PI Eligibility

POLICY

A Principal Investigator (PI) is the individual responsible for conduct of research. If the research is conducted by a team of individuals, the leader of the team is designated as PI. The PI is responsible for the proper conduct of research in compliance with IRB policies and applicable regulatory requirements as outlined in the IRB Policy - PI Responsibilities.

This policy is applicable only to UTHealth Houston faculty, students and staff.  UTHealth Houston IRB serves as the IRB for Memorial Hermann Health System. UTHealth Houston will rely on MHH policies on PI eligibility for any research studies submitted by MHH employees.  UTHealth Houston IRB sometimes serves as a reviewing IRB for external institutions. For these submissions, the IRB will rely on the external institution’s PI eligibility rules.

Who is eligible to serve as PI on an IRB Protocol Submission:

The PI of a human subjects research submitted to the IRB must meet all of the following:

• Have an appointment at UTHealth Houston that meets one or more of the following:
• Professor
• Associate Professor
• Assistant Professor
• Instructor
• Faculty Associate

Who is not eligible to serve as sole PI on an IRB Protocol Submission:

Individuals not qualified to serve as a PI at UTHealth Houston include:

• Residents, fellows and other trainees
• Masters level and PhD students doing research for a thesis
• RNs, therapists or technicians who do not hold an advanced degree that includes research training
• Individuals without a permanent UTHealth Houston appointment
• Individuals who are not paid employees of UTHealth Houston

Postdoctoral fellows, clinical fellows, residents and students are allowed to serve as co-PIs on IRB applications with faculty supervisor as PI.  

Student Researchers:

All student-conducted research involving human subjects must have a faculty sponsor who is eligible to serve as a Principal Investigator (PI). The faculty sponsor is required to assume the role of PI on the Institutional Review Board (IRB) application and is responsible for the oversight and ethical conduct of the student’s research activities.

Although the faculty sponsor is commonly the student’s dissertation or thesis chair, this is not a requirement. The faculty sponsor and the student investigator are jointly responsible for ensuring compliance with all applicable University policies, procedures, and federal regulations governing the conduct of research.

In the UTHealth Houston IRB system, the faculty sponsor must be designated as the PI. The student investigator must be listed as a co-investigator or collaborator on the IRB application.  The student investigator may complete the IRB application.

This policy does not govern or determine authorship decisions. Students may be designated as first authors on publications resulting from the research when that status is earned. The designation of Principal Investigator (PI) for IRB purposes is independent of authorship order and does not imply or determine first authorship.

UTHealth students conducting human subjects research at sites unaffiliated with UTHealth Houston may not require individual approval from the UTHealth Houston IRB if all of the following conditions are met:

• Their research mentor (PI) is not a UTHealth Houston faculty or staff.
• They have IRB approval from the external institution.
• Their research is not funded by extramural grants awarded to or submitted through UTHealth Houston
• The research does not involve UTHealth Houston facilities, medical records, patients, or personnel.

If any of these criteria are not met, the student must obtain individual approval from the UTHealth Houston IRB and work under the supervision of a qualified UTHealth Houston faculty member who will serve as the PI.

PI Eligibility Table

*Exceptions:

*Certain sponsored project grants may be specifically directed to the fund or designed to support individual students, fellows, or other non-permanent personnel—such as those offered through doctoral dissertation awards or individual predoctoral and postdoctoral fellowship programs. These proposals may require the individual applicant (e.g., the student or fellow) to be listed as the Principal Investigator (PI) in the application. In these cases, the student may request the IRB for an exception to PI eligibility requirements.

*The Institutional Official may grant permission for residents, fellows or students in a PhD program on a case by case basis.

REFERENCE TO OTHER POLICIES

1. PI Responsibilities

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