PI Eligibility
Principal Investigator Eligibility
IRB-40, PI Eligibility & Responsibilities, defines who is permitted to be PI on human subjects research (HSR) studies. The policy describes individuals who are automatically eligible to be PI, individuals who can be PI with an approved exception request, and individuals who are not permitted to be PI. Eligibility requirements apply to all exempt, expedited, and full board HSR studies.
To be eligible to serve as a PI, individuals are required to be a full-time employee within a Baylor school, department, center, or institute with one of the following Baylor titles:
- Tenured/Tenure-track Faculty: Assistant Professor, Associate Professor, Professor, Distinguished Professor, University Professor
- Lecturer Faculty: Lecturer, Senior Lecturer, Teaching Professor
- Clinical Faculty: Clinical Instructor, Clinical Assistant Professor, Clinical Associate Professor, Clinical Professor
- Academic Professionals
- Administrative, Center, or Institute Staff: Director-level or above
Undergraduate students, graduate students, post-doctoral, part-time, adjunct, and all other employees/appointees are not eligible to serve as PI without an approved exception request. Ineligible individuals may serve as co-investigators or senior/key personnel on HSR studies under the mentorship of an appropriately trained, qualified, and PI-eligible faculty member serving as PI.
Exception Requests
In compelling instances, it may be appropriate for individuals who do not meet the eligibility requirements to serve as PI (e.g., external funding requirement, significant research experience as a PI). Exception requests can be made for a specific HSR study or for blanket PI eligibility of an individual. To request an exception, the individual must submit a completed F-21, PI Eligibility Exception Request, along with a copy of their CV/resume to IRB@baylor.edu. The request must justify why the individual should be designated as PI.
FAQ
Yes – a student can create and/or submit the IRB application, protocol, consent documents, etc. in IRBNet. However, the PI must sign the IRBNet submission package.
A project that does not meet the definition of human subject research is not regulated or overseen by the IRB. The NHSR determination request is meant to proactively confirm that a project does not meet the definition of human subject research that requires IRB review. If the IRB office agrees with your decision that the project is NHSR, you will receive an official NHSR determination. Since this means that the IRB does not have oversight, the person who submits the NHSR application does not need to meet the PI eligibility criteria and an NHSR application can be submitted by any employee or student (so long as the project falls within the scope of their institutional role/responsibilities or academic activities).
The NHSR determination relates to the specific project details, not the individual who submits it. This also means that CITI training is not required in order to conduct NHSR. However, please note that if you submit an NHSR application and the IRB office determines that the project is HSR and thus requires an exempt or expedited/full board submission, the PI on the HSR submission must be someone who meets PI eligibility criteria and all research team members must have completed the appropriate CITI training.
