Institutional Review Board (IRB) Operations

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Policy Number:
UW-4144
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

This policy supplements the requirements and procedures for Human Research Protection Program (HRPP) Operations outlined in the University of Wisconsin Madison Human Research Protection Program (HRPP) Toolkit. The policy statements below describe additional requirements and considerations related to Institutional Review Board (IRB) Operations that are not described in the Toolkit.

Policy:
  1. Institutional Review Board (IRB) Purview
    1. 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. Studies are assigned to an IRB according to criteria outlined in the Human Research Protection Program Plan (HRP-101).
      1. Disagreements in IRB assignment can be addressed by emailing the IRB Director of the initially assigned IRB.
  2. IRB Composition and Quality Performance
    1. UW-Madison assures that IRB personnel have the knowledge, skills, and abilities necessary to carry out the function of the IRB.
    2. By agreement with the University of Wisconsin Hospital and Clinics Authority (UWHCA), IRB rosters will contain representatives from the UWHCA.
  3. IRB Members’ Conflicts of Interest
    1. UW–Madison IRB members cannot participate in the review (including initial, continuing or change of protocol, and non-compliance or unanticipated problems) of any research for which they have a conflict of interest, except to provide information at the IRB’s request.
  4. IRB Consultant Use and Conflicts of Interest
    1. UW-Madison IRBs obtain consultation on research studies from independent outside experts.
      1. Consultants may not participate in the review of any research for which they have a conflict of interest, except to provide information at the IRB’s request.
  5. Maintenance of IRB Records
    1. UW-Madison maintains IRB-related study records and IRB meeting minutes according to procedures outlined in the HRPP Toolkit.
  6. IRB Meetings
    1. UW-Madison assures that IRB members have sufficient time before meeting to review research study materials.
    2. For an IRB meeting to be properly convened, a quorum must exist.
  7. IRB Meeting Minutes and Regulatory Documentation
    1. UW-Madison IRBs document regulatory findings in IRB meeting minutes.
  8. Reporting to Institutional and External Authorities
    1. UW-Madison assures compliance with the federal regulations requiring prompt reporting of unanticipated problems, noncompliance, and suspensions and terminations of approved research.
  9. IRB Reliance
    1. UW-Madison follows the HRPP Toolkit to determine when it may act as IRB of record for a non-UW-Madison research site or a collaborating investigator not acting as an employee of a federalwide assurance holding institution and when a UW-Madison IRB may cede review of a research study to another institution’s IRB. 
  10. Single IRB for Multi-Site Federal Grants
    1. The University of Wisconsin-Madison implements federal agency requirements regarding the use of a single Institutional Review Board (sIRB) for multi-site, federally-supported research.
Related UW–Madison Documents, Web Pages, or Other Resources:

Policy Administration

Approval Authority:
Associate Vice Chancellor of Research Policy and Compliance
Policy Manager:
Associate Vice Chancellor of Research Policy and Compliance
Contact:
Associate Director, HRPP -- Travis Doran, travis.doran@wisc.edu, (608) 890-4399
Effective Date:
05-27-2021
Date Issued:
05-27-2021
Retrieved:
04-27-2024 08:06:54