Five Year Replacement/Renewal

This document describes the policies and procedures UW-Madison IRBs use for conducting review of non-exempt human participants research that continues beyond five years from the date of approval of the initial review application.

  1. For any non-exempt human participants research, UW-Madison requires replacement/renewal initial review applications every five years for ongoing studies, unless the study activities fit one of the exceptions to this policy.

    1. This policy applies regardless of whether a study is subject to the continuing review requirement.

    2. A replacement/renewal application is not required when studies meet one of the following criteria.

      1. The UW-Madison study team’s activities are limited only to data, sample, or image analysis or for a multi-center trial, the activities of an analysis or reading center.

      2. The study is permanently closed to enrollment at UW-Madison, even if other study activities (e.g. study interventions, analyses, data collection, subject follow-up, etc.) are still ongoing.

      3. The IRB application is for a non-exempt medical records review study.

      4. The IRB application is limited to review of a grant application, such as a core grant, training program grant, master grant, or umbrella grant unless the source or type of funding has changed.

      5. Local enrollment will be closed within the next 12 months (i.e., by the start of the sixth year the study is open).

        1. This exception may be granted only one time.

        2. A replacement application must be submitted if study activities are not limited to analysis or long-term follow up by the end of the 12-month extension period.

      6. Regardless of the above exceptions, UW-Madison IRBs may require study closure and re-submission of a new IRB application based on the criteria outlined in the Study Closure Policy.

    3. The replacement/renewal date is calculated within 5 calendar years from the date of the IRB approval of an initial review application.

  2. When studies are considered to fit one of the exceptions to this policy, the UW-Madison study team must submit a continuing review application in accordance with the Continuing Review Policy.

Adopted By: All Campus IRB
Adoption Date: December 7, 2000
Revised Date: May 6, 2010
Revised By: Cross-Campus Human Research Protection Program (HRPP) 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:five years five-year resubmit initial review application continuing review data analysis   Doc ID:29793
Owner:Travis D.Group:VCRGE and Graduate School
Created:2013-04-22 14:57 CSTUpdated:2017-10-03 11:07 CST
Sites:Health Sciences IRBs, VCRGE and Graduate School
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