Order Ecc / 566/2015 Of 20 March, Establishing The Training Requirements To Be Met By Personnel Handling Animals Used Or Supplied Bred For Experimental Purposes And Other Scientific Purposes Are Established, Including The D ...

Original Language Title: Orden ECC/566/2015, de 20 de marzo, por la que se establecen los requisitos de capacitación que debe cumplir el personal que maneje animales utilizados, criados o suministrados con fines de experimentación y otros fines científicos, incluyendo la d...

Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-3564

Protecting the welfare of experimental animals is a constant in Community law from its origins. At present this matter is governed by Directive 2010/63 / EU of the European Parliament and the Council of 22 September 2010 on the protection of animals used for scientific purposes.

In Spain the rules of basic character on the subject is contained in the Law 32/2007, of 7 November, for the care of animals, exploitation, transport, experimentation and sacrifice and as a development of that law in order to implement the changes introduced by Directive 2010/63 / EU in our domestic law, Royal Decree 53/2013, of February 1, laying down basic standards for the protection of animals used are set in experimental and other scientific purposes, including teaching.

An essential factor in protecting the welfare of animals used for experimental and other scientific purposes and teaching is adequate training of personnel responsible for handling.

This question addresses (picking the provisions of Sections 23, 24 and 25 and Annex V of Directive 2010/63 / EU) Article 15 of Royal Decree 53/2013, of February 1. This article establishes the general principle that persons handling experimental animals must have adequate prior training, then setting the basic training requirements that must be available; is attributed to the competent bodies the responsibility to ensure through authorization or by other appropriate means training staff to perform various functions; It states that staff training can have a modular structure based, where appropriate, guides, guidelines or recommendations of the European Union and the minimum training requirements shall be expressed in learning outcomes and recognition staff training will be valid throughout the national territory.

The transitory provision of 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 on the report of the Ministries of Education , Culture and Sports and Agriculture, Food and Environment, will develop training requirements of staff in Article 15 of that royal decree concerns, adding that such effects may assist one of a working group within the framework committee established by Article 44 of the royal decree, in education, training and staff training.

Pursuant to this mandate, the object of this ministerial order is to develop training requirements of personnel using animals in experiments and other scientific purposes, including teaching, generally regulated in Article 15 of Royal Decree 53 / 2013 of 1 February.

The ministerial order develops mainly the following aspects:
1st
requirements specific to each of the functions involved in animal handling training. These requirements consist (with the specific peculiarities of each function) in academic qualifications and relevant professional qualifications; specific training courses, modular character, whose content is based on guidelines recently adopted by the European Union, and in some functions, the performance of work under supervision, as the last link to perform them autonomously.

2nd Recognition of training by the competent authorities, by issuing a certification that enables to perform the function in question independently, after verification of compliance with the requirements applicable to the function . This recognition is adapted to the Law 20/2013, of December 9, assurance unit market, as it complies with the principles of necessity and proportionality, to so arrange it a rule in the European Union (in this case the Article 23.2 of Directive 2010/63 / EU), is effective throughout the national territory and subject to reciprocity with other Member States of the European Union.

3.º requirements training courses and institutions that impart, as well as recognition by the competent authorities.

4.º maintenance training through continuing education activities.


5th The transitional regime applicable to persons who have obtained recognition of their training under the previous rules, contained in Royal Decree 1201/2005, of October 10, on the protection of animals used for experimental 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 general provisions and incorporates the definitions that are useful for proper understanding of the text; Chapter II refers to obtaining initial training appropriate to the different functions: requirements, recognition and regulation of specific training required; Chapter III regulates the maintenance training; Chapter IV regulates the basic rules of procedures established and whose development corresponds to the relevant bodies. Annexes collect the training modules and learning outcomes, the classification of animal species involved and the minimum period required for training.

This ministerial order has basic character and is issued under the powers given to the State by Article 149.1.15.ª, 16th and 30th of the Spanish Constitution. Is considered justified to go to a regulatory standard this range to regulate a normative content of basic character because it is in turn a development of standards that have that character (Law 32/2007, of November 7 and Royal Decree 53 / 2013, February 1, which also expressly provides that the Ministry of Economy and Competitiveness requirements governing training of personnel referred to in Article 15). There is therefore an express regulatory authorization to do so, it is part of a content markedly technical, more typical of a provision of this range, and finally conforms to the ultimate objective of the rules of basic character, that is, ensure a common uniform throughout the national territory (in this case for staff training) it settled doctrine of the Constitutional Court.

In preparing this ministerial order they have been consulted the autonomous communities and the sectors affected by the hearing procedure specified in Article 24.1 c) of Law 50/1997, of 27 November, the Government, and has had the assistance of a working group established under the Spanish Committee for the protection of animals used for scientific purposes.

Preliminary report issued Ministries of Education, Culture and Sports and Agriculture, Food and Environment.

By virtue, with the prior approval of the Minister of Finance and Public Administration, I have:
CHAPTER
I
General provisions


Article 1. Object and purpose.

The purpose of this ministerial order is the regulation of the training requirements to be met by personnel who operate, performing some of the functions listed in Article 3.2, used animals bred or supplied for experiments and other scientific purposes , including its 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, the definitions contained in Law 32/2007, of 7 November, for the care of animals, exploitation, transport, experimentation and sacrifice and elReal Decree shall take into account 53/2013, of February 1, laying down basic standards for the protection of animals used for experimental and other scientific purposes are established, including teaching.

It will also be understood as:

A) Competent Body: The bodies, authorities or administrative units of the autonomous communities and the cities of Ceuta and Melilla responsible for policy development and implementation in each of the matters covered in this ministerial order.

B) Training: Knowledge and skills needed to perform independently any of the functions that Article 3.2 refers, in the manner and with the requirements established in this ministerial order.

C) Course: Training program for 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: Document issued an entity training ensures overcoming a course.


F) Learning outcomes: Achievements, expressed in obtaining knowledge and skills contained in one or more modules 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 tasks under supervision, once passed the theoretical and practical course content.

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

Article 3. Scope.

1. The scope of this ministerial order is set out in Article 2 of Royal Decree 53/2013, of February 1, such that:

A) shall apply when used or intended for use animals in procedures, or where they are bred specifically so that their organs or tissues may be used for scientific purposes.

B) shall apply until the animals referred to in point a) they have been killed, rehomed or returned to a suitable habitat or husbandry system.

C) are understood to be included within the scope of all animals used in procedures, although it has achieved the elimination of pain, suffering, distress or lasting harm by the successful use of anesthesia, analgesia or other methods.

D) shall apply to animals that Law 32/2007, of November 7 refers.

E) the animals that are in an earlier stage of development whether to allow the live beyond that stage of development and as a result of the procedures performed animal is likely to experience pain suffering shall also apply, , distress or lasting harm after it has reached that stage of development.

F) are excluded from the scope:

1. Non-experimental agricultural practices;

2. veterinary practices are not experimental clinics;

3. veterinary clinical studies required as part of obtaining marketing authorization of veterinary drugs;

4. recognized practices undertaken for zootechnical purposes;

5. practices undertaken for the primary purpose of identifying an animal;

6. practices which are not likely to cause them pain, suffering, distress or lasting harm equivalent or superior to those caused by the introduction of a needle according to good veterinary practices.

