Preventing Adverse Events at Research Facilities.

Area of Science:

• Animal research ethics
• Veterinary medicine
• Laboratory animal welfare

Background:

• Adverse events in animal research facilities pose risks to animal health and well-being.
• Identifying and mitigating these events is essential for effective risk management.
• The Animal and Plant Health Inspection Service (APHIS) regulates research facilities.

Purpose of the Study:

• To define adverse events in the context of animal research.
• To provide guidance to research facilities on identifying potential adverse events for risk management plans.
• To analyze APHIS data on direct noncompliances to understand common adverse event categories.

Main Methods:

• Defined adverse events as significant injury, illness, unrelieved pain, distress, or death, excluding research-related causes.
• Utilized news sources and APHIS website data for analysis.
• Examined APHIS direct noncompliance data from 2010-2014, as adverse event reporting is not mandated.

Main Results:

• Direct noncompliances constituted 4% of all documented noncompliances between 2010-2014.
• Veterinary care issues were the most frequent direct noncompliance (44%), followed by animal husbandry (34%).
• Other issues, including human error, equipment failure, and accidents, comprised 15% of direct noncompliances.

Conclusions:

• Veterinary care and animal husbandry issues represent significant areas for risk mitigation in research facilities.
• Analysis of APHIS direct noncompliances provides valuable insights into potential adverse events.
• Proactive risk management planning is vital for ensuring animal welfare in research settings.