HRPP Manual Section 4-9

Designation as Principal Investigator

Only certain persons may be designated as the Principal Investigator (PI) on a human subject research study.

The general PI requirement is that unless an exception is granted, to be designated as PI on a human research study, an individual must:

  • Be Michigan State University (MSU) regular faculty, emeritus / retired faculty, and fixed term faculty employees (including librarians),

  • Have a paid appointment, and

  • Have a rank of assistant professor or higher, or rank of librarian.

Students, staff, and individuals holding other appointment titles, such as research associate, specialist, post-doctoral fellow, visiting, adjunct, or clinical faculty, may be designated on the MSU Institutional Review Board (IRB) submission as an additional investigator, but not as the PI. If an emeritus / retired faculty no longer has a paid appointment, an exception request must be submitted for the individual to serve or continue to serve as a PI on a human research study. Exceptions to the general PI requirement are outlined in the “Exceptions” section below. In the case of graduate student research for theses or dissertations, the student's major advisor or another faculty member should be designated on the MSU IRB submission as the PI and the graduate student as an additional investigator.

When an individual accepts the role of PI on a human research study, they accept the responsibility for the proper execution of the research and are accountable for the conduct and oversight of the study.  The IRB does not have a specific limit on the number of research studies for which an individual may accept the role of PI since there are many factors to consider in addition to the number. However, an individual should not accept the role of PI unless they have the time, effort, and ability to maintain adequate oversight over the conduct of the study. This oversight includes, but is not limited to, protecting the rights and welfare of research subjects, overseeing the conduct of study personnel, complying with relevant standards and policies, and maintaining adequate resources to fulfill these commitments. See Human Research Protection Program (HRPP) Manual 4-6 “Responsibilities of Investigators.” The PI is responsible for assessing their overall workload and resources and determining whether they have the needed time, effort, and ability to appropriately oversee the study. The IRB, on a case-by-case basis, may assess the number of open studies in which an individual is the PI. Assessments should include, but not be limited to, information about studies with active enrollment (e.g., number of research staff, local subject enrollment, complexity of the research studies, risk level, number of studies), the PI’s role on other human research studies, and time commitment to other university activities.

Individuals who have academic year (AY) appointments that serve as PI on human research studies are expected to fulfil their responsibilities as PI on the study during duty and non-duty periods. If an individual is unable to fulfil their responsibilities as PI, a request to change the PI would need to be submitted.

When there is a change in PI for an active human research study, the new PI assumes responsibility and oversight for the study. When there is a request to change PI, the HRP-529 – Template – Change in Principal Investigator Document is submitted with the modification request. This form is completed by the current PI and the newly proposed PI. If the current PI is unavailable and unable to complete the change in PI request, the current PI’s department chair or unit administrator may provide permission for the change in PI request. A site visit is typically required for change in PI modifications for non-exempt studies. See HRPP Manual 8-1 “Exemptions” and 8-6 “Modifications to an Approved Research Study” for modification processes.

For non-exempt studies, if the PI leaves MSU without modifying or closing the study, the former PI’s department chair or unit administrator may be contacted by the IRB office to determine the status of the study. The study may be administratively closed. See HRPP Manual 8-9 “Closure.”

The MSU IRB online system allows the PI to designate PI proxy(ies). The PI proxy may perform actions in the MSU IRB online system that are otherwise limited to the PI, including performing the submit action (e.g., submitting a new submission, submitting a clarification). While the PI may designate a PI proxy(ies) to perform these actions, the PI retains full responsibility for the submissions and for the performance and oversight of the study. See HRPP Manual 3-1 “MSU Human Research Protection Program Plan” for a description of the MSU IRB online system.


Only with approval of an exception may an individual (e.g., director, specialist) who does not meet the general PI requirement listed above serve as the PI on a human subject research study. In these special circumstances, the individual may become a “waived PI” with the IRB if the request is approved. No individual who requests or has obtained waived PI status may serve as the PI on the study if the research is to satisfy their master’s thesis or Ph.D. dissertation requirement.

For externally sponsored research, the exception request and approval should follow the procedure outlined by the MSU Sponsored Programs Administration. Approval of an exception through the MSU Sponsored Programs Administration to serve as a PI for a contract or grant also approves the individual to serve as the PI on the related human research project. Such approvals should be provided to the IRB office when appropriate.

For non-externally sponsored human research studies, waived PI requests should be sent to the IRB office and should include the following:

  • Current curriculum vitae (CV) or resume, if one has not already been provided to the IRB office.

  • Written recommendations from their college (e.g., typically Research Dean) and /or their department chair or academic director as appropriate. A standard form may be used.

    • The recommendation letter should describe whether the exception to serve as PI is limited to a single study, a particular kind of studies, or is a blanket recommendation.

    • For individuals who have non-employee / no pay appointments, the recommendation letter should confirm that the research is being done as part of MSU designated activities. See HRPP Manual 4-12, Engagement, for more information.

    • The recommendation letter may be sent as an email sent from the individual’s MSU email account.

The request may be granted if the individual has the necessary experience and independence to serve as the PI. For individuals who have a non-employee / no-pay appointment, the exception shall be limited to the particular research study.

Exception requests for individuals who are employees paid by MSU are reviewed by an HRPP manager. If there are any questions about whether an exception may be granted, the IRB chair, HRPP director, and/or the Associate Vice President (AVP) for the Office of Research Regulatory Support (ORRS) will be consulted. If the waived PI status is granted, the individual does not need to reapply for each research study unless the recommendation letter(s) from the college or department indicate that the recommendation is limited to a particular study or types of studies.

Exception requests for individuals who have non-employee / no-pay appointments are reviewed by the AVP for ORRS. If the AVP for ORRS grants waived PI status, an individual investigator agreement must also be completed. However, an individual investigator agreement only needs to be completed once and does not need to be completed separately for any additional waived PI requests.  Recommendation letters and CVs or resumes may also be kept on file for future exceptions if so requested.

If an exception request is denied, the individual requesting the exception will be notified. The Institutional Official retains the final authority to determine whether an individual can serve as PI on a human research study.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research & Graduate Studies on 3-9-2008. Revision 1 approved by VP Research & Graduate Studies on 7-21-2011. Revision 2 approved by Assistant VP Regulatory Affairs on 6-27-2018. Revision 3 approved by Assistant VP Regulatory Affairs on 12-6-2021. Revision 4 approved by Associate VP Research Regulatory Support on 2-12-2024.

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