The protection of the welfare of experimental animals is a constant in Community law since its origins. This subject is currently covered by Directive 2010 /63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes.

In Spain, the basic regulation on the matter is contained in Law 32/2007 of 7 November for the care of animals, in their exploitation, transport, experimentation and slaughter and, as the development of the law, in order to implement in our internal law the novelties introduced by Directive 2010 /63/EU, in Royal Decree 53/2013 of 1 February, laying down the basic rules for the protection of animals used in experimentation and other scientific purposes, including teaching.

An essential factor in protecting the welfare of animals used for experimentation and other scientific and teaching purposes is the proper training of personnel in charge of their management.

This issue is dealt with (by collecting the provisions of Articles 23, 24 and 25 and Annex V of Directive 2010 /63/EU) in Article 15 of Royal Decree 53/2013 of 1 February 2013. This article establishes the general principle that people who handle experimental animals must have adequate prior training, and then establish the basic training requirements for those who need to be trained; the competent bodies are assigned the responsibility of ensuring by means of authorization or other appropriate means the training of the staff to carry out the various functions; it is established that the training of the staff may have a modular structure based, where appropriate, on guides, guidelines or recommendations of the European Union, as well as the minimum training requirements to be expressed in learning outcomes and recognition of staff training shall be valid throughout the national territory.

The transitional provision of the Royal Decree 53/2013, of February 1, provides that within 12 months from the publication of the royal decree, the Ministry of Economy and Competitiveness, prior to the report of the Ministries The Committee on Education, Culture and Sport and Agriculture, Food and the Environment will develop the training requirements of the staff referred to in Article 15 of the Royal Decree, adding that such effects may be provided by a group of in the framework of the committee established by Article 44 of the royal decree, in the field of education, training and training of staff.

In compliance with this mandate, the purpose of this ministerial order is to develop training requirements for personnel who use animals in experimentation and for other scientific purposes, including teaching, regulated with general character in Article 15 of Royal Decree 53/2013 of 1 February 2013.

The ministerial order mainly develops the following aspects:

1. The training requirements of each of the functions involved in the management of the animals. These requirements consist (with the specific characteristics of each function) in the academic qualifications and relevant professional accreditations; the specific training courses of a modular nature, the content of which is based on guidelines recently approved by the European Union, and, in some functions, the performance of work under supervision, as a final link to be able to perform them autonomously.

2. The recognition of the training by the competent bodies, by issuing a certification that enables the performance of the function in question in an autonomous manner, once the compliance of the the requirements applicable to that function. This recognition is in line with the Law 20/2013 of 9 December on the guarantee of the market unit, as it complies with the principles of necessity and proportionality, as a rule of the European Union is thus available (in this case the 23.2 of Directive 2010 /63/EU), is effective throughout the national territory and is subject to reciprocity with other Member States of the European Union.

3. The requirements of the training courses and the entities that provide them, as well as their recognition by the competent authorities.

4. The maintenance of training through continuous training activities.

5. The transitional regime applicable to persons who have obtained the recognition of their training in accordance with the previous regulations, contained in Royal Decree 1201/2005 of 10 October on the protection of animals used for experimentation and other scientific purposes.

This order is divided into four chapters, three additional provisions, two transitional provisions, three final provisions and three annexes. Chapter I contains the general provisions and incorporates the definitions that are useful for the proper understanding of the text; Chapter II refers to obtaining the appropriate initial training for the different functions: requirements, recognition and regulation of the necessary specific training courses; Chapter III regulates the maintenance of training; Chapter IV regulates the basic rules of procedures which are established and whose development corresponds to the competent bodies. The annexes include the training modules and their learning outcomes, the classification of the animal species involved and the minimum duration required for continuing training.

This ministerial order is of a basic nature and is dictated by the powers recognized by the State by Article 149.1.15., 16. and 30. It is considered justified to go to a regulatory standard in this range to regulate a basic normative content because it is in turn a development of rules that have such a character (Law 32/2007, 7 November and the Royal Decree). 53/2013 of 1 February, in which it is also expressly provided for the Ministry of Economy and Competitiveness to regulate the training requirements of the staff referred to in Article 15 thereof. There is therefore an express provision for this, which is a highly technical content, which is more specific to a provision of this range, and finally meets the ultimate objective of the basic rules, i.e. ensure a uniform common throughout the national territory (in this case for staff training), according to the Constitutional Court's repeated doctrine.

In the elaboration of this ministerial order, the autonomous communities and sectors affected by the hearing procedure under Article 24.1 (c) of Law 50/1997 of 27 November, of the Government, have been consulted. has been assisted by a working group established within the framework of the Spanish Committee for the Protection of Animals used for Scientific Purposes.

The Ministry of Education, Culture and Sport and Agriculture, Food and Environment have issued a report.

In its virtue, with the prior approval of the Minister of Finance and Public Administrations, I have:

CHAPTER I

General provisions

Article 1. Object and purpose.

The purpose of this ministerial order is to regulate the training requirements to be met by the personnel handling, carrying out any of the functions listed in Article 3.2, animals used, reared or provided for experimental and other scientific purposes, including their use in teaching.

The purpose of this order is to ensure the protection and welfare of animals.

Article 2. Definitions.

For the purposes of this ministerial order, account shall be taken of the definitions contained in Law 32/2007 of 7 November for the care of animals on their holding, transport, experimentation and slaughter and in the Royal Decree 53/2013 of 1 February 2013 laying down the applicable basic standards for the protection of animals used in experimental and other scientific purposes, including teaching.

Also, you will understand how:

(a) Competent Authority: The entities, authorities or administrative units of the Autonomous Communities and the cities of Ceuta and Melilla competent for the development of rules and implementation in each of the matters governed by the this ministerial order.

b) Training: Knowledge and skills required to perform in an autonomous manner some of the functions referred to in Article 3.2, in the form and with the requirements set out in this ministerial order.

c) Course: A training program that allows the acquisition of learning outcomes contained in one or more modules.

d) Module: Relationship of knowledge and skills with thematic uniformity and own entity.

e) Diploma: A document that issues a training entity that guarantees the improvement of a course.

f) Learning Results: Achievements, expressed in obtaining knowledge and skills contained in one or more modules that are expected as a final result of a course.

g) Work under supervision: Development of functions in a real working environment under the monitoring and control of a competent professional in the tasks under supervision, once the theoretical-practical contents have been overcome of a course.

h) Training Certificate: Document issued by the competent body that recognizes staff training.

Article 3. Scope of application.

1. The scope of this ministerial order shall be that laid down in Article 2 of Royal Decree 53/2013 of 1 February 2013, in such a way as to:

(a) It shall apply where animals are used or intended to be used in procedures, or when animals are reared specifically for use by their organs or tissues for scientific purposes.

(b) It shall apply until the animals referred to in point (a) have been slaughtered, rehoused or reintegrated into a suitable habitat or zootechnical system.

(c) All animals used in the procedures shall be understood within the scope of application, even if the elimination of pain, suffering, distress or lasting damage has been achieved through satisfactory use for analgesia, anesthesia, or other methods.

(d) It shall apply to the animals referred to in Law 32/2007 of 7 November.

e) It shall also apply to animals at an earlier stage of development if the animal is to be allowed to live beyond that stage of development and as a result of the procedures performed is likely to be suffer from pain, suffering, distress or lasting damage after having reached that stage of development.

f) They are excluded from the scope:

1. Non-experimental farming practices;

2. non-experimental clinical veterinary practices;

3. the clinical veterinary studies necessary for the purpose of obtaining the authorisation to place veterinary medicinal products on the market;

4. practices carried out for recognised zootechnical purposes;

5. practices carried out with the main objective of identifying an animal;

6. practices in which pain, suffering, distress or lasting damage equivalent to or greater than those caused by the introduction of a needle in accordance with good veterinary practice is not likely to occur.

2. Pursuant to Article 15.2 of Royal Decree 53/2013 of 1 February 2013, the training requirements that are regulated in this ministerial order shall apply to personnel who perform one or more of the following functions:

a) Care for the animals.

b) Euthanasia of animals.

c) Realizing the procedures.

d) Design of projects and procedures.

e) Assumption of responsibility for "in-situ" monitoring of animal welfare and care.

f) Assumption of designated veterinarian functions.

Article 4. General principles.

1. Persons carrying out the duties listed in Article 3.2 shall have the necessary training.

2. Recognition of training will be a prerequisite for performing the corresponding functions autonomously.

3. The training shall be obtained through the fulfilment of some or some of the following requirements, with the peculiarities that for each function are specified in Section 1 of Chapter II:

(a) Be in possession of the university degree to be determined, if any.

This requirement shall be met by equivalent qualifications issued abroad, provided that the persons concerned prove that such qualifications have been the subject of approval and validation or professional recognition in accordance with the rules in force in this field.

b) Overcome theoretical-practical training courses, aimed at the acquisition of the learning outcomes of the modules corresponding to each of the functions referred to in Article 3.2.

The modules and their learning outcomes are listed in Annex I and are based on guidelines published by the European Union. Learning outcomes may be the subject of concretions, extensions or adaptations by the competent authorities, who may also update them for their suitability for future Community guidelines.

