Quality assurance of LAS Education and Training
The following information about existing accrediting bodies has been 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. The information 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. (17 October 2016)
This document has been produced to explain, in broad terms, what accreditation is, the type of expertise involved and what the process entails for existing accrediting bodies in order to share this information and demonstrate how it might be possible to set up similar processes.
What is accreditation?
Accreditation can be defined as a process in which certification of competency, or credibility is independently verified. In the context of EU education and training (E&T) in laboratory animal science (LAS), where accreditation processes already exist, accrediting bodies are concerned with determining whether a course meets the criteria required for course accreditation, as outlined in the EU Education and Training Framework, to ensure that satisfactory course quality is established (and maintained) so that the learning outcomes (LOs) will be delivered. Courses are accredited, not people, and it is important to recognise that competence cannot be achieved just by attending a course (see the E&T Framework, link above, for further information about practical competence). However, it is expected that a certificate of achievement will be issued for satisfactory completion of a course, the requirements for successful completion having been set by the accrediting body.
In writing this document ETPLAS acknowledges that LAS E&T provision does vary, and that this will include anything from intensive short courses, some run in-house, others offered by commercial organisations, through to detailed programmes in LAS offered within academia.
What is required for accreditation?
A small number of independent accreditation bodies already exist and ETPLAS is currently aware of the following:
- the FELASA Accreditation Board;
- Institute of Animal Technology (IAT), UK
- the Royal Society of Biology Accreditation Board (RSB), UK;
- the Scottish Accreditation Board (SAB), UK; and
- the Universities Accreditation and Quality Audit Group (UAG), UK.
but there may be others we are not yet aware of. These are all independent of the competent authority and independent of the establishments/organisations/companies providing training courses. They all have been operational for many years. The processes and practices set out in this document are derived from elements of their experience.
Accrediting bodies for LAS E&T vary in their composition and constitution because they were developed and have evolved to meet particular needs in different research communities (geographical/regional/industry/academia).
Each accrediting body was established independently of each other and of the training providers whose courses were considered for accreditation. However, all of these organisations consider similar key factors in order to accredit a course initially (e.g. in some cases for up to five years) and then, subsequently, to monitor the delivery of training including course development and success in delivering the required learning outcomes (LOs) on an ongoing basis.
Each accrediting body recognises this as being a two-stage process involving accreditation, at the outset, followed by periodic quality audit (QA) (defined as systems to ensure the maintenance of a desired level of quality in a service or product, for example, as part of an accreditation process), to provide independent, comprehensive, interim review (or thematic review when specific issues/requirements need to be addressed) of courses ensuring that standards are being maintained so that the LOs continue to be met.
Of the existing accrediting bodies that ETPLAS is aware of, which are currently responsible for accreditation of LAS courses, it can be said that the accreditation and QA process is carried out by an entirely independent body, (that is recognised by but independent of legal bodies, such as Member States Competent Authorities and comprising individuals not involved in the delivery of training or assessment of trainees for the course being evaluated), which can offer a range of relevant expertise within the LAS field, from associated professions or the field of educational practice/standards.
The accrediting body applies and reviews a common combination of elements that together should provide confidence in course quality and expected delivery of the required LOs. The endorsed E&T framework suggested a list of provisions, including those for accreditation, on the basis of brief discussion and consideration of existing accreditation processes.
Initial accreditation - information required by existing accrediting bodies
In order to obtain accreditation (this can be at the request of an academic institution, an in-house course in industry or contract research, or from a commercial or charitable E&T organisation) the course organiser is asked to provide information for review and accreditation by the independent accrediting body before the course can be deemed to be accredited and certificates for the successful completion of accredited training issued.
Existing accrediting bodies in LAS E&T currently request the following information from course organisers/providers (although specific requirements will vary):
- Course details including the name of the course provider, institution and contact details. When applicable this will include appropriate quality reference (legal, regulatory or any relevant E&T reference).
- Qualifications/experience of educators, including trainers and assessors (to meet agreed performance standards for course provision appropriate to the type and nature of teaching).
- 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 LOs.
- Comprehensive, detailed, course content information including topics covered, such as regulatory and legal modules (European framework, national, local and other related legislation) and species specific modules.
