FELASA’s accreditation for high-quality training in laboratory animal sciences

‘Stand-alone module’ accreditation

FELASA accepts applications for only a limited number of stand-alone modules or combinations thereof. These include the Function B-specific modules (9–11), task-specific modules (20–25), additional modules (50 and 51), and module 6.3. The process and criteria for these stand-alone or combined modules are identical to those for the other courses.

FELASA will not apply the stand-alone module accreditation policy to any other modules or combination thereof. Accrediting all modules separately is not feasible. First, it would create significant administrative complexity, as each module would require a separate review and approval process. Additionally, many modules are interconnected and form a coherent learning pathway; accrediting them individually would neglect these connections and the course’s coherence. Instead, trainees may be granted an exemption for retaking modules they have already completed as part of an accredited course. For example, when transferring to a course that covers a new function, some compulsory modules may be waived.

Any course may add task-specific or additional modules to teach particular skills or specialised content; for example, modules 20–22 can be added to the compulsory and function-specific modules for function A. These additional modules will be considered alongside the required modules in the accreditation process and will also appear on the certificate.

Constructive alignment

The EU-WG document does not specify the content to be covered or the number of hours a course should encompass. ³ Instead, it identifies the learning outcomes. Using learning outcomes rather than topics and hours allows the course organiser to adjust the course’s content, level of understanding, methodologies, and number of training hours to the course context, for example, the species covered. This view reflects the concept of constructive alignment, in which learning outcomes guide course design across teaching materials, teaching methods, competency levels, and assessments. ⁷

FELASA emphasises that constructive alignment is essential. Thus, accreditation entails a comprehensive review of the course provider’s educational design, teaching materials (e.g. dummies), teaching methods (e.g. problem-based learning), assessment methods (e.g. multiple-choice questions), instructors’ didactic skills, and, importantly, their alignment. The teaching methods and materials must promote student-centred, reflective, and context-based learning. The learning activities must be supported by teachers who can clearly present concepts, design tasks, and provide feedback.^8,9 Thus, courses that solely consist of e-learning without teacher interaction are not accepted. Nevertheless, e-learning modules can be part of a course, provided that a teacher–trainee discourse supports them. The use and integration of e-learning are evaluated as part of the accreditation process.

The assessment method must align with both the teaching methodology and the competency level specified in the learning outcomes. Miller’s pyramid is a widely recognised framework for this purpose. The pyramid outlines four levels of ‘achievement’ (Figure 1). ¹⁰ Its basic levels – know and know how – focus on cognition, and are typically assessed through written tests and essays. The higher levels – show how and do – address performative and behavioural competencies. These require direct observation of professional tasks in progressively more authentic contexts: first, in simulations; and, for the ‘do’ level, in real workplace settings (see also skill training). Simulation-based assessments – even when on-the-job training is part of the course – often correlate positively with workplace performance. ¹¹ Such simulations are easier to implement and less susceptible to assessor bias. Therefore, if a course wishes to include on-the-job training, FELASA recommends organising a simulation-based assessment at the end. In addition, the integration and alignment of the on-the-job training will be reviewed during the accreditation process.

Level of competency

Competence represents a broad concept encompassing demonstrable skills, knowledge, and attitudes. Examples include applying for an animal experiment in compliance with current regulatory guidelines or performing anaesthesia on a laboratory animal. In contrast, competency denotes a narrower concept: the ability to perform a specific task correctly, such as determining the sample size or administering an intraperitoneal injection.

