University Standard
Title
University of North Carolina at Chapel Hill Standard for Reporting Non-Compliance with the Approved Animal Use Protocol, Animal Welfare Issues, and Unanticipated Adverse Outcomes
Introduction
Purpose
The standards and procedures described below provide guidance to all researchers and animal handlers experiencing non-compliance with the approved Institutional Animal Care and Use Committee (IACUC) protocol, animal welfare issues, and/or unanticipated adverse outcomes not described in the approved protocol.
Scope
This Standard applies to all personnel engaged in studies involving research animals.
The University of North Carolina at Chapel Hill ("UNC-Chapel Hill" or "University") IACUC expects that anyone involved in animal work at the University will comply with this Standard.
Standard
Unanticipated Adverse Outcomes
Principal Investigators (PIs) are expected to report unanticipated adverse events experienced by animals covered by an approved protocol which result from experimental or surgical procedures in a timely manner. The PI should:
- First consult with a Division of Comparative Medicine (DCM) veterinarian so that animals can receive proper veterinary care and necropsy, if necessary, to determine cause of adverse outcome.
- Following consultation with a DCM veterinarian, the PI should contact the IACUC or Office of Animal Care and Use (OACU) to self-report the event and determine the next steps.
Animal Welfare Concerns
There are multiple ways to report an animal welfare concern. Researchers may contact the OACU, the Office of the Vice Chancellor for Research, and may provide the information anonymously and to the extent that it is possible, the university will preserve anonymity. The USDA Animal Welfare Regulations and North Carolina law provide specific protection for employees, IACUC members, or laboratory personnel against discrimination or other reprisals for reporting violations of the Animal Welfare Act (i.e., Whistleblower Protection).
Preferred Methods of Reporting
- Contact the OACU at 919-966-5569 or iacuc@med.unc.edu. Ask for the OACU Education & Oversight Team or the IACUC Director, Dr. Tracy Heenan
Acceptable Methods of Reporting
Self-Reports
Self-reports demonstrate an individual’s proactive effort to make the IACUC aware of an issue, prevent future incidents, and contribute to the scientific community. As federal regulations require the IACUC to investigate any potential animal welfare issue or non-compliance, a redacted summary will be presented to the Animal Concern Subcommittee (ACS) to assist in providing recommendations to the IACUC. The ACS makes recommendations to the IACUC which determines what (if any) further action is needed.
To make a self-report:
- Consult with DCM (technician, veterinarian)
- Contact the OACU at 919-966-5569 or iacuc@med.unc.edu or
- Contact the Education & Oversight Team or the Institutional Animal Care and Use Committee (IACUC) Director, Tracy Heenan at 919-966-5569 or iacuc@med.unc.edu
Information to Provide to DCM Veterinarians and OACU
Information that should be disclosed:
- Date;
- Individuals involved;
- Species;
- Number of animals;
- Building and room location,
- Cage card number
- Detailed description of incident
- Incident reported to anyone else? If so, when and what action was taken?
Information that may be disclosed:
- Protocol number;
- PI name;
- Funding source (federal vs. not federal)
- Deviations from approved protocol and/or UNC Standards, if any
- Steps to avoid future incidents (for self-reports)
- Name and phone number or e-mail
Exceptions
Requests for exceptions to this Standard must be reviewed and approved by the IACUC.
Related Requirements
External Regulations
University Policies, Standards, and Procedures
Contact Information
Contacts
Subject: Animal Health
- Contact: DCM Vet Services
- Telephone: 919-966-2906
Subject: Office of Animal Care and Use