If a Principal Investigator (PI) would like to or is required to relinquish PI responsibility for a research project, a new PI must be identified and accept responsibility for the study in its entirety.
When transferring PI responsibility to a new PI, the following is required:
- A formal statement of transfer from the current PI and a statement of acceptance from the new PI
- Revisions to the current study documents to update the PI name and contact information
- A Modification submission in eIRB+ to change the PI
The new PI must also have access to all current and previous regulatory documentation and participant file documentation (if applicable).
HRP-1408 Principal Investigator (PI) Transfer of Responsibilities Checklist provides a comprehensive list of study record considerations and can be completed when transitioning a study to a new PI. This document does not have to be submitted to the IRB but can be retained in the regulatory binder/research record.
Incoming PIs with Ongoing Research:
- If you are joining the Northwestern from another institution and you plan to continue an existing research study:
- Email IRBReliance@Northwestern.edu to discuss your ongoing research, determine whether the research requires formal review by the Northwestern IRB, and determine whether IRB agreements between Northwestern and another entity are required
- Contact MTA@Northwestern.edu if you may be bringing data or specimens with you to Northwestern to establish the appropriate agreements
- If you are leaving and plan to continue to participate in the research:
- Submit the modification request to transfer the ongoing research to a new Northwestern PI
- When you have left the institution, the new PI may submit a modification request to add you back to the study in your new role if you will be engaged in Human Research, including access to identifiable research data
- Contact MTA@Northwestern.edu before you leave if you plan to access research data or specimens after you leave Northwestern to establish the appropriate agreements
PIs with Multiple Appointments:
- Investigators who maintain more than one faculty appointment are encouraged to contact the IRB to discuss when and if their research activities engage more than one institution
- When in doubt, submit a request to the IRB for a formal determination
- If your research engages Northwestern without obtaining IRB approval from Northwestern before you start your research, it cannot be subsequently reviewed and approved by the Northwestern IRB
If a study while be closed rather than transferred to a new PI:
If a PI wishes to close a study rather than transfer responsibility to a new PI, the following should be considered:
- All data and records, including regulatory documentation and participant files, should be retained per the University’s retention policy
- The study should be closed in eIRB+ through a Continuing Review application
Additional guidance on study closure can be found here.