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Ethics committees and project authorization

Ethic committees evaluate every research project that uses animals. The French Rural code sets the mission, structure and function of ethic committees. A favourable ethical evaluation is necessary to obtain authorization for the project to be carried out.

The mission of an ethic committee is to make an ethical evaluation that will be attached to the project authorizations.

 

The mission is defined by the structure and functioning of the committees in the articles R14-117 to 121 of the French rural code.

 

The committees are created at the establishment's suggestion and approved by the minister in charge of research.

To be approved a committee must:

- justify multidisciplinary competence
- respect the national chart
- dispose of sufficient funds

 

A committee must be composed of a minimum of five people with various competences, including a veterinarian. These people cannot participate in a deliberation in which they would have an interest, at the risk of invalidating the decision.

 

Each committee examines the project of one or several attached institutes regarding the following conditions:

- Project justifications (scientific, regulatory or educational)
- Justifications for the use of animals
- Conditions for the project’s realization

 

The conformity of the project to legal requirements of replacement, reduction and refinement are particularly verified. The necessity or interest in having a retrospective evaluation is examined.

 

The list of authorized national ethic committees is available on the Ministry’s website. On July 6th 2013, there were 114 authorized committees.

In France, ethic committees appeared more than 20 years ago at the suggestion of researchers because of the absence of any regulations caring for the application of ethical practices on animals.

 

The Grice (French group of interprofessional reflexion on ethics committees applied to animal research) is a team of Gircor created in 1991 to promote the development of ethics committees. In 1993 it adopted a chart and in 2000 established recommendations. Under its impulse many other committees were created.

 

The Grice wrote and published a Guide to ethical evaluation of studies on animals in 2009, describing in detail the principles and methods of ethical evaluation. This guide was sponsored by the Ministry of Higher Education and the Ministry of Agriculture and Fisheries. The national Committee of ethical reflexion on animal research made it a reference.

 

Since 2013 the French regulation demands a favourable ethical evaluation for each request for the authorization of a project using animals.

 

Members of the Grice, currently directed by Nicolas Dudoignon, researcher at Sanofi, continue their mission to promote ethic committees. They lead training courses for ethic committee members and draft documents with recommendations. The Grice is today in France the voice of ethics committees on animal research.


If you wish to contact the Grice, click here


To carry out a project using animals you need an authorization (article R214-122 of the rural code).

The conditions for submission are specified in an implementing order.

 

The authorization request is to be submitted by the project manager, together with a file that includes

                                 - The project proposal

                                 - A non-technical summery

                                 - information on:

                                                   - the justification for the project, the use of animals and the procedures

                                                   - the practice of reduction, replacement and refinement

                                                   - anaesthetics and analgesics

                                                   - endpoints

                                                   - statistics

                                                   - reuse

                                                   - the degree of gravity of the procedures (See Annex: classification)

                                                   - the eventual reuse of the animals

                                                   - the absence of repetition of the study

                                                   - the methods of execution

                                                   - the employees and the establishment's authorizations


A project can’t be authorized if it’s the object of a positive ethical evaluation that needs to be reviewed by the minister.

 

The authorizations are given for maximum 5 years. All substantial changes in the project require the submission of a new file.

 

Read more : Guide from the European Commission on project authorization and evaluation