The EU-WG document states that when performing a function (e.g. Function A, carrying out procedures), which can be considered as a competence, or its associated competencies (e.g. placing an intraperitoneal injection), and when there is potential to cause pain, suffering, distress, or lasting harm, completion of the relevant training modules is mandatory before working under supervision. ³ In addition, it states that a person is considered ‘competent’ only after a period of supervised work followed by assessment of demonstrated performance (Figure 1). ³ The meaning of ‘competent’ in the EU-WG document differs from that in educational frameworks (Figure 2). To capture stages of skill progression, terminology beyond the binary distinction of non-competent and competent is required. According to the Dreyfus Skill Model, there are five stages: novice, advanced beginner, competent, proficient, and expert (Figure 2). ¹² A novice is a trainee with no experience, lacking the knowledge and confidence to safely and with sufficient attention to animal welfare carry out procedures. Novices thus heavily rely on being provided with knowledge, clear directions, and feedback. Their training typically occurs in simplified settings and does not necessarily include hands-on practice (e.g. the different types and parts of syringes used for blood sampling). The advanced beginner notices situational aspects but still relies on examples provided by the instructor. The learning environment should encourage observation and guided practice to build pattern recognition. Hands-on training occurs in a context-poor setting that enables repetitive practice, with instructors providing regular feedback, thereby fostering a positive learning environment without undue stress. Such learning environments typically use dummies (e.g. learning to draw blood from an artificial rat tail). This stage should conclude with an assessment to determine whether the trainee is ready to progress to the next level. According to Dreyfus’s skill model, the next phase is ‘competent’, in which a trainee can handle complexity but is not yet able to work independently. The learning environment is becoming more complex and may involve live animals. At the start of this phase, guidance remains prominent, outlining alternative strategies and covering troubleshooting (e.g. what to do if a blood sample cannot be drawn from a rat’s tail). At the end of this stage, the assessment should confirm that the trainee can perform tasks under supervision without causing pain, suffering, distress, or lasting harm to the animal. ³ This assessment marks the completion of the course. ⁶ Furthermore, the assessment should determine the appropriate level of supervision required in the workplace.^3,6 Consequently, any course seeking FELASA accreditation must ensure that trainees reach this level of competence by the end of the course. Further development and proficiency, meaning the trainee can perform processes intuitively, occur in the workplace, where guidance shifts to supervision that fosters experiential learning and builds confidence. Overall, a final assessment is needed to determine whether a learner can work independently and thus be considered ‘competent’, in accordance with the EU-WG document (Figures 1 and 2).^3,6 The ‘expert’ level is achieved only through workplace experience in laboratory animal sciences across various settings, the development of a vast range of skills, and a comprehensive understanding of the field. Training to become proficient or expert falls outside the scope of FELASA accreditation.

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Figure 2.

Trainees progress through five stages of competency (Dreyfus Skill Model): novice, advanced beginner, competent, proficient, and expert. Their competency level increases as they advance, while the need for guidance, feedback, and supervision decreases. The novice and advanced beginner stages typically occur in simplified environments with high levels of instruction and guidance, as well as within courses. In contrast, progression to the proficient and expert levels depends on on-the-job training, with specific procedures, roles, and tasks carried out in complex workplace settings. The time needed for the several steps may vary depending on the skills to be achieved. The EU-WG document ³ uses a binary distinction between competent and non-competent and thus ‘competent’ has a different meaning than in the Dreyfus Skill Model.

Entry qualifications

Directive 2010/63/EU indicates that a person performing Function B shall have received instruction in a scientific discipline relevant to the work being undertaken. ⁴ In addition, the EU-WG document recommends that the person designing procedures and projects hold a university degree or an equivalent qualification in the relevant scientific discipline. ³ FELASA concurs with both documents and expects that the entry qualification for a Function B course is an academic degree or an equivalent qualification in Life Sciences. The Oxford Dictionary considers ‘Life sciences’ the sciences concerned with the study of living organisms. It is thus a broad, interdisciplinary domain that studies living organisms and life processes at all levels. It encompasses traditional disciplines such as biology and genetics, as well as applied fields such as biophysics and pharmacology.

Skill training and assessment

FELASA recommends integrating theoretical concepts into practical training as soon as possible after the corresponding theory is introduced (e.g. EU modules 7 and 8). As a teaching practice for teaching procedural skills, Peyton’s 4-step approach – a structured technique widely recognised as an effective method – is recommended.^13,14

