Guidance on the Five Year Renewal Policy and Replacement Studies in ARROW

Version Date: May 2018

Since 2000, the University of Wisconsin-Madison’s Human Research Protection Program maintained a 5-year replacement/renewal policy. With some exceptions, this policy required study teams to submit replacement/renewal initial review applications every five years for non-exempt human participants research. The IRBs working with the Associate Vice Chancellor for Research Policy and Compliance have determined that this requirement can be eliminated for most studies.

Effective immediately, the 5-year replacement/renewal policy will no longer be in place.

To facilitate the transition, the UW-Madison IRBs will proceed as follows for applications already submitted to the IRB as 5-year replacement/renewal studies:

  • If the submission includes changes of protocol, the UW-Madison IRBs will continue processing those as replacement initial reviews.
  • If the submission does not include changes of protocol, UW-Madison IRB Offices will reach out to the study team to find out whether they prefer to continue with the initial review or submit a continuing review to extend the study.

Please note that the campus IRBs still have the authority to require the submission of a replacement application instead of a continuing review application if the IRB determines that a de novo assessment of the research study is warranted. Examples of when a new application may be requested include when the IRB determines the need for a re-evaluation of the study is appropriate because an amendment or an accumulation of revisions across the life of the study appear to require a substantive re-assessment of prior determinations in regard to the research or substantive revisions to applicable regulations and laws suggest the need for a re-evaluation of the research in light of such changes. We expect requests for replacement studies to occur rarely in future.

FAQs about the Change in Policy

  • Do I still need to submit a replacement application?

    A replacement application will not be required unless the HS IRBs office reaches out to you directly to discuss submission of a replacement study. This means study teams may have protocols that are open well beyond the previous five year mark.
  • Do I still need to submit a continuing review?

    For studies that have not been excepted from ongoing continuing review, continuing review applications should still be submitted. See this Implementing the Campus Revised Continuing Review Policy for more information.
  • What if I have a five-year replacement in progress?

    The HS IRBs Office will work with you to identify whether your application will continued to be processed as a replacement initial review or if you will have a choice of initial review versus continuing review.

Keywords:5 year, 5-year, replacement, renewal, replace, five-year   Doc ID:18868
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-06-16 18:00 CSTUpdated:2018-05-16 13:30 CST
Sites:Health Sciences IRBs
Feedback:  0   0