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

A) Animal care.

B) Euthanasia of the animals.

C) Implementation of procedures.

D) Design of projects and procedures.

E) Assumption of responsibility for 'in situ' welfare and animal care supervision.

F) Assumption of veterinarian designated functions.

Article 4. General Principles.

1. Persons performing the functions listed in Article 3.2 must have the necessary training.

2. Recognition of training is an indispensable prerequisite for the corresponding functions autonomously.

3. The training will be achieved by meeting one or more of the following requirements, with the peculiarities for each function are specified in Section II of Chapter 1st:

A) Being in possession of the university degree to be determined, if necessary.

Meet this requirement equivalent degrees issued abroad, provided that the interested parties can prove that such qualifications have received approval and recognition or professional recognition in accordance with current legislation on the subject.

B) Overcoming courses theoretical and practical training, aimed at the acquisition of learning outcomes of the modules for each of the functions that Article 3.2 refers.

Modules and learning outcomes are listed in Annex I and are based on guidelines published by the European Union. Learning outcomes may be subject to concretions, extensions or adaptations by the competent authorities, who may also update to its adaptation to future Community guidelines.

The modules are classified as:


1. Fundamental or core: The acquisition of the corresponding learning outcomes is necessary to perform any of the functions referred to in Article 3.2. The fundamental or core modules will refer to all groups of species listed in Annex II.

2. Function: The acquisition of the corresponding learning outcomes is necessary to perform some of the functions mentioned in Article 3.2. They can 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 if their training programs cover the essential content of the learning outcomes of the relevant modules, depending on the function in question.

C) Conduct a further period of work under supervision for the functions to be determined.

4. In cases for which so provides this ministerial order shall be deemed sufficient to be in possession of vocational qualification or professional certificate that address the learning outcomes of the modules for each of the functions referred the Article 3.2. In these cases, recognition of training will refer to groups of animal species listed in Annex II of this ministerial order with which practices have been made in the actual work environment.

Meet this requirement equivalent degrees issued abroad, under the conditions indicated in paragraph 3 a), second paragraph.

5. The training obtained is maintained through continuous training in the form regulated in this ministerial order.
CHAPTER II


Obtaining initial training appropriate to the different functions

SECTION 1. Requirements for initial training

Article 5. Role of animal care.

For the recognition of training for the role of animal care, compliance with any of the following conditions are required:

A) be in possession of a vocational training or professional certificate that address the learning outcomes included in the modules for this function according to Annex I.

B) Overcoming training courses aimed at achieving the learning outcomes included in the modules for this function according to Annex I, accompanied by the development of a period of work under supervision until the acquisition of the skills necessary to perform such function autonomously.

Article 6. Role of euthanasia of animals.

For the recognition of the training function euthanize animals, compliance with any of the following conditions are required:

A) be in possession of a vocational training or professional certificate that address the learning outcomes included in the modules for this function according to Annex I.

B) Overcoming training courses aimed at achieving the learning outcomes included in the modules for this function according to Annex I, accompanied by the development of a period of work under supervision until the acquisition of the skills necessary to perform such function autonomously.

Article 7. Role of performing the procedures.

For the recognition of the training function performing the procedures, compliance with any of the following conditions are required:

A) be in possession of a vocational training or professional certificate that address the learning outcomes included in the modules for this function according to Annex I.

B) Overcoming training courses aimed at achieving the learning outcomes included in the modules for this function according to Annex I, accompanied by the development of a period of work under supervision until the acquisition of the skills necessary to perform such function autonomously.
Article 8. Function
project design and procedures.

For the recognition of training for the role of project design and procedures, compliance with the following requirements will be required:

A) Possess a university degree equivalent degree, degree, master's or doctor, or Biology (animal), Medicine, Veterinary or any other discipline that incorporates in its training program studies on biology and animal physiology.


B) Overcoming training courses aimed at achieving the learning outcomes included in the modules for this function according to Annex I.

It may also obtain training for this role who possess a bachelor's degree, bachelor, master or doctor, or equivalent, other than those referred to in point a) and exceeding the courses that the letter referred b) above, provided that these courses include an additional module on fundamentals of biology and animal physiology, oriented species or group of species involved.

Article 9. Monitoring function "in situ" the welfare and care of animals.

For the recognition of training for supervisory role "in situ" the welfare and care of the animals, compliance with the following requirements will be required:

A) Possess a university degree equivalent degree, degree, master's or doctor, or Biology (animal), Medicine, Veterinary or any other discipline that incorporates in its training program studies on biology and animal physiology.

B) Overcoming training courses aimed at achieving the learning outcomes included in the modules for this function according to Annex I.
Article 10.
veterinarian designated function.

For the recognition of training for the role of designated veterinarian, meeting the following requirements will be required:

A) Possession of a university bachelor's degree, bachelor, master or doctor, or equivalent to allow the practice of veterinary medicine.

B) Overcoming training courses aimed at achieving the learning outcomes included in the modules for this function according to Annex I.

The competent bodies may to derogate from overcoming these courses to demonstrate documented knowledge or experience in medicine of animals used in experimentation and others, equivalent to learning outcomes included in science or teaching modules that the preceding paragraph.
Article 11. Requirements
work under supervision.

1. Training for the functions of animal care, euthanasia of animals and performing the procedures in cases where this is required in Articles 5, 6 and 7 respectively, will be completed by undertaking a period of work under supervision.

2. Supervised work will start once passed the theoretical and practical training courses aimed at achieving the learning outcomes included in the training modules corresponding to these functions.
the competent bodies may
however, authorize persons who have not yet completed training courses for these functions begin to carry them temporarily and under responsible supervision, provided that in the case of the function of performing the procedures , actions on the animals are classified as a 'mild' or 'non-recovery' procedure. This interim period may not be longer than six months.

3. The work under supervision will take place in a real work environment, meaning the establishment of a breeder, supplier or user, subject to the exceptions may be authorized when working under supervision is carried out with wild animals.

If work under supervision involves performing procedures, these will be carried out in establishments authorized users, unless authorized by the competent authority, after scientific justification for the need or desirability of made outside these centers.

4. The development work under supervision may take place under a contract of employment, residence permit or any other permissible legal degree in law and relevant.

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

A) The personnel who may supervise.

B) The duration of supervision, which may be variable depending on the evolution of the process of acquiring skills.

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

D) Establishments and entities, in concert with those, can schedule the performance of work under supervision, ensuring mechanisms to ensure sufficient supply and free competition.


6. Overcoming the monitoring period it will be documented by issuing the appropriate certification by the establishment in which it is made.

Article 12. Exceptions to the requirements of initial training.

Are exempted from the requirements laid down in Articles previous use of live animals by students as part of teaching, training courses for training of staff and directed the capacity of health personnel or veterinarian, provided that meet the conditions regulated in Article 16.
Section 2
Recognition of initial training and acquisition of new skills

Article 13. Recognition of initial training.

1. It is up to the competent bodies recognized training for the exercise of each of the functions listed in Article 3.2 by issuing a certificate of training that enables to perform these functions autonomously and take effect throughout the National territory.

