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Principal Investigator Status for UW–Madison Studies Involving Human Participants

This policy defines who may serve as Principal Investigator on human participants research that falls under UW–Madison purview.

This policy only applies to the ability to serve as PI on a UW–Madison IRB protocol. A separate process—link here—to the ability to serve as PI on a grant/sponsored project.

  1. To qualify as a principal investigator (PI) on a study involving human participants reviewed by a UW–Madison Institutional Review Board (IRB), individuals must meet the requirements described in section II or meet an exception described in section III.

  2. PIs must have an appropriate UW–Madison appointment and be performing the relevant research within the scope of that appointment:

    1. Faculty (generally, a 50% or more appointment), this includes:

      1. Faculty with a full-time UW–Madison position but who hold a $0 UW–Madison appointment only because their position is funded by the federal government.

      2. UW–Madison Clinical/Health Sciences (CHS) appointments.

    2. Academic staff and limited appointees who have obtained approval from their Chair/Director using the “Request for Approval to Serve as Principal Investigator on a Human Participants Study” form.

    3. Visiting faculty, or visiting academic staff who have obtained approval from their Chair/Director using the “Request for Approval to Serve as Principal Investigator on a Human Participants Study” form.

    4. An emeritus appointment is an honorary title and anyone with emeritus status who wishes to act as PI must provide evidence that they have a volunteer appointment (also called “zero dollar appointment”) which includes permission to conduct human participants research.

      1. The requirement of a volunteer appointment does not apply to re-hired annuitants. Re-hired annuitants are employees of UW–Madison, and often carry the title of “Professor Emeritus” (as opposed to the title of “Emeritus” only).

      2. Additionally, any individual with an emeritus appointment who was previously employed as academic staff or a limited appointee must follow the requirements in II.B.

  3. Exceptions exist for the following individuals (subject to an IRB Authorization Agreement or Individual Investigator Agreement, when applicable):

    1. UW Hospital and Clinics' (UWHC) employees with the approval of their supervising UWHC Vice President.

    2. Individuals who have an appointment at the William S. Middleton VA Hospital with approval of the VA Research & Development Committee.

    3. Physician staff at UW Comprehensive Cancer Center (UWCCC) outreach clinics who hold a UW–Madison appointment.

    4. Employees of the Morgridge Institute for Research, Inc. (Morgridge).

    5. Employees of the State of Wisconsin Department of Health Services (DHS).

    6. When the study is a graduate student project, a UW–Madison PI who leaves the university, but maintains a 0% or other small percentage appointment with UW–Madison, may remain as PI on the study for up to one year to transition the study to a new PI, subject to UW IRB approval.

      1. The purpose of this provision is to ensure the student’s research project is not interrupted.

    7. Employees of UW System administration and campuses (consistent with their own campus policies)

  4. Subject to UW–Madison’s Conflict of Interest Policies, there are cases when an otherwise qualified individual may be prohibited from serving as PI.

  5. Notwithstanding the above criteria, a reviewing IRB may determine that an individual does not qualify to serve as PI on a study involving human participants.

    1. Examples of this may include when the IRB determines that subject protections may be compromised due to existing circumstances, such as the individual's lack of training, expertise, past performance or physical location in proximity to research participants.

  6. Subject to sections IV and V above, the Institutional Official may grant an exception to this policy upon request. Exceptions will only be granted for individuals who the Institutional Official believes, based on information provided in the “Request for Approval to Serve as Principal Investigator on a Human Participants Study” form, have sufficient training and expertise to safely conduct the research at issue.

Adopted By: Human Research Protection Program Advisory Committee
Adoption Date: July 10, 2008
Revised: December 4, 2008
Revised: November 4, 2010
Revised By: Cross-Campus HRPP Committee
Revised: August 28, 2015
Revised: August 15, 2018
Revised: November 9, 2019

Copyright © 2015 University of Wisconsin System Board of Regents

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Keywords:principal investigator human participants research pi qualify appointment exception request for approval by chair director   Doc ID:29557
Owner:Travis D.Group:VCRGE and Graduate School
Created:2013-04-18 11:18 CDTUpdated:2020-05-15 14:06 CDT
Sites:Health Sciences IRBs, VCRGE and Graduate School
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