The modules are classified into:

1. Fundamental or trunk: The acquisition of their corresponding learning outcomes is necessary for the performance of any of the functions mentioned in article 3.2. The basic modules or trunk modules shall be referred to all groups of species listed in Annex II.

2. Function: The acquisition of their corresponding learning results is necessary for the performance of one of the functions mentioned in article 3.2. They may be referred to one or more of the groups of animal species listed in Annex II.

Training courses conducted abroad may be considered equivalent by the competent bodies provided that their training programmes cover the essential content of the learning outcomes of the modules corresponding to the function in question.

c) Further perform a work period under monitoring for functions to be determined.

4. In the cases for which this ministerial order so provides, it shall be deemed sufficient to be in possession of the professional training certificate or certificate of professionalism which provides for the learning results of the modules. for each of the functions referred to in Article 3.2. In such cases, the recognition of the training shall refer to the groups of animal species listed in Annex II to this ministerial order with which practices have been carried out in the actual working environment.

This requirement shall be met by equivalent qualifications issued abroad, under the conditions set out in the second subparagraph of paragraph 3 (a).

5. The training obtained will be maintained through continuous training in the regulated form in this ministerial order.

CHAPTER II

Obtaining the appropriate initial training for the different functions

Section 1.th Requirements to get initial training

Article 5. Animal care function.

To obtain recognition of training for the care function of animals, compliance with any of the following requirements will be required:

(a) to be in possession of a professional training certificate or certificate of professionalism which provides for the learning outcomes included in the modules corresponding to this function according to Annex I.

b) Overcome training courses aimed at achieving the learning outcomes included in the modules corresponding to this function according to Annex I, accompanied by the development of a working period under supervision up to the acquisition of the skill required to perform such a function autonomously.

Article 6. Function of euthanasia of animals.

To obtain recognition of training for the euthanasia function of animals, compliance with any of the following requirements will be required:

(a) to be in possession of a professional training certificate or certificate of professionalism which provides for the learning outcomes included in the modules corresponding to this function according to Annex I.

b) Overcome training courses aimed at achieving the learning outcomes included in the modules corresponding to this function according to Annex I, accompanied by the development of a working period under supervision up to the acquisition of the skill required to perform such a function autonomously.

Article 7. Function of performing the procedures.

To gain recognition of training for the function of performing the procedures, compliance with any of the following requirements will be required:

(a) to be in possession of a professional training certificate or certificate of professionalism which provides for the learning outcomes included in the modules corresponding to this function according to Annex I.

b) Overcome training courses aimed at achieving the learning outcomes included in the modules corresponding to this function according to Annex I, accompanied by the development of a working period under supervision up to the acquisition of the skill required to perform such a function autonomously.

Article 8. Design function of the projects and procedures.

To gain recognition of training for the design function of projects and procedures, compliance with the following requirements will be required:

(a) Possession of a bachelor's degree, degree, master or doctor, or equivalent, in Biology (animal), Medicine, Veterinary or any other discipline that incorporates in its formative program studies on biology and animal physiology.

b) Overcome training courses aimed at achieving the learning outcomes included in the modules corresponding to this function according to Annex I.

You may also obtain training for this function who holds a degree, degree, master or doctor, or equivalent, other than those referred to in point (a), and who exceed the courses referred to in the (b) above, provided that these courses include an additional module on the basis of animal biology and physiology, oriented to the species or group of species involved.

Article 9. "in situ" monitoring function of animal welfare and care.

To gain recognition of training for the "in situ" monitoring function of animal welfare and care, compliance with the following requirements will be required:

(a) Possession of a bachelor's degree, degree, master or doctor, or equivalent, in Biology (animal), Medicine, Veterinary or any other discipline that incorporates in its formative program studies on biology and animal physiology.

b) Overcome training courses aimed at achieving the learning outcomes included in the modules corresponding to this function according to Annex I.

Article 10. Designated veterinarian function.

To gain recognition of training for the designated veterinarian function, compliance with the following requirements will be required:

(a) Be in possession of a degree, degree, master or doctor's degree of university degree, or equivalent to permit the exercise of the veterinarian.

b) Overcome training courses aimed at achieving the learning outcomes included in the modules corresponding to this function according to Annex I.

The competent bodies may derogate from these courses to those who demonstrate complete knowledge or experience in animal medicine used in experimentation and for other scientific or teaching purposes, equivalent to those of the learning outcomes included in the modules referred to in the preceding paragraph.

Article 11. Job requirements under monitoring.

1. Training for the care of animals, euthanasia of animals and procedures, in cases where this is required in Articles 5, 6 and 7 respectively, shall be completed by means of the completion of a period of work under monitoring.

2. The work under supervision will be initiated once the theoretical and practical content of the training courses aimed at achieving the learning outcomes included in the training modules corresponding to these functions will be overcome.

However, the competent bodies may authorise persons who have not yet completed the training courses for these functions to start performing them on a provisional basis and under responsible supervision, provided that, the case of the function of performing the procedures, the action on the animals is a procedure classified as 'mild' or 'without recovery'. This provisional period may not be longer than six months.

3. The work under supervision shall be carried out in a real working environment, with the understanding of the establishment of a breeder, supplier or user, without prejudice to the exceptions that may be allowed when the work under supervision is perform with wild animals.

If the work under supervision involves the carrying out of procedures, they shall be carried out in approved user establishments, unless the competent body is authorised, on the basis of scientific justification of the need or convenience of being performed outside such centres.

4. The development of work under supervision may take place within the framework of a work contract, permit to stay or any other legal title which is admissible in law and which is relevant.

5. The competent bodies shall develop the conditions under which the work shall be carried out under supervision, and in particular:

a) The personnel who can perform the monitoring.

b) The duration of the monitoring, which may be variable depending on the evolution of the skills acquisition process.

c) The assessment system of skills acquired to demonstrate that the supervised person is able to work without supervision.

(d) establishments and entities that, in concert with those, can schedule the performance of the work under supervision, ensuring mechanisms that ensure a sufficient supply and in free competition.

6. The improvement of the monitoring period shall be documented by the issue of the corresponding certification by the establishment in which it is carried out.

Article 12. Exceptions to initial training requirements.

The use of live animals by students in the teaching framework, training courses for the training of staff and those directed to the improvement of the teaching staff is excepted from the requirements of previous articles. health or veterinary staff, provided that the conditions laid down in Article 16 are met.

Section 2.First Recognition of initial training and acquisition of news trainings

Article 13. Recognition of initial training.

1. It is for the competent bodies to recognise the training for the exercise of each of the functions referred to in Article 3.2 by issuing a training certificate to enable them to carry out such training. functions autonomously and which will take effect throughout the national territory.

2. Recognition of training for the performance of the tasks referred to in Article 3.2 by the competent authorities of another Member State shall take effect throughout the national territory, in accordance with the principle of reciprocity.

3. Recognition of training obtained in third countries shall ensure that prior recognition has been based at least on requirements equivalent to those required in this ministerial order.

4. The competent bodies shall develop the procedure for the recognition of training, which shall respect the basis of Article 21.

Article 14. Acquisition of new trainings.

1. Those who have obtained the training to develop a certain function of those related to Article 3.2 and opt for training for the development of another function will have to demonstrate the improvement of the courses aimed at achieving the learning outcomes included in the modules of the new function not yet acquired and, where appropriate, being in possession of the required qualification.

2. The development of the same function in animals of a group of species other than those reflected in the training certificate will require overcoming the learning outcomes of the modules with specific content for the new group of species. animals.

3. In the two cases referred to in this Article, the relevant work under supervision prior to the issue of the training certificate by the competent bodies shall be required where appropriate.

Section 3. Coursestion

Article 15. Entities providing the training courses.

1. Training courses aimed at achieving the learning outcomes included in the modules referred to in Article 4.3 (b) shall be provided by legally constituted entities.

These entities must have the technical solvency and the human and material resources necessary for the development of the courses.

2. Institutions providing training shall keep the documentation concerning each course and the modules which it includes at the disposal of the competent bodies for a period of at least five years from the date of completion of each course. editing them.

3. Within the framework of the above paragraphs, the competent bodies may develop the minimum requirements to be met by the entities providing the training.

Article 16. Use of live animals in teaching and training practices.

The use of live animals in teaching and training practices will be carried out under the following conditions:

1. It will strictly comply with the principle of replacement, reduction and refinement so that:

(a) Successful training strategies or methods which do not involve the use of live animals shall be used wherever possible.

(b) Procedures for exclusive training and teaching purposes should be limited to what is strictly necessary.

(c) The design of the courses or training activities shall minimize the number of animals used.

(d) Animals shall be subjected, where possible, to procedures which are described as "mild" or "without recovery".

e) The use of animals will be refined as much as possible to eliminate or minimize any potential pain, suffering or lasting harm to animals.

f) As soon as the purpose of the use of each animal has been achieved, appropriate measures will be taken to minimize their suffering.

The competent bodies shall ensure the application of this paragraph first and shall contribute to the development and validation of training strategies or methods to obtain a level of training equal to or higher than that obtained by the use of animals, but which do not use them, use them in fewer numbers or involve actions with less pain, stress or distress.

2. It shall be carried out in the establishment of a breeder, supplier or user, without prejudice to any derogations which may be authorised where wild animals are used.

If the practices involve the carrying out of procedures, they shall be carried out in approved user establishments, unless the competent body is authorised, on the basis of scientific justification for the need or convenience. to be performed outside such centers.

3. It will be after the acquisition, at least, of theoretical knowledge on physiology, anatomy, etology and recognition of pain.

4. The teaching staff must be properly trained for the appropriate role in the form set out in this ministerial order.

5. Any other requirements or conditions that for the use of animals in experimentation and other scientific purposes, including teaching, are to be met, as set out in Royal Decree 53/2013 of 1 February, and which are applicable.

Article 17. Requirements for training courses.

1. The training courses referred to in Article 4.3 (b) may be aimed at achieving the learning outcomes of all or any of the modules of one or more functions.

The competent bodies may set up training programmes for courses and modules.

2. Training courses shall be provided by institutions which meet the requirements referred to in Article 15.

3. The training courses shall comply with the conditions laid down in Article 16 for the use of live animals.

In addition, you will meet the following requirements:

(a) The training programmes proposed by the training institutions or, where appropriate, the type programmes for each course shall be based on the learning outcomes of the corresponding modules as set out in Annex I.

(b) The training programmes shall contain a theoretical part and a practical part, taking into account the nature of the modules to be provided, and details of their duration, which shall respect the minimum requirements set out in Annex I (a) and (b).

c) The training context must have sufficient and adequate human and material resources for the programme of each course. Each course will be assigned a tutor.

(d) The teaching staff shall have an appropriate qualification in the subject matter assigned to them.

e) The courses will contain objective evidence to check the acquisition of the corresponding learning outcomes.

4. Training courses may be provided in whole or in part in both face-to-face and non-face-to-face training, provided that, in the latter case, the nature of the module or modules to be provided allows it.

Non-face-to-face courses will have an appropriate electronic platform to ensure:

a) The availability of theoretical and practical teaching content in easily accessible multimedia formats, such as texts, images, voice files, demonstrative videos, web connections or interactive exercises enable the acquisition of the required skills.

b) The interaction between teachers and students, tutoring, debate forums and real-time transmission systems.

c) The realization, if any, of objective tests to overcome the course.

5. An institution providing the training shall issue a certificate to the students who have completed each course. The diploma shall contain, in addition to the identifying data of the training institution, the student and the course, information on the modules, the function or functions concerned (if they provide all the modules of one or more functions), their duration and the species to which it relates.

Article 18. Recognition of training courses.

1. It is up to the competent bodies to recognise training courses which are enabled to achieve the learning outcomes included in the modules referred to in Article 4.3 (b) which are given in their territorial scope. To this end, they shall develop the relevant recognition procedure, which shall respect the bases set out in Article 21.

2. Recognition of training courses and their corresponding diplomas shall take effect throughout the national territory.

3. The competent bodies may suspend or withdraw the recognition of training courses if the conditions which gave rise to such recognition are not met, subject to a file being dealt with with the person concerned.

4. The competent bodies shall communicate to the Ministry of Economy and Competitiveness the training courses recognised for the sole purpose of their advertising through their electronic headquarters. Such communication shall be made within three months of its recognition.

Article 19. Control of training courses.

1. The competent bodies shall establish regular checks on the institutions which provide the training to verify compliance with this ministerial order, in particular the adequacy of the development of training courses to the conditions of their training. recognition.

2. The competent bodies shall adapt the frequency of checks or inspections on the basis of a risk analysis taking into account at least:

(a) The number, type and contents of training courses and training activities that are given.

b) The number of animals used and the types of uses.

c) The entity's record of compliances or defaults.

d) Any data that may indicate possible non-compliance.

CHAPTER III

Maintenance of the training

Article 20. Continuing training activities.

1. Initial training for the development of the functions referred to in Article 3.2 shall be maintained by continuing training activities.

2. Continuing training activities will aim to ensure the improvement and updating of the skills and knowledge initially acquired and will meet the following conditions:

(a) Include the delivery or attendance of courses, seminars, lectures, workshops or scientific days; stays authorized in research centres, or other similar activities to be determined by the competent bodies; which are intended for learning in the face of new techniques, methods or regulations applicable to animal testing or to its updating.

(b) They shall be related to the learning outcomes of the modules corresponding to the function in question.

(c) They shall, as a whole, have the minimum duration specified in Annex III for each function.

(d) They shall be accredited by means of diplomas or certificates of assistance in respect of their content and duration.

e) They will have a content that allows the training of one or more functions to be maintained.

(f) They shall respect the conditions laid down in Article 16 for the use of live animals in training courses.

3. The training activities covered by this Article shall not require prior recognition by the competent bodies. However, the competent bodies may adopt control actions on the same terms as laid down in Article 19.

4. The "on site" officer referred to in Article 14.4 (c) of Royal Decree 53/2013 of 1 February 2013 shall ensure that the staff of the establishment have access to training activities appropriate to the function which it develops.

5. It is up to the competent bodies which have recognised the training to check that the persons concerned demonstrate the maintenance of their training in the form provided for in this Article at least every eight years. To this end, they shall develop the procedure for their accreditation, which shall respect the basis of Article 21.

6. The competent body may suspend the recognition of the training if the continuing training requirements of this Article are not met, and withdraw it, subject to the case with a hearing of the person concerned.

CHAPTER IV

Procedures

Article 21. Basic rules of procedure.

1. In the development of procedures for the recognition of training, the recognition of courses and the accreditation of the maintenance of training, the competent bodies shall comply with the provisions of a basic nature. contained in Law 30/1992 of 26 November 1992, of the Legal Regime of Public Administrations and of the Common Administrative Procedure.

Likewise, they will comply with the basic provisions contained in Law 11/2007, of June 22, of electronic access of citizens to Public Services.

2. The procedures shall be initiated at the request of the person concerned. The application shall be accompanied by at least the following documentation:

(a) In the procedure for the recognition of the training, the supporting documentation of the interested in possession of the academic and professional titles, diplomas and certifications required for each one will be provided. function in Articles 5 to 11. In the case of diplomas obtained abroad, the accreditation of approval and validation or professional recognition shall also be required. In the case of courses held abroad, their content must be accredited.

(b) In the procedure for the recognition of training courses, the supporting documentation of the following shall be provided:

1. That the training entities have the technical solvency requirements and the human and material resources necessary for the development of the courses, as well as the other requirements required in Article 15.

2. That the courses respect the conditions for the use of live animals as required by Article 16 for training practices.

3. That the courses meet the rest of the requirements set out in Article 17.

The exemption from the obligation to credit requirements may be established, the compliance of which is already established with the competent bodies when applying for the adaptation of training courses already recognised under Royal Decree 1201/2005, of 10 October on the protection of animals used for experimental and other scientific purposes.

(c) In the procedure for the accreditation of the maintenance of the training, the supporting documentation of the diplomas or certificates of assistance relating to the training activities carried out and to the compliance with the rest of the requirements listed in Article 20 (2).

3. It may be established that the accreditation of any of the requirements laid down in this ministerial order is made by means of a responsible declaration, in accordance with Article 71a of Law 30/1992, of 26 November.

4. The competent bodies shall acknowledge receipt of the applicant for the submission of their application in accordance with the terms laid down in Article 42.4 of Law 30/1992 of 26 November.

5. In the event of an incomplete or incorrect application, the competent body shall inform the applicant of the need to remedy its application in accordance with Article 71 of Law 30/1992 of 26 November.

6. For the purposes of the decision of the procedure, those reports which are required by legal provisions, and those which are deemed necessary to resolve, shall be requested, with the provision requiring or based on the case of convenience. to reclaim them.

7. Unless a shorter period is established, the maximum time limit for resolving and notifying the relevant decision shall be three months after the application has entered the register of the competent body. The expiry of the maximum period without the notification of an express decision, legitimate to the person concerned, which would have deducted the application to be understood by administrative silence, in accordance with Article 43.1 of Law 30/1992 of 26 November.

8. The judgment shall be accompanied by:

a) In the procedure for the recognition of the training, the issue of the training certificate. This certificate shall detail the functions and species or groups of animal species to which it relates, as well as its initial date of validity.

(b) In the procedure for the recognition of training courses, the issue of the certificate of recognition of the training course, specifying the modules, functions and species or group of species to which reaches.

c) In the procedure for the accreditation of the maintenance of the training, the issue of the certification of the maintenance of the training for the function and species or group of species initially recognized, with expression of its term of validity.

Additional disposition first. Human and material resources.

The provisions of this ministerial order will not result in an increase in expenditure or in the allocation or remuneration of personnel for the General Administration of the State.

In the development and implementation of the provisions of this ministerial order, the competent bodies must be strictly subject to compliance with the requirements of the principles of budgetary stability and sustainability. financial.

Additional provision second. Stricter provisions.

