A Principal Investigator (PI) is the individual responsible for carrying out a scientifically sound, ethical research study consistent with the research plans approved by an IRB. The PI must possess the expertise, time and commitment to conduct and provide the necessary oversight for all aspects of the study, and must be willing to accept full responsibility for the study, including the supervision of any co-investigators, research staff and students. Any co-investigator appointed to act on behalf of the principal investigator (acting in the absence of the PI, for example) must meet all institutional requirements to act as a principal investigator. As an integral part of Tufts’ Human Research Protection Program, PIs share in the responsibility for protecting the rights, safety, and welfare of subjects who participate in research.
Tufts Health Sciences IRB oversees research for Tufts Medical Center (Tufts MC) and Tufts University Health Sciences Campus. Tufts Social-Behavioral-Educational Research IRB (Tufts SBER IRB) oversees SBE research for Tufts University. Tufts IRBs recognize only one principal investigator per human subjects research study. Other individuals may be named co-investigators. In multi-site studies for which Tufts acts as the coordinating institution, the principal investigator assumes the responsibility for the conduct of the study at each performance site and by each site-specific principal investigator.
The PI eligibility criteria described below have been approved by each institution’s respective Institutional Official. Exceptions to this policy are made on a case-by-case basis and must be approved by the IRB Chair and the Institutional Official (IO).
Tufts Health Sciences IRB: Fellows, Residents, PhD candidates/students, graduate students, trainees, and other employees or staff members in learning positions are not eligible to serve as PI. In order to act as an investigator, individuals in learning positions should identify an appropriate mentor to serve as PI.
Tufts SBER IRB: Students and individuals in learning positions are eligible to serve as PI. All student PIs must identify a faculty advisor to oversee the research and fulfill the responsibilities described in Investigator and Faculty Advisor Responsibilities.
Tufts University faculty members have a range of appointment and employment arrangements that may allow for eligibility to serve as a PI. The following classes of individual may serve as PI on human subjects research studies overseen by the Tufts IRBs:
Additional PI Eligibility Criteria in Clinical Research: