ETPLAS brings together stakeholders to support common principles for education and training in laboratory animal science, as set out in legal documents and guidelines in order to promote harmonisation and mutual recognition among member states.

ETPLAS

• offers advice and information to new and existing accreditation/approval bodies;
• offers advice and information to existing and prospective course providers;
• facilitates the process to develop and reach common quality criteria;
• maintains a list of courses which meet the common quality criteria;
• encourages consistency of content and outcomes across modules and between LAS E&T providers; 
• encourages compliance with declared objectives and procedures in relation to the delivery of LAS E&T and assessment of the LOs;
• reviews and updates the mechanisms for monitoring the successful outcome of E&T and assessment when deemed useful.

The legal background on competence of personnel is laid down in article 23 of the European Directive 2010/63/EU.

Persons carrying out functions (a-d) shall have received instruction in a scientific discipline relevant to the work being undertaken and shall have species-specific knowledge. 

 

Staff carrying out functions (a-d) shall be supervised in the performance of their tasks until they have demonstrated the requisite competence.

 

Member states shall ensure, through authorisation or by other means, that staff are adequately educated, trained and competent.

 

Member States shall publish, on the basis of the elements set out in Annex V, minimum requirements with regard to education and training and the requirements for obtaining, maintaining and demonstrating requisite competence for the functions (a-d).

 

Non-binding guidelines at the level of the Union concerning educational requirements may be adopted. 

 

The EU has developed further guidance - The Education & Training Framework - to respond to the need for harmonisation and a common framework to ensure competence and to facilitate free movement of personnel. The outcome is on the basis of general agreement on not binding. It is left to each Member State to interpret whether and how this general guidance is to be implemented.

Although arrangements for LAS education and training is at the discretion of the Member States, there is the risk that different requirements for assuring the quality of courses may arise. There is the need, therefore, to develop common principles for Education and Training (E&T) programmes on which Member States could agree in order to achieve mutual recognition based upon confidence in the quality of E&T and its assessment process. Such principles could also be beneficial to aid programme providers in setting up courses of agreed quality and content.

The Education & Training Framework includes the principles and criteria for a modular, outcome-based E&T programme. In its own words the document discusses supervision and competence assessment, as well as continued professional development. These provide the basis for the development of a mutual recognition of training courses across countries. The guidance document also contains general principles for the use of live animals in education and training.

The following recommendations for a framework of Minimal Requirements for Mutual Recognition of Courses, developed by the ETPLAS Steering Group with the assistance of a wider Reference Group representing various stakeholder interests, are intended to contribute to free movement of personnel, quality of research with animals and high animal welfare standards. The recommendations are based on the E&T Framework and do not impose additional obligations beyond those laid out in the Directive 2010/63/EU.

This is a living document which will be kept under review and updated as required by ETPLAS.

Currently, there are many different approaches providing LAS E&T within the EU. Also, different arrangements for approval/accreditation exist. Therefore, ETPLAS has developed a set of key mutual recognition factors and information requirements that would allow mutual recognition of E&T courses between EU Member States (MSs). This ETPLAS framework is intended to provide guidance to the different stakeholders. The decision whether or not a course fulfils the educational and training requirements in a given situation will be taken by the Competent Authority (CA), their nominee, by delegated authority or by another responsible institution/body as applicable.

Since arrangements for E&T are at the discretion of the MS, often overseen and managed through their nominees or by delegated authority, different requirements for assuring the quality of LAS courses may arise as a consequence. Without mutual recognition of education and training and acceptance of a person’s training/ competence records free movement of personnel could be hindered. Lack of mutual recognition of E&T courses within the EU could in some cases lead to animals being used unnecessarily for training purposes if the training with live animals has to be repeated. 

Furthermore, if education, training and subsequently work is being done to different standards, this could lead to variable quality of science outcomes and animal welfare standards. There is a need, therefore, to develop a common European framework of reference for E&T in laboratory animal science (learning/teaching/assessment), in order to set common principles and information requirements for E&T courses on which relevant stakeholders in MS, and other countries could rely.

