Preparing for a PI Departure

This page focuses on the actions that must be taken before a PI leaves NIH. If the departing investigator will continue to conduct human subjects research on the NIH protocol after leaving NIH, see Investigators Leaving the NIH for information about Federalwide Assurance (FWA) coverage and IRB oversight requirements.

There can be only one NIH PI for an Intramural Research Program protocol.

If a PI is leaving NIH and the study will continue, another qualified investigator must be identified to assume responsibility for the protocol before the departing PI leaves NIH. The incoming PI must meet NIH requirements for serving as a PI and be approved by the Institute or Center.

A modification must be submitted in PROTECT requesting approval of the new PI. The submission should:

• Remove the departing PI
• Add the incoming PI
• Update the Basic Study Information Smart Form
• Update the protocol
• Update consent documents, if applicable
• Include any other supporting documents necessary to reflect the change

The change in PI must be approved before the departing PI leaves NIH.

If the protocol will not continue after the PI leaves NIH, the study should be closed before departure.

Follow the requirements in Policy 205 – Requirements for IRB Submission and submit all required closure materials through PROTECT for IRB review and approval.

If a departing investigator wishes to take data and/or specimens to a new institution, the transfer must occur only with the appropriate permissions, approvals, and Institute or Center oversight.

Any transfer must be:

• Consistent with the protocol
• Consistent with the informed consent document
• Consistent with NIH records management requirements
• Approved through any required Institute or Center processes

Investigators should begin these discussions early, as approvals and agreements may take time to complete.

If the protocol is associated with a CRADA, licensing agreement, or other technology transfer agreement, the investigator should contact their Technology Transfer Office well before departure.

These agreements may need to be revised or amended to reflect changes in personnel or institutional affiliations.

Before leaving NIH, investigators must work with their Institute or Center to identify the individual who will assume responsibility for maintaining study records at NIH.

Research records must be maintained in accordance with applicable NIH records retention requirements and privacy requirements.

If a departing PI or AI plans to continue conducting human subjects research on the NIH protocol after leaving NIH, additional arrangements may be required to ensure appropriate IRB oversight and FWA coverage.

These requirements vary depending on:

• Whether the investigator will continue as an NIH Special Volunteer
• Whether the investigator will be affiliated with an institution that holds a Federalwide Assurance
• Whether the NIH IRB or an external IRB is providing oversight

For detailed guidance, see Investigators Leaving the NIH.

If you are planning to leave NIH and have questions about protocol management, transfer of responsibilities, record retention, or continued participation in NIH research, contact OHSRP as early as possible to discuss the appropriate next steps.

NIH Manual Chapter 1743 – Managing Federal Records

NIH Manual Chapter 2300-940 – Clearance of Personnel for Separation or Transfer

NIH Intramural Records Retention Schedule

PHS Technology Transfer Policies and Procedures Manual