2. Recognition of training to perform the functions listed in Article 3.2 by the competent authorities of another Member State shall be effective throughout the national territory, under the principle of reciprocity.

3. The recognition of qualifications obtained in third countries shall ensure that preliminary recognition is based at least equivalent to those required in this ministerial order requirements.

4. The competent bodies develop the procedure led to the recognition of training which respect the bases contained in Article 21.

Article 14. Acquisition of new skills.

1. Those who have received the training to develop a specific function related to Article 3.2 and opt to training for the development of another function must demonstrate the improvement of courses aimed at achieving the learning outcomes included in the modules of the new feature not yet acquired and, where appropriate, be in possession of the required qualifications.

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

3. In both cases covered in this article require the corresponding work under pre-training certificate has been issued by the competent organs supervision, where appropriate.
Section

3rd Training Courses
Article 15. Entities that provide training courses.

1. Training courses aimed at achieving the learning outcomes included in the modules in Article 4.3 refers b) they shall be conducted by legally constituted entities.

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

2. Entities keep out practical training documentation concerning each course and modules available include the competent bodies for a minimum period of five years from the date of completion of each edit them.

3. Under the provisions of the preceding paragraphs, the competent bodies may develop the minimum requirements to be met by institutions imparting training.

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

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

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

A) shall be used, whenever possible, strategies or satisfactory training methods that do not involve the use of live animals.

B) Procedures exclusively for purposes of training and teaching must be limited to what is strictly necessary.

C) The design of practical courses or training activities minimize the number of animals used.

D) The animals shall be submitted, whenever possible, classified as 'mild' or 'non-recovery' procedures.

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

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


The competent bodies shall ensure the application of this section first and contribute to the development and validation of strategies or training methods to obtain a level equal or superior to that obtained with the use of animal training, but not use them, use them in actions involving fewer or less pain, stress or distress.

2. It will take place in the establishment of a breeder, supplier or user, subject to the exceptions may be authorized when wild animals are used.

If the practices involve making procedures, these will be carried out in establishments authorized users, unless authorized by the competent authority, after scientific justification for the need or desirability of made outside these centers.

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

4. Teaching staff should be adequately trained for the corresponding function in the manner set forth in this ministerial order.

5. any other requirements or conditions for the use of animals for experimental and other scientific purposes, including teaching will be met, established by Royal Decree 53/2013, of February 1, and that may be applicable.

Article 17. Requirements for training courses.

1. Training courses to which Article 4.3 refers 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 provide such training programs for courses and modules.

2. The training courses will be taught by qualified entities referred to in Article 15.

3. Training courses comply with the conditions set out in Article 16 for the use of live animals.

Addition, shall meet the following requirements:

A) The training programs proposed by the educational institutions or, where applicable, the type of each course programs will be based on the learning outcomes of the modules that apply, as detailed in Annex I.

B) Training programs contain a theoretical part and a practical part, based on the nature of the modules that are taught, and detailed its duration, which respect the minimum set out in Annex I a) and b).

C) The training context must have sufficient human and material appropriate to the program and each course. Each course will be assigned a tutor.

D) Teachers should have adequate qualification in the art that has been assigned.

E) The courses contain objective evidence to verify the acquisition of the learning outcomes.

4. The training may be imparted both wholly or partially in person not always face as that, in the latter case, the nature permits module or modules to impart.

The distance courses will have adequate electronic platform that ensures:

A) The availability of knowledge and educational content in multimedia formats easily accessible, such as text, images, voice files, demonstration videos, web links or interactive exercises so that the acquisition of the required skills is made possible.

B) The interaction between teachers and students, tutorials, discussion forums and transmission systems in real time.

C) Undertaking, where appropriate, of objective evidence of improvement course.

5. Institutions imparting training issue a diploma to students who have passed the course. The diploma will contain, in addition to the data identifying the training institution, the student and the course, information about the taught modules, function or functions affected (if taught all modules of one or more functions), its duration and the species which relates.

Article 18. Recognition of training courses.

1. It is up to the competent bodies recognition of training courses enabled to achieve the learning outcomes included in the modules in Article 4.3 b) taught in their territory is concerned. To this end, they will develop the corresponding recognition procedure, which respect the bases contained in Article 21.

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


3. The competent bodies may suspend or withdraw recognition of the training if the conditions that led to such recognition are not met, prior record transacted with the interested audience.

4. The competent bodies shall inform the Ministry of Economy and Competitiveness recognized training courses for the sole purpose of advertising through its electronic site. Such notification shall be made within three months of its recognition.

Article 19. Control of training courses.

1. The competent bodies shall establish regular checks to entities imparting training to ensure compliance with this ministerial order, in particular, the adequacy of the development of training courses to the conditions of its recognition.

2. The competent bodies adapt the frequency of monitoring or inspections based on a risk analysis that takes into account at least:

A) The number, type and content of training courses and training activities are given.

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

C) the record of compliance or non-compliance of the entity.

D) any information that might indicate a possible breach.
CHAPTER III

Maintenance training


Article 20. Activities of training.

1. Initial training for the development of the functions that Article 3.2 refers will be maintained through continuing education activities.

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

A) include the teaching or attending courses, seminars, lectures, workshops and scientific conferences; stays authorized research centers, and other similar activities determined by the competent bodies and which are aimed at learning new techniques, methods or rules applicable to animal testing or its updating.

B) They shall be related to the learning outcomes of the modules for the function in question.

C) Be given, together, the minimum duration as detailed in Annex III for each function.

D) is credited with diplomas or certificates of attendance that mention their content and duration is made.

E) will have a content that allows the maintenance of training one or more functions.

F) respect the conditions set out in Article 16 for the use of live animals in training courses.

3. The training activities covered in this article do not necessarily have the prior endorsement by the competent bodies. However, competent bodies may take control actions on the same terms as provided in Article 19.

4. Responsible "in situ" to which Article 14.4 c) of Royal Decree 53/2013, of February 1, ensure respect for the facility staff have access to appropriate to the role this develops training activities.

5. For the competent bodies had recognized training checking that stakeholders demonstrate the maintenance of their training in the manner provided in this Article at least every eight years. To this end, they will develop the procedure for accreditation, which respect the bases contained in Article 21.

6. The body may suspend the recognition of training if continuing education requirements regulated in this article are not met, and remove, after proceedings transacted with hearing the person concerned.
CHAPTER IV

Procedures


Article 21. Basic rules of procedure.

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

Also satisfying the requirements of basic character contained in Law 11/2007 of 22 June, electronic access of citizens to Public Services.

2. The procedures will be initiated at his request. The application must be accompanied by at least the following documentation:


A) In the procedure for recognition of training, documentation certifying the applicant be in possession of academic and professional degrees, diplomas and certifications required for each function in Articles 5 to 11. In the case it shall be furnished qualifications obtained abroad, the accreditation of its approval and recognition or professional recognition is also required. In the case of courses taken abroad must prove its contents.

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

1. Training entities that possess technical solvency requirements and the human and material resources necessary for the development of courses and other requirements in Article 15.