In accordance with the provisions of the Sixth Royal Decree 53/2013's sixth transitional provision of 1 February, the maintenance by the competent bodies of provisions stricter than those laid down in this ministerial order with The aim of ensuring greater protection for animals within its territory will be limited to those already in force on 9 November 2010, compatible with the general principles of the Treaty on European Union. Functioning of the European Union and communicated to the Directorate before 1 December 2012 General competent animal welfare general of the General Administration of the State.

Additional provision third. Application of training requirements in public administration establishments.

Public Administrations shall ensure that personnel who access the provision of services in their holding, performing any of the functions referred to in Article 3.2, comply with the requirements of this Directive. training regulated in this ministerial order, without prejudice to the provisions of the transitional provision first for those who have obtained the training according to Royal Decree 1201/2005 of 10 October.

Also, they will adapt the training courses that come with the initial training of their staff to the requirements regulated in this ministerial order and will guarantee the maintenance of the training in the terms that establishes Article 20, adapting, if necessary, its continuing training programmes.

First transient disposition. Categories recognised under Royal Decree 1201/2005 of 10 October.

1. Persons who, at the entry into force of Royal Decree 53/2013 of 1 February 2013, were entitled to the functions corresponding to the categories established under the provisions of the repealed Royal Decree No 53/2013 of 1 February 2013. Decree 1201/2005 of 10 October shall maintain that power, without limitation of species, in reference to the above mentioned functions, according to the following:

(a) It is considered to be capable of assuming the function of caring for animals to the recognized or approved staff as category A as set out in Annex I to Royal Decree 1201/2005 of 10 October.

(b) is considered to be capable of assuming the function of euthanasia of animals to the recognised or approved staff as categories A, B and D2 as set out in Annex I to Royal Decree 1201/2005 of 10 October.

(c) Is considered to be qualified to assume the function of performing the procedures to the recognized or approved staff as category B and C as set out in Annex I to Royal Decree 1201/2005 of 10 October.

d) It is considered to be capable of assuming the design function of the projects and procedures to the staff recognized or approved as category C as set out in Annex I to Royal Decree 1201/2005 of 10 October.

e) is considered to be qualified to assume the "in situ" supervision function of the welfare and care of animals to the recognized or approved staff as category D1 as set out in Annex I to Royal Decree 1201/2005, October 10.

f) is considered to be qualified to assume the role of designated veterinarian to the recognized or approved staff as category D2 as set out in Annex I to Royal Decree 1201/2005 of 10 October.

2. The rules contained in paragraph 1 of this transitional provision shall also apply to the period from the entry into force of Royal Decree 53/2013 of 1 February 2013 until the entry into force of this ministerial order.

Training courses which, according to Royal Decree 1201/2005 of 10 October, enabled for the acquisition of the training and which had been delivered in the period referred to in the preceding paragraph, will have effects for recognition of training.

The same effect shall be for courses which at the time of entry into force of this order are in the process of being imparted or have been scheduled to be imparted within a period of not more than six months.

3. The staff affected by this transitional provision shall be subject to the provisions of Article 20 on the maintenance of training, and the period of eight years from the date of entry into force of this order shall be counted. ministerial.

Second transient disposition. Registration of personnel recognised under Royal Decree 1201/2005 of 10 October.

The competent bodies shall keep a record of the staff to whom the training is recognised in accordance with the first transitional provision, indicating the function or functions of Article 3.2 to which they are refers.

Final disposition first. Basic character and competence title.

This ministerial order is of a basic nature and is dictated by the powers recognized by the State by Article 149.1.15., 16. and 30. of the Spanish Constitution, in the field of general promotion and coordination of the scientific and technical research; bases and general coordination of health and regulation of the conditions for obtaining, issuing and approval of academic and professional qualifications and basic standards for the development of Article 27 of the Constitution, respectively.

Final disposition second. Guidelines, guidelines and recommendations of the European Union.

In the regulatory development and implementation of the matters covered by this ministerial order, the competent bodies shall take into account the guidelines, guidelines or recommendations published by the European Union.

Final disposition third. Entry into force.

This ministerial order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, March 20, 2015. -Minister of Economy and Competitiveness, Luis de Guindos Jurado.

ANNEX I

Training modules

a) Relationship of modules by functions.

This section lists the fundamental modules (common to all functions and species) and the specific modules of each function, which will be directed to a species or group of species.

Core or trunk modules

	Naming	Minimum Duration (hours)
Legislation national	1
Ethics, animal welfare and the "three errors", level 1	2
and appropriate biology, level 1
	5
5
Table_table_izq"> Recognition of pain, suffering, and distress	3
sacrifice methods, Level 1	2

Function-specific modules

Denomination of the module

to the institutional organization (establishment)

Function on whose itinerary the module should be included						Minimum duration (hours)
to	b	c	d	e	f
Ethics, animal welfare and the "three errors", level 2					x	x	x	10
and appropriate biology, level 2	x		x			x		3
biology and physiology foundations (*)				x			20
Care, Animal Health and Management, Level 2					x		45
sacrifice methods, Level 2		x
Minimally Invasive Procedures without Anesthesia, Level 1			x		x	x		5
minimally invasive procedures without anesthesia, level 2			x				10
Anesthesia for minor procedures			x				5
Advanced anesthesia for surgical interventions or extended procedures							8
principles			x				5
Design of projects and procedures, level 1				x			5
Design of the projects and procedures, level 2				x
				x	x	5
Designated Veterinary						x	65

(*) The basic module for animal biology and physiology shall be compulsory only in function (d) for those who hold a degree, degree, master or doctor other than those referred to in Article 8 (a).

b) Minimum duration of training courses for different functions.

1. The duration of the courses shall be adapted to the characteristics of the students, to the species involved or to any other circumstances to be taken into account, respecting the minimum duration of each module, as detailed in paragraph (a).

2. Where training courses are designed for staff who are trained for a function and species or group of species, in order to acquire training for a new species or group of species, the entities providing the training may propose training programmes which take into account only the particularities of the new species or group of species, and which will have a shorter duration than that laid down in general for each of the corresponding modules. The competent authorities shall assess the adequacy of the content of the courses and their duration in the course of the course recognition.

c) Understanding and learning results of modules:

1. This section succinctly describes the contents and purpose of the modules listed in a).

2. Their learning outcomes are also related, which are based on the "working document for the development of a common framework in education and training to meet the requirements of Directive 2010 /63/EU", published on the website of the European Union, hereinafter referred to as "EU document".

To this effect, a numerical reference to the equivalent module is included with the name of each module in the document.

3. These learning outcomes are without prejudice to the concretions, extensions, adaptations or updates to new Community guidelines which may be carried out by the competent bodies.

4. Training institutions shall make up the training programmes on the basis of at least the learning outcomes that correspond to each module being delivered.

c.1) Fundamental or trunk modules.

National legislation; theoretical; module 1 of the EU document

Description:

This module provides a relevant level of understanding of the national and international legal and regulatory framework within which animal projects are created and managed, in addition to the legal responsibilities of individuals. involved (i.e. those who carry out the procedures with animals; who design the procedures and the projects; who take care of the animals; who sacrifice them). It may also cover other relevant legislation.

Learning Results:

This module will allow the trainee to be able to:

1. Identify and describe national and European legislation and guidelines governing the use of animals reared, supplied or used for scientific purposes, including teaching (hereinafter 'experimental animals') and, in particular, activities of persons carrying out scientific procedures with animals.

2. Identify and describe animal welfare legislation, both at Community and national level (state and regional).

3. Describe the necessary authorisation before acting as a user, breeder or supplier of experimental animals and, in particular, the necessary authorisation for projects and, where appropriate, for persons.

4. To know the set of information and support sources that are available (in relation to national legislation).

5. Describe the role of the staff referred to in Articles 23, 24, 25 and 26 of Directive 2010 /63/EU; in Royal Decree 53/2013 of 1 February (which regulates in Article 15.2 the various staff functions and in the following 37 and the following: (a) in respect of animal welfare-OEBA-); or in the applicable autonomous legislation, and its legal and other obligations under national (state or regional) legislation.

6. Describe the roles and responsibilities of the animal welfare agencies and the national committee for the protection of experimental animals.

7. Identify who is responsible for regulatory compliance in an establishment and how this responsibility can be exercised (p. (e) by means of an organ in charge of animal welfare at local level).

8. Describe when a procedure becomes regulated by national legislation (minimum threshold of pain, suffering, distress or lasting damage).

9. Identify who is the primary responsibility of the animals submitted to procedures.

10. To be aware of species classes and their stages of development, including in the field of Directive 2010 /63/EU and Royal Decree 53/2013 of 1 February 2013, or other implementing rules, both at the state and regional level.

11. Identify the circumstances in which the animals under Directive 2010 /63/EU and Royal Decree 53/2013 of 1 February 2013 must be slaughtered in a bloodless or withdrawn manner from the study for veterinary treatment.

12. Describe the legislative controls of the slaughter of experimental animals.

Ethics, animal welfare and the "three errors", level 1; theoretical-practice; module 2 of the EU document

Description:

This module provides guidance and information to enable people who work with animals to identify, understand and respond appropriately to the ethical and welfare issues raised by the use of animals in scientific procedures in general and, where appropriate, within their own work programme. It provides information to enable these people to understand and apply the basic principles of the "three errors".

