Closing protocols or PI departures

We understand that unexpected staffing changes and other challenges may, for some human subjects research protocols, result in the need to close protocols or transfer responsibility to a new PI. In such circumstances, it is essential that there is an orderly process to ensure the safety and welfare of participants.

If the Principal Investigator is leaving the institution, either the protocol must be closed or responsibility transferred to a new PI. There can be no period in which there is no NIH PI available and responsible for the protocol.

• If the protocol is to be closed and there remain participants that are actively participating in the research, the process and responsibilities will differ depending on the nature of the protocol.
  • If the participants are receiving an intervention that has the prospect of direct benefit or that requires ongoing monitoring for safety and welfare, there must be a plan to safely transfer their care to another responsible physician, either within NIH or in the community. If the reason the protocol is closing is because of the departure of the PI, it may be necessary to assign a new PI for at least an interim period while the participants are transitioned. If a PI cannot be identified and the protocol must remain open to facilitate transitioning participants, the IRB will assign the Clinical Director as the PI of the protocol. Any active participants should be notified any change in PI or closure of the protocol.
  • If there are no participants actively participating, or if the nature of the protocol is such that there is no need for ongoing monitoring or care, for example a study that enrolls healthy volunteers, the protocol may be closed. Any active subjects should be notified that the protocol is terminated.
• Once a protocol is closed with the IRB;
  • No further interventions or interactions with participants for the purposes of research are permissible.
  • No identifiable data or identifiable biospecimens can be used for research purposes without submission and approval by the IRB of a secondary research protocol. However, identifiable data and biospecimens can be retained consistent with the terms of the informed consent.
• If the PI is leaving the institution and wishes to transfer specimens and/or data to a new institution, appropriate clearances must be obtained from IC leadership and if necessary, NIH Tech Transfer and the IRB office.
• If there is a lapse in PI oversight, an RNI must be submitted via PROTECT.
• Exempt protocols do not need to be closed with the IRB.

Please also refer to our guidance document on this topic posted with the policy below.