2. That courses meet the conditions for the use of live animals required under Article 16 for training practices.

3. That the courses meet the other requirements stipulated in Article 17.

It may provide exemption from the obligation to prove compliance requirements which already included the relevant bodies when adapting training courses already recognized under the Royal Decree 1201/2005, of 10 October, requesting protection of animals used for experimental and other scientific purposes.

C) In the process for the accreditation of maintenance training, documentation certifying diplomas or certificates of attendance related to the training activities and compliance with the other requirements listed in paragraph 2 of Article shall be furnished 20.

3. It may provide for the accreditation of any of the requirements of this ministerial order is made by sworn statement, under the terms of Article 71a of Law 30/1992 of 26 November.

4. The competent bodies shall acknowledge receipt to the applicant for the submission of its application under the terms provided in Article 42.4 of Law 30/1992 of 26 November.

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

6. For the purposes of the resolution of the procedure, those reports that are mandatory by legal provisions be requested, and those deemed necessary to resolve, citing the provision that requires or basing, where appropriate, the desirability of claim them.

7. Unless a shorter period is established, the maximum period to resolve and notify the relevant resolution will be three months since the application has been entered in the register of the competent body. The expiration of the deadline without having notified express resolution, legitimizes the interest it deducted the application to understand estimated administrative silence, in accordance with Article 43.1 of Law 30/1992 of 26 November.

8. The positive decision shall be accompanied by:

A) In the procedure for recognition of training, the certificate of training. This certificate will detail the functions and species or groups of animals species to which it refers, as well as its initial effective date.

B) In the procedure for recognition of training courses, the certificate of recognition of the training course, having to specify the modules, functions and species or group of species that reached.

C) In the process for the accreditation of maintenance training, issuing certification maintenance training for the function and species or group of species recognized initially, with an expression of its term.

First additional provision. human and material resources.

The provisions of this ministerial order will not increase spending or allowances or remuneration of staff for the General State Administration.

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

Second additional provision. more stringent provisions.


According to the provisions of the sixth transitory provision of Royal Decree 53/2013, of February 1, maintenance by stricter than those established in this ministerial order to ensure competent bodies greater protection provisions animals within its territory shall be limited to those provisions that were in force on 9 November 2010, are compatible with the general principles of the Treaty on the Functioning of the European Union and had communicated before December 1, 2012 to Directorate-General animal welfare General Administration.

Third additional provision. Implementation of the training requirements in local public administrations.

The Public Administrations shall ensure that the personnel access provision of services in local ownership, performing some of the functions that Article 3.2 refers, meets the training requirements regulated in this ministerial order, without prejudice the provisions of the first transitional provision for those who had received training under the Royal Decree 1201/2005, of 10 October.

They adapt training courses to come by providing for initial training of its staff to the requirements regulated in this ministerial order and ensure the maintenance of training on the terms set out in Article 20, adjusting, if necessary, their training programs.

First transitional provision. recognized categories under the Royal Decree 1201/2005, of 10 October.

1. People the entry into force of Royal Decree 53/2013, of February 1, were authorized by the competent bodies to perform the functions corresponding to the categories established under the provisions of the repealed Royal Decree 1201/2005, of 10 October, maintain that power, without limitation species, referring to the aforementioned functions according to the following:

A) It is considered qualified to assume the role of animal care to recognized or accepted as category A staff as provided in Annex I of Royal Decree 1201/2005, of 10 October.

B) are considered qualified to assume the role of euthanasia of animals to recognized or accepted as categories A, B and D2 staff as set out in Annex I of Royal Decree 1201/2005, of 10 October.

C) it is considered qualified to assume the role of performing the procedures to recognized or accepted as category B and C as set out in Annex I of Royal Decree 1201/2005, of October 10 staff.

D) it is considered qualified to assume the role of project design and procedures to staff recognized or approved as category C as set out in Annex I of Royal Decree 1201/2005, of 10 October.

E) is considered able to assume the supervisory function 'in situ' welfare and care of animals to recognized or accepted as a category D1 staff as set out in Annex I of Royal Decree 1201/2005, of 10 October.

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

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

Training courses under the Royal Decree 1201/2005, of October 10, habilitasen to acquire training and had been taught in the period covered by the preceding paragraph shall take effect for the recognition of the training.

The same effect will the courses at the time of the entry into force of this order were in the process of teaching or had expected delivery within a period not exceeding six months time.

3. The staff concerned by this transitional provision shall be applicable first as provided in Article 20 on maintaining training, having to count the period of eight years from the date of entry into force of this ministerial order.

Second transitional provision. Registration staff recognized under the Royal Decree 1201/2005, of 10 October.


The competent bodies shall keep records of the training personnel as established in the first transitory provision, indicating the function or functions of Article 3.2 to respect recognized.

First final provision. basic character and competence title.

This ministerial order has basic character and is issued under the powers given to the State by Article 149.1.15.ª, 16th and 30th of the Spanish Constitution, in the promotion and general coordination scientific and technical research; bases and overall coordination of health and regulation of the conditions for obtaining, issuing and standardization of academic degrees and professional qualifications and basic rules for the development of Article 27 of the Constitution, respectively.

Second final provision. Guides, guidelines and recommendations of the European Union.

Policy development and implementation of the matters covered in this ministerial order, the competent authorities shall take into account the guidelines, guidelines or recommendations issued by the European Union.

Final disposition third. Entry into force.

This ministerial order shall come into force on the day following its publication in the "Official Gazette" day.

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

Training modules


A) Ratio function modules.

This section (common to all functions and species) core modules and specific modules for each function, which is directed to a species or group of species are related.


Fundamental or core modules



Module name





Minimum duration (hours)






National legislation





1






Ethics, animal welfare and the 'three Rs' level 1





2






Basic and adequate Biology, level 1





3






Care, health and animal management, level 1





5






Recognition of pain, suffering and anguish





3






non-lethal methods of slaughter, level 1





2





Specific function modules




Module name





Depending on which route the module must be included





Minimum duration (hours)






to





b





c





d





e





f






Ethics, animal welfare and the 'three Rs' level 2























x





x





x





10






Basic and adequate biology, Level 2





x





x





x











x











3






Fundamentals of biology and animal physiology (*)























x

















20






Care, health and animal handling, Level 2





























x











45






non-lethal methods of slaughter, Level 2











x






























3






Minimally invasive procedures without anesthesia, level 1

















x





x





x











5






Minimally invasive procedures without anesthesia, Level 2

















x











x











10






Anesthesia for minor procedures

















x























5






Advanced anesthesia for surgery or lengthy procedures

















x























8






Principles of surgery

















x























5






Project design and procedures, level 1























x

















5






Project design and procedures, Level 2























x

















10






Introduction to institutional organization (establishment)





























x





x





5






Veterinarian designated



































x





65





(*) The module basics of biology and animal physiology only be binding on d) function to holders of a bachelor's degree, bachelor, master or doctor different those listed in Article 8 a).

B) Minimum training courses for different functions Duration.

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

2. When training courses for personnel who are trained to function and species or group of species in order to acquire training for a new species or group of species are designed, institutions imparting training may propose training programs to collect only the characteristics of the new species or group of species, and have a shorter duration than generally established for each of the modules that apply. The competent authorities will assess the adequacy of the course content and duration in the procedure for recognition of the courses.