Learning Results:

This module will allow the trainee to be able to:

1. Describe the different opinions in society about scientific uses of animals and recognize the need to respect them.

2. Describe people's responsibility when working with experimental animals and recognize the importance of adopting a respectful and bloodless attitude toward working with animals in research.

3. Identify ethical and animal welfare issues in your own work and be aware and able to reflect on the consequences of your own actions.

4. Recognize that compliance with ethical principles can contribute to the long-term trust and acceptance of scientific research by the public.

5. Describe how the legislation is based on an ethical framework that requires: 1) weigh the damage and benefits of projects (damage and benefits assessment); 2) apply the "three errs" to minimize harm and maximize profits; and 3) encourage good practices in relation to animal welfare.

6. Describe and analyze the importance of the "three errs" as the guiding principle of the use of experimental animals.

7. Describe the five freedoms and how they apply to animal species of experimentation.

8. Describe the concept of harm to animals, including avoidable and unavoidable suffering, and direct, probable and cumulative suffering.

9. Describe the severity classification system and provide examples of each category. Describe the cumulative severity and the effect it can have on the severity classification.

10. Describe the existing regulation on the reuse of animals.

11. Describe the importance of good animal welfare and its effect on scientific results, in addition to its social and moral justification.

12. Describe the need for a culture of care and the role of each person in contributing to it.

13. Describe relevant sources of information related to ethics, animal welfare and the implementation of the "three errs".

14. Know the different tools (p.  e.g. eURL ECVAM search guide, Go3Rs) and search methods (p.  e.g., systematic reviews, meta-analyses).

Basic and appropriate biology, level 1; theoretical; module 3.1 of the EU document

Description:

This module provides an introduction to the basic principles of animal behavior, its care, biology and zootechnics. It incorporates information related to the anatomy and physiological characteristics, including reproduction and behavior, as well as ordinary zoological and enrichment practices. It does not intend to offer more than the minimum general information needed for someone to start working under supervision.

At the end of this module, a practical training under supervision must provide each person with the necessary experience and skills to perform their specific function. The requirements of practical training will inevitably vary depending on the function.

Learning Results:

This module will allow the trainee to be able to:

1. Describe the anatomy, physiology, reproduction and basic behavior of the relevant species.

2. Recognise and describe vital events that may lead to suffering, including supply, transport, accommodation, zootechnics, handling and procedures (at the basic level).

3. Understanding how a good level of well-being can foster good scientific practice, for example, how the lack of attention to biological and behavioral needs can affect the outcome of the procedures.

4. Understanding how zootechnics and care can influence the outcome of experiments and the number of animals needed, for example, when the place of the room influences the outcome and, therefore, in randomization.

5. Describe the dietary requirements of the relevant animal species and explain how they can be met.

6. Describe the importance of providing a rich environment (suitable for both the species and science) that includes social housing and opportunities for exercise, rest and sleep.

7. When relevant to the species, recognize that there are different strains and that they may have different characteristics that can affect both well-being and science.

8. When relevant to the species, recognize that the alterations in the genome may affect the phenotype in unexpected and subtle forms, as well as the importance of monitoring these animals with special care.

9. Maintain and interpret the exact and complete records of the animals kept in the facility, including their well-being.

Care, health and management of animals, level 1; theoretical; module 4 of the EU document

Description:

This module provides information on various aspects of animal health, care and management, including environmental controls, zootechnical practices, diet, health status, and disease. In addition, it includes basic learning outcomes related to people's health and zoonoses.

Learning Results:

This module will allow the trainee to be able to:

1. Describe routines and zootechnical practices (breeding) suitable for the maintenance, care and welfare of a range of experimental animals, including species of small animals and large species, where appropriate.

2. Describe the appropriate environmental and housing conditions for experimental animals, how the conditions are monitored and how the consequences for the animal are identified by inadequate environmental conditions.

3. Recognize that changes or alteration of circadian rhythms or photoperiods can affect animals.

4. Describe the biological consequences of acclimation, habituation and training.

5. Describe how the installation of animals is organized to maintain an adequate state of health for these animals and for scientific procedures.

6. Describe how to provide adequate water and a diet to animals for experimentation, including the supply, storage and presentation of adequate food and water.

7. To know the existing methods and to demonstrate an understanding of the appropriate handling, sexage and containment of one or more specific species for common scientific procedures.

8. Designate the different methods of individual identification of animals and list the advantages and disadvantages of each method.

9. To know the list of possible risks of diseases in the installation of the animals, including specific predisposition factors that may be relevant. Designate the methods available to maintain an adequate health status (including the use of barriers, different levels of containment, use of sentinels, as appropriate for the species).

10. Describe the appropriate breeding programs.

11. Describe how genetically modified animals can be used in scientific research and the importance of monitoring these animals with special care.

12. Know the correct procedures in place to ensure the health, welfare and care of animals during transport.

13. Know the list of possible health risks for people associated with contact with experimental animals (e.g., allergies, injuries, infections, and zoonoses) and how they can be prevented.

Recognition of pain, suffering and distress; theoretical-practice; module 5 of the EU document

Description:

This module prepares people to be able to identify the normal condition and behaviors of experimental animals, and to allow them to differentiate a normal animal from one that shows signs of pain, suffering or distress that could be the result of factors such as the environment, the zootechnics or the effect of the protocols of the experiments. It will also provide information about severity classifications, cumulative severity, and use of final points.

Learning Results:

This module will allow the trainee to be able to:

1. Recognize the normal or desirable behavior and appearance of individuals in the context of the species, the environment, and the physiological state.

2. Recognize abnormal behavior and signs of discomfort, pain, suffering, or distress, as well as signs of positive well-being and the principles of how pain, suffering, or distress can be treated.

3. Analyse the factors to be taken into account and the methods available for assessing and recording animal welfare (p. e.g., scorecards).

4. Describe that it is a bloodless end point. Identify the criteria to be used to determine the raw endpoints. Define the measures to be taken when a bloodless endpoint is reached and consider possible options for refining the methods and achieving that end point.

5. Describe the severity classifications included in the Directive and offer examples of each category; explain the cumulative severity and the effect it can have on the severity classification.

6. Describe the circumstances in which anesthesia or analgesia may be needed to minimize pain, distress, distress, or lasting damage.

Slaughter methods, level 1; theoretical; module 6.1 of the EU document

Description:

This module provides information about the principles of the bloodless sacrifice and the need to have at all times someone who can sacrifice an animal quickly and bloodless if necessary. The module will include information and descriptions of the different methods available, detailed data on species for which these methods are appropriate and information to help pupils compare the permitted methods and determine how select the most appropriate.

Learning Results:

This module will allow the trainee to be able to:

1. Describe the principles of the bloodless sacrifice (p. This is a "good death").

2. Describe the different methods by which it is permissible to sacrifice individual animals and the influence that different methods can have on scientific results and how to select the most appropriate one.

3. Reason why there should be a competent person available at all times for the slaughter of the animals (whether it is a caregiver or the person performing the procedures).

c.2) Function modules.

Ethics, animal welfare and the "three errors", level 2; theoretical-practice; module 9 of the EU document

Description:

This module allows people who design projects and procedures (function d) to analyze, in detail, the different ethical aspects and the "three errors" and apply the principles learned to the issues ethical and welfare issues raised by the use of experimental animals from their own work program.

The objective of this module is to address the issue that people who design these procedures should have a deeper and deeper understanding of the general questions of animal research. For this reason, the main difference between level 1 and level 2 modules on "Ethics, animal welfare and the" three errors " does not necessarily lie in the issues addressed (which have not been repeated here), but rather that some of them are More detailed and more detailed treatment of each outcome of the learning process. For example, at level 1 there are elements that the student should know and be able to describe, and that in level 2 he should know in greater depth and be able to discuss them. This module also prepares students to be able to stay up to date and continuously apply the "three errs" to their work as new methods appear and approaches evolve.

Because of its orientation and learning outcomes, this module is also suitable for people performing functions e) and f).

Learning Results:

This module will allow the trainee to be able to:

1. Understand that there is a broad set of ethical, welfare and scientific perspectives on the use of animals in scientific procedures and that reflection on all these issues evolves over time and is influenced by culture and the context.

2. Understand that this implies the need for a continuous critical assessment of the justification for the use of animals and the implementation of the "three errs" at all stages of a project.

3. Recognise that there are ethical limits to what is considered permissible under the Directive and that even within this legal framework there are also likely to be national and institutional differences in this respect.

4. To know that the legislation requires that the justification for the work programmes be assessed by weighting the possible adverse effects on the animals against the possible benefits and that the damage to the animals is minimised and maximize the benefits.

5. Understand and provide the necessary information to enable a sound assessment of damage and benefits and explain why, personally, they consider the potential benefits to outweigh the potential adverse effects.

6. Understand the need to communicate appropriate information to a wider audience and be able to prepare an appropriate non-technical summary of a project to facilitate it.

