Standard on Exceptions

Title

University of North Carolina at Chapel Hill Standard on Exceptions

Introduction

Purpose

The standards and procedures described below provide guidance to all researchers and animal handlers on submitting requests for exceptions to federal and institutional Standards in place for the humane care and use of animals used in teaching and research at UNC-CH.

The Institutional Animal Care and Use Committee (IACUC) requires that a Principal Investigator (PI) formally apply for an ‘exception’ when wishing to deviate from the below listed Federal regulations, ‘Guide’ and University Standards, unless otherwise adequately scientifically justified in the IACUC protocol (i.e. single housing, already addressed in ACAP section 6.05). All requests for exceptions must be reviewed and approved by the IACUC and the PI must receive written approval prior to implementation.

Scope of Applicability

All personnel engaged in the humane care and use of animals in teaching and research.

The UNC-CH IACUC expects that everyone involved in animal work at the University will comply with this Standard.

The IACUC expects that everyone involved in animal work at the University will comply with the following:

  • All applicable federal regulations: Public Health Service policy, Animal Welfare Act and Regulations, etc. (links provided in External Regulations and Consequences section of this Standard)
  • The Guide for the Care and Use of Laboratory Animals (links provided in External Regulations and Consequences section of this Standard)
  • University Policies and Standards (some still titled as IACUC Policies/Guidelines): The minimum acceptable limits or rules used to achieve Policy implementation, enforceable by the IACUC.
  • IACUC Animal Protocols, as approved by the IACUC

Standard

Exception requests are made by completing addendum 8.0 of the Animal Care Application (ACAP). The Principal Investigator (PI) must provide the following information: a description of exception; the rationale (i.e., scientific justification and/or justification based on animal welfare); potential adverse effects/clinical signs resulting from exception; and an indication of which animals in the approved application will be affected.

After the exception is approved, the PI is responsible for meeting with the Division of Comparative Medicine (DCM) Facility Manager/Supervisor to review the exception and for filing the exception in the notebook within the metal box outside the animal room. Place the exception in the back pocket of the three-ring binder within the metal box (or other DCM approved method, dependent upon the building). The PI must maintain a current copy of all exceptions in the metal folder outside all rooms in every animal facility where his/her animals are housed. Cages covered under the exception must be clearly identified with a capital red letter “E” in the upper right corner of the DCM barcoded cage card, unless an Exception applies to all cages in a room or all cages on a rack. In that case, the PI may discuss labelling the door of the room or labeling the rack, instead of each individual cage, with the DCM Facility Manager. In a reverse light cycle room, this capital “E” should be in black or blue ink.

Definitions

IACUC: Institutional Animal Care and Use Committee

DCM: Division of Comparative Medicine

University Standard: The minimum acceptable limits or rules used to achieve Policy implementation, enforceable by the IACUC.

ACAP: Animal Care Application

PI: Principal Investigator

Related Requirements

External Regulations and Consequences

University Policies, Standards, and Procedures

For more detailed guidance, please refer to the University Policy on the Care and Use of Vertebrate Animals for Research, Training and Teaching Purposes.

Contact Information

Contact Information Table
Subject Contact Telephone Email
General Questions Office of Animal Care and Use 919-966-5569 iacuc@med.unc.edu

Important Dates

  • Effective Date and title of Approver: 10/2013; UNC IACUC
  • Revision and Review Dates, Change notes, title of Reviewer or Approver: 03/02/2018; UNC IACUC

Approved by: UNC IACUC

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Details

Article ID: 132197
Created
Thu 4/8/21 9:26 PM
Modified
Tue 7/20/21 3:10 PM
Effective Date
If the date on which this document became/becomes enforceable differs from the Origination or Last Revision, this attribute reflects the date on which it is/was enforcable.
10/21/2020 12:00 AM
Issuing Officer
Name of the document Issuing Officer. This is the individual whose organizational authority covers the policy scope and who is primarily responsible for the policy.
Issuing Officer Title
Title of the person who is primarily responsible for issuing this policy.
Vice Chancellor for Research
Last Review
Date on which the most recent document review was completed.
10/21/2020 12:00 AM
Last Revised
Date on which the most recent changes to this document were approved.
10/21/2020 12:00 AM
Origination
Date on which the original version of this document was first made official.
09/12/2019 12:00 AM
Responsible Unit
School, Department, or other organizational unit issuing this document.
Research-Institutional Animal Care & Use Committee