C) Description and learning outcomes of the modules:

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


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

To that end, next to the name of each module it includes a reference numeral equivalent module among described in the document.

3. These learning outcomes are without prejudice to the concretions, additions, adaptations or updates to new guidelines that may make the competent bodies.

4. The training entities make up training programs based at least in the learning outcomes corresponding to each module being conducted.

C.1) fundamental or core modules.

National legislation; theoretical; EU Module 1 Document

Description:

This module offers an appropriate level of understanding of the legal framework and regulatory national and international within which are created and managed projects with animals, besides the legal responsibilities of those involved (ie, those who perform the procedures with animals designing procedures and projects; caring for the animals that sacrifice). You can also include other relevant legislation.
Learning outcomes
:

This module will allow the trainee be able to:

1. Identify and describe the legislation and national and European guidelines governing the use of animals bred, supplied or used for scientific purposes, including teaching (hereinafter experimental animals) and, in particular, the activities of persons performing procedures animal scientists.

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

3. Describe the necessary authorization before acting as a user, breeder or supplier of experimental animals and, especially, the necessary authorization for the projects and, where appropriate, for people.

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

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

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 you can exercise this responsibility (p. Eg., By a body responsible for animal welfare locally).

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

9. Identify who is the principal responsible for animals undergoing procedures.

10. Knowing the kinds of species and their stages of development, within the scope of Directive 2010/63 / EU and Royal Decree 53/2013, of February 1, or other applicable regulations, both state and regional level.

11. Identify the circumstances in which animals under Directive 2010/63 / EU and Royal Decree 53/2013, of February 1, they should be killed or removed noninvasively study to receive veterinary treatment.

12. Describe the legislative controls the sacrifice of animals.

Ethics, animal welfare and the 'three Rs' level 1; Theoretical and practical; EU Document Module 2

Description:

This module provides guidance and information to enable people who work with animals identify, understand and respond appropriately to the ethical issues related to the welfare and raised by the use of animals in scientific procedures in general and, where appropriate within its own work program. It provides information to allow these people understand and apply the basic principles of the 'three Rs'.
Learning outcomes
:

This module will allow the trainee be able to:


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

2. Describe the responsibility of people to work with experimental animals and recognize the importance of adopting a respectful and humane to work with animals in research attitude.

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

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

5. Describe how legislation is based on an ethical framework that requires: 1) weigh the harms and benefits of projects (assessment of harms and benefits); 2) implement the 'three Rs' to minimize harm and maximize benefits; and 3) promote good practices in relation to animal welfare.

6. Describe and analyze the importance of the 'three Rs' as a guiding principle the use of experimental animals.

7. Describe the five freedoms and how they apply to species of experimental animals.

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

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

10. Describe the existing rules governing the re-use of animals.

11. Describe the importance of good animal welfare and its effect on the scientific findings, 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 the relevant sources of information related to ethics, animal welfare and the implementation of the 'three Rs'.

14. Knowing the different tools (p. Eg., Search guide EURL ECVAM, Go3Rs) and search methods (p. Eg., Systematic reviews, meta-analyzes).

Basic and adequate Biology, level 1; theoretical; EU Document Module 3.1

Description:

This module provides an introduction to the basic principles of animal behavior, care, biology and animal breeding. It incorporates information related to anatomy and physiological characteristics, including reproduction and behavior, as well as ordinary husbandry and enrichment practices. It not intended to offer more than the minimum necessary general information for anyone to start working under supervision.

Upon completion of this module, a supervised practical training shall provide each person the experience and skills necessary to perform their specific function. The practical training requirements vary, inevitably, depending on the function.
Learning outcomes
:

This module will allow the trainee be able to:

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

2. Recognize and describe life events that may cause suffering, including the supply, transport, housing, husbandry, handling and procedures (basic level).

3. Understand how a good welfare can foster good scientific practice, for example, how the lack of attention to the biological and behavioral needs can affect the outcome of the proceedings.

4. Understanding how the husbandry and care can influence the outcome of experiments and the number of animals required, for example, when the place of the room influences the outcome and therefore at randomization.

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

6. Describe the importance of providing (suitable for both the species for science) enriched environment including social housing and opportunities for exercise, rest and sleep.

7. Where appropriate for the species, recognize that there are different strains and that these may have different characteristics that can affect both the welfare and science.

8. Where appropriate for the species, recognize that alterations in the genome can affect the phenotype of unexpected and subtle forms, as well as the importance of monitoring these animals with special care.


9. Maintain and interpret accurate and complete records kept in the facility, including animal welfare.

Care, health and animal management, level 1; theoretical; EU Document Module 4

Description:

This module provides information about various aspects of health, care and handling of animals, including environmental controls, husbandry practices, diet, health and disease. It also includes basic learning outcomes related to the health of people and zoonoses.
Learning outcomes
:

This module will allow the trainee be able to:

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

2. Describe the environmental and suitable for experimental animals housing conditions, how conditions are monitored and how the consequences for animal generated by a poor environmental conditions are identified.

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

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

5. Describe how the animal facility is organized to maintain a state suitable for these scientific procedures and health.

6. Describe how to provide water and proper diet to experimental animals, including supply, storage and presentation of adequate food and water.

7. Knowing existing methods and demonstrate an understanding of manipulation, sexing and adequate, safe and bloodless one or more specific species for common scientific procedures containment.

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

9. Knowing the list of possible risk of disease in the animal facility, including specific predisposing factors that may be relevant. Designate the methods available to maintain adequate health status (including the use of barriers, different levels of containment, use of sentinels, as appropriate to the species).

10. Describe appropriate breeding programs.

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

12. Knowing the existing correct procedures to ensure the health, welfare and care of animals during transport.

13. Knowing the list of possible health risks of people associated with contact with animals (eg, allergies, injuries, infections and zoonoses) and how they can be prevented.

Recognition of pain, suffering and emotional distress; Theoretical and practical; EU Document Module 5

Description:

This module prepares people to be able to identify the condition and normal behaviors of experimental animals, and to allow them to differentiate a normal one that shows signs of pain, suffering or distress that could be an animal the result of factors such as environment, animal husbandry or effect of the protocols of the experiments. It will also provide information on the severity classifications, the cumulative severity and use of non-lethal endpoints.
Learning outcomes
:

This module will allow the trainee be able to:

1. Recognize the behavior and normal or desirable 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 welfare and principles of how to treat pain, suffering or distress.

3. Analyze the factors to be taken into consideration and methods available to assess and record the welfare of animals (p. Eg., Score sheets).

4. Describe what a bloodless end point. Identify the criteria to be used to determine endpoints bloodless. Define the measures to be taken when a bloodless end point is reached and consider possible options to refine the methods and get reached before the end point.


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

6. Describe the circumstances that may be necessary anesthesia or analgesia to minimize pain, suffering, distress or lasting harm.

