Fundamental training for individuals involved in the care and use of laboratory animals: a review and update of the 1991 NRC Core Training Module

Public trust demands that individuals who do research, testing, or teaching with animals use humane, ethical, and scientifically sound methods. Furthermore, the Animal Welfare Act and the Public Health Service Policy require research institutions to provide basic training and to ensure that anyone who cares for and/or works with laboratory animals has the appropriate training or experience relevant to their job responsibilities. Institutions accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International must also provide training programs and ensure the qualifications of personnel. The primary goal of this training is to provide individuals with basic knowledge and to reinforce attitudes and behaviors that help to ensure humane animal care and use. This article provides an overview of the core training module outline and content from the 1991 report of the Institute for Laboratory Animal Research, Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs, as well as pertinent updates for introducing personnel to information regarding the care and use of laboratory animals. Both mandatory and suggested training topics are reviewed, including relevant regulations and standards, ethical considerations, humane methods of animal experimentation and maintenance, and other pertinent topics. Although the fundamental training course content and delivery will vary depending on the nature and complexity of an institution's animal care and use program, this basic training provides the foundation for more in-depth training programs and supports humane and ethical animal care and use.     

Institutional and IACUC responsibilities for animal care and use education and training programs

Training and instruction of personnel are important components of animal care and use programs because they help to ensure the health and welfare of the animals and the integrity of the research or testing results. Training also helps to promote the consideration of alternatives, recognition of animal pain and distress, appropriate use of pain-relieving agents, aseptic technique, pre- and post-procedural care, and personnel health and safety. While individuals who provide the care for or conduct research or testing in laboratory animals should take personal responsibility for ensuring that they have the skills to perform their duties, the institution is ultimately responsible for ensuring their competency. The institution is also responsible for providing the training or instruction that is required by federal legislation, regulations, and policies. The institutional animal care and use committee (IACUC) is responsible for ensuring, as part of their review of research activities, that the personnel are capable of performing the procedures described. The IACUC must also assess the institution's training program as part of their semiannual animal care and use program review and make recommendations regarding training to the institutional official. This article provides a comprehensive overview of the US regulatory mandates for training and personnel qualification.     

A training primer for Institutional Officials

The laws and policies governing the care and use of animals in research in the US require institutions to establish training programs to assure that personnel are qualified for their roles in animal care and use programs. Few programs define specific training requirements for the Institutional Official (IO), one of the most important roles in an animal care program. In some cases, IOs may have little or no experience in biomedical science. In this article, the author provides an overview of the IO's role in an animal care and use program as defined by US government laws and policies for use in training IOs and chief executive officers. The author outlines the key responsibilities of the IO in an animal care program, the implications of noncompliance with federal requirements and some of the pitfalls in program design.     

Postapproval monitoring and the IACUC

Monitoring of the use of live vertebrate animals in research, teaching, and testing after approval of their use by an institutional animal care and use committee (IACUC) are receiving increased attention in the laboratory animal community. In this article the author provides his opinions on the value of postapproval monitoring (PAM) to the overall self-regulation that is the responsibility of an IACUC. PAM must never supersede or replace federally mandated IACUC responsibilities, but an efficient PAM process can provide significant additional information that enables an institution to be confident that it is meeting both the letter and the spirit of the federal regulations developed to ensure humane animal care. PAM personnel should be excellent communicators and able to maintain a professional demeanor in challenging circumstances. Their knowledge of laboratory animal care, invasive procedures, and regulations will enable them to align the pursuit of scientific research with adherence to these regulations. An effective PAM program involves knowledgeable individuals who can, on behalf of the IACUC, monitor new procedures and personnel and provide IACUC-mandated training or retraining.     

