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:

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