Delegation of Principal Investigator (PI) responsibilities during a Leave-of-Absence (LOA)

During any period of unavailability, the principal investigator (PI) should delegate responsibility for study oversight to an appropriately qualified research staff person, typically a sub-investigator (SI). 

Planned leave of less than one month does not require a management plan to be submitted to the IRB.

Planned leave of one to three months is generally acceptable with submission of a management plan detailing how study oversight will continue uninterrupted.

The management plan should include the following information:

• Anticipated dates of absence.
• Name(s) of the SI/research staff person who will provide oversight during the LOA. [And, if not previously submitted, Curriculum Vitae, any Financial Conflict-of-Interest disclosure, and acknowledgement of Human Subjects Research training].
• A list of the impacted studies under WCG oversight.
• Whether the PI will be available for consultation purposes during the LOA period to help the designated SI with the study conduct.
• Any concurrence from the sponsor/CRO regarding nomination of the SI providing coverage, if available.

Planned leave of more than three months requires a change in PI (see “A Change of Principal Investigator”).

For unplanned PI leave of absences of any length, the site should inform the IRB as soon as possible so that either a management plan can be developed or a change in investigator initiated.