Avoiding an overzealous approach: a perspective on regulatory burden

The authors discuss the impact of regulatory burden on the research enterprise, with emphasis on animal care and use programs. They identify three sources of regulatory burden: specific requirements in law and regulation, interpretive requirements or "guidance" by regulatory agencies, and self-imposed regulatory burden resulting from institutional interpretations. Attempting to minimize the risks of noncompliance through the overzealous application of "requirements" does not necessarily benefit the animals. Balancing risks associated with animal research and burden in a successful program requires clear and consistent communication among all stakeholders--the institutional leadership, institutional animal care and use committee (IACUC), attending veterinarian and staff, and scientists. An evaluation tool is provided for institutions to assess their approach to required and voluntary activities in their animal care program. Drawing on the knowledge and experience gained in a combined 40 years of serving on, managing, training, and evaluating animal care programs, the authors conclude that institutions must thoughtfully balance their research and compliance needs to successfully maintain their institutional goals. They stress that a culture of compliance based on knowledge of the regulations, dedication to quality animal care, reasoned use of science-based performance standards, and the judicious application of professional judgment is the foundation for facilitation of research in the context of animal welfare and regulatory compliance.     

Establishing a culture of care, conscience, and responsibility: addressing the improvement of scientific discovery and animal welfare through science-based performance standards

Science-based performance standards offer a viable means of reducing regulatory burden while ensuring that research animal welfare and high-quality research data are realized. Unlike rigid regulations, science-based performance standards evolve as new information becomes available, thereby allowing new discoveries to be implemented in a timely manner and in a way that more effectively benefits the animals and the science. The implementation of performance standards requires a well-coordinated institutional team composed of the administration, research staff, the institutional animal care and use committee, professional and technical animal care personnel, occupational health and safety staff, and physical plant staff. This animal program team is best supported in an institutional environment that reflects a culture of care, compliance, and responsibility. In such a culture, the professional judgment exercised by the team is well grounded in meeting the diverse needs of the program's customers, who include the animals, the researchers, and research stakeholders such as the public. The institutional culture of care, compliance, and responsibility fosters workplace integrity, an ethics-based decision-making paradigm, sound understanding of institutional expectations through good communication and clear lines of authority, the hiring and retention of trained and well-qualified individuals, and a system for continuous development and improvement of the program.     

Training strategies for animal care technicians and veterinary technical staff

An institutional training program for animal care and veterinary technicians should be planned and implemented to provide these individuals with knowledge and skills for performing their duties within a laboratory animal care and use program. The complexity in the regulatory and scientific features of the animal research environment necessitates a strong training program on diverse topics according to staff duties. Orientation training should include ethics and compliance with relevant laws, policies, and guidelines. Depending on specific staff responsibilities, training may be general or in depth on topics of species-specific biology and behavior, animal facility equipment and operations, animal health procedures, animal research policies, occupational health and safety equipment and practices, computer usage, training, and management. Staff training should be an ongoing mission for incorporating new equipment, practices, and procedures in the laboratory animal program; for providing periodic refresher training to maintain a high level of staff qualifications; and for retraining when skills or knowledge are found deficient. Large institutions often have a dedicated training staff to implement the institutional training program.     

Chemical safety in animal care,use, and research

Chemical safety is an essential element of an effective occupational health and safety program. Controlling exposures to chemical agents requires a careful process of hazard recognition, risk assessment, development of control measures, communication of the risks and control measures, and training to ensure that the indicated controls will be utilized. Managing chemical safety in animal care and use presents a unique challenge, in part because research is frequently conducted in two very different environments--the research laboratory and the animal care facility. The chemical agents specific to each of these environments are typically well understood by the employees working there; however, the extent of understanding may not be adequate when these individuals, or chemicals, cross over into the other environment. In addition, many chemicals utilized in animal research are not typically used in the research laboratory, and therefore the level of employee knowledge and proficiency may be less compared with more routinely used materials. Finally, the research protocol may involve the exposure of laboratory animals to either toxic chemicals or chemicals with unknown hazards. Such animal protocols require careful review to minimize the potential for unanticipated exposures of the research staff or animal care personnel. Numerous guidelines and regulations are cited, which define the standard of practice for the safe use of chemicals. Key chemical safety issues relevant to personnel involved in the care and use of research animals are discussed.     