- Course programme including approximate timings and information about the type of teaching in each session.
- Course materials including hand-outs, pre-course reading, other resources and teaching aids, including any e-learning.
- Information on the use of live animals where this is required, justified and permitted.
- Information about the time recommended for pre and post-course reading so it is clear that students have sufficient time to study and assimilate the course information.
- Details of the ratio of trainees to lecturers/trainers in both theory and practical sessions of the course and/or the allocation of time per student for individual instructions/ feedback by trainers.
- If distance learning is used, information about the methods used and how invigilation of the assessment is provided (to be certain that the person taking the assessment is the person who should be taking the assessment).
- Attendance and assessment information including minimum attendance requirements, critical attendance sessions, time allowed for revision and timing of the written and practical assessments along with requirements and arrangements for reassessment.
- Theory and practical assessment; how the LOs are to be assessed, including assessment criteria for both theoretical and practical elements and consideration of specimen exam scripts.
- Language of the course; with an understanding that certification should be in the language of the course and in English to promote free movement.
- Certificate which should include EU module details (or provide a link to the relevant information).
The accrediting body undertakes an impartial, independent, objective assessment of the way the course will be taught and trainees assessed, and in particular whether it will deliver the LOs and assesses the information provided against their defined criteria before determining whether and on what terms a course should be accredited and which is then subject to ongoing interim review and QA.
The accrediting body should undertake a site visit to scrutinise the delivery of the training before full accreditation is confirmed.
Interim review - course review and quality audit
Accrediting bodies are responsible for the interim review through QA of the courses they accredit to ensure that appropriate standards of teaching, training and assessment are being maintained.
QA, is an essential component of the accreditation process. It is important, once a course is up and running, to ensure that it remains up-to-date and that things such as new initiatives, changes in teaching practice, changes in educators/trainers, refinements in experimental practices and improvements in animal welfare are all incorporated as they occur.
Without regular, independent, reviews there can only be limited confidence in the quality of a course and little or no evidence that quality is being maintained over time.
QA will involve a visit to the institution providing the course to review its operation over a given period (e.g. 5 years) along with a requirement for regular updates from course organisers in the interim such as an annual report including information about any changes which could include incorporation of new information/techniques, review of new training materials, any change of trainers, delivery methods and detailed assessment success/failure statistics.
The independent accrediting body will have set criteria for accreditation against which a course will be measured and key components will be considered in the review and assessment of the course. The review and QA visit will usually undertake the following:
- eview of records of participants and course assessment results.
- Review of other records in accordance with requirements of the Member State (MS) or against criteria defined by the accrediting body.
- Visit to the course by auditors independent of the course and the establishment running the course.
- Observation of the delivery of education training including observation of a practical session involving animals.
- Consideration of facilities, that is the room/s where a course is taking place, to ensure that the place used is likely to provide a suitable learning environment and is appropriate to the teaching (e.g. theatres used for teaching anaesthesia and surgery). This is particularly relevant to commercial courses or a course with a movable venue.
- Review of methods and timings of communication with students/trainees.
- Review of the proportion of trainees to lecturers/trainers in both theory and practical elements and/or the time allocated to each student individually.
- When distance learning is used, review of the methods, opportunities for interaction and means of seeking help from tutors and also how independent (see above) assessments are ensured (i.e. for the trainer to be sure that the person taking the assessment is the person who should be taking the assessment).
- Information on attendance levels and pass/fail frequency of course.
- Review of course feedback from trainees.
- Review of course management and organisation (e.g. minutes of an education and training group or committee responsible for local course review and development) and evidence that any issues that have arisen have been followed up and resolved in a timely manner. Includes changes to the course made as a result of previous recommendations for action/change/improvement provided to the trainer/course organiser.
- Review of any previous issues which should have been actioned.
- Feedback the outcomes in terms of both recommendations for action/change/ improvement and commendations for good practice and other information to the course provider.
- Provide information to the MS or competent authority as required.
- Share with other course providers recommendations and commendations (anonymised) as required, plus information, outcomes, resources … which is where ETPLAS may be able to help.
Circumstances change so, importantly, once an amount of information and knowledge has been built up following accreditation and QA visits this is used by the accrediting body to inform all course organisers; to revise and update their own accreditation processes; and to facilitate ongoing improvements in course standards.