7. Describe the importance of disseminating information that will help to understand ethical issues, adequate animal welfare, good scientific practice, and the application of the "three errs".

Basic and appropriate biology, level 2; practical; module 3.2 of the EU document

Learning Results:

This module will allow the trainee to be able to approach, manipulate, catch and immobilize an animal and return it to its cage or pen in a calm, safe and empathetic manner so that the animal does not stress or suffer damage.

Fundamentals of animal biology and physiology; theoretical

Description:

This module aims to allow staff who in their training have not had the opportunity to acquire the necessary knowledge on the fundamentals of animal biology and physiology (with a deeper focus the basic backbone of the basic biology required for the function d) acquire them and allow it to be able to perform the rest of the specific modules of this function and particularly those of design of projects and procedures. The module should combine general knowledge with the particularities of the biology and physiology of the species involved.

Learning Results:

This module will allow the trainee to be able to:

1. Describe the main features of the animal phylogenetic scale and in particular of the species referred to in Annex II.

2. Know the organic and functional structure of the animal organism.

3. Understand the basic functions that maintain homeostasis in animals.

4. Understand the physiological needs of animals and the neurophysiological bases of stress and pain.

5. Reason about which elements may affect animal welfare and how to prevent animals from suffering pain, suffering, distress or lasting harm.

This module has no correspondence in the UE document.

Care, Health and Management of Animals, Level 2; Theoretical-Practice; Module 23 of the EU Document

Description:

This module provides an in-depth understanding of animal care practices aimed at those who take responsibility as welfare and animal care in an establishment, function (e), but it is also useful for those who assume the function (a).

Learning Results:

This module will allow the trainee to be able to:

A. Demonstrate a broad understanding of how animal welfare is maintained in the animalarium:

1. Describe how environmental conditions may have to be modified according to the species, age and stage of development or specific conditions of care (e.g., perioperative care, immunodeficient animals, modified strains). genetically).

2. Analyze the possible effects of an uncontrolled environment on animal welfare and on the results of experiments.

3. Know how environmental enrichment is achieved.

4. Understanding how the "three errors" contribute to the constant improvement of the well-being and the zootechnical and enrichment practices.

B. Know the appropriate environmental conditions for experimental animals and how to monitor them:

5. Describe the appropriate environmental conditions and enrichment for the relevant animal species and how these conditions are monitored.

6. Use environmental measurement equipment, read charts, curves and tables generated by environmental monitoring teams and evaluate potential problems.

C. Understanding how the organisation of the installation of animals maintains an adequate state of health for these and for scientific procedures:

7. Describe appropriate accommodation routines and conditions for animals housed for different scientific reasons.

8. Understand how your routines and hosting conditions can change based on specific conditions.

9. Assess the use of barriers to control the health status of animals.

D. Identify the possible risks of disease in the installation of animals:

10. Describe an appropriate health screening program for the animals to be cared for.

11. Analyze the possible sources of disease in the installation of the animals.

12. Recognize examples of parasites from experimental animals.

13. Describe the life cycle of some common pathological organisms in experimental animals.

E. Evaluate methods to minimize the risks of possible pathogenic organisms:

14. Describe methods to minimize the risks of pathogenic organisms.

15. Apply appropriate methods for disease control under specific conditions.

F. Devise suitable breeding programmes for experimental animals based on specific conditions:

16. Summarize the basic data of the breeding of usual experimental animals.

17. Describe in detail appropriate breeding programmes for specific species under specific conditions.

18. Select an appropriate "stock" for future breeding.

G. Evaluate the methods for determining the heat, check that the pairing has occurred and confirm the pregnancy in a whole series of laboratory species:

19. To know the list of methods for determining the heat, pairing and confirmation of pregnancy in experimental animals and to assess their effectiveness.

H. Analyze the reproductive indexes:

20. Analyze the reproductive data and tokens to describe the reproductive results of a reproductive group.

21. Describe the identified problems and suggest appropriate corrective measures.

I. Describe the use and problems associated with genetically modified animals (where appropriate in the appropriate species):

22. Know how genetically modified animals are used for research purposes.

23. Describe potential problems associated with the use of genetically modified animals.

24. Describe methods for producing genetically modified animals.

J. Know the procedures for the safe and legal transport of animals:

25. Identify the fundamental legislation governing the transport of animals.

26. Describe the procedures, equipment, legal responsibilities and persons responsible for the transport of animals.

27. Describe how standards are maintained regarding the health status and welfare of animals during transport.

K. Properly implement legislation governing the use of experimental animals:

28. Summarize the main aspects of legislation that protects animals from experimentation.

29. Understand how legislation controls the use of animals for scientific purposes.

Slaughter methods, level 2; practical; module 6.2 of the EU document

Description:

This module provides practical training to reflect the information and principles imparted in the Slaughter Methods module (level 1) and involves practical training in the appropriate methods for the species and for confirmation of death.

Learning Results:

This module will allow the trainee to be able to:

1. Carry out, in a competent and bloodless manner, euthanasia using appropriate techniques in the species of relevant experimental animals.

2. Demonstrate competence to confirm death and to which treatment or method of disposal the corpses should be submitted.

minimally invasive procedures without anesthesia, level 1; theoretical; module 7 of the EU document

Description:

This module provides an introduction to the theory of minor procedures. It provides information on the appropriate methods of handling and immobilization and describes the appropriate techniques for injection, dose administration and the collection of samples relevant to each species. It should provide sufficient information for staff to understand what is expected of them before they are trained in the practicalities of these skills while under supervision.

Learning Results:

This module will allow the trainee to be able to:

1. Describe the appropriate methods and principles to be followed when handling animals (including methods of manual immobilization and restriction of conduct).

2. Describe the biological impact of procedures and containment on physiology.

3. Describe the opportunities for refinement of procedures and containment, for example through training (using positive reinforcement), habituation and socialization of animals.

4. Describe techniques and procedures, for example, injection techniques, sampling and administration of doses (pathways, volumes, frequency), diet modification, forced feeding, tissue biopsy, testing behavioural or the use of metabolic cages.

5. Describe how to perform minor techniques and relate the appropriate sample volumes to the frequency of sampling for each species.

6. Describe the need for rigour and consistency in the conduct of scientific procedures and the proper recording and handling of samples.

7. Describe appropriate methods for the assessment of animal welfare with regard to the severity of the procedures and to know what measures to take.

8. Recognize that refinement is a continuous process and know where to find relevant and up-to-date information.

9. Describe the biological consequences of transport, acclimatisation, zootechnical conditions and experimental procedures in the relevant species and describe how they can be minimised.

minimally invasive procedures without anesthesia, level 2; practical; module 8 of the EU document

Description:

This module provides practical training elements relevant to the previous module. Practical training to perform minor procedures can be taught through a range of methods, using the different tools available that have been designed for this purpose (it is likely to include animal models or simulators and the Use of carcasses). The module shall be designed in such a way as to enable the student to reach a level of skill such that, when he starts working under supervision, he does not cause pain, suffering, distress or lasting damage to the animal.

Learning Results:

This module will allow the trainee to be able to:

1. Select and explain the best methods for performing common procedures (such as obtaining blood samples and administering substances), including via, volume and frequency, when appropriate.

2. Demonstrate competence to manage and hold the animal in the best position in relation to the technique.

3. Perform minor techniques under supervision in a way that does not inflict unnecessary pain, suffering, distress, or lasting harm.

Anesthesia for minor procedures; theoretical-practice; module 20 of the EU document

Description:

This module provides guidance and information to people who, during their work with animals, have to apply sedation or short-term anesthesia to perform a short procedure and to bring a level of pain. mild.

Learning Results:

This module will allow the trainee to be able to:

1. Define sedation, local and general anesthesia.

2. Identify the three components of the anesthesia triad and understand that the different anesthetics produce them in varying degrees.

3. Define the balanced anesthesia and indicate that the best way to achieve this is by using the combination of drugs so that all components of the anesthetic triad are obtained at an acceptable level.

4. Describe why and when sedation or anesthesia can be used to immobilize an animal.

5. To know the set of factors to be taken into consideration in the evaluation prior to the anesthesia of the animals: how to perform a basic health examination, how to consider the physiological and pathological state of the model with which work and how they can influence the choice of anesthetic.

6. To analyse the advantages and disadvantages and the principles of selection of the different anaesthetics and their application, including the calculation of the doses (in the relevant species), the injectable and inhalational drugs (or dissolved in the case of aquatic species), including local and regional anesthesia techniques.

7. Describe the importance of minimizing stress before anesthesia to reduce the likelihood that it will cause complications.

8. Recognize when it is beneficial to add premedication to the anesthetic regimen.

9. Describe and demonstrate the correct preparation, handling and maintenance of the appropriate anesthetic equipment for the species concerned.

10. Assess and assess the different levels and levels of anesthesia [voluntary and involuntary excitatory response, surgical anesthesia (mild, medium and deep), too deep].

11. To know the set of factors that indicate that an animal is properly anaesthetized (stable and with adequate depth) in order to perform the interventions and the measures to be taken if a complication occurs. It shall include basic 'practical' and 'descriptive' techniques for the supervision of anaesthesia, including an assessment of the appropriate reflexes for each species.

