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Research Compliance and Tech Transfer

Principal Investigator Criteria and Responsibilities for Animal Use Protocols (AUP)

Number: IACUC-POL-019 

Responsible Office: Office of Research and Creative Scholarship (ORCS)

Applies to: Principal Investigators Conducting Animal Research  

1. Purpose 

This policy defines who is eligible to serve as a Principal Investigator (PI) on an Institutional Animal Care and Use Committee (IACUC) protocol. Establishing clear eligibility criteria ensures that all animal activities are led by individuals with the appropriate authority, qualifications, and oversight responsibilities required under federal regulations, accreditation standards, and institutional policy.  

2. Policy 

The PI is ultimately responsible for assuring compliance with applicable university IACUC policies and procedures, the Animal Welfare Act, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, the National Institutes of Health, the Guide for the Care and Use of Laboratory Animals, and/or the Guide for the Care and Use of Agricultural Animals in Research and Teaching. Although the PI may delegate tasks to members of his/her research team, s/he retains the ultimate responsibility for the conduct of the study. 

3. Definitions and Background  

Who may serve as a Principal Investigator on an AUP 

All animal research that is conducted by or under the direction of any employee, faculty, staff, student or agent of UM in connection with his or her responsibilities must be under the direct supervision of a member of the UM faculty or be sponsored by a UM department. PIs leaving the institution are responsible for notifying the IACUC should be notified at least 60 days in advance of departure whenever possible, or as soon as practicable when 60 days’ notice cannot be met so that they can arrange to either close the study or name another qualified individual currently at the institution to serve as the PI. Studies may be paused until a new PI is approved by the IACUC. Given the responsibilities of PIs, students may not serve as principal investigators for their own research projects and cannot submit an IACUC application. At its discretion, the IACUC may determine that a faculty member lacks sufficient expertise to carry out any particular research project based on their relevant training and experience. 

To be a PI, an individual must meet the criteria as defined in the Office of Sponsored Programs Principal Investigator Eligibility. Note that IACUC PI eligibility may differ from PI eligibility definitions used by other units. 

The following individuals may serve as PI: 

  • Faculty members: All categories of compensated faculty members may serve as PI. Visiting faculty, adjunct faculty, lecturers, and instructors, are not permitted to serve as a PI but may serve as co-investigators.  
  • Staff: Staff may serve in this role if they have appropriate qualifications to conduct the research. 
  • Non-UM employees: Non-UM employees may serve as PIs on an IACUC Protocol, with eligibility limited to contractual agreements that provide for IACUC oversight between UM and the non-UM entity. A non-UM PI must maintain campus affiliation status. 

Co-investigators and research staff 

Qualified co-investigators and research staff may perform tasks as delegated by the PIbut they do not accept primary responsibility for the research study. Research conducted by non-faculty, academic support staff, post-doctoral fellows, staff appointments, graduate students or undergraduate students must be under the direction of a faculty member, as defined above. In such cases, the faculty member shall be considered the Principal Investigator. The PI may delegate the performance of any or all components of the research to non-faculty if they certify to the IACUC that the individuals are sufficiently trained to perform the functions assigned. 

Change in PI 

A PI change is a significant modification to a protocol which requires standard IACUC review and approval. If the current PI is not available to submit this amendment to the IACUC, a supervising Department Head or equivalent will be asked to either close the AUP or nominate another eligible PI in writing. The nominated PI may then submit a change in PI amendment to the IACUC for review and approval. 

4. Accountability/Responsibility 

The PI is responsible for: 

