Principal Investigator Status for UW–Madison Studies Involving Human Participants

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Policy Number:
UW-4063
Responsible Office:
Office of Research Compliance

University Policy

Rationale/​Purpose:

This policy defines who may serve as principal investigator (PI) on human-participants research that falls under UW–Madison purview.

Scope:

This policy only applies to the ability to serve as principal investigator on a UW–Madison Institutional Review Board (IRB) protocol. A separate process applies to the ability to serve as principal investigator on a grant/sponsored project.

Policy:
  1. To qualify as a principal investigator (PI) on a study involving human participants, 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. Individuals classified as having University Principal Investigator Status, this includes:
      1. Tenured or Tenure Track Faculty (including full-time UW–Madison faculty who hold a $0 UW–Madison appointment only because their position is funded by the federal government),
      2. Clinical/Health Sciences (CHS) Track appointments,
      3. Research Professor Track appointments,
      4. UW-Madison Staff with Permanent PI Status, and
      5. Rehired annuitants who previously qualified according to A-D above.
    2. Academic staff (including former academic staff with an emeritus appointment [zero dollar, voluntary appointment]) and limited appointees can serve as PI with approval from their Chair/Director (using the “Request for Approval to Serve as Principal Investigator” form).
    3. Faculty and academic staff with an emeritus appointment (zero-dollar, voluntary appointment) must provide evidence that their appointment includes permission to conduct human participants research.
  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.
  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.
    1. This may include incoming faculty with funding that requires a year in an “in training” position or other temporary title prior to transitioning to faculty title series.
  7. Notwithstanding exceptions granted in III and VI, individuals in training positions (e.g. graduate students, post-doctoral fellows, residents and fellows in any clinical field or research discipline) cannot serve as PI.
Related UW-Madison Policies:
Related UW–Madison Documents, Web Pages, or Other Resources:

Policy Administration

Approval Authority:
Associate Vice Chancellor of Research Policy and Compliance
Policy Manager:
Associate Vice Chancellor of Research Policy and Compliance
Contact:
Associate Director, HRPP -- Travis Doran, travis.doran@wisc.edu, (608) 890-4399
Date Issued:
07-10-2008
Revised Dates:

12-04-2008, 11-04-2010, 08-28-2015, 08-15-2018,11-09-2019, 08-31-2021, 01-06-2022, 12-02-2022

Retrieved:
09-29-2023 14:35:19