United States

Legal Requirement for Training

The regulatory environment for the care and use of laboratory animals, and therefore the basis for the training of personnel to work with these animals, is anchored on a series of federal mandates: two laws, one regulation, and a policy. One federal law is the Animal Welfare Act, which is supported by the Code of Federal Regulations, Title 9, Subchapter A — "Animal Welfare," and enforced by the U.S. Department of Agriculture (USDA).6,7 The second federal law, the Health Research Extension Act of 1985, "Animals in Research," is implemented by the Public Health Service Policy on Humane Care and Use of Laboratory Animals, which is enforced by the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health.8,9 Most research institutions in the United States are covered by one of these laws and the corresponding regulations or policy, and many institutions are indeed covered by both sets of mandates.

In addition, many institutions are voluntarily accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC), including many of those that are not covered by either federal law. (AAALAC accreditation is also available to institutions in other countries.) An additional mandate that addresses personnel training and qualifications is the Guide for the Care and Use of Laboratory Animals from the National Research Council.10 Although a guideline, both the Public Health Service Policy and AAALAC accreditation require compliance with the Guide's standards. For the protection of farm animals used for nonagricultural purposes, the United States Department of Agriculture/Animal and Plant Health Inspection Service adopted this guideline, as well as the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching, published by the Federated Animal Science Societies.11,12

Altogether, there is a great deal of overlap in institutional coverage by these federal mandates. There is also similarity in the requirements for staff training and qualifications, although the precise language varies somewhat among these mandates. The Animal Welfare Regulations specify the training topics in greater detail than does the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Because the policy requires institutions to comply with the Animal Welfare Act and other federal statutes and regulations relating to animals, it refers specification of training requirements to these other mandates, such as the Animal Welfare Act regulations and the Guide for the Care and Use of Laboratory Animals.

From the Code of Federal Regulations, Title 9, Subchapter A — Animal Welfare, Sec. 2.32, Personnel qualifications:7

(a) It shall be the responsibility of the research facility to ensure that all scientists, research technicians, animal technicians, and other personnel involved in animal care, treatment, and use are qualified to perform their duties. This responsibility shall be fulfilled, in part, through the provision of training and instruction to those personnel.

(b) Training and instruction shall be made available, and the qualifications of personnel reviewed, with sufficient frequency to fulfill the research facility's responsibilities under this section and Sec. 2.31.

(c) Training and instruction of personnel must include guidance in at least the following areas:

(1) Humane methods of animal maintenance and experimentation, including:

(1) The basic needs of each species of animal

(ii) Proper handling and care for the various species of animals used by the facility

(iii) Proper pre-procedural and post-procedural care of animals

(iv) Aseptic surgical methods and procedures

(2) The concept, availability, and use of research or testing methods that limit the use of animals or minimize animal distress.

(3) Proper use of anesthetics, analgesics, and tranquilizers for any species of animals used by the facility.

(4) Methods whereby deficiencies in animal care and treatment are reported, including deficiencies in animal care and treatment reported by any employee of the facility. No facility employee, committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act.

(5) Utilization ofservices (e.g., National Agricultural Library, National Library of Medicine) available to provide information:

(i) On appropriate methods of animal care and use

(ii) On alternatives to the use of live animals in research

(iii) That could prevent unintended and unnecessary duplication of research involving animals

(iv) Regarding the intent and requirements of the Act

In addition to the training of research staff, there is also an obligation to provide training to the members of the Institutional Animal Care and Use Committee (IACUC). Neither USDA or PHS have issued guidelines, formally or informally, on IACUC training. Nevertheless, these regulatory agencies and AAALAC commonly expect that IACUC members receive training specific to their role in the animal-research program.

Common Approaches to Training

Collectively, the United States mandates on laboratory animal welfare apply a performance standard to the assessment of compliance with all programmatic requirements, including the training of personnel. The opposite of performance standards is engineering standards, in which regulatory requirements define the procedural details in the conduct of a process: for example, in training, what is taught, how, when, and by whom. A performance standard instead focuses on the outcome of a process. In such a stafftraining program, the outcome is measured in how well-qualified personnel are to carry out the animal-related procedures. The institution can determine how that program is constituted in terms of staff resources and training objectives, activities, and frequency.