12. Describe methods to optimize recovery after anesthesia (p.  e.g., heat blankets, analgesia, antagonists, access to food and water, environmental conditions) to ensure rapid and uncomplicated recovery from anesthesia.

13. Demonstrate competence to understand appropriate and safe working practices regarding the use, storage, and elimination of anesthetics and analgesics.

Advanced anesthesia for surgical interventions or prolonged procedures; theoretical-practice; module 21 of the EU document

Description:

This module is related, though not exclusively, to the "principles of surgery" module. "Surgical interventions" shall be considered as "surgical interventions", which are not defined as "minor interventions" in the preamble of the previous module. They will be considered "prolonged" when the duration exceeds 15 minutes, which can be an additional or continuous dose (including anesthesia to make a diagnosis by the image).

This module also addresses pain relief during painful interventions such as surgery by the use of anesthetics and analgesics. Anesthesia is also used to achieve muscle relaxation, suppression of reflexes, and loss of consciousness for purposes other than the prevention of pain perception. For example, anesthesia is necessary to perform imaging techniques by MRI, computed tomography, and other minimally invasive imaging modalities.

Due to the great variability of species and strains of experimental animals, as well as anaesthetics, a veterinarian will have to be consulted to determine an appropriate anesthetic regimen.

If not used solely for the purpose of immobilizing the animal, the need for an anesthetic to perform procedures implies that the intervention will be painful if the animal is awake. In addition, you may have residual pain after the recovery of the anaesthetic animal, and pain relievers should be used. Some of the drugs described here are mentioned in both the anesthesia and surgery modules.

Learning Results:

This module will allow the trainee to be able to:

1. Describe why and when anesthesia may be used, including additional factors relevant to prolonged anesthesia.

2. Describe the need and list the factors to be taken into consideration when performing the pre-anesthesia evaluation of the animals, including acclimatisation.

3. Analyze the use of pre-anesthesia drugs and analgesics as part of a balanced anesthetic regimen.

4. Understand that a variety of drugs are commonly used for premedication, induction, and maintenance of anesthesia in relevant laboratory species and identify where to obtain advice about the different drugs available and its use.

5. Describe how a simultaneous pathology of an animal may require an anesthetic regimen, supervision, or specific nursing care.

6. Describe the types of agents used for induction and maintenance of general anesthesia, its advantages and disadvantages, and when each can be used.

7. Describe how anesthetics interact to produce the three components of the anesthetic triad in different degrees and how a balanced anesthesia can be best obtained by using combinations.

8. Demonstrate a sufficient understanding of anesthetics that have a low analgesic effect and may require the use of additional analgesia.

9. To know the set of factors to be taken into account when monitoring anesthesia, both in terms of anesthetic depth and physiological stability. Indicate how to determine that an animal receives a sufficient depth of anesthesia to be able to make painful interventions and what measures to take if an adverse event occurs.

10. Know the set of methods that can be used to help with anesthesia monitoring (p.  e.g., ECG, blood pressure, diuresis, oxygen saturation, CO₂) and how they can be monitored.

11. Monitor the depth of anesthesia and vital animal constants, using both clinical signs and electronic devices, where appropriate.

12. Describe and demonstrate the correct preparation, handling and maintenance of the appropriate anesthetic and monitoring equipment for the species concerned.

13. Demonstrate competence in the maintenance and interpretation of prior and post-anesthetic induction records and while the animal is anaesthetized, as well as in proper management of animal care.

14. Describe problems that may occur during anesthesia and understand how to avoid or treat them when they occur.

15. Demonstrate that mechanical ventilation is understood.

16. Describe methods to optimize recovery after anesthesia to ensure rapid and uncomplicated recovery, as in the basic module but with other additional methods, including analgesia and rehydration, in the case of of animals undergoing prolonged anesthesia during a surgical procedure.

17. Consider the consequences of anesthesia and surgical interventions in recovery.

18. Assessing how the choice of an anesthetic will determine the pace of recovery and describe how the duration and quality of anesthesia determine the rhythm.

19. Describe problems that may occur (during the postoperative period) and indicate how to avoid or treat them when they occur.

20. Analyze how to integrate a pain management program into a general perioperative care plan.

21. Describe some of the problems associated with the recognition of pain and treatment in animals.

22. Demonstrate a fairly detailed understanding of painkillers to be able to administer them safely, including routes of administration and possible side effects.

23. Demonstrate competence to understand appropriate and safe working practices regarding the use, storage, and elimination of anesthetics and analgesics.

Principles of surgery; theoretical-practice; module 22 of the EU document

Description:

This module covers the principles of preoperative evaluation and care of animals, preparations for surgery (including preparation of the equipment and aseptic technique) and the principles of successful surgery. The module provides information about possible complications, postoperative care and monitoring, as well as detailed information about the healing process. It also includes more practical aspects, such as the demonstration of the most widely used instruments, and provides the opportunity for students to practice some of the practical aspects of the surgical technique, for example, suture methods, using appropriate non-animal models.

Learning Results:

This module will allow the trainee to be able to:

1. Describe the relevance and necessity of the preoperative assessment and, where appropriate, the conditioning of the animal.

2. Identify sources of reference for good surgical practice.

3. Describe the process of healing and healing of tissues and relate this process to the importance of asepsis and asepsy practices, surgical wound formation, tissue manipulation principles and selection of tissues. an appropriate surgical method.

4. To analyze the possible causes of delay or interruption of wound healing or other postoperative complications, and to describe how they can be avoided or treated when they occur.

5. Describe, in general terms, how to prepare the staff, animals, instruments and equipment for aseptic surgery.

6. Know the principles of successful surgery (p.  e.g., Halstead principles) and indicate how to meet them.

7. Describe the characteristics of the different instruments, suture materials, and needles that are most used.

8. To understand the importance of a good technique of surgical approach, tissue handling, and surgical incisions.

9. Describe the characteristics of different suture patterns and their applicability to different situations.

10. Demonstrate competence to perform a suture correctly.

11. Describe the usual postoperative complications and their causes.

12. Describe the principles of postoperative care and monitoring.

13. Describe the planning of surgical interventions and discuss the competencies required of all staff involved.

14. Demonstrate competence in performing surgical techniques, including ablations and incisions and their closure by appropriate methods for the corresponding tissue.

15. Describe the specific aspects of proper care for animals before, during and after surgery or any other potentially painful intervention.

Design of projects and procedures, level 1; theoretical-practice; module 10 of the EU document

Description:

This module is a prerequisite for people who are going to design projects (function d), but it is also beneficial for scientists who are involved in some way in designing the procedures they perform (function c). The module includes information about concepts of experiment design, possible causes and elimination of bias, statistical analysis and information about where to obtain the necessary experience to help with the procedure, design, the planning and interpretation of the results.

Learning Results:

This module will allow the trainee to be able to:

1. Describe the concepts of fidelity and discrimination (p.  e.g., such as those addressed by Russell, Burch and others).

2. Describe the concept of variability, its causes and methods for reducing it (uses and limitations of isogenic, non-consanguine, genetically modified strains, provenance, stress and the value of habituation, clinical infections, or Asymptomatic and basic biology).

3. Describe the possible causes of bias and ways to reduce it (p.  e.g., formal randomization, blind trials, and possible measures when randomization and masking are not possible.

4. Identify the experimental unit and recognize the problems of non-independence (pseudorreplication).

5. Describe the variables that affect the significance, including the meaning of the statistical power and the "p values".

6. Identify ways to determine sample size (power analysis or resource equation method).

7. Know the list of different types of experiment designs [p.  e.g., fully randomized, block-randomized, repeated measures (in the same subject), factorial or Latin-square experiment designs].

8. Describe how to access the help of experts in the design of an experiment and the interpretation of their results.

Design of projects and procedures, level 2; theoretical-practice; module 11 of the EU document

Description:

This module provides a relevant level of understanding of the national and international legal and regulatory framework within which projects are created and managed, and where their legal responsibilities are framed.

The student must be able to identify, understand and respond appropriately to the ethical and welfare issues raised by the use of animals in scientific procedures in general and, more specifically, within its own work programme. These issues have already been addressed in the Ethics, Animal Welfare and the "three errors" module, level 1.

The student must be able to develop, direct and control a work program to achieve his established objectives, in addition to ensuring compliance with the regulations governing the project. The implementation of the "three errors" throughout the work programme is part of this process. The learning outcomes relative to the reduction have already been treated in the Ethics, Animal Welfare and the "three errors" module, level 1.

Learning Results:

This module will allow the trainee to be able to:

(A) In relation to legal aspects:

1. Describe in detail the main components of national (state and regional) legislation governing the scientific use of animals; in particular, explain the legal responsibilities of those who design the procedures and projects (d) and for those with legal responsibilities under national law (p.  the person responsible for compliance, the veterinarian, the staff caring for the animals or the trainers.

