Eligibility to Serve as Principal Investigator of a Research Activity Governed by Compliance Requirements

Purpose

To establish the role and responsibilities of a Principal Investigator of an activity governed by one or more compliance requirements; the categories of appointments for those individuals who are eligible to serve as a principal investigator; and an approval procedure to allow those individuals who are not included in the default categories to serve as principal investigators.

Scope

This policy applies to all members of the campus community, including but not limited to university faculty (tenure system, specialized faculty at the professorial ranks of assistant, associate, and full, and modified professorial ranks such as adjunct and visiting), staff, students, postdoctoral appointees, visiting scholars, and visiting scientists.

Authority

Vice Chancellor for Research and Innovation

Policy

The Principal Investigator (PI) is responsible for the design, scientific and technical conduct, administrative oversight, fiscal accountability, regulatory compliance, and reporting for a research or teaching activity governed by one or more compliance requirements as described in a Compliance Protocol. Furthermore, to fulfill their responsibilities as a Principal Investigator, the PI must have access to all data collected as part of an activity governed by a Compliance Protocol.

An individual with an appointment in one of the following categories, with a Significant Physical Presence on campus as defined below, may serve as a Principal Investigator of a Compliance Protocol without the need to seek approval under this policy:

  • Professor (Assistant, Associate, and Full)
  • Research Professor (Assistant, Associate, and Full)
  • Teaching Professor (Assistant, Associate, and Full)
  • Clinical Professor (Assistant, Associate, and Full)

All other individuals not listed above must seek approval to serve as a PI of a Compliance Protocol in accordance with this policy.

The Vice Chancellor for Research and Innovation delegates the authority to provide and revoke approval to serve as a PI to academic deans, institute directors, and campus administrative officers.

Upon approval by the applicable academic dean, institute director, or campus administrative officer, an individual with a Significant Physical Presence on campus as defined below and holding an appointment in one of the following categories may serve as a Principal Investigator for the purposes of designing, conducting, and supervising a Compliance Protocol:

  • Postdoctoral Appointee
  • Academic Professional
  • Civil Service Exempt
  • Professor Emeritus/Emerita

An individual with an appointment in one of the following categories may not serve as a Principal Investigator of a Compliance Protocol:

  • Undergraduate or graduate student employee
  • Hourly employee
  • Individual whose only University appointment is either a zero percent or visiting appointment

Eligibility to serve as a Principal Investigator of an externally-sponsored activity is the subject of a separate policy (see RP-06).

Definitions

Principal Investigator (PI)
An individual vested by the university with the primary responsibility to independently design, conduct, and supervise activity that is subject to regulatory compliance as described in a Compliance Protocol.

Postdoctoral Appointee
An individual with an appointment as a postdoctoral associate, trainee, fellow, scholar or other postdoctoral position, who has received a doctoral degree (or terminal degree), and is engaged in a temporary and defined period of mentored advanced training to enhance necessary professional skills and research independence to pursue his/her chosen career path.

Significant Physical Presence
An individual is considered to have a “Significant Physical Presence” if they are routinely available at their assigned location. A visible and active presence is essential for appropriate oversight.

Compliance Protocol
One or more Federal and/or State regulatory requirements that are planned to be met as described in a document to be reviewed and approved by a compliance board, panel, committee or program, such as, but not limited to:

  • Institutional Animal Care and Use Committee, supported by the Office of Animal Research Compliance (see RP-12),
  • an Institutional Review Board, supported by the Office for the Protection of Research Subjects (see RP-09),
  • Institutional Biosafety Committee, supported by the Division of Research Safety (see RP-02),
  • Radiation and Laser Safety Committee, supported by the Division of Research Safety (see RP-11),
  • Laboratory Safety Program, supported by the Division of Research Safety (see RP-04, RP-07, and RP-17),
  • Controlled Substance Surveillance Program, supported by the Division of Research Safety (see RP-16).

Processes/Procedures/Guidelines

A unit executive officer shall first decide whether or not to request approval for an employee to serve as a Principal Investigator of a specific activity governed by one or more Compliance Protocols.  If not, then the process stops here. If so, then the unit executive officer shall submit to the applicable academic dean, institute director, or campus administrative officer a request for approval of an individual to serve as a Principal Investigator, which should include the following information:

  • The category of appointment of the proposed Principal Investigator identifying their current appointment, planned appointment or changes in appointment, and the duration of the appointment.
  • A brief description of the proposed activity, including the title, scope of work, and sponsor (if any), and how the project aligns with the individual’s responsibilities.
  • A brief description of the qualifications of the proposed principal investigator, and the level of mentorship available, if applicable.
  • A confirmation that the proposed PI is able to provide the required significant physical presence for the duration of the activity.
  • An affirmation from the unit executive officer that space and facilities will be provided without detriment to the regular instructional or research responsibilities of the unit in which the activity will be performed.

The academic dean, institute director, or campus administrative officer should review all requests for approval taking into consideration the qualifications of the individual, the scope of work, and the level of mentorship available, if applicable. Depending upon the circumstances, the academic dean, institute director, or campus administrative officer may limit the approval to a specific activity or subject to specific conditions. The academic dean, institute director, or campus administrative officer will document all approvals and make them available upon request to relevant units, including University Legal Counsel, University Audits, and other compliance units.

The academic dean, institute director, or campus administrative officer may revoke approval for an individual to serve as a PI for repeated and substantiated non-compliance.

For more information, refer to Office of the Provost, Communication 19: Sabbatical Leaves of Absence, Communication 25: Employment Guidelines for Specialized Faculty Holding Non-Tenure Systems Positions, and Communication 26: Promotion to Teaching, Research or Clinical Associate or Full Professor Titles.

Exceptions

The Vice Chancellor for Research and Innovation may approve exceptions to this policy.