Office of Research Integrity

Adverse Events Policy

Definition

An adverse event is defined as any outcome which negatively impacts animal well‐being. For the purposes of this policy, an adverse event includes any such outcome which was not described as an expected or likely adverse outcome in the approved protocol. An adverse event also includes adverse outcomes which were described as expected or likely outcomes in the approved protocol, but occur at higher rates than originally anticipated.

Reporting to the Veterinarians

It is the responsibility of the Principal Investigator (PI) to promptly report any adverse events to the veterinary staff for assessment. The veterinarians will work with the researcher to develop a resolution plan to ensure the well‐being of the animals by circumventing or alleviating the impact of the adverse events.

Examples of adverse events which must be reported include, but are not limited to:

  • Genetically modified or mutant animals that manifest a phenotype that negatively affects animal well‐being;
  • Physical restraint of an animal that results in lesions, illness, or behavioral changes;
  • A surgical procedure that results in unexpected complications; and/or
  • Morbidity or mortality rates more than 10% higher than described in the protocol, regardless of the reason.

Examples of potential resolution plan modifications which might be requested include, but are not limited to:

  • Change in anesthetic;
  • Procedural modifications;
  • More frequent monitoring intervals;
  • Additional humane endpoints;
  • Updated description of expected or likely adverse outcomes in the approved protocol; and/or
  • Adverse events report to the IACUC.

Examples of adverse outcomes that are not required to be reported as an adverse event include:

  • Injury/illness unrelated to approved procedures and being treated by the clinical veterinarians.
  • Death or morbidity of animals described as expected in the approved IACUC protocol.

Reporting to the IACUC

In most cases, the veterinarians will assist in determining whether it is necessary for the PI to submit an adverse events report to the IACUC.

When the adverse event is the result of noncompliance with the approved protocol, or morbidity or mortality rates are more than 10% higher than described in the protocol, the PI must promptly submit an adverse event report to the IACUC.

References:

  1. Guide for the Care and Use of Laboratory Animals (Guide), NRC, 2011.
  2. Guide for the Care and Use of Agricultural Animals in Research and Teaching (FASS Guide), FASS, 2010.
  3. Animal Welfare Regulations, 9 CFR, chapter I, subchapter A.