From the Guide for the Care and Use of Laboratory Animals (National Research Council), Institutional Policies and Responsibilities — Personnel Qualifications and Training:10

AWRs [Animal Welfare Act Regulations] and PHS [Public Health Policy] require institutions to ensure that people caring for or using animals are qualified to do so. The number and qualifications of personnel required to conduct and support an animal care and use program depend on several factors, including the type and size of institution, the administrative structure for providing adequate animal care, the characteristics of the physical plant, the number and species of animals maintained, and the nature of the research, testing, and educational activities.

Personnel caring for animals should be appropriately trained (see Appendix A, "Technical and Professional Education"), and the institution should provide for formal or on-the-job training to facilitate effective implementation of the program and humane care and use of animals. According to the programmatic scope, personnel will be required to have expertise in other disciplines, such as animal husbandry, administration, laboratory animal medicine and pathology, occupational health and safety, behavioral management, genetic management, and various other aspects of research support.

Not only can training services be customized for the type of procedures and species used, but training can also be adapted to the level of staff experience, competence, and the degree of staff turnover. Training requirements can be satisfied by formal or on-the-job training. This provides flexibility for each institution to meet its needs and to utilize personnel and other resources as best fits the institution. In an informal statement, the Office for Laboratory Animal Welfare (OLAW) addressed the question of how much flexibility an institution may have in the development of a training program to satisfy federal requirements:13

Each assured institution is responsible for training its staff to meet the performance requirements cited in paragraph IV.C.l.a-g. of the PHS policy, and guidelines have been developed to assist institutions to meet these objectives. OLAW recognizes research programs vary from one institution to another, and are relative to the size and nature of the institution, staffing, numbers of species and individual animals maintained, and the kinds of research conducted. Therefore, the scope and depth of instructional programs and the frequency at which they are offered will also vary. At a minimum, however, the policy requires institutions to ensure that individuals who use or provide care for animals are trained and qualified in the appropriate, species-specific housing methods, husbandry procedures, and handling techniques. The institution must ensure that research staff members performing experimental manipulation, including anesthesia and surgery, are qualified through training or experience to accomplish such procedures humanely and in a scientifically acceptable fashion. They must also provide training or instruction in research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress. Institutions must also ensure that professional staff whose work involves hazardous biological, chemical, or physical agents have training or experience to assess potential dangers and select and oversee the implementation of appropriate safeguards.

As an example of the degree of flexibility in institutional training programs, if influxes of new staff are frequent, a program may emphasize entry-level training. In an institution with a low turnover of staff, there is an opportunity to present advanced topics for continuing-education purposes. Furthermore, depending on the amount of service needed, training can be assigned as a principal job responsibility or as a part-time duty along with other research or veterinary responsibilities. When used to evaluate a training program, performance standards direct attention toward assessing staff expertise in animal care and use procedures as a means of determining the effectiveness of a training program. An effective training program is expected to result in staff competence and therefore in the humane and appropriate treatment of animals. A lack of competence in how animals are handled or used points to a need for improvement in an institution's training program. Typically, governmental and accrediting inspectors will observe and query staff working with animals as a means of evaluating the effectiveness of a training program.

Types of Personnel and Related Training Requirements

Individuals who are about to work with animals in the research program should be assessed for training needs based on the nature of their contact with the animals. General topic areas for training in an institutional program are presented in Table 5.1 for staff in the following categories: animal care technician, researcher, and staff involved in maintenance, transportation, and administration.14 Animal facility managers and directors are excluded from this table because it is assumed that these individuals will receive training appropriate for their positions from sources outside of the institutional training program. For example, attending veterinarians are typically trained through programs for professional degrees and specialty board certification in laboratory animal medicine.

To compare the training needs of those served by the institutional training program, husbandry staff and research staff have similar requirements for training in animal behavior, care, and handling. Both husbandry and research staff require an orientation to the animal welfare laws, regulations, policies, and guidelines. However, husbandry staff require more detailed training on animal housing requirements and housekeeping practices for the animal facility environment.

