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.

UNC-CH Affiliation	Permitted to serve as PI?
Faculty with a permanent EHRA faculty appointment and 0.75 to 1.0 Full-Time Equivalency (FTE) hours.	Yes
Faculty member with FTE is between 0.50 and 0.74	Yes. PI Eligibility Waiver Request Form must be approved and signed by the dean, director, or department head/chair of the faculty member’s appointing department.
Faculty member with FTE less than 0.50	Yes. PI Eligibility Waiver Request Form must be approved and signed by the responsible dean, director, or department head/chair of the faculty member’s appointing department and sent to the Office of Human Research Ethics Director for approval. This will delay the start of the project.
EHRA Non-Faculty Employees	Yes
UNC Students (Graduate and Undergraduate Students)	Yes, but required to have a faculty advisor at  UNC-CH who meets PI eligibility criteria
Fogarty Global Health Fellows (UNC Institute for Global Health & Infectious Diseases)	Yes, but required to have a faculty advisor at  UNC-CH who meets PI eligibility criteria
UNC-CH SOM Residents and Fellows	Yes, but required to have a faculty advisor at  UNC-CH who meets PI eligibility criteria
Post-Doctoral Fellows	Yes, but required to have a faculty advisor at   UNC-CH who meets PI eligibility criteria
Emeritus Faculty who do not have affiliations at other institutions or organizations	No, with the exception of studies that are minimal risk or are in data analysis only.  PI Eligibility Waiver Request Form must be approved and signed by the dean, director, or department head/chair of the faculty member’s previous department.
Emeritus Faculty who have primary affiliations at other institutions or organizations	No
SHRA Employees and SHRA Temporary Employees	No
Staff Retirees	No
Adjunct Faculty who do not have primary appointments at other institutions or organizations.	Yes. PI Eligibility Waiver Request Form must be approved and signed by the dean, director, or department head/chair of the faculty member’s appointing department.
Adjunct Faculty who hold primary appointments at other institutions or organizations.	No
Other UNC Academic Affiliation	No
UNC Health or other UNC Medical Center employees	No
Visiting Scholars (holding primary appointments at other academic or research institutions)	No
Research Affiliates associated with other institutions or organizations	No
Research Affiliates not affiliated with other institutions or organizations, with no other contract to work as a UNC employee	No
Contractors with no executed contract for employment with UNC	No
Contractors with executed contracts for employment with UNC	No
Volunteers with executed contracts for volunteer employment with UNC	No
Interns who are not UNC Students but are affiliated with another institution and do not have a contract for employment with UNC	No
Interns who have a contract for employment with UNC	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]