IRB Reliance

This document describes how UW-Madison manages IRB oversight of research studies.

  1. A UW-Madison IRB 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 (FWA)-holding institution. A UW-Madison IRB may cede review of a research study to another institution’s IRB.

  2. UW-Madison may act as an IRB of record or cede review to another IRB when the institution determines that doing so is warranted and ceding oversight complies with federal and institutional requirements and does not compromise the ability of the institution to adequately oversee its HRPP.

  3. When an IRB Authorization Agreement (IAA) or written agreement is required by federal regulations, the responsibilities of both the designated and ceding institution are apportioned in the relevant IAA and corresponding institutional standard operating procedures.

  4. The authority to make decisions regarding whether to serve as IRB of record for another site or cede IRB review rests with the UW-Madison IRB office that will oversee the review of the research or would have been responsible for the review of the research study if IRB oversight were not ceded, except as described below.

    1. In the case of requests for a UW-Madison IRB to act as IRB of record for a non-UW-Madison research site or an individual engaged in human participants research, the applicable IRB will consider whether, by accepting this role, UW-Madison will need to encumber other significant institutional resources to oversee the study (e.g., Conflict of Interest Committee, Legal Counsel, Post-Approval Monitoring) and will consult with applicable institutional officials regarding the appropriateness of serving as a Reviewing IRB.

    2. If a UW-Madison IRB determines that it cannot meet its regulatory requirements in serving as a reviewing IRB or ceding IRB review to another institution, in order to preserve the regulatorily required independence of the IRBs, institutional officials cannot overturn this decision.

  5. For non-exempt research, a UW-Madison IRB may act as IRB of record for a non-UW-Madison research site or individual engaged in human participants research if the following conditions are met:

    1. A formal request is submitted to the relevant UW-Madison IRB office.

    2. Individuals engaged in human participants research activities from outside the UW-Madison will meet relevant UW-Madison requirements (e.g. completion of human participants protection training).

    3. Individuals engaged in human participants research from outside UW-Madison must be collaborating with a UW-Madison investigator, except when special arrangements are made.

    4. The UW-Madison IRB serving as the IRB of record satisfies the Office for Human Research Protections (OHRP) guidelines for knowledge of the local research context.

    5. The UW-Madison IRB determines there is acceptable plan in place for monitoring activities at and communications amongst other sites and ensuring compliance with applicable human participants regulations.

    6. For federally funded, supported, or regulated research studies:

      1. If a non-UW-Madison site has its own FWA, an IAA is required between the UW-Madison and the other site.

        1. If a non-UW-Madison site is the primary awardee or routinely engages in federally funded or supported research activities, the site must have its own FWA.

      2. If UW-Madison is the primary awardee of the federal grant or coordinating center for the research study, then the institution must ensure that all collaborating institutions engaged in such research operate under an appropriate FWA for the protection of human participants.

      3. If the non-UW-Madison site does not have a FWA, or the collaborating investigator is not acting as an employee of an FWA-holding institution, each collaborating investigator engaged in research activities will be required to enter into an institutional/individual investigator agreement (IIA).

        1. If individuals are associated with a particular organization (e.g., employees at a community center) and will engage in human participants research as part of their association with that institution, the UW-Madison study team must obtain a letter from an appropriate official from that organization acknowledging their employees’ engagement in human participants research.

    7. For non-federally funded research studies:

      1. If a non-UW-Madison site has its own FWA, an IAA is required between the UW-Madison and the other site.

      2. If a non-UW-Madison site does not have an FWA, or the collaborating investigator is not acting as an employee of an FWA-holding institution, the UW-Madison study team must obtain a letter from an appropriate official from that organization acknowledging their employees’ engagement in human participants research.

      3. If a non-UW-Madison site does not have an FWA, or the collaborating investigator is not acting as an employee of an FWA-holding institution, the UW-Madison study team must provide each person engaged in research with the Collaborating Investigator Responsibilities Summary, which is available from UW-Madison IRB offices.

  6. UW-Madison may cede review of human participants research to another IRB or ethics committee of record if the following conditions are met:

    1. A formal request is submitted to the UW-Madison IRB office that would oversee the human participants research if oversight were not ceded and the IRB office agrees to a ceded review.

      1. For grants that require ceding review to an external IRB, the grant applicant must consult with the UW-Madison IRB office that would oversee the human participants research if oversight were not ceded prior to submission of the grant application.

    2. An IAA is required between the UW-Madison and the other site.

    3. For federally funded or supported research studies, the non-UW-Madison site must have its own FWA.

  7. In addition to the above criteria, UW-Madison considers factors like those outlined in the “Considerations for Accepting or Ceding IRB Review Guidance” when deciding whether to accept or cede review to another IRB.

  8. Although, in most cases, a UW-Madison IRB will agree to act as IRB of record for another institution or cede review of a research study to another institution’s IRB only on a study-by-study basis, a UW-Madison IRB may enter into a “blanket” IAA under which it may review all studies or studies of a particular kind from another institution or may cede review of all studies of a particular kind to another institution.

    1. When a “blanket” IAA is in place with another institution, requests to cede IRB review must be made to the relevant IRB office for each individual study in order to allow the UW-Madison to ensure compliance with institutional requirements and to track and monitor human participants research conducted under its HRPP.

  9. In the case of exempt human participants research, regardless of funding source, a UW-Madison IRB will not act as IRB of record for a non-UW-Madison research site or cede review of a project to another institution’s IRB, except when special arrangements are made ( e.g., the Wisconsin IRB Consortium agreement). Instead, the UW-Madison IRB must review and determine the human participants research to be exempt and the other institution will be required to follow its own policies and procedures related to exemption determinations.

    1. Only UW-Madison employees, students or agents will be listed as study team personnel on the UW-Madison application.

    2. For those non-UW-Madison sites that do not have an IRB, the UW-Madison IRB may require the investigator to obtain a letter of support for the conduct of the research at the site signed by an appropriate official.

  10. When UW-Madison is serving as the IRB of record for research outside Wisconsin, UW-Madison takes into account applicable laws, regulations, and institutional policies where the research is occurring.

Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: April 10, 2008
Revised: December 4, 2008
Revised: May 6, 2010
Revised By: Cross Campus Human Research Protection Program Advisory Committee
Revision Date: March 26, 2015
Revision Date: November 11, 2015
Revision Date: May 31, 2017

Copyright © 2017 University of Wisconsin System Board of Regents

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Keywords:multi multisite multi-site research FWA IRB of record defer IRB authorization agreement individual investigator agreement IRB of record site permission letter   Doc ID:29565
Owner:Ryan M.Group:VCRGE and Graduate School
Created:2013-04-18 12:12 CDTUpdated:2017-06-07 15:12 CDT
Sites:VCRGE and Graduate School
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