Preventing Adverse Events at Research Facilities.

In this article, adverse events are defined as events that lead to significant injury or illness, unrelieved pain or distress, orthe death of an animal, excluding those caused by IACUC-approved research procedures. The ability to identify possible adverse events is an essential step in planning for risk prevention and mitigation. Using data from news sources and the Animal and Plant Health Inspection Service (APHIS) website, this article provides guidance to research facilities regarding various types of adverse events to consider in risk management plans because these events might occur or have occurred and, in some cases, have been documented as noncompliances at APHIS-regulated research facilities. APHIS classifies noncompliances as 'direct' when they currently (at the time of the inspection) have a serious or severe adverse effect on the health and wellbeing of animals. Not all direct noncompliances are associated with adverse events, and not all adverse events are documented as direct noncompliances (for example, a past adverse event that does not currently affect the wellbeing of animals is not a direct noncompliance). However, because APHIS does not require reporting of adverse events, the information regarding direct noncompliances was the only APHIS data available to study adverse events at research facilities. Direct noncompliances documented by APHIS were 4% of all documented noncompliances from 2010 through 2014. The greatestnumber of direct noncompliances was in the category of veterinary care issues (44%), followed by animal husbandry issues(34%), 'other issues' (15%), and physical plant issues (7%). The category of other issues included events due to human error,equipment failures, and accidents.

Celebrating a life by recognizing realities.

This special issue on nonhuman primate behavior and welfare, the proceedings of a special Animal Behavior Society session, celebrates the life of Dr. Sylvia Taylor (1963-2005). Sylvia's premature death reminded her friends to recognize the reality that life is short, but one can make the most of it. Many individuals and organizations have also recognized the reality that an educational venture such as this one requires adequate funding and support. Their generosity has made this undertaking a success. The idea behind the session was to recognize the reality that one cannot ensure nonhuman animal welfare without understanding animal behavior, and to explore the ways in which this principle applies to primates. One must also recognize the reality that nonhuman primate welfare depends on understanding the behavior of the human primate as well as the nonhuman primate. Ensuring the welfare of the nonhuman primate sometimes requires educating and motivating the human primate. This special issue will hopefully provide helpful information to increase the reader's knowledge of primate behavior and welfare and to help the reader educate others on these important topics.

Pain and distress: what really matters?

Federal regulations mandate the minimization of both pain and distress in laboratory animals. That no clear definition exists for 'distress' complicates its recognition, quantification, and alleviation. The author argues that IACUCs and investigators should shift their focus from pain to distress, and that in doing so both problems will be better dealt with. She discusses criteria for defining 'significant' distress, and offers suggestions for the conduct of studies to determine levels of distress.

The Animal Welfare Act, USDA, & research.

In the above discussion, the concept and evolution of IACUC oversight of research facility animal care and use programs and common USDA citations concerning these programs was reviewed. The majority of USDA citations are program-related and involve both IACUC and veterinary care functions. Common IACUC-related citations concern inadequacies involving required information in protocols (such as rationales for the species and numbers used and descriptions of the procedures proposed), searches for alternatives to painful or distressful procedures, and minimization of pain and distress. Common veterinary care citations concern inadequacies involving veterinary care facilities, daily observation of the animals, and veterinary care itself (e.g., maintaining inadequate records or using expired medications). IACUC's are advised to ensure that their program records are comprehensive enough to demonstrate that their facility's animal care and use program complies with the AWA and USDA regulations. The overall ongoing success of self-regulation in the research industry is acknowledged, and APHIS's current concentration on the recognition and alleviation of distress, as well as pain, is noted. In the future, APHIS will continue in its oversight role as IACUC programs continue to evolve in their awareness and application of the advances in pain and distress recognition and management. Together, we will continue to work for the benefit of the animals used in research, whose welfare is so important to the quality of that very research.