A sample postapproval monitoring program in academia

The primary goal of an animal care and use program (ACUP) should be to ensure animal well-being while fostering progressive science. Both the Animal Welfare Act (and associated regulations) and the Public Health Service (PHS) Policy require the institutional animal care and use committee (IACUC) to provide oversight of the animal program through continuing reviews to ensure that procedures are performed as approved by the committee. But for many committees the semiannual assessment does not provide an opportunity to observe research procedures being performed. Furthermore, IACUC members are typically volunteers with other full-time commitments and may not be able to dedicate sufficient time to observe protocol performance. Postapproval monitoring (PAM) is a tool that the IACUC can use to ensure that the institution fulfills its regulatory obligation for animal program oversight. When performed by attentive and observant individuals, PAM can extend the IACUC's oversight, management, training, and communication resources, regardless of program size or complexity. No defined PAM process fits all institutions or all situations; rather, the monitoring must match the program under review. Nonetheless, certain concepts, concerns, and conditions affect all PAM processes; they are described in this article. Regardless of the style or depth of PAM chosen for a given program, one thing is sure: failure of the IACUC to engage all available and effective oversight methods to ensure humane, compassionate, efficient, and progressive animal care and use is a disservice to the institution, to the research community and to the animals used for biomedical research, testing, or teaching.     

Selection, acclimation, training, and preparation of dogs for the research setting

Dogs have made and will continue to make valuable contributions as animal models in biomedical research. A comprehensive approach from time of breeding through completion of in-life usage is necessary to ensure that high-quality dog models are used in studies. This approach ensures good care and minimizes the impact of interanimal variability on experimental results. Guidance related to choosing and developing high-quality laboratory dogs and managing canine research colonies is provided in this article. Ensuring that dogs are healthy, well adapted, and cooperative involves good communication between vendors, veterinarians, care staff, and researchers to develop appropriate dog husbandry programs. These programs are designed to minimize animal stress and distress from the postweaning period through the transfer and acclimation period within the research facility. Canine socialization and training programs provided by skilled personnel, together with comprehensive veterinary health programs, can further enhance animal welfare and minimize interanimal and group variability in studies.     

Training in the laboratory animal science community: strategies to support adult learning

The essence of learning is change; learning is the process by which learners customize new information to make it personally meaningful and relevant. Training is the process of helping students make those changes. Research indicates that adults learn differently than children or adolescents and that adults consistently use the following six learning strategies: prior experiences; conversations; metacognition; reflection; authentic experiences; and images, pictures, or other types of visuals. Each of these learning strategies can be combined with the other strategies and often build upon each other. A recent study on how health care professionals learn indicated that the learning strategy they used most often was reflection, which supports learning before, during, and after training. Numerous examples are provided in this article describing how to integrate each of the six adult learning strategies into laboratory animal science training. While lectures and other types of direct instruction are appropriate, they are inadequate and ineffective unless they are integrated with and support adult learning strategies. Both the US Department of Agriculture regulations and the Public Health Service Policy mandate that research institutions must ensure that all personnel involved in animal care, treatment, or use are qualified to perform their duties. Applying adult learning strategies to training for the laboratory animal science community will enhance learning and improve both the science and the humane care of the animals, which is a goal our community must continuously strive to achieve.     

Residency training in internal medicine: program design in an era of constraint.

Directors of postgraduate internal medicine programs face many problems in program design, particularly when numbers of house staff continue to decrease. This paper examines the training requirements of a resident in internal medicine and proposes a curriculum based on set rotations in the three key areas of training--subspecialty services, critical care and the clinical teaching unit. The distribution of time in these three areas and the balance of exposure to inpatients and outpatients are discussed in detail. This program design ensures exposure to all the key elements of internal medicine in 3 years and should prevent significant gaps in knowledge at the time of certification. The implications for "service" in major teaching hospitals is discussed. Hospital departments and administrators must confront the prospect of hospital units without house staff. Most important, program directors must resist sacrificing the pedagogic essentials of a training program for service requirements.     

