IRB Policy 110 - Requirements for Acting as a Principal Investigator

IRB Policy 110 - Requirements for Acting as a Principal Investigator

Effective Date: October 11, 2024 (revised version; originally adopted on March 12, 2021)

I. Policy Purpose

The principal investigator (PI) holds primary responsibility for the design, implementation, and ethical conduct of the research protocol. Given the level of accountability and responsibility involved in conducting work with human subjects, the SIUC Institutional Review Board (IRB) requires PIs to hold an appointment as listed in section (A) of this policy. The IRB recognizes that in some situations the role of PI may be appropriate for individuals with other University appointments, provided they receive an exception as stated in section (B) of this policy. 

II. Policy Definitions

Investigator: Department of Health and Human Services (HHS) guidance uses the term “investigator” to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and/or studying, interpreting, or analyzing identifiable subject data.

Principal Investigator: The “principal investigator” holds overall responsibility for the study. The Principal Investigator is responsible for the submittal of the proposed protocol, ethical design and conduct of protocol activities, and supervision of all study personnel.

III. Policy Statement

A. To serve as a Principal Investigator for a human subjects research protocol at SIUC, the investigator must be currently employed by, or enrolled as a student, at SIUC and must
meet one of the following four eligibility criteria:

1. Hold an appointment as a tenured or tenure-track faculty or hold graduate faculty status with the SIUC Graduate School. 
2. Undergraduate and graduate students may serve as a PI for their own projects if they have a faculty advisor who co-signs the protocol application and who is qualified as enumerated in #1.
3. Staff and non tenure-track faculty may act as PI for their own projects with the co-signature of the unit executive (Dean, Director, or other).
4. Retired faculty, staff, or instructors may act as a PI for their own projects with the co-signature of a unit executive (Dean, Director, or other).

B. The IRB may grant an exception to this policy during a convened meeting with a quorum present, provided that a majority of the voting members in attendance approve the exception. To consider the eligibility of individuals who do not meet the criteria outlined in Section A, the IRB requires a rationale for the request, along with details of the individual's relevant experience for serving as a principal investigator.