Purpose

This document defines eligibility criteria for individuals serving as a Principal Investigator (PI) or Faculty Advisor (FA) of a human subjects research study at the University of North Carolina at Chapel Hill.

Given that human subjects research is at the core of the University of North Carolina at Chapel Hill’s mission, it is essential that highly qualified individuals are designated to serve in the role of Principal Investigator (PI) in a manner consistent with the Board of Governor’s policy regarding the appropriateness of University Research, and aligned with the University’s policy on ethics in research.

Position Statement

Principal Investigator (PI) or Faculty Advisor (FA) are responsible for conducting ethical, scientifically sound research in accordance with IRB-approved protocols. They must demonstrate appropriate expertise, availability, and commitment to oversee all aspects of the study, including supervision of co-investigators, research staff, and students.

As part of UNC-Chapel Hill’s Human Research Protection Program, PIs and FAs share responsibility for safeguarding the rights, safety, and welfare of research participants.

UNC-Chapel Hill IRBs recognize only one PI per human subjects research study. Additional individuals may be listed as sub-investigators or study team members. In multi-site studies where UNC-Chapel Hill serves as the coordinating center, the PI is accountable for study conduct across all participating sites and investigators.

In accordance with the University eligibility policy, a faculty member is eligible to serve as a Principal Investigator (PI) on human subjects research studies if they have:

• a permanent EHRA faculty appointment and
• 0.75 to 1.0 Full-Time Equivalency (FTE) hours.

A faculty member is eligible to serve as a Faculty Advisor on human subjects research studies if they have:

• a permanent EHRA faculty appointment and
• 0.75 to 1.0 Full-Time Equivalency (FTE) hours.

Other individuals may be permitted to be PI based on their role within UNC and their qualifications, as detailed in the table below. The completed PI Eligibility Waiver Request Form must be submitted as an attachment in the IRBIS application. The IRB and/or Institutional Official retain the final authority to determine if an individual will be covered by the UNC-CH IRB and if an individual is appropriate to serve in the role of PI.

If covered by UNC-CH IRB is “No,” a request for reliance may be submitted for consideration: [email protected]

UNC-CH Affiliation	Covered by UNC-CH IRB?	Permitted to serve as PI?
Faculty (EHRA, 0.75–1.0 FTE); Professor, Associate, Assistant, Instructor, Lecturer, Teaching, Clinical, Research	Yes	Yes
Faculty (0.50–0.74 FTE)	Yes, when acting in UNC-CH role	Yes, but PI Eligibility Waiver required (dept leadership approval)
Faculty (<0.50 FTE)	Yes, when acting in UNC-CH role	Yes, but PI Eligibility Waiver and OHRE approval required (may delay start)
EHRA Non-Faculty Employees	Yes	Yes
UNC-CH Students	Yes, when acting in UNC-CH role	Yes, with eligible faculty advisor
UNC-CH Fellows and Trainees	Yes	Yes, with eligible faculty advisor
Emeritus Faculty (with no other external primary affiliation)	Yes	No, except minimal risk/data-only with waiver
SHRA Employees	Yes	No
Adjunct Faculty (no other primary affiliation)	Yes	No
Contractors with UNC-CH contract	Yes	No
Volunteers with UNC-CH contract	Yes	No
Interns with UNC-CH contract	Yes	No
Emeritus Faculty (with other external primary affiliation)	No	No
Staff Retirees	No	No
Adjunct Faculty (with other affiliation)	No	No
Other UNC Institutions	No	No
UNC Medical Center Residents/Fellows	No	No
Visiting Scholars	No	No
Research Affiliates (external)	No	No
Research Affiliates (no affiliation)	No	No
Contractors without UNC-CH contract	No	No
Interns (no contract)	No	No
Emeritus Faculty (with other affiliation)	No	No

References:

Office of Human Research Ethics SOP 1501: Investigator Responsibilities
Office of Sponsored Programs – 200.03 – Principal Investigator Eligibility

Policy Contact

Name: Carley Emerson
Title:  Director 
Unit: Office of Human Research Ethics (OHRE)
Email: [email protected]

Version History

• Version 1: 09/12/2025
• Version 2: 06/11/26, revisions include added column for “Covered under UNC-CH” and updated affiliation titles