A guide to defining and implementing protocols for the welfare assessment of laboratory animals: eleventh report of the BVAAWF/FRAME/RSPCA/UFAW Joint Working Group on Refinement

The refinement of husbandry and procedures to reduce animal suffering and improve welfare is an essential component of humane science. Successful refinement depends upon the ability to assess animal welfare effectively, and detect any signs of pain or distress as rapidly as possible, so that any suffering can be alleviated. This document provides practical guidance on setting up and operating effective protocols for the welfare assessment of animals used in research and testing. It sets out general principles for more objective observation of animals, recognizing and assessing indicators of pain or distress and tailoring these to individual projects. Systems for recording indicators, including score sheets, are reviewed and guidance is set out on determining practical monitoring regimes that are more likely to detect any signs of suffering. This guidance is intended for all staff required to assess or monitor animal welfare, including animal technologists and care staff, veterinarians and scientists. It will also be of use to members of ethics or animal care and use committees. A longer version of this document, with further background information and extra topics including training and information sharing, is available on the Laboratory Animals website.     

Technical team approaches to rodent care: cost savings, reduced risk, and improved stewardship

With the increasing decentralization of animal care operations, lack of training and higher-density animal rooms make achieving humane assurances difficult. To offset these problems, some facilities have developed centralized animal care programs, including dispersed teams of qualified animal care specialists.     

Training strategies for IACUC members and the institutional official

Institutions are required by federal laws and regulations to oversee and evaluate their programs, facilities, and procedures for using animals in research, teaching, and/or testing activities. These responsibilities are specifically charged to an institutional official (IO) and an institutional animal care and use committee (IACUC). Initially, the individuals tasked with these responsibilities seldom have the requisite knowledge or experience to fulfill their charges effectively. Furthermore, simply reading the regulatory requirements does not prepare the novice IO and IACUC members to effectively monitor and guide the program. As a result, many new IOs and IACUC members are managing their responsibilities with insufficient understanding of the laws, regulations, standards, and policies. Specific training strategies for inexperienced IACUC members are needed to help them understand their responsibilities for ensuring animal welfare through an effective, high-quality, and compliant animal care and use program that supports the critical research needed to improve human and animal health. Likewise, most IOs would benefit from training to help them better understand their responsibility for enhancing or maintaining the quality of the institution's animal care and use program. Education and training should begin with an orientation to the laws, regulations, standards, and policies. Continuing training and education are also important to keep abreast of the changes in the interpretation of these laws and regulations as well as the changes in veterinary science. For both the IO and the IACUC, understanding and acceptance of their authority and responsibilities are significant factors in establishing and maintaining a quality animal care and use program.     

IACUC issues associated with amphibian research

Numerous species of amphibians are frequently utilized as animal models in biomedical research. Despite their relatively common occurrence as laboratory animals, the regulatory guidelines that institutional animal care and use committees (IACUCs) must employ provide little in the way of written standards for ectothermic animals. Yet, as vertebrates, laboratory amphibians are covered by the National Research Council Guide for the Care and Use of Laboratory Animals and the Public Health Service (PHS) Policy for federally funded research. This article focuses on three issues that are relevant to IACUC oversight of the use of amphibians in research: (1) recommended educational requirements of investigators and animal care staff engaged in research with amphibians, (2) zoonoses and other issues of occupational health importance, and (3) indicators of stress and disease. Addressing these issues should enable investigators, IACUCs, and animal care staff to meet the regulatory expectations of the PHS and accrediting bodies such as the Association for Assessment and Accreditation of Laboratory Animal Care International.     

