Section IX:

Principal Investigator Requirements

WPP #: IX-2

Title 2:

Principal Investigator Absences

Effective Date:

05-14-14

Revision History:

06-21-06, 11-1-06

Policy Statement

It is the responsibility of the principal investigator to ensure the ongoing safety of all research subjects participating in the protocol and to ensure that they actively oversee the research, including the supervision of personnel. In the case of any PI absence, where the person listed as PI on the IRB-approved protocol cannot fulfill responsibilities of the PI, the appointment of a permanent replacement PI must be approved by the VCU IRB.

If the VCU IRB has a specific need to contact a PI, who is unavailable and has not designated an interim or replacement PI, the PI’s department chairperson will serve as acting PI until such time as he/she appoints an official interim or replacement PI.

Description and Procedures

In accordance with federal regulations, any changes in the PI’s research plan must be submitted to the IRB for review and approval prior to implementation of such a change. This includes changes in investigator, interventions, inclusion/exclusion criteria, location of research, advertisements for the recruitment of subjects, and any other change. If an immediate change is needed in order to ensure the ongoing safety of human research subjects, than the change should be implemented and reported to the IRB as soon as possible.

In most cases, reliable availability via email or telephone does not constitute an absence (under this policy), as long as the principal investigator remains able to fulfill his or her responsibilities during that time.

If an absence is planned that will render the PI unable to fulfill his/her duties as PI, he or she must appoint a duly qualified individual to serve as the replacement PI. VCU IRB approval of the replacement PI must be requested with a modification submission.

If an absence is unplanned (where the PI is not able to fulfill his/her duties as PI), an appropriate representative (such as a co-investigator or department chairperson) must identify a comparably qualified individual to assume the PI responsibilities immediately, in order to ensure the ongoing protection of the human subjects. The IRB must be notified of this action and a new permanent PI must be requested with a modification submission as soon as possible. The IRB is required to review and approve the qualifications of the newly designated PI.

References

VCU IRB WPP IX-1 Requirements for Serving as PI and Statement of Responsibilities