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.
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.
Incoming PIs with Ongoing Research
- If you are joining Northwestern University 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 in order 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 Human Research Determination Form (HRP-503) and 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 Will 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 information on study closure can be found on our Policies & Guidance webpage.