PI Temporary Leave/Sabbatical, etc.
Description
Temporary changes in PI may be needed if the PI cannot provide oversight of a research study for a planned period of time (e.g., parental leave, sabbatical) or unplanned leave for a substantial period of time. For federally funded research, it is the responsibility of the PI to ensure that funding agencies are notified of any temporary changes.
Note: The PI must be available on a daily basis to provide oversight of the research study, study team, and student researchers and be accessible and responsive via email to IRB/OPRS requests.
In cases where the leave will be less than 6 weeks, but is assumed to be temporary, the PI is responsible either for ceasing study activities or ensuring oversight of these activities is delegated to a qualified member of the study team. The study team does not need to inform the IRB in these cases. Delegation of tasks must be appropriately documented via the study Delegation Log and potentially a Note to File/memo.
In cases where the leave will be 6 weeks or longer, but is assumed to be temporary, the study team should submit a Report Form of Information to the IRB confirming one of the following:
- Specifies the anticipated length of absence,
- No study activities will occur during the PI’s leave,
- Only activities involving data analysis will occur, or
- Identify who will assume PI responsibilities and/or how oversight of study teams will be ensured during the leave
The Report Form should be provided to the IRB as soon as possible, preferably before the PI takes leave. The IRB will acknowledge the report form if the plan provided is acceptable, but may require changes to the plan depending on specifics of the study and circumstances.
If the PI cannot return from leave as planned or changes their role after the leave ends (e.g., becomes a sub-investigator), an amendment to formally update the PI for the study would be required.
If a change of PI is necessary, carefully review the approved file and ALL supporting documents (recruitment, consent, etc.) to ensure that updates are made to reflect the change in PI.
Related Documents
- Delegation Log Template 1
- Delegation Log Template 2
- Delegation Log Template 3
- Note to File Template
- Report Form