2. To know the main purposes of other relevant international and EU legislation and the associated guidelines that influence the welfare and use of animals. Directive 2010 /63/EU, Royal Decree 53/2013 of 1 February 2013, and the guidelines or rules relating to veterinary care, animal health, welfare, genetic modification, transport, health, safety and health are part of this legislation. quarantine, safety and hygiene, wildlife and conservation.

(B) In relation to good scientific practice:

3. Describe the principles of good scientific strategy (which are necessary to achieve solid results), among others, the need to define clear and unambiguous hypotheses, a good design of experiments, experimental measures and analysis of the results. Give examples of the consequences of failing to implement a sound scientific strategy.

4. Demonstrate that there is a need to accept expert advice and to use the appropriate statistical methods, to recognise the causes of biological variability and to ensure consistency between experiments.

5. Understand the importance of being able to justify, both from a scientific and ethical point of view, the decision to use live animals, for example, referring to the choice of models, their origins, their estimated number and the phases of development. Describe the scientific, ethical and welfare-related factors that influence the choice of a particular animal or non-animal model.

6. Describe situations where pilot experiments may be necessary.

7. Understand the need to keep abreast of developments in science and technology related to experimental animals to ensure good scientific practice and animal welfare.

8. Understand the importance of a rigorous scientific technique and the requirements of guaranteed quality standards, such as good laboratory practice.

9. To understand the importance of the dissemination of the results of the studies, regardless of the outcome, and to describe the main problems to be reported when using live animals in research, p.  e.g. ARRIVE guidelines.

(C) In relation to the implementation of the "three errs":

10. Demonstrate a complete understanding of the principles of replacement, reduction and refinement, and how such principles ensure good scientific practice and adequate animal welfare.

11. Understand the importance of bibliographic and Internet searches and discussion with colleagues and relevant professional organizations when identifying opportunities to apply each "erre".

12. Describe relevant sources of information related to ethics, animal welfare and the implementation of the "three errs".

13. Describe how different tools are used (p. e.g. eURL ECVAM search guide, Go3Rs) and search methods (p. e.g., systematic reviews, meta-analyses).

14. Describe examples of search strategies and alternative methods to replace, avoid or supplement the use of animals in different types of research programs.

15. Identify, assess and minimise the limitations of animal welfare over the course of life (including adverse effects related to provenance, transport, accommodation, zootechnics, handling, procedures and the use of animal welfare). Bloodless Sacrifice); explain and offer examples of welfare assessment protocols.

16. Define and apply the appropriate final points; establish the appropriate criteria to determine when the final point has been reached.

17. Describe potential conflicts between refinement and reduction (p. In the case of reuse) and the factors to be taken into consideration to resolve this conflict.

18. Define the requirements and controls of the realojo of the animals; identify the relevant realojo guidelines.

(D) In relation to responsibilities:

19. To understand the need to know the state and regional provisions relating to the management of project authorizations, for example, procedures for requesting animals, standards for housing, disposal of the animals, the safe working practices and the safety and the measures to be taken in the event of an unexpected problem arising from any of these points.

Introduction to the institutional organisation (establishment); theoretical; module 50 of the EU document

Description:

This module provides the necessary information about the structure of the establishment, the main functions and their corresponding tasks, as well as an assessment of how they contribute to animal welfare, the good science, the implementation of the "three errors" and the consolidation of the culture of care.

Learning Results:

This module will allow the trainee to be able to:

1. Understand how the scope and spirit of the current legislation, as well as other legislative texts and guidelines, concern the care and use of animals for scientific purposes in the establishment.

2. Describe the local organization chart and its function within it.

3. To distinguish the functions, responsibilities and interactions of those working in accordance with Directive 2010 /63/EU, the Royal Decree, 53/2013 of 1 February, (listed in Articles 14 and 15) or other applicable legislation in the institution.

4. Understand the tasks of the animal welfare organ and describe each person's role in helping with these tasks.

5. Analyze how individual function can contribute to the promotion, implementation and dissemination of the "three errs" in the establishment.

6. Understand the importance of taking a proactive approach (and of communication mechanisms) as an instrument to foster "three mistakes" and the culture of care.

Designated veterinarian; theoretical-practice; module 24 of the EU document

Description:

This module provides the veterinarian with the initial tools for the effective acquisition of responsibilities and tasks as a designated veterinarian (VD), function f).

The exemption of training elements can be considered according to the individual analysis of both the educational base and the experience and its deficiencies.

This module focuses on the basic principles for veterinary management of animal health and the welfare of animals maintained, reared or used for scientific purposes to ensure that the VD understands the role of the veterinarian in the research environment in accordance with professional obligations.

Learning Results:

This module will allow the trainee to be able to:

(A) In relation to legislation:

1. Summarize the legal obligations and professional requirements of the VD.

2. To compare the roles, responsibilities and interactions of persons working under Royal Decree 53/2013 of 1 February 2013 in an establishment and to explain the legal composition and role of the body in charge of the welfare of the animals.

3. Describe the function of the VD in directing the prescription, ordering, storage, dispensing and disposal of drugs for animals kept in approved establishments and used in procedures.

4. Describe the function of the VD in the import, export and transport of experimental animals.

5. Highlight legislative controls in the creation and use of genetically modified animals.

(B) In relation to ethics, animal welfare and the "three errs":

6. To define the principles of the "three errors" and to provide examples of the application of each of them in an establishment of breeders, suppliers or users; in particular, to discuss pain relief and potentially lasting damage.

7. To justify the importance of good animal health and welfare (taking into consideration scientific results and social or moral reasons) and to recognize the relationship between health and welfare, on the one hand, and scientific validity, on the other.

8. Identify sources of information related to ethics, animal welfare and veterinary information that allow the implementation of the "three errs".

9. Understand the need for a culture of care and the role of each person in contributing to it.

10. Understand how the VD can contribute to the dissemination of information that will help to understand ethical issues, adequate animal welfare, good scientific practice and the application of the "three errs".

11. Identify the criteria used to make an assessment of the damages and benefits and be able to apply them.

12. Identify the role of the VD in advising on the choice of the animal model and the refinement of the model.

(C) In relation to the care, health and management of animals:

13. Relate the purposes of a routine inspection to an animalarium with how to address the problems that arise.

14. Highlight the preparation required for routine inspections.

15. Raise the information to be included in the health records and reports for the animals ' carers and for third parties.

16. To summarise the basic principles of surveillance, prevention and treatment of diseases in experimental animals and the principles of health monitoring programmes, with information on relevant micro-organisms, infect animals such as their classification, the possible impact on research and animal health, their zoonotic potential, their prevention, diagnosis, treatment and eradication, in addition to the clinical aspect, the etiology and pathology of the usual diseases in experimental animals.

17. Highlight the requirements for health control, for example, the FELASA guidelines.

18. Highlight appropriate treatment and control strategies for biosafety and disease outbreaks in experimental animals.

19. Carry out a general description of the principles of animal husbandry of experimental animals, highlighting the main points of design and construction of cages and closed enclosures and the advantages and disadvantages of different types of animals. systems.

20. Describe the principles concerning the choice of appropriate environmental conditions and the types of environmental enrichment used with experimental animals.

21. Describe the different methods by which it is allowed to sacrifice individual animals, the influence that different methods can have on scientific results and how to select the most appropriate one.

22. To highlight the principles of hygiene, disinfection and sterilisation that are applicable to the installation of experimental animals, including parameters that influence water quality, how to check this quality and how to interpret results.

23. Demonstrate that awareness of the main hazards that can be found in an installation of experimental animals and the function of the VD in minimizing risks can be found.

24. Describe the main biological characteristics of the relevant species and recognize the factors that may influence their care or use as experimental animals.

25. To analyse the creation and use of genetically modified animals in research, including the usual types of genetically modified animals, common uses in research and the different ways of creating and evaluating such animals, in addition to how they are designated according to the international guidelines of the nomenclature.

(D) In relation to anesthesia, analgesia and surgery:

26. Demonstrate adequate knowledge of the use of anesthesia, analgesia, and surgery in the context of experimental animals.

27. Relate factors that influence the choice of anesthetic protocols in different situations.

28. Describe the specific problems posed by the experimental surgery and identify the function of the VD as it relates to it.

(E) In relation to the principles of veterinary communications:

29. Define strategies for effective communication and explain how such strategies foster animal welfare and good science.

30. Review opportunities to collect more veterinary information in medicine and science with experimental animals.

ANNEX II

Animal species groups

1. Rodents.

2. Lagomorphs.

3. Carnivores.

4. Equidae, ruminants and pigs.

5. Primates.

6. Birds.

7. Reptiles.

8. Fish and amphibians.

9. Cephalopods.

10. Wild animals.

11. Other species.

ANNEX III

Minimum duration of the training activities referred to in Article 20

The training activities for continuing training referred to in Article 20 shall be at least equivalent to the following number of hours of training:

1. Function a): 20 hours in 8 years.

2. Function b): 25 hours in 8 years.

3. Function c): 45 hours in 8 years.

4. Function d): 40 hours in 8 years.

5. Function e): 90 hours in 8 years.

6. Function f): 90 hours in 8 years.

In the case of applying for the maintenance of multiple categories simultaneously, at least the requirements of the category requiring the greatest number of hours will be required.