Researchers, in turn, need to be qualified in the particular procedures that they will carry out on animals in their experimental studies. A "procedure" is any activity performed on the animal, such as behavioral observations, venipuncture, or surgery. The care that must be provided to the animals during experimental manipulations includes preparing the animal to humanely undergo the procedure, supporting and monitoring the animal's physiological function during the procedure, providing adequate analgesia to minimize pain, and providing additional supportive monitoring and care to aid the animal in recovering from the procedure.

Researchers should also have instruction on animal alternatives and on the conduct of an alternatives search, i.e., research and testing methods that minimize the number of animals required to obtain valid results, that minimize animal pain and distress, and that replace animals with alternative models. It is recognized that many institutions assign their staff to positions that combine husbandry and research functions, in which case, the training requirements would reflect the range of their duties.

For researchers, the animal-use protocol serves as a vehicle to formally identify research personnel who will have contact with animals and to describe their individual qualifications for performing their animal-related duties. The animal-use protocol is then used by a training coordinator or the attending veterinarian to assess the training needs of the investigator's staff in the proposed research activity. Assessment of training needs should take place in collaboration with the principal investigator or staff.

Husbandry and research staff should receive training in the hazards involved in animal research and related safety practices and equipment. These hazards are classified as biological, chemical, radiological, or physical agents. A federal law called the Occupational Safety and Health Act of 1970 requires that a safe working environment be provided to employees.15 That training on the nature of the occupational hazards and related safety practices is integral to compliance with that law. This standard applies to all staff with regard to hazards associated with the animal facility. For specific recommendations on hazard assessment and safety practices in an animal facility refer to the "Occupational Health and Safety in Animal Care and Use Programs" from the National Research Council.16

Staff who only work in the vicinity of animals or who work with biological samples obtained from animals also require training as relates to the institutional occupational health and safety program. This includes individuals who perform tasks involving maintenance, transportation, or administration. Such staff may be exposed to allergens, animal wastes and biological samples, or physical and radiological hazards used in research. The level of risk should be assessed for each type of staff to determine whether safety training is necessary and what topics should be included.

Staff having indirect contact with animals should also be offered training on how the animals used in the research program are appropriately handled and treated in compliance with the relevant laws. Workers with duties peripheral to an animal facility may fear the nature of the work performed on the animals, or they may have qualms that the care of the animals may be inappropriate. These individuals can benefit from learning about the general nature of the regulatory mandates and the institution's commitment to these standards. This training may also be helpful to the organization to avert the development of animal rights activism in persons who have no preconceived bias against animal research, but may be receptive to animal rights notions in an institutional environment where information is not forthcoming about the animal care and use program.

Professional Qualifications

Certification in competence areas by professional organizations in the United States are encouraged by regulatory authorities (USDA and OLAW) and by accrediting bodies (AAALAC). The Guide for the Care and Use of Laboratory Animals identifies technician certification as an option for the provision of staff training (Institutional Responsibilities, Personnel Qualifications, and Training, page 13):10

There are a number of options for the training of technicians. Nondegree training, with certification programs for laboratory animal technicians and technologists, can be obtained from the American

Association for Laboratory Animal Science (AALAS).

Professional societies have developed three certification systems to certify the knowledge and competence of animal research staff in key job descriptions:

Laboratory animal technician certification (three levels) by the American Association for Laboratory Animal Science (AALAS):

Assistant Laboratory Animal Technician (ALAT) Laboratory Animal Technician (LAT) Laboratory Animal Technologist (LATG)

Table 5.1 General Training Objectives Recommended for Each Staff

Adapted from Education and Training in the Care and Use of Laboratory Animals: A Guide for Developing Institutional Programs, a report of the Institute of Laboratory Animal Resources Committee on educational programs in laboratory animal science (U.S. National Research Council).14

Regulatory Matters

Be aware of animal welfare laws, regulations, policies, and guidelines.

Know that all animals are covered by a protocol.

Know and fill out cage card information.

Know how to report perceived deficiencies of animal care and use.

Animal Care Technicians Animal-Related Procedures

Know healthy behavior and appearance of animals, and recognize abnormalities.

