Principal Investigator Transfer of Responsibility Guidelines
If a Principal Investigator (PI) would like to, or is required to, relinquish PI responsibility for a research project, they must identify a new PI who will accept responsibility for the study in its entirety, including those actions taken before resuming the role of PI. In addition, if a PI is leaving Northwestern University or transferring to a new institution, they are required to either identify a qualified replacement to serve as the new PI or obtain the appropriate permissions and agreements to continue serving as PI in their new role. Please review the IRB’s Principal Investigator Eligibility and Permissions webpage for our policy on who may serve as PI at Northwestern.
Required Materials for New Principal Investigators
When transferring PI responsibility to a new PI, the following is required:
- A written 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.
Outgoing Principal Investigators
If you are leaving and intend to stay engaged in a human research study you must submit a modification in eIRB+. If you are leaving Northwestern and joining another institution please contact firstname.lastname@example.org to discuss when and if your research activities engage more than one institution.
- If you will retain a Northwestern appointment (i.e. adjunct appointment) and would like to remain as the PI until a new PI is identified please reference the section Principal Investigator Permissions. Once your appointment expires you must be removed from the Northwestern study team.
- If you will no longer have a Northwestern appointment you can NOT be on the Northwestern study team.
- It is our preferred practice for an individual to be on only one study team. If your activities will engage your new institution it is likely inappropriate to be listed as a Northwestern study team member. Please contact email@example.com for assistance.
- Contact MTA@Northwestern.edu before you leave if you plan to access research data or specimens after you leave Northwestern in order to establish the appropriate agreements.
Principal Investigator Permissions
Principal Investigators who leave the institution are responsible for notifying the IRB well in advance of their departure so that he or she can make arrangements to either close their study or name another appropriately qualified individual who is currently at the institution to serve as the study’s PI. However, there may be instances where the PI of an active IRB approved study may have their faculty status changed from regular to adjunct and request to retain their Principal Investigator role for their existing IRB approved study or studies.
When their status changes, the Principal Investigator must obtain permission from the Associate Vice President for Research to continue to serve as the Principal Investigator for each of their active studies. In such cases, please contact the Associate Vice President for Research via email to request permission to continue to serve in the capacity of Principal Investigator. The email must include the following:
- An explanation for your request to retain your PI role
- A current copy of the PI’s CV
- Copy of the IRB approved protocol and most recent initial or continuing review approval letter
- A letter of support from the PI’s department chair, division chief, school dean, unit director, or hospital supervisor
- A supplemental document that contains the PI’s plan to manage the study, provide oversight, communicate with study team members and participants, and adhere to other compliance obligations.
If approval is granted you, as the study’s PI, must submit a modification application to inform the IRB of the appointment change. The submission must also include the management plan submitted to the Associate Vice President for Research and a PDF copy of the confirmation email. These materials should be uploaded into the “Supporting Documents” section of the corresponding eIRB+ submission.
If a Study Will Be Closed, Not Transferred
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 information on study closure can be found on our Policies & Guidance webpage.