Also, whenever possible, an accrediting body will provide general information (anonymised) to trainers and course organisers concerning good practice and potential issues that have been encountered elsewhere so that trainers can benefit and learn from the experiences of others.
How might you form an accrediting body?
We know, from the experience of the existing accrediting bodies, that it is possible to develop an accreditation process which is accepted at all levels and by all parties (i.e. MS, competent authority, research/breeding/supplying establishment, course providers, trainees).
Some examples of how independent accrediting bodies/processes have been formed are:
1) established by an existing professional body with an interest/involvement in or representation of LAS (e.g. FELASA); or
2) by the coming together of recognised experts or organisations with a professional interest and expertise in LAS E&T to form an independent accrediting body (e.g. UK IAT, RSB, SAB and UAG).
3) accreditation systems that already exist within places of learning e.g. universities, and have been adapted to enable the accreditation of LAS E&T courses both within and external to the university.
One other possibility is for the MS competent authority to invite applications from interested parties wishing to form an accrediting body and for the competent authority to establish a system in which the work of the accrediting body is recognised and certificates for successful completion of an accredited courses are accepted (which is how the UK accrediting bodies were originally established).
The most appropriate way for an accreditation process to develop depends entirely on existing processes and requirements including the way in which responsibilities under the Directive are delegated within the MS. In order to set up an accrediting body/process consideration of the following points would be a good place to start:
- get in touch with other people who are involved in accreditation of LAS courses;
- review existing processes of accreditation;
- establish criteria that a course should encompass;
- decide what you want to accredit (courses/modules);
- find your target audience, for example staff or students involved in the different Directive Article 23 Functions;
- involve/recruit people who are involved in or have a professional interest in LAS E&T;
- consider the resources and processes that will be required. Who should be involved in accreditation?
Who should be involved in accreditation?
As stated at the beginning of this document, because of the different arrangements within MS and how the education and training for people defined in Article 23 is organised and provided, accreditation bodies are likely to vary in their composition and constitution and in terms of any responsibilities and reporting requirements. They can also function as regional, national or international bodies.
However, as a guide, membership of an accrediting body could, for example, include:
- individuals nominated by the person responsible for compliance (Article 20) e.g. from breeder, supplier or user establishments;
- individuals from independent professional, commercial and/or other relevant LAS or educational organisations;
- individuals from national and local animal welfare organisations/bodies;
- educationalists, statisticians, 3Rs experts or other appropriate specialists.
In each case the individuals appointed should be able to offer impartial, expert, input and advice.
Composition of an accreditation body should involve an adequate number of individuals to undertake the work associated with accreditation which will depend on the number of courses to be accredited and taking account of periodic review arrangements etc. Members should be drawn from a range of backgrounds (as indicated above) with the collective expertise necessary to undertake the work associated with accreditation and QA of LAS E&T.
Accreditation body members should, between them, be able to provide the range of expertise necessary to objectively consider, evaluate and accredit courses and where any gaps in expertise arise they should be able to seek advice and information from other experts who do have the relevant expertise, taking account of and seeking agreement in relation to any issues of confidentiality.
Whilst course organisers can be members of an accreditation body the members must be independent of the specific course being evaluated for accreditation or reviewed and audited to avoid any potential conflicts of interest.
Accreditation at present is a two-stage process undertaken by specialists/experts who are independent of the course/programme involving:
1) initial accreditation of a course based on defined criteria; followed by
2) interim review and Quality Audit in which course delivery and performance is measured against these criteria.
The Steering Committee firmly believes that course quality is essential for mutual recognition, mutual acceptance and harmonisation and that the only way for course quality to be confirmed and maintained in the long term is through a process of course accreditation.
This reflects the information in the EU Education and Training Framework (page 16 to 18).
Abbreviations used in this document
- E&T Education & Training
- FELASA Federation of European Laboratory Animal Science Associations
- IAT Institute of Animal Technology
- LAS Laboratory Animal Science
- LO’s learning outcomes
- MS Member State
- QA Quality Audit
- RSB Royal Society of Biology Accreditation Board, UK
- SAB Scottish Accreditation Board, UK
- UAG Universities’ Accreditation Group, UK