Non-lethal methods of killing, level 1; theoretical; EU 6.1 Document module

Description:

This module provides information about the principles of humane killing and the need at all times to someone who can sacrifice an animal quickly and bloodless if necessary. The module will include information and descriptions of the different methods available, details of the species for which these methods are suitable and information to help students compare permitted methods and determine how to select the most appropriate.
Learning outcomes
:

This module will allow the trainee be able to:

1. Describe the principles of bloodless sacrifice (p. Eg., What constitutes a "good death").

2. Describe the different methods by which it is permitted to sacrifice to specific animals and the influence that different methods may have on scientific results and how to select the most appropriate.

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

C.2) Function modules.

Ethics, animal welfare and the 'three Rs' level 2; Theoretical and practical; Document module 9 EU

Description:

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

The purpose of this module is to address the issue of people who design these procedures must have a greater and deeper understanding of general issues of animal research. Therefore, the main difference between modules of Level 1 and Level 2 on "Ethics, animal welfare and the 'three Rs'' does not necessarily reside in the topics (which have not been repeated here), but rather some of them are treated in more detail and more is expected of each learning outcome. For example, at level 1 there are elements that students must know and be able to describe, and at level 2 you need to know in greater depth and to discuss them. This module also prepares students so they can keep up and continuously apply the 'three Rs' to work as new methods and approaches appear to evolve.

By their orientation and learning outcomes, this module is also suitable for people who perform the functions e) and f).
Learning outcomes
:

This module will allow the trainee be able to:

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

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

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

4. Knowing that the law requires that the justification of the work programs is assessed by weighting the possible adverse effects on the animals against the potential benefits and that damages the animals are minimized and profits are maximized.

5. Understand and provide the information necessary to enable the realization of a solid assessment of damages and the benefits and explain why, personally, believe that the potential benefits outweigh the possible adverse effects.

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


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

Basic and adequate Biology, level 2; practical; EU Document Module 3.2
Learning outcomes
:

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

Fundamentals of biology and animal physiology; theoretical

Description:

This module aims to enable staff in their training has not had the opportunity to acquire the necessary knowledge of the fundamentals of biology and animal physiology (with a deeper than the basic biology core approach) that required for d) the purchase function and allows it to perform other specific modules of this function and particularly the project design and procedures. The module should combine general knowledge with the peculiarities of the biology and physiology of the species involved.
Learning outcomes
:

This module will allow the trainee be able to:

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

2. Knowing the organizational and functional structure of the animal organism.

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

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

5. Think about what elements can affect animal welfare and how to prevent animals suffer pain, suffering, distress or lasting harm.

This module has no correspondence in the EU document.

Care, health and animal management, level 2; Theoretical and practical; Document module 23 EU

Description:

This module provides a more in-depth knowledge of the practices of animal care intended for those who take responsibility as responsible for the welfare and care of animals in a facility, function e), although it is also useful for who assume the role a).
Learning outcomes
:

This module will allow the trainee be able to:

A. Demonstrate a broad understanding of how the welfare of animals kept in the animal:

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

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

3. Knowing how environmental enrichment is achieved.

4. Understanding how the 'three Rs' contribute to the constant improvement of welfare and husbandry practices and enrichment.

B. Knowing suitable for experimental animals and how to monitor them environmental conditions:

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

6. Using environmental measurement equipment, reading charts, curves and tables generated by environmental monitoring equipment and assess potential problems.

C. Understand how the organization of the animal facility maintains a state suitable for these scientific procedures and health:

7. Describe routines and housing conditions suitable for scientific reasons hosted by different animals.

8. Understand how routines and housing conditions may change depending on specific conditions.

9. Evaluate the use of barriers in controlling health status of the animals.

D. Identify potential risks of disease in the animal facility:

10. Describe a program of appropriate health examination for the animals to be caring.

11. Analyze possible sources of disease in the animal facility.

12. Examples of parasites recognize experimental animals.

13. Describe the life cycle of some common disease-causing organisms in experimental animals.

E. Evaluate methods to minimize the risks of possible pathogens:

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


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

F. Devise programs suitable for experimental animals depending on specific conditions breeding:

16. Summarize the basic data of animal husbandry common experimentation.

17. Describe in detail suitable breeding programs for specific species under specific conditions.

18. Select a "stock" suitable for future breeding.

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

19. Knowing the list of methods to determine the zeal, matching and confirmation of pregnancy in experimental animals and evaluating their effectiveness.

H. Analyze reproductive indices:

20. Analyze the chips and reproductive data to describe the reproductive outcomes of a player group.

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

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

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

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

24. Describe methods of producing genetically modified animals.

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

25. Identify key legislation governing the transport of animals.

26. Describe procedures, equipment, legal responsibilities and people responsible for transporting animals.

27. Describe how standards relating to the health and welfare of the animals are kept during transport.

K. correctly apply the legislation governing the use of experimental animals:

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

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

Non-lethal methods of killing, level 2; practical; EU Document Module 6.2

Description:

This module provides practical training to reflect information and principles taught in the module non-lethal methods of killing (level 1) and involves practical training in appropriate methods for the species and for the confirmation of death.
Learning outcomes
:

This module will allow the trainee be able to:

1. Perform competently and bloodless way, euthanasia using appropriate animal species relevant experimental techniques.

2. Demonstrate competence to confirm death and what treatment or disposal method must undergo the bodies.

Minimally invasive procedures without anesthesia, level 1; theoretical; EU Document Module 7

Description:

This module provides an introduction to the theory of minor procedures. It provides information about proper methods of handling and restraint and describes suitable for injection techniques, dosing and obtaining relevant samples for each species. It should provide enough information for staff understand what is expected of them before they receive training in the practical aspects of these skills while under supervision.
Learning outcomes
:

This module will allow the trainee be able to:

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

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

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

4. Describe techniques and procedures, for example, injection techniques, sampling and dosing (channels, volumes, frequency), diet modification, forced feeding, biopsy tissue, behavioral testing or use of metabolic cages.

5. Describe how to make minor technical and relate appropriate volumes of samples with frequencies of sampling for each species.


6. Describe the need for rigor and consistency when carrying out scientific procedures and to record and properly handle the samples.

7. Describe proper methods for assessing animal welfare with respect to the severity of the procedures and know what action to take.

8. Recognize that refinement is an ongoing process and know where to find relevant and updated information.

9. Describe the biological consequences of transport, acclimatization, zootechnical and experimental procedures in the species concerned and describe how they can be minimized.

Minimally invasive procedures without anesthesia, level 2; practical; EU Document Module 8

Description:

This module provides practical training elements relevant to the previous module. Practical training for minor procedures can be taught through a variety of methods, using different tools available that are designed for this purpose (it is likely to include animal models or simulators and using cadavers). The module must be designed in such a way that allows the student to reach a skill level such that, when I started working under supervision, does not cause pain, suffering, distress or lasting harm to the animal.
Learning outcomes
:

This module will allow the trainee be able to:

1. Selecting and explaining the best methods for performing common procedures (such as obtaining blood samples and administering substances), including the route, volume and frequency, where applicable.