Handle and restrain animals humanely and safely.

Identify, sex, and mark individual animals.

Perform sanitation procedures for caging and facilities.

Monitor and record room conditions, e.g., temperature and humidity.

Perform animal use procedures humanely, e.g., blood collection and injections, if these are appropriate to the job functions.

Occupational Safety and Health

Identify workplace hazards.

Know precautions to take for each hazard.

Use protective equipment properly.

Know how and where to get medical aid.

Regulatory Matters

Know the principles of laws, regulations, policies, and guidelines that apply to animal research.

Know the animal issues that are covered by a protocol, i.e., pain and distress; justification of animal use, species, and animal numbers; consideration of alternatives; etc.

Understand responsibilities of a principal investigator for overseeing animal welfare compliance and occupational safety by staff.

Understand the authority and function of the IACUC.

Know how to report perceived deficiencies of animal care and use.

Researchers Animal-Related Procedures

Understand species anatomy and physiology.

Perform humane procedures for animal use methodologies, i.e., restraint, anesthesia, asepsis, surgery, euthanasia, etc.

Know methods to alleviate pain and distress related to the procedures conducted on animals.

Know how to provide support for the animal before, during, and after a procedure, such as, but not limited to, anesthetic monitoring and postsurgical care.

Assure that staff are qualified to perform animal use methodologies (principal investigators).

Occupational Safety and Health

Identify hazards and use precautions related to research projects.

Oversee training on proper precautions for staff (principal investigators).

Ensure all staff are enrolled in an occupational-health program (principal investigators).

Institutional Staff Having Indirect Contact with Animals (Technical, Administrative, Transportation, and Maintenance)

Regulatory Matters Occupational Safety and Health

Know animal welfare laws, etc., ensure the humane Know safety procedures and practices. care of animals in research. Know how and where to get medical aid.

Know how to report perceived deficiencies of animal care and use. Be aware of animal-related and other hazards in facility areas.

Laboratory animal facility manager certification by the American Association for Laboratory Animal Science (AALAS), Laboratory Animal Management Association (LAMA), and the Institute for Certified Professional Managers (ICPM):

Certified Manager of Animal Resources (CMAR) Surgical Technician Certification by the Academy of Surgical Research (ASR) Surgical Research Specialist (SRS)

In each of these certification programs, educational and work-experience criteria are specified for eligibility, and candidates must pass an examination to attain certification. Certified laboratory animal technicians may maintain an additional credential as a registered animal technician (at all three certification levels) by continuing their education in a voluntary program known as the AALAS Technician Certification Registry. To maintain their credentials, certified managers of animal resources and certified surgical research specialists must periodically recertify by complying with continuing-education requirements. AALAS provides educational resources to support its certification programs and to offer con-tinuing-education opportunities.

Many institutions encourage their staff to attain certification in the previously mentioned specialty areas to support compliance with the training requirements of the federal laws and policies. Oftentimes, institutions offer financial incentives, such as pay raises, bonuses, and payment of certification fees. Some institutions may even require certifications as a job requirement or a promotion criterion.

Although the training for professional qualifications (i.e., as veterinarians or veterinary technicians) is beyond the scope of an institutional training program, the institution can enhance its compliance with U.S. national animal-welfare mandates by hiring technical staff with degrees and licensing as veterinary technicians. For example, veterinary technicians who have a two-year degree in veterinary technology and are state-licensed are well qualified to fill positions as research technicians, in addition to assuming duties in veterinary technical and animal care positions.

Institutions should provide opportunities and support for continuing education to staff who are professionally licensed, certified, or registered, so that they may maintain their qualifications. In informal statements on the attributes of a training program, the NIH Office for Laboratory Animal Welfare (OLAW) refers to AALAS technician certification and state professional licensing as indications of staff qualification:13

[OLAW] strongly recommends that institutions offer their staff access to training leading to certification in animal technology, such as that available from AALAS or a formally designated academic program. Institutions should also know and ensure compliance with any initial and continuing-education [s]tate requirements for the licensing of veterinary or animal health technicians.

