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. A change in PI cannot be addressed via the Update Personnel function, but rather requires a Change of Protocol application.
If the former PI is leaving the institution but will remain a study team member, please contact the Reliance and Navigation Team (irbreliance@wisc.edu) to discuss what additional steps may need to be taken to ensure appropriate IRB oversight is in place.
If the PI (or another study team member) is leaving the UW and plans to take research data or specimens with them, there are contractual agreements that may be needed in order to share individual level human subjects research data/specimens. Please see this guidance.
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 less than 6 weeks, but is assumed to be temporary, the PI is responsible either for ceasing study activities or ensuring oversight of these activities is delegated to a qualified member of the study team. The study team does not need to inform the IRB in these cases.
In cases where the leave will be 6 weeks 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:
- Specifies the anticipated length of absence,
- No study activities will occur during the PI’s leave,
- Only activities involving data analysis will occur, or
- Identify who will assume PI responsibilities and/or how oversight of study teams will be ensured during the leave
The New Information Report should be provided to the IRB as soon as possible, preferably before the PI takes leave. If the PI cannot return from leave as planned or changes their role after the leave ends (e.g., becomes a sub-investigator), a change of protocol to formally update the PI for the study would be required.
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.