2. Demonstrate competence to manage and restrain the animal in the best position in relation to the art.

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

Anesthesia for minor procedures; Theoretical and practical; Document module 20 EU

Description:

This module provides guidance and information to people who, while working with animals, have to apply sedation or anesthesia of short duration for a short procedure and involving a level of mild pain.
Learning outcomes
:

This module will allow the trainee be able to:

1. Define sedation, local anesthesia and general.

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

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

4. Describe why and when you can use sedation or anesthesia to immobilize an animal.

5. Knowing all the factors to be taken into consideration in the assessment prior to anesthesia of animals: how to perform a basic health examination, how to consider the physiological and pathological state of the model with which it will work and how these they may influence the choice of anesthetic.

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

7. Describe the importance of minimizing stress before anesthesia to reduce the likelihood that this causes complications.

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

9. Describe and demonstrate the proper preparation, handling and maintenance of equipment suitable anesthetic for the relevant species.

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

11. Knowing all the factors indicating that an animal is anesthetized properly (stable and adequate depth) to make interventions and measures to be taken if a complication occurs. It will include basic techniques 'practical' and 'descriptive' monitoring of anesthesia, including an assessment of the proper reflexes for each species.

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


13. Demonstrate competence to understand the appropriate and safe practices with regard to the use, storage and disposal of anesthetics and analgesics work.

Advanced anesthesia for surgery or lengthy procedures; Theoretical and practical; Document module 21 EU

Description:

This module is related, although not exclusively, with the module "early surgery." "Surgical interventions" all those who are not defined as "minor interventions" in the preamble of the previous module will be considered. They are considered "prolonged" when the duration exceeds 15 minutes, which can be an additional or continuous doses (including anesthesia for a diagnostic imaging).

This module also addresses pain relief during painful procedures such as surgery by using 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 required to perform imaging by MRI, CT scan and other minimally invasive modalities of diagnostic imaging.

Due to the high variability of species and strains of experimental animals, as well as anesthetics, it will be necessary to consult a veterinarian to determine an appropriate anesthetic regimen.

If not used only in order to immobilize the animal, the need for an anesthetic procedures implies that intervention be painful if the animal is awake. In addition, you may have residual pain after animal recovery from anesthesia and analgesics should be used. Some of the drugs described herein mentioned both the module anesthesia in surgery.
Learning outcomes
:

This module will allow the trainee be able to:

1. Describe why and when you can use anesthesia, including relevant additional factors for prolonged anesthesia.

2. Describe the need and list the factors to be taken into consideration when making the assessment prior to anesthesia of animals, including acclimatization.

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

4. Understanding often used a variety of drugs for premedication, induction and maintenance of anesthesia in relevant laboratory species and identify where to get advice about the different drugs available and their use.

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

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

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

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

9. Knowing the set of factors to be taken into consideration when monitoring anesthesia, both with regard to the depth of anesthesia as physiological stability. Indicate how to determine that an animal receives anesthesia sufficient to perform painful procedures and what measures will be taken if an adverse event occurs depth.

10. Knowing the set of methods that can be used to help monitor of anesthesia (p. Eg., ECG, blood pressure, urine output, oxygen saturation, CO2) and how they can be monitored.

11. Monitor the depth of anesthesia and vital signs of the animals, using both clinical signs and electronic equipment, where applicable.

12. Describe and demonstrate the proper preparation, handling and maintenance of anesthesia monitoring equipment and suitable for the relevant species.

13. Demonstrate competence in maintaining and interpreting before and after induction of anesthesia records and while the animal is anesthetized, as well as the proper management of animal care.

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


15. Demonstrate that mechanical ventilation understood.

16. Describe methods to optimize recovery after anesthesia in order to ensure a quick recovery and no complications, as in the basic module but with additional methods, including analgesia and rehydration, in the case of animals subjected to prolonged anesthesia during surgery.

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

18. Assess how the choice of an anesthetic will determine the pace of recovery and describe how the length and quality of anesthesia determine this rate.

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

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

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

22. Demonstrate a sufficiently detailed understanding of analgesics to manage safely, including routes of administration and possible adverse effects.

23. Demonstrate competence to understand the appropriate and safe practices with regard to the use, storage and disposal of anesthetics and analgesics work.

Principles of surgery; Theoretical and practical; Document module 22 EU

Description:

This module covers the principles of pre-operative evaluation and care of animals, preparations for surgery (including preparation of equipment and aseptic technique) and the principles of a successful surgery. The module provides information about possible complications, postoperative care and monitoring, as well as detailed information about the process of healing. It also includes more practical aspects, such as the demonstration of the most commonly used instruments, and provides the opportunity for students to practice some of the practical aspects of the surgical technique, for example, suturing methods using not suitable animal models.
Learning outcomes
:

This module will allow the trainee be able to:

1. Describe the relevance and need for preoperative evaluation and, where appropriate, the conditioning of the animal.

2. Identify sources of reference for good surgical practice.

3. Describe the process of healing and tissue healing and relate this process with the importance of antisepsis and aseptic practices, the formation of the surgical wound, the principles of tissue manipulation and selection of a suitable surgical method.

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

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

6. Knowing the principles of successful surgery (p. Eg., Early Halstead) and indicate how to fulfill them.

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

8. Understanding the importance of good technique surgical approach, tissue handling and closure of 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 early postoperative care and monitoring.

13. Describe the planning of surgical interventions and debate skills required of all personnel involved in them.

14. Demonstrate proficiency in performing surgical techniques, including ablations and closing incisions and using appropriate methods for the corresponding tissue.

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

Design projects and procedures, level 1; Theoretical and practical; Document module 10 EU

Description:


This module is a prerequisite for people who will design projects (feature d), but also beneficial for scientists involved in some way in the design of procedures performed (function c). The module includes information about concepts of experimental design, possible causes and elimination of bias, statistical analysis and information about where to obtain necessary to help with the procedure, the design, planning and interpretation of the results experience.
Learning outcomes
:

This module will allow the trainee be able to:

1. Describe the concepts of fidelity and discrimination (p. Eg., As the address Russell, Burch and others).

2. Describe the concept of variability, its causes and methods to reduce it (uses and limitations of isogenic strains, outbred, genetically modified strains, origin, stress and the value of habituation, clinical or asymptomatic infections and basic biology).

3. Describe the possible sources of bias and ways to reduce it (p. Eg., 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 (pseudorreplicación).

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

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

7. Knowing the list of different types of designs of experiments [p. eg., completely randomized, randomized block, repeated measures (in the same subject), designs or factorial experiments Latin square].

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

Design projects and procedures, level 2; Theoretical and practical; Document module 11 EU

Description:

This module offers an appropriate level of understanding of the legal framework and regulatory national and international within which are created and managed the projects, and in which their legal responsibilities are framed.

The student must be able to identify, understand and respond appropriately to the ethical and related to the welfare posed by the use of animals in scientific procedures in general and, more specifically, within its own work program issues. These issues have already been addressed in the module Ethics, animal welfare and the 'three Rs' level 1

The student must be able to develop, manage and control a work program to achieve its stated objectives, and ensure compliance with the conditions of the regulations governing the project. The implementation of the "three Rs" throughout the work program is part of this process. Learning outcomes concerning the reduction have already been treated in the module Ethics, animal welfare and the 'three Rs' level 1
Learning outcomes
:

This module will allow the trainee be able to:

(A) Concerning the legal aspects:

1. Describe in detail the major components of the (national and regional) national legislation governing the scientific use of animals; in particular, explain the legal responsibilities of those designing procedures and projects (personnel d function) and those who have legal responsibilities under national law (p. eg., the person responsible for compliance, the veterinarian the staff who care for the animals or trainers).

