IRB Guidance: Change in PI

This page addresses issues related to a temporary or permanent leave of the principal investigator (PI) from UW-Madison.

If a PI is leaving UW-Madison, changes in the PI should be reported to the IRB prior to the former PI leaving the research study, if possible.  In all cases, a PI change should be submitted within 14 business days after the departure of the former PI (per Study Closure Policy).  A change in PI cannot be addressed via the Update Personnel function, but rather requires a Change of Protocol application.

Temporary changes in PI may be needed if the PI cannot provide oversight of a research study for a planned period of time (e.g. parental leave, sabbatical) or unplanned leave for a substantial period of time.  For federally funded research, it is the responsibility of the PI to ensure that funding agencies are notified of any temporary changes.

In cases where the leave will be a month or longer, but is assumed to be temporary, the study team should submit a New Information Report to the IRB confirming one of the following:

  1. No study activities will occur during the PI's leave,
  2. Only activities involving data analysis will occur, or
  3. Identify who will assume PI responsibilities and/or how oversight of study teams will be ensured during the leave
This New Information Report should be provided to the IRB as soon as possible, preferably before the PI takes leave.  A second New Information Report should be submitted when the PI resumes his/her role after the leave ends.

If a change of PI is necessary, carefully review the approved file and ALL supporting documents (recruitment, consent, etc) to ensure that updates are made to reflect the change in PI.

Keywords:PI, study closure   Doc ID:65298
Owner:Laura C.Group:Education and Social/Behavioral Science IRB
Created:2016-07-20 13:51 CSTUpdated:2020-02-28 15:33 CST
Sites:Education and Social/Behavioral Science IRB, VCRGE and Graduate School
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