Likewise, the Guide for the Care and Use of Laboratory Animals stresses the importance of continuing education (page 13) to maintain staff qualifications:10

Personnel using or caring for animals should also participate regularly in continuing-education activities relevant to their responsibilities. They are encouraged to be involved in local and national meetings of AALAS and other relevant professional organizations.

Program Trainers

The legal responsibility for meeting training requirements related to animals used in research technically lies with the institution, and so this responsibility falls to the Institutional Animal Care and Use Committee (IACUC). Since the IACUC has oversight responsibilities over all aspects of the animal care and use program, it takes on the role of assuring that staff training meets the standards imposed by federal mandates. A common approach is to designate a staff member as a training coordinator to assure that all staff who work with animals are provided with appropriate training services. Oftentimes under the direction of a training coordinator, additional individuals on staff at U.S. animal facilities are involved in providing training services on species and methods for which they have particular expertise. When expertise is not available within the animal facility, training may be sought from outside sources, such as researchers in academic departments, i.e., individuals with no reporting relationship to the animal facility, and experts from other institutions. In areas where multiple research institutions are in close proximity, training programs should capitalize on the expertise available at other institutions. Whether training is provided by in-house staff or outside experts, it is a best practice that the institutional training coordinator oversee all training activities.

The training of the IACUC to perform its program oversight may be beyond the scope of many program trainers. The IACUC's training should encompass the review of animal protocols and activities, review of program policies, and inspection of facilities. Often, the IACUC chair, the IACUC administrator, or the attending veterinarian have the task of orienting and training new IACUC members to their role. It is also desirable if an experienced IACUC member can be assigned as a mentor to the new member; this is especially important for the nonscientist or nonaffiliated member, since such persons require an additional orientation to the science and terminology of animal research.

Verification of Training — Animal Use Competence

In response to the U.S. federal requirement that animal research staff be qualified to work with laboratory animals, many institutions verify the competence of staff in animal-use activities however the skills are obtained, e.g., via the institutional training program or training by colleagues. Verification of competence is relatively straightforward with animal care staff, due to the lines of authority within the animal facility. A greater challenge is to verify competence for research staff who have no reporting relationship with the animal facility unit. Implementing a system for research staff necessitates an institution-wide policy and administrative support. Methods to assess competence in animal use among research staff generally follow two basic approaches. Some institutions utilize a "certification" process whereby designated trainers visit the lab and observe the conduct of animal-use procedures. Individual researchers, or in some cases entire labs, receive a recognition, or "certification," of their competence for specific procedures. This recognition may encompass the authorization to train others in the same procedure. Institutions using this method typically maintain a documentation of "certified" individuals or labs. A second approach couples competence verification with a generalized assessment of compliance with animal welfare mandates. Designated compliance staff visit labs in a rotating schedule to assess compliance and to offer training as needed. Such visits should have the objectives of verifying that animal-use procedures are conducted in accordance with relevant mandates, verifying that drugs and medical materials are current with respect to product expiration dates, providing information on federal mandates and institutional policies, and distributing related literature, including guidelines and news bulletins. Whatever the approach used by an institution, the balance between training and compliance should emphasize foremost the training service. Both training and compliance staff should have a cooperative and helpful attitude toward the research staff, commensurate with principles of customer service. Training and compliance staff should remain mindful that their primary goal is to provide a support service to animal research through their role of assuring compliance with federal and institutional mandates.

Recordkeeping

In the United States, there is no specific statement in federal laws, regulations, or policies to maintain documentation of training. That is, documentation of training is not included among the types of facility records that must be maintained by an institution and which are inspectable by federal authorities, according to federal laws or regulations. Nevertheless, federal and accrediting authorities consistently expect to have access to training records during an inspection of a research institution. The USDA has affirmed this expectation in published articles on the subject of training for compliance with the Animal Welfare Act.17,18 Because training programs are federally mandated, a system of documentation is the only practical way for an institution to prove, and for inspectors to verify, compliance with the training requirements. Record keeping of training activities is therefore a practical necessity for compliance with federal animal welfare mandates.