The key concepts of Peyton’s method are demonstration, deconstruction, comprehension, and performance. In the first step, the instructor demonstrates the entire procedure in accordance with current best practices. This stage already offers the opportunity to engage trainees in a culture of care. It is an ideal platform for discussing how to improve animal welfare, adopt alternative approaches to skill training and animal work, and address the well-being of both students and staff working with animals. ¹⁵ Subsequently, the procedure is decomposed into smaller steps, with each component explained in detail. In the third step, the trainee verbally describes each step to demonstrate understanding. Finally, the trainee performs the procedure under the instructor’s guidance, who corrects and provides feedback. This teaching method has a minimum time lag between theoretical instruction and practical training. Minimising the delay between theory and practice will not only lead to more effective learning but also enable the immediate application of theory through hands-on practice, thereby reinforcing understanding, preventing cognitive decay, ¹⁶ and building confidence in performing tasks effectively.^6,17 Experiencing the real-life application of theoretical concepts also enhances their appreciation of the content’s relevance and improves attitudes towards the culture of care.^15,18,19 Although some educational programmes separate theoretical preparation from practical training, or incorporate on-the-job training at a later stage, any gap between theory and practice should be exceptional and is not ideal. A delay of up to 12 months between theory and practical training is acceptable only when clearly justified by the 3Rs and only if the theoretical content is explicitly refreshed during the practical training.

Practising Peyton’s four steps in skill training requires demonstration, guided practice, and individualised feedback. ¹³ This requires adequate staffing and time for staff to spend with each student. Peyton’s four steps were originally designed for a 1:1 student-to-staff ratio ¹³ ; however, they can be effective in small training groups of up to 10 students per tutor. ¹⁴ FELASA requires that skill-training sessions provide student guidance, with a minimum staff-to-student ratio of 1:5.^17,20 The 1:5 ratio may be increased if the skill’s context and complexity (e.g. 1:2, depending on the species and procedure) require it.

FELASA requests that course organisers use assessment methods that are valid, reliable, and feasible, including for assessing competency in practical skills. Direct observation of procedural/practical skills (DOPS) is explicitly designed to assess practical skills and provide standardised feedback.^6,21–23 This assessment method is implemented either in the workplace or in a test environment that replicates real-world conditions (Figure 1). ²¹ A test environment that builds on the OSCE (Objective Structured Clinical Examination) model used in medicine – an Objective Structured Laboratory Animal Science Exam (OSLASE) – greatly benefits the assessment of competencies and skills. ²³ The test environment must be introduced during the course to ensure constructive alignment. Consequently, the training environment must transition from a context-free setting (a room with materials to review) to one that closely mirrors the workplace, creating a contextualised and authentic learning experience (Figure 1). Thus, spaces designated for skill training must be conducive to learning and include, for example, waste disposal and personal protective equipment, even when no live animals are used.

Use of live animals

Directive 2010/63/EU permits the use of live animals for higher education or training to acquire, maintain, or improve vocational skills. Live animals may be used only when a non-animal alternative is unavailable. However, national and institutional guidelines may further restrict the use of live animals. ²⁴

The development of alternatives to using live animals in education is an ongoing process.^24–26 Certain simulators yield learning outcomes equivalent to those achieved through live-animal use, such as basic surgical skill.^24,27,28 Nevertheless, some alternatives exhibit limited realism, thereby reducing their validity.^24,26,29 Consequently, the implementation of non-live animal alternatives must be strategically planned, i.e. early in the learning trajectory, and their design evaluated to ensure alignment with the intended learning outcomes, required competency levels, and assessment strategies (Figure 1).^24,26,30

Where live animals are used, this can only be done when (1) part of a tiered approach, namely progressing from non-animal alternatives to live animals, (2) trainees have shown they have mastered the skill on non-live animal alternatives, and (3) when a ‘culture of care’ attitude is embedded in these training activities. Moreover, any potentially harmful procedures involving live animals for teaching and training must be carefully evaluated and justified from both scientific and educational perspectives.^3,4 In this regard, training on live animals should be limited to minor techniques when such use is part of initial training. More advanced procedures and techniques can be taught through continuing professional education.