  1. The development and obtaining IACUC approval of a protocol describing required experimental procedures and associated animal care and use, and ensuring active protocols are current through amendments and annual renewals. 
  2. Consultation with the Attending Veterinarian regarding husbandry, handling, medical treatment, immobilization, sedation, analgesia, euthanasia, surgical planning, perioperative care and all procedures involving pain and/or distress for the development of protocols. 
  3. Consultation with the Attending Veterinarian for amendments involving pain and/or distress. 
  4. Ensuring the conduct of the research, testing and/or teaching involving the care and use of animals, following the methodologies described in the IACUC-approved protocol. 
  5. The care and use of animals in ways judged to be scientifically, technically and humanely appropriate (e.g., minimized pain and distress). 
  6. Reporting of events impacting or potentially impacting animal care, use and welfare to the AV or designee or IACUC. 
  7. Reporting deviations from approved protocols to the AV or designee, or IACUC. 
  8. The oversight of animal census associated with the approved IACUC protocol. This is accomplished in collaboration with the Animal Resources Center, the IACUC and/or any other appropriate Animal Resources personnel.  Activities may include: 
    1. Transferring animals to another protocol (e.g., holding, training or active protocol).
    2. Discontinuing, delaying or confirming standing orders for animal(s)
    3. Tracking animal numbers.
    4. Updating cage cards. 
    5. Euthanizing animals.
  9. Ensuring maintenance of complete and current animal study records in a secure accessible location. Records must be available at all times for review by the Attending Veterinarian, the IACUC, the USDA, the funding agency and/or AAALAC. 
  10. Assuring all animals in the protocol are identified using appropriate cage cards.
  11. Adhering to the IACUC Protocol Review Process. 
  12. Justifying the specific need for the use of animals (species and numbers) in the IACUC approved protocol. 
  13. Working with individual(s) during an internal audit of their protocol (e.g. IACUC Post Approval Monitoring). The PI is also responsible for completing any corrective action(s) assigned as a result of an audit within the given timeframe. 
  14. Providing information requested by the IACUC during the semi-annual Facility Inspection/Program Review.  The PI is also responsible for completing any corrective action(s) assigned to him/her within the given timeframe. 
  15. Providing information requested by regulatory official(s) or AAALAC and answering questions if requested.  

The PIs have the authority to provide the following assurances:  

  1. The activities described in this protocol do not unnecessarily duplicate previous experiments, and any potential pain or distress to animals has been minimized in both degree and duration. 
  2. All activities proposed in this protocol: Are consistent with the Guide for the Care and Use of Laboratory Animals and applicable provisions of the Animal Welfare Act and Regulations, as amended. 
  3. Comply with 91次元 (UM) policies, procedures, and guidelines governing the humane care and use of animals in research and teaching, unless deviations have been appropriately justified and approved by the IACUC. 
  4. No activities involving live vertebrate animals will begin without an approved IACUC Animal Use Protocol (AUP) or amendment, as applicable. All IACUC-approved protocols will be maintained in an accurate and current manner and submitted in a timely fashion to ensure required continuing review and approval. 
  5. The PI certifies that: 
    1. All individuals working under this protocol must read and understand the approved procedures prior to initiating animal work and will review and understand all future approved modifications before performing work covered by those changes. 
    2. All personnel have completed the required Documentation of Reading the Specified AUP form and submitted it to the IACUC Office. 
    3. All personnel will be informed of potential occupational health and safety hazards associated with this protocol, will complete all applicable training requirements, and will be trained in appropriate risk mitigation measures. 
    4. Personnel will be provided sufficient time to complete required training and will be adequately educated, trained, and verified as competent prior to performing experimental procedures, except where training activities are specifically approved. 
  6. All experiments involving live animals will be conducted under the PI’s direct or appropriately delegated supervision. While hands-on animal work may be delegated to qualified members of the research team, the PI remains ultimately responsible and accountable for all animal-related activities conducted under this IACUC-approved protocol. 
  7. All animals will be lawfully acquired, and no animal activities will begin until all required permits and committee approvals have been obtained. 
  8. All personnel conducting activities under this protocol are required to promptly report animals exhibiting signs of pain, distress, illness, or abnormal clinical conditions to the Attending Veterinarian (AV) or designee. 
  9. Emergency veterinary care may be administered, or euthanasia may be ordered by the AV or designee, when necessary to protect animal welfare. 
  10. The IACUC will be notified of any unexpected study outcomes or incidents resulting in more than slight or momentary pain or distress, including unexpected morbidity or mortality. 
  11. In the event of unanticipated adverse events, an Adverse Event form will be completed or the AV will be notified within 24 hours. 
  12. A good faith effort has been made to identify alternatives to potentially painful procedures. The relevant literature has been reviewed, and a written analysis of the utility of any applicable alternatives is included in the IACUC protocol. 
  13. Failure to comply constitutes non-compliance and may result in protocol approval delays, suspension, or termination of any or all animal-related activities associated with this protocol.  

5. Review, Approval and Version History 

Review and approval version history for this policy

Version 

Date 

Description of Changes 

Approved By 

1.0 

January 13, 2026 

Initial policy creation 

IACUC Committee