Protocol Noncompliance: Overview

Protocol Noncompliance: Overview
Protocol Noncompliance   Institutional Animal Care and Use Committees

Both the U.S. Department of Agriculture (USDA) animal welfare regulations (AWR) and the Public Health Service Policy on the Humane Care and Use of Laboratory Animals mandate the review of animal research protocols by the animal care and use committee before any research may begin. Protocol noncompliance can occur in a variety of ways, either intentionally or unintentionally. The National Institutes of Health (NIH) Office of Laboratory Animal Welfare offers some examples described below:

  • conduct of animal-related activities without appropriate IACUC review and approval;
  • failure to adhere to IACUC-approved protocols;
  • implementation of any significant change to IACUC-approved protocols without prior IACUC approval;
  • conduct of animal-related activities beyond the expiration date established by the IACUC;
  • participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained;
  • failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures);
  • failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry);
  • failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO2);
  • failure of animal care and use personnel to carry out veterinary orders (e.g., treatments).