Animals must, whenever possible, come from surplus stocks. In addition, animals may be reused in accordance with applicable regulations. The severity of the procedures used should be non-recovery or mild, and, if applicable, performed on an anaesthetised animal. In the case of animal reuse, it is crucial to consider the cumulative severity of individual cases. Using trained animals and docile strains is regarded as good practice because it contributes to the 3Rs. For handling and restraint, this practice falls below the threshold that would require project authorisation. ²⁶

Quality assurance

Each course should implement a system for regular quality review and monitoring, conducted at least annually. This system must enable trainees to provide feedback on the effectiveness and overall quality of their learning experience, with an emphasis on achieving a high response rate to ensure representative input. In addition to trainee feedback, other performance indicators such as trainee success rates and satisfaction should be systematically collected and analysed. These insights must then be translated into concrete improvement actions using the PDCA cycle – Plan, Do, Check, Act. The PDCA cycle is a continuous, iterative framework designed to drive process improvement and maintain high-quality standards (e.g. Sangpikul ³² ).

The application package

The ‘course application package’ includes the information to enable FELASA to conduct a comprehensive evaluation of the course, with particular attention to constructive alignment and the extent to which all relevant modules and their learning outcomes are addressed. It is designed to help the course provider self-assess the course.

The course provider must define the course’s scope, specify the functions or roles it addresses, identify any additional modules, specify the selected species, and define the certificates. Comprehensive details on the course structure, including the pedagogical approach and assessment methods, should be provided. This information must be substantiated by a copy of the assessment and accompanied by access to the relevant teaching materials. When live animals are used in training, demonstrating authorisation for the use of laboratory animals is required.

Furthermore, the course organiser is expected to provide evidence of the teaching staff’s qualifications and expertise in the subject and in teaching. The exact form of such teacher training is left to institutional discretion. In addition, the application should include information on its quality assurance system, supported by trainee feedback and related documentation. Importantly, for accreditation to be granted, the course must have been delivered at least once in the format for which accreditation is sought, thereby demonstrating its practical implementation and effectiveness in line with continuous improvement principles such as the PDCA cycle.

Accreditation process

The process is organised according to the principles outlined in the EU-WG document ³ and utilises standards and guiding principles for quality assurance in higher education. ³³ The accreditation process consists of two consecutive steps (Figure 3). Step 1 involves reviewing the application package. It focuses on the constructive alignment, whether a course meets the intended learning objectives, teaching staff competencies, and reviews the quality assurance system. This review process can take up to 4 months. Afterwards, the accreditation process proceeds to the second step: the on-site audit, which takes place while the course is in operation. For a timely process, the application should be submitted at least 6 months before the start of a course.

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Figure 3.

The accreditation process. Course organisers (red) begin by conducting a self-assessment to compile an application package. Ideally, a course should be planned 6 months after the application. Following an administrative review, the application is evaluated by the FELASA Education & Training Board (green). After this review (step 1), an interim report is drafted (no later than 4 months). This interim report guides discussions and the course review during the on-site visit to an ongoing course (Step 2). Based on the findings from steps 1 and 2, a final report is produced (no later than 3 months). If the course meets the accreditation criteria, an agreement is drafted, granting accreditation for a period of 5 years.

The on-site audit involves reviewing the course organisers’ documentation, attending lectures and practical sessions, and interviewing course participants and teaching staff. The audit report summarising the findings of both reviews may take up to 3 months to issue after the on-site audit. The final audit report forms the basis for the FELASA final evaluation of whether to grant or to refuse accreditation. The accreditation process concludes with the signing of an agreement between FELASA and the course organisation to issue certificates.

The accreditation is valid for 5 years, except when a course exceeds 1 year. An accreditation’s validity cannot exceed 10 years. Accreditation can be renewed by repeating the process. To maintain course accreditation, the course organiser must submit an annual report.

Certificate format and content

All course providers receive a FELASA certificate template and instructions for its use. The certificate is proof that an individual has completed a FELASA-accredited course. It can be used by national authorities to recognise the individual’s qualifications. ⁴ In addition, the certificate’s content facilitates mutual recognition of previously acquired competencies. To this end, the certificate clearly states which EU modules were covered and which EU modules the trainees used live animals in. If the teaching staff uses live animals to demonstrate a technique, their use is not listed on the certificate, as it does not indicate the certificate holder’s mastery. Nevertheless, it is advisable to include a reference to demonstrations or the use of non-live animal alternatives, as well as to the specific procedures that are trained (e.g. intraperitoneal injection), in an annex to the certificate.