According to the European Directive 2010/63/EU, to improve the welfare of experimental animals, “Member states should ensure through authorisation or by other means that staff are adequately educated, trained and competent”. Also: “Non-binding guidelines at the level of the Union concerning educational requirements would, in the long run, promote the free movement of personnel.”
In other words, both for the welfare of animals and free movement of personnel, it is recommended that agreement at the European level on the minimal requirements of education and training in laboratory animal science be sought.
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 E & T courses may arise. This could also lead to a variable quality of animal welfare and the science using live animals. There is the need, therefore, to develop common principles for Education and Training 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.
A reference text is the European Commission’s Guidance Document on the Education and Training Network , which includes the principles and criteria for a modular, outcome-based education and training framework. 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.”
One of the assignments of ETPLAS is to facilitate the process of good communication between all stakeholders in order to agree on these common principles and thereby aiding harmonisation and mutual recognition.
Mutual recognition of education and training
Minimal requirements for mutual recognition of courses in laboratory animal science - An ETPLAS initiative
The following recommendations for a framework of Minimal Requirements for Mutual Recognition of Courses, developed by the Education & Training Platform for Laboratory Animal Science (ETPLAS) Steering Group with the assistance of a wider Reference Group representing various stakeholder interests, is intended to contribute to free movement of personnel and maintaining education and training of high animal welfare standards at EU level. The recommendations are based on the endorsed EU Education and Training (E&T) Working Document1 and are at the discretion of the Member States. These recommendations do not impose additional obligations beyond those laid out in the Directive 2010/63/EU on the protection of animals used for scientific purposes.
This is a living document which will be kept under review and updated as required by ETPLAS. (3 March 2016)
‘A working document with guidance on the development of a common education and training framework to fulfil requirements under the Directive’, (hereafter referred to as the EU E&T Working Document) has been endorsed by the EU National Competent Authorities for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes at their meeting of 19-20 February 2014. The aim of this document is to facilitate meeting the requirements for education, training and competence of all those involved in use and care of animals for scientific purposes, as laid down in the Directive, and to further free movement of personnel. Within the EU E& T Working Document, one topic covered is that of approval and accreditation of education and training (E&T) in Laboratory Animal Science (LAS) courses. However, the EU E&T Working Document does not differentiate between processes of approval and accreditation and sets out requirements that could be applicable to both.
Currently, there are many different approaches employed within the EU to provide LAS E&T and differing arrangements for approval/accreditation.2 For this reason there is a need to address the current situation and develop a set of key mutual recognition factors and information requirements that would allow mutual recognition of E&T courses between the relevant stakeholders in MS. In this context, the endorsed EU E&T Working Document states that there is a need for a common approach to assure confidence in the quality of E&T and assessments being provided even though it does not differentiate between processes of approval and accreditation. For this reason, ETPLAS has established guiding principles for a mutual approach to recognizing each other’s processes.
The recommended framework from ETPLAS on information required for mutual recognition is intended to serve as advice and give 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 applicable3.
The need for mutual recognition and acceptance
Without mutual recognition of education and training and acceptance of a person’s training/ competence records free movement of personnel could be hindered. Since arrangements for LAS E&T is at the discretion of the MS, often overseen and managed through their nominees or by delegated authority, different requirements for assuring the quality of E & T courses may arise as a consequence.
This could lead to a variable quality of both the welfare of research animals and laboratory animal science if education, training and subsequently work is being done to different 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 as things progress, in other countries could rely.
Common key factors and information requirements should assist MS (CA or employers) in having confidence in the quality of E&T in laboratory animal science being delivered to an appropriate standard and its related assessment and hence facilitate mutual recognition. Such common principles could also be beneficial to aid E&T providers in setting up courses of required quality and content.
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 training has to be repeated and the course uses live animals. 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.
E&T is a multi-step/stage process which encompasses initial attendance at a modular E&T course (as proposed in the EU E&T Working Document) followed by on-the-job education, practical training and therefore, the development of competence through work experience.
This document sets out guidance for stakeholders involved in establishing programmes in LAS in the context of the guidelines laid down in the EU E&T Working Document and which aim to achieve mutual recognition of E&T courses within the EU. The document uses the EU E&T Working Document as the basis for further development.
Further work by ETPLAS will be required to establish a common evaluation framework to permit acceptance of a person’s practical education and training carried out in the workplace.
Key factors for mutual recognition of introductory E&T courses
To meet obligations under Article 23 of the Directive, MS have to ensure that all staff are appropriately trained and competent. There is a need for relevant stakeholders in MS to rely on E&T provisions and competence assessment whether delivered locally, regionally, nationally or internationally.
Course recognition may be achieved in a number of ways, including approval by MS (or delegated) authority, through educational management and quality control (for example in the case of courses run in academia) or through independent organisations, such as independent accrediting bodies, providing relevant expertise and objectivity to evaluate the various (local, regional, independent, academic/industry/commercial) courses.
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 an E&T course. Relevant stakeholders in MS could agree to accept courses that have undergone an approval or accreditation process meeting the information requirements set out below.
Information Requirements for Mutual Recognition of of Each Other’s E&T Courses
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 accrediting4 bodies. The information requirements set out below are considered the minimum to allow for mutual recognition. The list in the EU E&T Working Document (page 17) that details those requirements for approval/accreditation has been adapted and expanded upon here. The information requirements listed in the EU E&T Working Document but not considered essential for achieving mutual recognition have also been reviewed and updated. These are presented in Appendix C.
The information should include:
- 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).
- Qualifications/experience of educators, trainers and assessors (to meet agreed performance standards for course provision).
- 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).
- Comprehensive, detailed, course information including topics covered, for example regarding regulatory and legal modules (European framework, national, local and other related legislation).
- Example course programme including an indication of approximate timings.
- Details of the minimum attendance requirements for the course and any critical sessions that must be attended.
- How the LOs are to be assessed, including assessment criteria.
- Language of the course. Certification to be in the recognised language of the MS and in English to promote free movement.
- Certificate, issued by the accreditation or approval body where these exist, which should include EU module details for information (or link to relevant information).
- 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).
The role of ETPLAS in aiding mutual recognition
The Education & Training Platform for Laboratory Animal Science (ETPLAS), formerly the EU Platform, has been established to enable information sharing and communication between course providers, approval/accrediting bodies, employers and MS authorities. Mutual recognition is a continuing process which is reliant on good communication between all interested parties. ETPLAS can facilitate this process and can:
- offer advice and information to new and existing accreditation/approval bodies; 5
- offer advice and information to existing and prospective course providers;
- facilitate the process to develop and reach common quality criteria;
- maintain a list of courses which meet the common quality criteria;
- encourage consistency of content and outcomes across modules and between E&T providers;
- encourage compliance with declared objectives and procedures in relation to the delivery of E&T and assessment of the LOs;
- review and update the mechanisms for monitoring the successful outcome of E&T and assessment when deemed useful.
Additional elements required for course accreditation
The following list of requirements, usually required for course accreditation, are partly extracted from the EU E&T Working Document 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).
1 National Competent Authorities for the implementation of Directive 2010/63/EU on the protection of animals used for scientific purposes. A working document on the development of a common education and training framework to fulfil the requirements under the Directive.
2 For definitions see Appendix B
3 See Appendix A for further information about the role of ETPLAS.
4 See definitions of approval and accreditation in Appendix B
5 See Appendix B, Glossary of Terms