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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).

IRB-Specific PI Eligibility Criteria

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.

PI Eligibility Criteria for Tufts Medical Center

  1. Active Staff Physicians employed by an organization contracted to provide physician services at Tufts Medical Center
  1. Non-physicians who hold a full-time employment position at the Medical Center, are conducting research related to their specialized field and/or official duties, and have adequate expertise to conduct the research study.
  1. Administrative Staff who hold a full-time employment position at the Medical Center, are conducting research related to the individual’s official duties at Tufts MC, and have adequate expertise to conduct the research study.
  1. Registered nurses may conduct research as principal investigators (PI) under the extent and provisions of their licensure. The registered nurse must be a 36-hour/week employee at Tufts Medical Center. A registered nurse is excluded from serving as a PI for clinical trials related to medications, devices, medical treatments or interventions. In these cases a registered nurse may serve as a research team member.
  1. Any other person who wishes to act as a PI for a project undertaken at Tufts Medical Center must have adequate expertise to conduct the research study and permission from the appropriate Departmental Chairperson/Division Chief. These decisions are made on a case-by-case basis and must be approved by the IRB Chair and the Institutional Official.
  1. For studies involving administration of a drug or device for research purposes OR for studies involving patient care, also refer to the requirements listed under Additional PI Eligibility Criteria in Clinical Research below.

PI Eligibility Criteria for Tufts University

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:

  1. Individuals with paid faculty appointments at Tufts University. This does not include individuals with faculty appointments listed in #5.
  1. Senior Scientist, Scientist I, II, or III (HNRCA only).
  1. Non-faculty, professional staff who hold a full-time employment position at the University, are conducting research related to their specialized field and/or official duties, and have adequate expertise to conduct the research study.
  1. Administrative Staff who hold a full-time employment position at the University, are conducting research related to the individual’s official duties at the University, and have adequate expertise to conduct the research study.
  1. Emeritus, Adjunct or Visiting Professors and employees appointed as an Instructor, Lecturer, or Professor of Practice are not eligible to serve as PI, unless they are if granted an exception to the University’s PI status policy. These decisions are made on a case-by-case basis and must be approved by the IRB Chair and the Institutional Official.
  1. Students and individuals in learning positions may be eligible to serve as PI, according to the IRB-Specific PI Eligibility Criteria listed above.
  1. For studies involving administration of a drug or device for research purposes OR for studies involving patient care, also refer to the requirements listed under Additional PI Eligibility Criteria in Clinical Research below.

Additional PI Eligibility Criteria in Clinical Research:

  1. When the research involves the administration of a drug or use of a device for research purposes, the PI must be a licensed physician or the study must include a named Study Physician.
  1. For all research studies involving patient care, if the PI is not a physician:
    1. An appropriate physician must be identified as a co-investigator to be responsible for the clinical aspects of the study; or
    2. The appropriate Departmental Chairperson/Division Chief must submit an oversight plan to be approved by the IRB Chair and IO.
  1. For any study, whether the study site is Tufts Medical Center, Tufts University, or elsewhere, physicians, nurses, and other research team members must be credentialed/approved at that site prior to initiating clinical research, if required based on their role in the research study and at Tufts. The PI and research team members must be sure to satisfy the credential requirements of each institution involved in the research, as credentials are not transferable from one institution to the next.