The University of Arizona

Conducting Human Subjects Research

Investigators who can Conduct a Research Study Overseen by the UA IRB

Serving in the role of Principal Investigator on a human research project is a privilege granted to certain people associated with the University of Arizona. This role carries with it important responsibilities. With the oversight responsibility implicit in the University's review and approval of a project, the University must be in a position of authority over the Principal Investigator's actions. Therefore, an individual's participation in University of Arizona research is dependent upon that individual's relationship with the institution. Research, Discovery & Innovation has set out guidelines that must be met for the consideration of granting status as a Principal Investigator to any individual.

The Principal Investigator (PI) is the individual bearing ultimate responsibility for the design, execution, and management of human research. This includes compliance with government, sponsor, and University policies and regulations, fiscal stewardship of sponsored funds, and all administrative requirements of the project. A Co-Principal Investigator (Co-PI) bears the same rights and responsibilities for the research study as the PI.

Research, Discovery & Innovation has set out guidelines that must be met for the consideration of granting status as a Principal Investigator to any individual (see Principal Investigator Eligibility).

  • An individual to whom the University has issued and the individual has signed an annual Notice of Appointment or Notice of Reappointment, including Emeriti Appointments, or
  • An individual employed by a Federal agency with which the University has an ongoing relationship, pursuant to other formal agreements such as cooperative agreements, or
  • A University of Arizona student who has provided proof of satisfactory completion of all pertinent research training as well as formal approval by a supervising faculty member who meets the criteria set out above, or
  • A visiting professor who has a formal relationship with a University department

If involved in clinical research, as determined by the Institutional Review Board (IRB), the PI is either:

  • A UA faculty physician who holds a College of Medicine Tucson faculty title or appointment; or
  • A physician appointed as an affiliate or associate by the College of Medicine Phoenix, performing clinical work in the Phoenix Metro Area and covered under institutional affiliation agreements that cover such relationships
  • A faculty physician of Banner - Medical Group (B-UMG) conducting research at a Select Site (Tucson, South or Phoenix campuses); or
  • Residents under the direct supervision of a B-UMG physician or University of Arizona Faculty physician

Students or Residents who can Serve as a Principal Investigator

University of Arizona students/residents who act as PIs are held to the same ethical and regulatory standards as faculty PIs. They are expected to follow all University policies and processes regarding human research.

It is at the College and/or Department’s discretion whether a student or resident can serve as a PI. If a student (whether undergraduate or graduate) or a resident is serving as the PI, then a University advisor must be listed on the Verification of Human Subjects Training Form (VOTF) and have current training. The advisor does not need to be the student’s academic advisor or dissertation/thesis committee member, but must have an academic appointment at the University of Arizona. Advisors must sign off on the human research application and will be copied on all correspondence regarding the student’s human research project.

When an Investigator can no Longer Serve as Principal Investigator

If it is foreseen that the PI will be leaving the University of Arizona, or unable to serve as PI for a length of time, measures should be taken to transfer oversight of the human research project to another investigator (see “Amending Approved Research”).

If a principal investigator leaves the University of Arizona or ceases serving as a PI without receiving IRB approval to transfer oversight to another investigator, the project will be administratively closed.

To ensure continuity of research activities, the PI should communicate with their new institution as soon as possible regarding transfer of studies. The University of Arizona Human Subjects Protection Program (HSPP) will work with the PI and the new institution to get the appropriate agreements signed.