The purpose of this document is to describe available options and next steps when a Principal Investigator (PI) on a Health Sciences Institutional Review Boards (HS-IRBs)-approved human subjects research study departs from the University of Wisconsin-Madison (UW-Madison).
- Study Closure
- New PI at UW-Madison
- Transferring Study to New Institution
- IRB Reliance Options
- Other Institutional Considerations
Closing the StudyIf study activities are complete, including data analysis, and the PI will not have access to identifiable data, then the study can be closed at UW-Madison. Please see the Study Closure policy and How to Close Studies to determine if a study can be closed and, if so, how to close it in ARROW.
New PI at UW-MadisonIf study activities are not complete and the study will continue at UW-Madison, then a new UW-Madison PI will need to assume responsibility for the study. This is the case even if the current PI holds an honorary appointment at the UW. Per campus policy, an honorary appointment does not meet the requirements to serve as a PI on a human subjects research study. Follow How to Complete Changes of Protocol to submit a full change in ARROW and use the following guidance documents as needed: How do you change the responsible principal investigator? and Personnel Change Guidance. A PI change 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. Prompt reporting of PI changes is required to ensure adequate oversight is in place for the conduct of the protocol and the protection of human subjects.
Transferring Study to New InstitutionIf study activities are not complete but the PI will be continuing his or her work at the new institution, then the IRB at the new institution will need to approve the study. Depending on the institutional requirements, the study consent forms, recruitment materials, etc. may need to be altered before receiving approval. Once the new institution has approved the study, then the PI should follow the UW Policy on Data Stewardship, Access, and Retention to receive approval for transferring data. If specimens are involved, a Material Transfer Agreement may also be necessary. Finally, the study will need to be closed out at UW-Madison. Please see the Study Closure policy and How to Close Studies to determine if a study can be closed and, if so, how to close it in ARROW.
IRB Reliance OptionsFor studies that will remain open, the study team should consider whether an IRB reliance arrangement may be an option for streamlining the IRB process. An IRB reliance arrangement allows the UW to serve as IRB of record for another institution or vice versa. Such arrangements can be helpful in situations where the former UW PI wishes to continue limited work on the study or limited study activities will be occurring at the UW and the study will also be opened at the PI’s new institution. For help in determining whether an IRB reliance arrangement may be helpful when a UW PI is leaving the UW, please contact the HS-IRBs’ Reliance Team (firstname.lastname@example.org).
Other Institutional ConsiderationsThe PI will be responsible for following campus policy on lab close-out. The checklist of necessary activities is not only limited to research materials and laboratory space but also includes tasks addressing university data and materials, access control, and human resources and administration. If transferring data, please also refer to the UW Policy on Data Stewardship, Access, and Retention to receive approval. If specimens are involved, a Material Transfer Agreement may also be necessary. PIs with ClinicalTrials.gov records who are leaving the UW should contact ClinicalTrials.gov_Support@research.wisc.edu or call (608) 890-1241 to arrange for either a CT.gov record update (as the protocol is amended to include a new PI) or to record transfer to the new institution.
- Study Closure
- How to Close Studies
- Principal Investigator Status for UW–Madison Studies Involving Human Participants
- How to Complete Changes of Protocol
- How do you change the responsible principal investigator (PI)?
- Principal Investigator Changes and Personnel Updates Guidance
- Research Close-Out Checklist