Regulations and Ethics in Animal Studies

Research using animal models is controlled from a legislative and regulatory perspective. The European and French texts have been regularly revised, giving increasing consideration to animal well-being.

The European and French legislation on animal studies is taken from Convention STE 123, drawn up by the Council of Europe in 1985. This convention aims to reduce the number of studies and animals used for scientific purposes. It encourages the development of alternative methods and recourse to animal models only when no other methods are available for the purposes of the study.

The first European directive regarding the protection of animals used for scientific purposes, adopted in 1986 (Directive 86/609), is a transcription of this convention. It was revised in 2010 (Directive 2010/63) and should be re-examined before the end of November 2017. This European directive was transposed into French law in 2013 (Decree 2013-118 associated with 5 implementing laws).

As a general rule, this regulation is based on the 3 R Principle, aiming for the reduction, elimination and improvement as far as possible in the use of animals in research.

Main themes of the regulation

Animal research is only lawful if "it is of strict necessity".
Scientists are "determined to limit the use of animals for experimental purposes (…) ultimately aiming to find an alternative for this use whenever possible".
This point is stated as from Convention STE 123.

Authorization of projects

All research projects involving the use of animals must receive authorization from the French Ministry of Research before they can begin. Authorization is granted for a maximum period of 5 years, providing the project has received a favorable opinion from the Ethics Committee at the institution in which it is to be conducted.

An authorized institution conforming to requirements

Any institutions which use animals for scientific purposes must have been granted authorization. This is granted by prefectorial decree, further to visits by veterinary inspectors from the Direction départementale de la cohésion sociale et de la protection des populations (DDPP or DDCSPP, departmental division for social cohesion and population protection). This authorization, valid for 6 years, is dependent on the French Ministry of Agriculture, and must be renewed upon written request. It is granted based on compliance with housing and operational standards defined by ministerial decree, aiming to ensure animal well-being. The same obligations must also be met for animal breeders or suppliers.

Additional authorization is required for the use of genetically modified animals. This specific authorization is issued by the French Ministry of Research.

Competent, trained personnel

All personnel who handle animals must be suitably qualified, and undergo training to maintain and update their skills. Continuing training lasting at least 3 days every 6 years is now required. Personnel who work with non-domestic animal species are further required to hold a certificate of proficiency in the upkeep and rearing of the species in question.

Justified choice of species, associated with the minimum number of animals

The European directive states that projects "should use the minimum number of animals that would provide reliable results and require the use of species with the lowest capacity to experience pain, suffering, distress or lasting harm that are optimal for extrapolation into target species". Furthermore, "Animals used or intended to be used in experimental procedures (…) must have been bred for this use, and originate from authorized breeders or suppliers".

Minimization of constraints

The constraints to which the animals are subjected during studies must be minimized as far as possible. This principle has been affirmed since Convention STE 123: "when choosing between procedures, those which (...) cause the least lasting harm, pain, suffering and distress, and liable to yield the most satisfactory results, should be selected".

Ethics in animal studies: a major concern

Inserm, CNRS, CEA and Inra increased animal protection by setting in place a national charter on ethics in animal studies (1992). Inter-organizational regional ethics committees were also created at the same time. Their role is to assess the compatibility between the proposed study protocols and ethical principles, to assist investigators in this process when the use of animals is inevitable. Initially optional, the ethical evaluation of projects by ethics committees in the field of animal studies became compulsory in 2013.

Ethics Committees in the field of animal studies

Ethics Committees on animal testing (Comités d’éthique en expérimentation animale CEEA) are recognized as the competent authority for the ethical evaluation of authorization applications for projects involving animal models. The CEEA comprise at least 5 members: a veterinary surgeon, a scientist, an investigator, an animal keeper, and a person from the social profession not involved in research activities. In 2016, 126 CEEA were authorized by the French Ministry of Research..