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Single Institutional Review Board (IRB) for Multi-Site Federal Grants Policy

The purpose of this document is to clarify how the University of Wisconsin-Madison implements federal agency requirements regarding the use of a single Institutional Review Board (sIRB) for multi-site research.

  1. This policy does not supersede or alter other related University of Wisconsin-Madison policies.

  2. This policy applies only to federally funded research.

  3. Unless other requirements must be followed under a specific federal agency’s policy and/or guidelines, the University of Wisconsin-Madison will follow the National Institutes of Health (NIH) policy and guidance regarding sIRB, including the costs associated with IRB review, when a University of Wisconsin-Madison IRB serves as the Reviewing IRB for a federally funded multi-site study.

    1. Reviewing IRB means the “IRB of record” to which authority for IRB review and oversight has been ceded by another institution for one or more research studies.

    2. Multi-site study means a study that uses the same protocol to conduct non-exempt human subjects research at more than one site.

    3. The NIH policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.

      1. NIH policy does not apply:

        1. to career development, research training or fellowship awards;

        2. to foreign sites;

        3. when prohibited by a federal, tribal, or state law, regulation, or policy;

        4. or, in limited circumstances, when there is a compelling justification for an exception and the NIH grants an exception following an assessment of the need.

    4. The NIH policy states that the activities of the sIRB will generally fall into two categories, primary activities and secondary activities and defines these activities as follows:

      1. Primary activities refer to the activities associated with conducting the ethical review of the proposed research protocol that will be carried out at all of the participating sites and the review of the template informed consent document describing the study.

      2. Secondary activities refer to the activities associated with the review of site-specific considerations for all of the participating sites, including investigator qualifications, institutional capabilities, state/local regulatory requirements, and community ethos.

        1. Following initial approval, there are additional activities associated with fulfilling IRB oversight responsibilities, including:

          • (1) reviewing reportable events from all participating sites (e.g., unanticipated problems, protocol deviation) and reporting them as appropriate to the Office for Human Research Protections (OHRP) and the funding Institute or Center

          • (2) receiving and reviewing any complaints that arise with regard to the conduct of the study

          • (3) notifying all participating sites of serious or continuing non-compliance and all other determinations

          • (4) communicating with participating sites on matters related to sIRB determinations.

    5. In general, the University of Wisconsin-Madison will treat primary activities as those costs already included in an organization’s Federally-approved indirect cost rate agreement.

      1. Secondary activities may be charged for work performed for the relying institutions and paid from direct costs as part of the budget proposal for federal funding with appropriate budget justification.

  4. Proposals submitted to NIH to support human subjects research on or after the NIH implementation date must include a plan describing the use of an sIRB that will be selected to serve as the IRB of record for all study sites.

    1. This plan should include:

      1. a statement confirming that participating sites will adhere to the sIRB Policy

      2. and a description of how communications between sites and the sIRB will be handled.

    2. When an investigator plans on submitting a funding proposal to a federal agency that requires the use of an sIRB for the research, the investigator must contact the relevant University of Wisconsin-Madison IRB office for assistance with:

      1. identification of the Reviewing IRB,

      2. budgeting for sIRB review,

      3. identifying any other regulatory issues that may need to be addressed as part of the proposal to use an sIRB.

    3. The IRB office will review the request to assess the appropriateness and feasibility (e.g. resources and expertise needed) of:

      1. the proposed Reviewing IRB (whether an internal or external IRB is proposed)

      2. and the plan describing how communications between sites participating and the sIRB will be handled

Adopted By: Cross Campus Human Research Protection Program (HRPP) Committee
Adoption Date: May 31, 2017

Copyright © 2017 University of Wisconsin System Board of Regents

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Keywords:multi-site, sirb, single irb   Doc ID:73991
Owner:Travis D.Group:VCRGE and Graduate School
Created:2017-06-12 10:51 CDTUpdated:2017-10-03 12:07 CDT
Sites:VCRGE and Graduate School
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