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Designing and conducting experiments on animals

Latest update: : 2020-04-15 17:20:51

1. Defining the activity

The mission of the person designing and carrying out experiments on animals is to set up experimental protocols to:

  • verifying scientific hypotheses
  • assess the possible side effects of new drugs, treatments or new products on humans in particular;
  • collect or examine cells, organs or body fluids to verify the health status of animal populations.

The person is also required to monitor the welfare of animals in the experimental centres and to ensure that the care given to them is properly practiced.

In some cases, she may also have to perform surgical procedures on animals.

Note that

Being a designer and director of animal experiments is not a profession in the strict sense of the word but an additional function that is part of a regulated profession.

Two degrees. Professional qualifications

a. National requirements

National legislation

The function of designer and director of animal experiments is reserved for holders:

  • a master's degree or an engineering degree that requires at least five years of graduate school;
  • a diploma or a designation that requires at least two years of graduate studies in a scientific field and which justify five years of professional experience under the direct responsibility of a person with a master's degree or a minimum engineering degree;
  • a C-level sanction to the European Federation of Laboratory Animal Sciences (FELASA) for nationals of a Member State of the European Union (EU) or party to the European Economic Area (EEA).

To go further Article 2 of the 1 February 2013 relating to the acquisition and validation of the skills of staff of user, breeder and suppliers of animals used for scientific purposes.

Training

As long as the person is justified by one of the above titles, he or she must undergo additional training to perform the role of designer and director of animal experiments. This training takes place within one year of taking the job and consists of a general module covering all species and specific modules covering one of the groups of species determined below:

  • rodents;
  • rent mammals;
  • carnivores;
  • Birds;
  • cold-blooded animals;
  • primates;
  • wildlife.

When the project he is working on involves surgical procedures, the designer and director of animal experiments will have to be trained on aspects of surgical propedeutics (pre- and post-operative care, aseptia, anesthesia and analgesia) during an adapted training of a minimum of 24 hours.

Note that

The designer and director of animal experiments with a title of surgeon, dental surgeon or veterinarian is exempt from this complementary module.

To go further Article 3 and annex to the 1 February 2013 relating to the acquisition and validation of the skills of staff of user, breeder and suppliers of animals used for scientific purposes.

Costs associated with qualification

The training leading to the activity of designer and director of experiments on animals pays off. For more information, it is advisable to get closer to the dispensing establishments.

b. EU or EEA nationals: for temporary or casual exercise (Free Service)

In order to perform the role of designer and director of animal experiments in France on a temporary or casual basis, the national of a Member State of the European Union (EU) or party to the agreement of the European Economic Area (EEA) must be defer to the regulations applicable to the profession practised as a principal.

If the person concerned has undergo been trained in the design and carrying out of animal experiments in his home state, he may, if necessary, apply for recognition in France if he fulfils the following two conditions:

  • justify by any means of following this training;
  • follow one module on French regulations and another on ethics in one of the establishments approved by the Ministry of Agriculture.

In the event that the national does not justify the follow-up of the specific training in his State of origin, he will have to follow the one given in France (see above "2. a. Training").

c. EU or EEA nationals: for a permanent exercise (Free Establishment)

In order to act as designer and director of animal experiments in France for a permanent exercise, the national of an EU or EEA Member State must refer to the regulations applicable to the profession practised as a principal.

If the person concerned has undergo been trained in the design and carrying out of animal experiments in his home state, he may, if necessary, apply for recognition in France if he fulfils the following two conditions:

  • justify by any means of following this training;
  • follow one module on French regulations and another on ethics in one of the establishments approved by the Ministry of Agriculture.

In the event that the national does not justify the follow-up of the specific training in his State of origin, he will have to follow the one given in France (see above "2. a. Training").

Three degrees. Conditions of honorability, ethical rules, ethics

a. Ethics

Anyone who designs and performs animal experiments has an obligation to abide by ethical rules, including the 3R rule, which includes:

  • Reducing the number of animals used for experimental purposes
  • refine the methodology applied and find solutions to reduce the suffering of animals by applying boundary points;
  • replace animal models.

b. Continuing vocational training

The designer and director of animal experiments is required to undergo a mandatory three-day continuing education every six years.

This training should enable him to update his knowledge and can be acquired during practical training or participation in seminars in the fields related to animal experimentation.

The follow-up of continuing education is justified by the possession of training certificates or, at a minimum, certificates of attendance at seminars recorded in a competency booklet including:

  • The title of the training;
  • The acquisition method
  • The date and duration of the training
  • validation date for the training.

To go further Articles 5 and 6 of the February 1, 2013 order.

v. Sanctions

Any user, breeder or supplier of animals for experimental purposes must be able to justify that its staff has followed the required regulatory and ongoing training.

In the event of non-compliance with this obligation during the accreditation visit by the department of agriculture accompanied by a veterinary inspector of the department, the head of the establishment and his untrained staff may be seen punish for a 4th class ticket up to 750 euros. It can also jeopardize the certification or renewal of the institution.

It's a four-degree one. Insurance

In the event of a liberal exercise, the person designing and carrying out experiments on animals is obliged to take out professional liability insurance.

On the other hand, if he practises as an employee, this insurance is only optional. In this case, it is up to the employer to take out such insurance for its employees for the acts carried out on occasion.

Five degrees. Qualification recognition procedures and formalities

a. Obligation to take training for EU or EEA nationals

A national of an EU or EEA state who has received training leading to the role of designer and developer of animal experiments in that state may apply for recognition in France provided they receive further training including a module on French regulations and ethics in one of the establishments approved by the Ministry of Agriculture.

b. Remedies

French assistance centre

The ENIC-NARIC Centre is the French centre for information on academic and professional recognition of diplomas.

Solvit

SOLVIT is a service provided by the National Administration of each EU member state or party to the EEA agreement. Its aim is to find a solution to a dispute between an EU national and the administration of another of these states. SOLVIT intervenes in particular in the recognition of professional qualifications.

Conditions

The person concerned can only use SOLVIT if he establishes:

  • that the public administration of one EU state has not respected its rights under EU law as a citizen or business of another EU state;
  • that it has not already initiated legal action (administrative action is not considered as such).

Procedure

The national must complete a online complaint form .

Once his file has been submitted, SOLVIT contacts him within a week to request, if necessary, additional information and to verify that the problem is within his competence.

Supporting documents

To enter SOLVIT, the national must communicate:

  • Full contact details
  • Detailed description of his problem
  • all the evidence in the file (for example, correspondence and decisions received from the relevant administrative authority).

Time

SOLVIT is committed to finding a solution within ten weeks of the day the case was taken over by the SOLVIT centre in the country in which the problem occurred.

Cost

Free.

Outcome of the procedure

At the end of the 10-week period, SOLVIT presents a solution:

  • If this solution resolves the dispute over the application of European law, the solution is accepted and the case is closed;
  • if there is no solution, the case is closed as unresolved and referred to the European Commission.

More information

SOLVIT in France: General Secretariat for European Affairs, 68 rue de Bellechasse, 75700 Paris ( official website ).