Adoption of common key factors and information requirements should assist MS in having confidence in the quality of E&T in LAS being delivered to an appropriate standard and its related assessment. Such common principles could also be beneficial to aid E&T providers in setting up courses of required quality and content. Mutual recognition and acceptance of LAS education and training should be the immediate aim, with the option of working toward the development of accreditation and quality audit processes to maintain quality in the long-term. 

Common E&T provisions and competence assessment with quality assurance should contribute to confidence in E&T standards. Key factors are:

• Common principles for competence assessment and confidence in adherence to these principles.
• Good communication between relevant stakeholders in MS to deliver mutual recognition within a MS.
• A recognition process to ensure quality, based on availability of comparable information and assessment complying with EU recommendations.
• A common evaluation framework for courses as the basis for mutual recognition of E&T carried out elsewhere in other MS and, where appropriate, in non-EU countries

Adherence to these key factors should facilitate mutual recognition of a particular LAS course. Relevant stakeholders in MS could agree to accept courses that have undergone an approval by the competent authority of a MS or accreditation process by an indepedent accrediting body meeting the information requirements set out below. 

Any process to ensure mutual recognition should specify clearly the information on course content, delivery and assessment which should be provided by the course providers to approval or accrediting bodies. The information requirements set out below are considered the minimum to allow for mutual recognition. The list in the EU E&T Framework that details those requirements for approval/accreditation has been adapted and expanded upon.

The information should include:

1. The name of the E&T provider, institution and contact details. When applicable include appropriate quality reference (legal, regulatory or any relevant E&T reference).
2. Qualifications/experience of educators, trainers and assessors (to meet agreed performance standards for course provision).
3. Syllabus for the module(s), including type/s of delivery (e.g. lectures/video materials/e-learning/interactive small group sessions etc.) including practical elements if applicable, and the associated Learning Outcomes (LOs).
4. Comprehensive, detailed, course information including topics covered, for example regarding regulatory and legal modules (European framework, national, local and other related legislation).
5. Example course programme including an indication of approximate timings.
6. Details of the minimum attendance requirements for the course and any critical sessions that must be attended.
7. How the LOs are to be assessed, including assessment criteria.
8. Language of the course. Certification to be in the recognised language of the MS and in English to promote free movement.
9. Certificate, issued by the accreditation or approval body where these exist, which should include EU module details for information (or link to relevant information).
10. Information on the means to access records of participants and course assessment results kept by the course provider and any other related records in accordance with requirements of the MS (those records should be kept for 5 years after the E&T course).

In Appendix A (below), items of the EU E&T Framework list not considered essential for achieving mutual recognition have also been reviewed and updated.

The following list of requirements, usually required for course accreditation, are partly extracted from the EU E&T Framework and have been further developed and rephrased. These points are considered to be optional and not essential for a course to meet minimum quality criteria for the purposes of mutual recognition:

Independent consideration of the way the course will be taught and whether it is likely to deliver the learning outcomes.

• Visit to course by independent quality assurers.
• Review of course material including hand-outs, pre-course reading and teaching aids.
• Consideration of a description of facilities where course is taking place, to ensure that the place used is likely to provide a suitable learning environment.
• Timetable and information about the type of teaching in each session.
• Methods and timings of communication with students/trainees.
• Information about the time allowed for pre- and post-course reading/revision and the timing of written assessments.
• Proportion of trainees to lecturers /trainers in both theory and practical elements.
• If distance learning, what methods will be used and how independent assessments are ensured.
• Information on use (and justification for the use) of live animals.
• Information on attendance levels and pass/fail frequency of course.
• Minimum of two courses to be held prior to confirmation of approval/accreditation.
• Independent review of course feedback from trainees.
• Review of course management and organisation (e.g. minutes of a training group or committee responsible for local course review and development).