There is no mandate for the system of training documentation, i.e., as an engineering standard. That is, there is no specification for the format to be used for the records, who should maintain the records, or where or how the records should be stored. The training records may be electronic (e.g., residing in a database, spreadsheet, etc.) or paper-based. If electronic, they may be stored locally on a computer, or on an intranet, or on a host server inside or outside of the institution. Records may be accessed or filed primarily by individuals, departments, or by training activities. The training records may be generated and archived by a training coordinator, the IACUC, or another administrative unit. The records may be stored centrally or segregated by administrative units.

As in the operation of a training program, federal and accrediting authorities apply a performance standard for the documentation of training activities. The expectation is that the documentation system reflects a complete profile of the training program, that the records accurately reflect the training activities, that the records are comprehensible, and that all documentation are readily accessible on demand. To be adequate, the documentation should demonstrate that the institution's training program meets the objectives of government mandates (see previous sections).

Many institutions use database software systems as a means to track and document staff training activities. Commercial database systems for animal facility management often incorporate a module for training documentation. Such systems may allow some software customization to enhance the system's accommodation of the institution's training program features. In addition, some database systems offer connectivity of the database with e-mail to facilitate the communication with staff on training matters. For institutions that choose a stand-alone training records database, a system customized for training in the laboratory animal field is available for free from the Laboratory Animal Welfare Training Exchange (LAWTE). The program, based on Microsoft Access 1997, can be downloaded from the LAWTE Web site (http://www.lawte.org) from the "Exchange" page. This program contains two tracking systems to document staff training and compliance with institutional programs of occupational health and safety.

Training Resources

Investigators should look to the veterinary or training staff of the animal facility for information about and training on animal care and use procedures. The veterinary and training staff members offer expertise in basic methodologies, and they can recommend other resources that may best address a specialized training need.

A growing number of resources are available for enhancing a training program. Instructional media (videotapes, CD-ROM, and Web-based) offer content that can be used to either augment in-class teaching or be used for self-directed learning. Models and devices that simulate anatomical structures are valuable aids for teaching skills for performing animal procedures.

The following organizations offer information on training materials that are available from a variety of sources.

ORGANIZATIONS American Association for Laboratory Animal Science (AALAS)

As a membership organization of laboratory animal professionals, AALAS (http://www.aalas.org) offers an exchange of information and expertise in the care and use of laboratory animals:

♦ AALAS provides training materials for animal researchers and animal care technicians, including an online learning system, the AALAS Learning Library (http://www.aalaslearninglibrary.org/).

♦ The AALAS National Meeting includes a Learning Resource Center that has a large assortment of instructional media for viewing by meeting attendees.

♦ Educational sessions at the AALAS National Meeting offer many training opportunities in the laboratory animal field, including Train the Trainer workshops, which focus on basic and advanced methods of teaching.

♦ The COMPMED and TECHLINK listservs hosted by AALAS provide a forum for discussion of laboratory animal issues and methodologies.

♦ The IACUC Web site (http://www.iacuc.org) includes links to training programs on laboratory animal welfare at U.S. research institutions and links to online information on training media for the laboratory animal training field.

International Network for Humane Education (InterNICHE)

InterNICHE (http://www.interniche.org) is a network of students, teachers, and animal campaigners that focuses on animal use and alternatives within biological science, medical, and veterinary medical education. The InterNICHE Alternatives Loan System maintains a library of multimedia for lending to teachers and students in any country. These materials include CD-ROMs, videos, models, and mannequins that can be used for the teaching of anatomy, physiology, and surgery.

Laboratory Animal Welfare Training Exchange (LAWTE)

LAWTE is an organization for trainers and training coordinators in the laboratory animal field. Members use a listserv for discussions about training issues and methods. The Web site (http://www.lawte.org) offers information on training media and methodologies. A conference is held every two years in the U.S.

Norwegian Inventory of Alternatives (Norina)

The Norwegian Reference Centre for Laboratory Animal Science and Alternatives maintains the Norina database (http://oslovet.veths.no/NORINA/), which is an English-language archive of information on training materials for use in biological science education. This database offers an overview of training media (computer programs, CD-ROMs, interactive videos, films, and traditional teaching aids) that can serve as alternatives or supplements to the use of animals in student teaching at all levels of education.

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