2. Knowing the main purposes of international law and other relevant EU and associated guidelines affecting the welfare and use of animals. Part of this legislation Directive 2010/63 / EU, Royal Decree 53/2013, of February 1, and guidelines or standards for veterinary care, animal health, welfare, genetic modification, transport , quarantine, health and safety, 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 hypothesis, good design of experiments, experimental measurements and analysis of results. Provide examples of the consequences of failing to implement a sound scientific strategy.


4. Demonstrate that understands the need to accept the advice of experts and using appropriate statistical methods, to recognize the causes of biological variability and ensure consistency between experiments.

5. Understand the importance of being able to justify, both scientifically and ethically, the decision to use live animals, referring, for example, the choice of models, their origins, their estimated number and development stages. Describe the scientific, ethical and wellness-related influencing the choice of a particular animal or non-animal model factors.

6. Describe the situations in which it may be necessary to conduct pilot experiments.

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

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

9. Understand the importance of disseminating the results of studies, regardless of the result, and describe the main problems that must be reported to use live animals in research, p. eg., the ARRIVE guidelines.

(C) In connection with the implementation of the 'three Rs':

10. Demonstrate a thorough understanding of the principles of replacement, reduction and refinement, and how these principles ensure good scientific practice and proper animal welfare.

11. Understand the importance of literature searches and Internet and debate with peers and relevant professional organizations in identifying opportunities to apply each "erre".

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

13. Describe how different tools (p. Eg., Search guide EURL ECVAM, Go3Rs) and search methods (p. Eg., Systematic reviews, meta-analyzes) are used.

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

15. Identify, assess and minimize the limitations of animal welfare throughout his life (including adverse effects related to the origin, transport, housing, husbandry, handling, procedures and bloodless sacrifice); explain and provide examples of welfare assessment protocols.

16. Define and apply appropriate non-lethal endpoints; establish appropriate criteria for determining when it has reached the bloodless end point.

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

18. Define requirements and controls re-housing of animals; identify relevant resettlement guidelines.

(D) Regarding the responsibilities:

19. Understand the need to know the state and regional provisions concerning the management of project authorizations, for example, the procedures for requesting animals, standards of accommodation, removing animals, safe work practices and safety and the measures to be taken in the event of an unexpected problem arises related to any of these points.

Introduction to institutional organization (establishment); theoretical; Document module 50 EU

Description:

This module provides the necessary information about the structure of the establishment, the main functions and related tasks in addition to an assessment of how they contribute to animal welfare, good science, implementation of the 'three Rs' and the consolidation of the culture of care.
Learning outcomes
:

This module will allow the trainee be able to:

1. Understand how the scope and spirit of current legislation and other legislation and guidelines regarding the care and use of animals for scientific purposes on site.

2. Describe the local organization and their role within it.


3. Distinguish the roles, responsibilities and interactions of those who work in line with Directive 2010/63 / EU, the Royal Decree 53/2013, of February 1, (listed in Articles 14 and 15) or other applicable regulations in the institution .

4. Understanding the tasks of the body responsible for animal welfare and describe the function of each person time to help with these tasks.

5. Analyze how individual function may contribute to the development, implementation and dissemination of the 'three Rs' on site.

6. Understand the importance of adopting a proactive (and communication mechanisms) approach as a tool to promote the 'three Rs' care and culture.

Designated veterinarian; Theoretical and practical; Document module 24 EU

Description:

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

May be considered exempt formative elements depending on the individual analysis of both the educational background and experience and its shortcomings.

This module focuses on the basic principles for the veterinary management of animal health and welfare kept, bred or used for scientific purposes to ensure that the VD understands the role of the veterinarian in the environment of the research animals according to professional obligations.
Learning outcomes
:

This module will allow the trainee be able to:

(A) In relation to legislation:

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

2. Compare the roles, responsibilities and interactions of persons working under Royal Decree 53/2013, of February 1, in an establishment and explain the legal composition and function of the body responsible for animal welfare.

3. Describe RV function when direct prescription, ordering, storage, dispensing and disposal of medicines to those held in approved establishments and animals used in procedures.

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

5. Highlighting the legislative controls on the creation and use of genetically modified animals.

(B) Regarding ethics, animal welfare and the 'three Rs':

6. Defining the principles of the 'three Rs' and provide examples of the application of each in an establishment of breeders, suppliers and users; in particular, discuss pain relief and potentially lasting damage.

7. Justify the importance of good animal health and welfare (taking into account scientific findings and social or moral reasons) and 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 to enable the implementation of the 'three Rs'.

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

10. Understanding how you can contribute VD disclosure of information that will help to understand the ethical issues, proper animal welfare, good scientific practice and the application of the 'three Rs'.

11. Identify the criteria used to make an assessment of the damage and benefits and to apply them.

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

(C) Regarding care, health and animal management:

13. Relate the purposes of a routine to a vivarium with how to address the problems encountered inspection.

14. Highlight the necessary preparation for routine inspections.

15. Ask information that must be included in the records and reports for animal keepers and third parties.

16. Summarize basic principles of surveillance, prevention and treatment of diseases in experimental animals and the principles of monitoring programs of health, with information about relevant microorganisms that infect experimental animals, their classification, the possible impact on research and animal health, zoonotic potential, prevention, diagnosis, treatment and eradication, in addition to the clinical appearance, etiology and pathology of the common diseases in experimental animals.


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

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

19. Perform an overview of the principles of husbandry of experimental animals, highlighting the main points of the design and construction of cages and enclosures and the advantages and disadvantages of different types of systems.

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

21. Describe the different methods by which it is permitted to sacrifice to specific animals, the influence that different methods may have on scientific results and how to select the most appropriate.

22. Highlight the principles of hygiene, disinfection and sterilization that are applicable to the installation of experimental animals, including parameters affecting water quality, how to check that quality and how to interpret the results.

23. Demonstrate aware of the main dangers that can be found in an experimental animal facility and RV function when minimize risks.

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

25. Analyze the creation and use of genetically modified animals in research, including common types of genetically modified animals, common uses in research and the different ways to create and evaluate these animals, and how are designated according to international guidelines nomenclature.

(D) Regarding anesthesia, analgesia and surgery:

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

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

28. Describe the specific problems encountered in the experimental surgery and identify RV function in regard to it.

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

29. Define strategies for effective communication and explain how these strategies promote animal welfare and good science.

30. Reviewing opportunities to gather more information in medicine and veterinary science with experimental animals.
ANNEX II

Groups of animal species


1. Rodents.

2. Lagomorphs.

3. Carnivores.

4. Equines, 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 to which Article 20 refers

The training activities for continuing education to which Article 20 refers must be equivalent to at least the following number of training hours:

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.

For maintenance ordered several categories simultaneously at least be required to meet the requirements of the category that requires more hours.