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. These include Michigan State University (MSU) regular faculty, emeritus faculty, and fixed term faculty employees with rank of assistant professor or higher. 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. Exceptions to this general 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, s/he accepts the responsibility for the proper execution of the research and is 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 s/he has 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 personnel, complying with relevant standards and policies, and maintaining adequate resources to fulfill these commitments. See HRPP Manual 4-6 “Responsibilities of Investigators.” The PI is responsible for assessing his/her overall workload and resources and determining whether s/he has 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.

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.

Exceptions
Only with approval of an exception may an individual (e.g., director, specialist) who is not MSU regular faculty, emeritus faculty, or fixed term faculty employee with a rank of assistant professor or higher 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.

For externally sponsored research, the 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.

For non-externally sponsored human research studies, waived PI requests should be sent to the IRB office. The request  may be granted if the following criteria have been met:

  1. Have the necessary experience and independence to be approved to serve as the PI.
  2. Submit a current curriculum vitae.
  3. Obtain a written recommendation from the college and/or department chair or academic director as appropriate.
  4. For non-MSU individuals, an investigator agreement.

Once the Institutional Official (IO) or designee (e.g. IRB chair, Assistant Vice President for Regulatory Affairs) has granted waived PI status, the PI does not need to reapply for each research study unless they are a non-MSU individual. The designation of a non-MSU individual as a PI shall be limited to the particular research study.

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.

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.

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