Legal Requirement for Training

The European Union (EU) and Council of Europe (CoE) are federations including most, but not all, European countries. Both have statutes to govern and regulate the use of vertebrate animals for scientific purposes1,2 (see also Chapter 3). In addition to these statutes each nation has its own legislation. National legislation should be harmonized with the European regulations, and may exceed the requirements of the European regulations, which serve as the minimum standard.

The Council of Europe Convention 123, Article 26, states that: "Persons who carry out, take part in, or supervise procedures on animals, or take care of animals used in procedures, shall have had appropriate education and training."

The CoE Convention ETS 123 contains the provision that parties should hold multilateral consultations to examine the progress of its implementation and the need for revision or extension of any of its provisions on the basis of new facts or developments. During the last decades, three multilateral consultations have been held. At these multilateral consultations, the parties in 1993 adopted the following resolution on education and training of persons working with animals: "This resolution presents guidelines for topics to be included in educational and training programs for four categories of persons working with laboratory animals (from animal caretakers to specialists in animal science." This requirement is reiterated in the European Directive.

Article 5 of the European Directive states that a competent person must oversee the well-being and the state of health of the animals. Article 19 stipulates that a veterinarian or other competent person should be charged with advisory duties in relation to the well-being of the animals. The provisions on competence warrant special attention. Laws and regulations are poor tools when not based upon an understanding of what constitutes humane and responsible animal care and use. Therefore, well-directed education and training provide the means for gaining this understanding and for evaluating the ethical ramifications.

Article 7 of the Directive states that only a person considered to be competent, or under the direct responsibility of such a person, should perform animal experiments. This provision is amplified by Article 14, which states that persons conducting, collaborating in, or supervising experiments or the care of laboratory animals should have appropriate education and training. It is essential that the people involved in the design and conduct of experiments should have received an education in a scientific discipline relevant to the experimental work. They also need to be capable of handling and taking care of laboratory animals. Each member state must specify how the provision of competence is to be implemented within national legislation.

FELASA Guidelines for Teaching and Training

The Federation of European Laboratory Animal Science Associations (FELASA) has prepared proposals concerning educational and training requirements for staff and personnel working with laboratory animals. Some countries have already introduced strict regulations regarding competence based upon these FELASA guidelines.

The categories are:

Category A3 - persons taking care of animals (animal technicians)

Category B4 - persons carrying out animal experiments (research technicians)

Category C3 - persons responsible for directing animal experiments (scientists)

Category D5 - specialists in laboratory animal science or laboratory higher-management (specialists)

These recommendations, published as FELASA Working Party Reports in the journal Laboratory Animals (U.K.), are in the form of syllabi for the training of each category of personnel. The recommendations for categories A and D are in-depth, career-type educations, while categories B and C are relatively short courses. Because of the multilingual nature of the continent and differences in job titles, recommendations for training objectives are handled through descriptions of duties and responsibilities instead of a defined nomenclature for each category. CoE has adopted the competence categories; hence they can be regarded as the basic competence classification in Europe.

FELASA Category A training is organized to address four levels of staff needs and experience: Level 1 for basic laboratory animal care, Level 2 for those with at least two years of work experience, Level 3 for those with an additional three years work experience (five years total), and Level 4 for those in higher management or specialization.

FELASA Category B guidelines contain a set of topics and subtopics to be taught during 40 hours. Practical exercises are emphasized by means of a recommendation that half of the instruction be devoted to hands-on exercises or demonstrations. Category B guidelines have been published as the last of the four categories, and hence the very first courses have recently been established.

Category C training has a prerequisite of a full university degree in a biomedical discipline, such as animal biology, medicine, or veterinary medicine. The Category C curriculum is double the volume of Category B, i.e., 80 hours, or an equivalent. The multilateral consultations of CoE have adopted this curriculum.

Category D training has a prerequisite of a degree in biomedical or veterinary sciences, demonstrated competence at Category C level, and appropriate experience in the field of laboratory animal science. Since laboratory animal science combines knowledge of the scientific method and animal welfare principles, as well as specific research on laboratory animals, the Category D curriculum includes completion of a scientific project to be published in a peer-reviewed journal. In all, the curriculum is expected to take two years.

Common Approaches to Training

In order to avoid confusion or inappropriate reference to FELASA guidelines, the FELASA Board established a working group, the purpose of which was to make recommendations for the delivery of education and training in accordance with FELASA. This document, which will soon be published, should assure the quality of education and training in laboratory animal science and promote further harmonization within Europe. This scheme is tailored to accredit courses, not institutes or individuals.

At the same time, the European Science Foundation (ESF), the umbrella organization of the European research coordinating and funding organizations, issued a statement that reads: "Investigators and other personnel involved in the design and performance of animal-based experiments should be adequately educated and trained. ESF member organizations should encourage the development and organization of accredited courses on laboratory animal science, including information on animal alternatives, welfare, and ethics." The FELASA accreditation system on laboratory animal science training will be the only one in existence.

A specialty board for laboratory animal veterinarians has been established in Europe. Following an application period for de facto specialists, European board examination is based on work experience and passing an examination on topics of FELASA D-category, supplemented with specific, veterinary-oriented topics.

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