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.
- 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.
- This policy applies regardless of whether a study is subject to the continuing review requirement.
- A replacement/renewal application is not required when studies meet one of the following criteria.
- 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.
- 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.
- The IRB application is for a non-exempt medical records review study.
- 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.
- Local enrollment will be closed within the next 12 months (i.e., by the start of the sixth year the study is open).
- This exception may be granted only one time.
- 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.
- 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.
- The replacement/renewal date is calculated within 5 calendar years from the date of the IRB approval of an initial review application.
- 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
- Study Closure
- Continuing Review: Submission and Review
- Additional Requirements When Conducting Human Subjects Research with Department of Defense (DOD) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Justice (DOJ) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Energy (DOE) Support
- Additional Requirements When Conducting Human Subjects Research with Department of Education (ED) Support
- Additional Requirements When Conducting Human Subjects Research with Environmental Protection Agency (EPA) Support