Frequently Asked Question
Given the level of responsibility they assume for protocols, the Heath Sciences IRBs require changes of PIs to be reviewed as full changes of protocol to ensure adequate vetting of the newly proposed PI's ability to serve in this capacity and determine whether he or she meets Principal Investigator Status for UW–Madison Studies Involving Human Participants.
The research team should consider whether study documents were affected by this change:
- consent form
- HIPAA form
- study protocol
- recruitment materials
If the subjects are still participating in a research study, the IRB recommends research teams provide a written update to these participants, such as an information sheet or letter, to inform them of the change in PI and to update them regarding changes in relevant telephone numbers (e.g., for study related questions) and addresses (e.g., to withdraw authorization).
These changes should be submitted within 14 days of the departure of the former PI to obtain review and approval by the IRB prior to the new PI assuming oversight of the study.