Study PI Eligibility Guidance

For clinical research projects requiring full IRB review, including most prospective studies intended to generate generalizable knowledge and retrospective chart reviews involving more than three patient records, the faculty mentor should generally be PI-eligible (or Affiliate PI-eligible, as applicable) at the institution where the research is conducted.

PI eligibility requirements are often determined by the research institution rather than the UA Human Subjects Protection Program. Mentors are responsible for ensuring they have the appropriate authority and institutional permissions to oversee student research. If a mentor is not PI-eligible at the study site, the project may need to be modified to a minimal-risk design or an eligible PI identified. The research mentor can subsequently become a co-PI on the project.

Requirements vary by institution and study design. For example:

• Banner Health: Studies using Banner resources (e.g., patient charts, EMR/CRDW data, biological specimens, recruitment services, clinical space, or staff support) typically require Banner feasibility review in addition to UA IRB review. Banner verifies that the faculty mentor meets PI or Affiliate PI eligibility before feasibility review proceeds. 
• UA IRB-only Minimal-risk Studies: Projects such as quality improvement, program evaluation, de-identified or publicly available data analyses, determinations of human research, case reports/series (≤3 patients), and many exempt or Flex-reviewed studies generally do not require mentor PI eligibility, provided they do not involve Banner resources, PHI, or other regulated activities.
• External Institutions (e.g., Mayo Clinic, Valleywise, Phoenix Children's, VA, St. Joseph's): The local institutional IRB is often the IRB of record, with UA relying on or deferring to that review when appropriate.
• Private Practices or Clinics Without an IRB: UA typically requires written site authorization before review can proceed.

The level of oversight depends on factors such as:

• Study design and intent to generate generalizable knowledge
• Access to PHI or coded patient data
• Participant interaction or intervention
• Vulnerable populations
• Drugs, devices, or other regulated activities
• The institution and resources involved
• External funding

Because of the UA-Banner academic partnership, the UA IRB is frequently the IRB of record for Banner studies; however, Banner feasibility approval remains a prerequisite for applicable projects.

Resources (Requires NetID Access):

•    UA Principal Investigator Eligibility Guidelines. 
•    Banner Health Collaborative Activities Guidance

Faculty mentors should be PI-eligible at the institution where the research is conducted whenever required by the study design and institutional policies. PI eligibility is determined by the institution, risk level, and resources used - not by a single universal standard. Please verify this information before starting to develop your project and submitting for feasibility review.

Research Transition & Notification Resources 

Incoming Research Notification Form

For researchers joining the University of Arizona who have research-related activities that may require institutional coordination or compliance review. This form helps the Office of Research & Partnerships (ORP) identify research activities that may need follow-up support, even when no active sponsored funding is involved.

Research Transition Notification Form

For Principal Investigators departing the University of Arizona or changing their institutional status. This form helps coordinate research continuity, compliance requirements, and administrative transitions associated with research projects.