Reporting Adverse Events and Noncompliance Situations to the IACUC

Adverse Events

An adverse event is defined as any unexpected or unplanned incident that negatively affects the health or welfare of the animal. Adverse events can occur during approved procedures/activities or be caused by natural disasters, accidents, and mechanical failures. Regardless of its origin, any unplanned event that causes harm to animals or results in their unplanned death should be viewed as being adverse and reported to the IACUC.

Adverse Event Examples:

• Higher than expected mortality or morbidity that is a direct result of approved procedures/activities:
  • A principal investigator is using an approved cardiac surgery technique for which the mortality rate normally is 10% but they observe 30% instead.
  • A principal investigator is conducting a dietary study in which no mortalities are expected  (death was not mentioned as a possibility in the approved IACUC protocol) but they observe a mortality rate of 5% in one of the treatments.
• Unexpected death or euthanasia:
  • An animal dies or is euthanized due to post-surgical trauma or infection during a routine ovariectomy.
  • An animal dies during or is euthanized after a routine intubation procedure due to tracheal damage.
• Development of unexpected clinical signs resulting from approved procedures or activities:
  • An animal develops skin lesions after receiving a pharmaceutical that was administered to treat diarrhea.
  • An animal develops diarrhea after receiving a pharmaceutical that was administered to alleviate glaucoma.
• Discovery of novel, negative phenotypes:
  • Tumors begin to develop spontaneously in the offspring of two genetics lines that have no tumors
  • High neonatal mortality rates observed in the offspring of two genetic lines whose normal neonatal mortality rate is low.
  • Blindness in a transgenic line developed to study kidney function
• Death, morbidity, or injury caused by the animal’s physical environment or routine management procedures:
  • An animal escapes from its fenced pasture and is injured or dies.
  • The heating and air condition system in an animal room fails resulting in an increase in the ambient temperature and the death of animals or some animals become so dehydrated they need to be euthanized.
  • Winds from a severe thunderstorm or hurricane cause a shelter to collapse, killing or injuring animals.
  • Lightning from a storm causes a power outage that decreases pastured animals’ access to water and they become dehydrated to the point where they require rehydration with electrolytes, etc.
  • Animals drown or develop infections and other complications because their cages become flooded because nearby water lines break or leak.
  • Animals are injured when being moved from one location to another.
  • Animals are injured, die, or are euthanized because they were transported in a vehicle or trailer during extreme temperature conditions.
  • Animals are injured, die, or are euthanized because they were transported under crowded conditions or in a vehicle not previously inspected and approved by the IACUC.
  • Animals are received from a commercial vendor that are morbid, die, or need to be euthanized before they are used for approved activities.
• In the case where responsible personnel encounter incidents for which there is uncertainty as to whether it is a reportable adverse event, then they should contact the IACUC office for guidance.

Noncompliance Situations

A noncompliance situation is defined as a deviation from an IACUC-approved protocol/activity or regulatory standard. These include the following:

• conducting animal-related activities without appropriate IACUC review and approval
• failure to follow standards described in the Animal Welfare Act, the NIH Guide for the Care and Use of Laboratory Animals, or the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching (as appropriate)
• failure to follow IACUC-approved protocols
• performing procedures that have not been approved by the IACUC as part of a currently approved educational, research, or outreach animal activity.

Noncompliance Examples:

• Teaching students how to obtain blood samples from a marginal ear vein when the approved IACUC protocol only lists teaching them how to obtain a blood sample from the jugular vein.
• Increasing the blood sample collection frequency from once per day to twice per day when only the frequency of once per day was approved by the IACUC.
• Holding a training session for extension agents using NCSU animals without submitting an IACUC application.
• Using a pharmaceutical as part of routine examinations that has not been approved (see Dos and Don’ts for Clinical Researchers)
• Moving animals from a pasture to a pen in a barn when the pen in the barn has not been approved and inspected previously by the IACUC and is not listed on the approved protocol.
• Other situations:
  • The IACUC recognizes there are situations in which it may be necessary for personnel to perform activities with animals that are not approved but are done so to benefit the safety and welfare of the animals. In such instances, a laboratory animal veterinarian should be contacted and included in the decision making process, but the IACUC understands that sometimes personnel and time availability may make that impossible.  
  • An example might be administration of a pharmaceutical to stimulate breathing in an animal that has become moribund due to an experimental procedure that was not listed or approved by the IACUC. These are still noncompliant situations and need to be reported to the IACUC even though they enhance the welfare and safety of the animal. If animal personnel have questions as to whether an activity should be reported as a noncompliance situation, then they should contact the IACUC office for clarification.