IRB Authority and Independence
This document describes the authority of UW-Madison IRBs and the process for maintaining IRB independence.
- Authority of IRBs
- The Chancellor of the UW-Madison grants, recognizes and maintains the UW-Madison IRBs' authority, as stated in the federal regulations.
- 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.
- 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.
- All UW IRBs also have the authority to:
- Disapprove a research study
- Disapprove particular research activities
- Suspend IRB approval of enrollment
- Suspend IRB approval of a study
- Terminate IRB approval of a study
- Independence of IRBs
- 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.
- Research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution.
- 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.
- Attempts to Unduly Influence IRB Chairs, Members and Staff
- 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) or Deputy Institutional Official (DIO) when needed.
- Any attempts to unduly influence an IRB chair in the performance of his or her IRB duties should be reported to the IO or DIO.
- Any attempts by the IO or DIOs to unduly influence an IRB chair, members and/or staff should be reported to the Vice Chancellor for Research.
- Attempts to unduly influence IRB chairs, members, or staff will be handled by the IRB Chair, IRB Director, DIO, IO, and/or Vice Chancellor for Research as follows:
- A prompt and thorough investigation of all allegations will be conducted.
- A written report describing the incident, the investigation and actions taken will be submitted to the Vice Chancellor for Research.
- 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.
- The IRB Chair, IRB Director, DIOs, IO and/or Vice Chancellor for Research 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
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