Rodent quarantine programs: purpose, principles, and practice

In animal research, validity and reproducibility of data are critically influenced by the microbial status of the experimental animals. One of the most crucial aspects of assuring quality in animal research is providing research personnel with confidence that experimental results will not be invalidated due to interference caused by infectious disease. An effective quarantine program is essential to providing this assurance. Quarantine programs are generally instituted to prevent the introduction of rodent pathogens into established specific-pathogen-free colonies in a facility. Therefore, programs should be designed to isolate newly acquired rodents until their health status can be determined and to maximize the probability that microorganisms of interest will be detected before the animals are introduced into (and thus, could potentially contaminate) established colonies. Important principles that are critical to designing an effective quarantine program will be discussed here, as will the practical implementation of these principles. Although quarantine programs may be costly in terms of time and effort, these costs must be balanced against the potential costs of disease outbreaks that could invalidate long-term studies, alter normal biological baselines, and cause the loss or necessitate re-derivation of rare or valuable strains of rodents. Reducing the incidence of quarantine failures through appropriate program design and implementation helps to maintain the confidence of research personnel in the value of quarantine programs and in our competence as specialists in laboratory animal management and as partners in the research process.     

Guidelines for developing and managing an environmental enrichment program for nonhuman primates.

Before implementing an environmental enrichment program for nonhuman primates, several issues should be considered. The assignment of enrichment tasks can be made to caretakers, a dedicated "enrichment technician," volunteers, students or individuals with training in behavioral science. Determining the enrichment techniques to be used must take into account personnel time available; the species, age, sex, and individual histories of the nonhuman primates; and experimental protocols for which animals are being maintained. Identifying the most beneficial way to use the available personnel time must be tailored for each institution. To meet federal regulations, records must be kept of the environmental enhancements available to each nonhuman primate. Good record-keeping will allow appropriate evaluation of the program. This evaluation should involve the animals' responses to the enrichment opportunity, cost and durability of enrichment items, human and nonhuman safety considerations, and personnel required. The well-being of captive nonhuman primates will be most improved if well-informed decisions are made in developing and managing environmental enrichment programs.     

Institutional responsibilities in contamination control in research animals and occupational health and safety for animal handlers

The mechanisms for controlling microbial contamination in research animals are similar to those for preventing exposure among animal handlers to naturally occurring pathogens, research-related biohazards, or animal allergens. Research and resource preservation are the primary goals of each approach, and an appropriate assessment of risk is their foundation. The identification of potential risks enables the implementation of relevant risk management or control measures. This article summarizes the components of an occupational health and safety program for animal handlers, including screening, training, work practices, effective use of engineering controls, selection and use of personal protective equipment, and emergency response protocols. The features of a risk assessment and risk management program and the level of interaction and training required to implement and sustain the program correlate well with programs designed to control microbial contamination in laboratory animals. This article includes an explanation of the five Ps of risk assessment and risk management. Pathogens and the proposed experimental procedures account for the first two Ps; the other three focus on training and awareness of the personnel involved in the experiment, protective equipment and work practices, and factors associated with the place (or facility) where the research will be conducted. Animal handlers comprehension and knowledge determine the success of any containment program, and so this review also includes a discussion of critical teaching points for animal handlers and of the importance of evaluating personnel to verify their proficiency and competence in required protocols.     

Individual and collective responsibility to enhance regulatory compliance of the Three Rs

Investigators planning to use animals in their research and the Institutional Animal Care and Use Committee (IACUC) members who review the research protocols must take personal responsibility for ensuring that they have the skills and knowledge to perform their duties, applying the Three Rs principles of Russell and Burch. The two Korean laws introduced in 2008 and 2009 regulating animal use for scientific purposes in line with the Three Rs principles have been revised a total of 11 times over the last 6 years. Both regulatory agencies, e.g., the Animal and Plant Quarantine Agency and the Ministry of Food and Drug Safety, provide regular training based on the legal requirements. Based on the amended Animal Welfare Act, the IACUC appointment framework has been upgraded: appointments are now for two-year terms and require a qualified training certificate issued by the Animal and Plant Quarantine Agency since 2012. The authors reviewed the current curricular programs and types of training conducted by the two governing agencies through Internet searches. Our Internet survey results suggest that: a) diversity should be provided in training curricula, based on the roles, backgrounds and needs of the individual trainees; b) proper and continued educational programs should be provided, based on trainees’ experiences; and c) active encouragement by government authorities can improve the quality of training curricula. [BMB Reports 2014; 47(4): 179-183]