revised By: Cross Campus Human Research Protection Program Advisory Committee
Revised: August 6, 2014
Revised: January 3, 2019
Copyright © 2014 University of Wisconsin System Board of Regent