Opinions and Recommendations
Improving the assessment of projects using animals for scientific purposes
Recalling that:
– The use of animals for scientific purposes is regulated by the Rural and Maritime Fishing Code ‘Section 6: Use of live animals for scientific purposes (Articles R214-87 to R214-137)’.
– The terms of the ethical evaluation are set out by a joint decree of ministers of agriculture and research and minister of defense (decree of February 1, 2013 relating to the ethical evaluation and authorization of projects involving the use of animals in experimental procedures and their annexes, amended by decree of September 1, 2021).
– The protection of animals used for scientific purposes is a permanent and major concern for research teams.
Noting that:
– Despite considerable progress in in vitro and ex vivo study methods, the use of animals for scientific purposes remains essential in many areas of research, for the protection of human, animal and environmental health,
– There are currently 89 animal experimentation ethics committees (CEEAs) in France that, in 2023 processed 2965 project authorization requests (DAP), 93.6% of which resulting in a favorable opinion.
– The steps leading from the submission of a project by a designer to its examination by a CEEA, then to its possible authorization by the Ministry of Higher Education and Research (MESR) follow a heterogeneous flow of exchanges between CEEAs and often result in a total duration much longer than the 8-week deadline imposed by the regulations (in fact, 42% of opinions were issued beyond the formal cut-off date in 2023).
Considering that:
– The mission of the CEEAs is, in accordance with the National Charter on the ethics of animal experimentation, to conduct an applied ethical approach (and not a normative one, which would consist in creating ethical rules) based on the ‘3R’ rule (Replace, Reduce, Refine), animal welfare and environmental enrichment, themes on which ethics committees have acquired significant expertise (cf. report ‘National Annual Activity Report́ of the CEEAs, 2022/2023).
– The full benefits of scientific research are difficult to assess a priori. Beyond their intrinsic value, the results obtained contribute to a wider field and may serve as a breeding ground for a new area of research.
– The National Charter on the ethics of animal experimentation (French Rural Code R214-134) specifies that during the ethical evaluation of a project, the CEEA analyses the objective of the project in order to be able to assess the ethical acceptability of the model choice, the experimental procedures and the related methodology. It ensures that this objective has been evaluated, but it is not its task to evaluate it as such, a role that belongs to the scientific or educational committees of institutions1.
– It is important to avoid adding to the constraints, particularly administrative ones, that can be detrimental to the European and French research performance and competitiveness, if they do not contribute to improving animal protection.
Recommends:
1. To reiterate that these committees are not entitled to evaluate the scientific objectives of the projects submitted to them, this being the responsibility of the funding institutions and organizations scientific committees.
2. To simplify the project authorization application document by avoiding redundancy and shortening it.
3. To reiterate the prescriptive (and not normative) role of ethics committees in animal experimentation.
4. To encourage the use of benchmarks and guides to good practice during the ethical reviews for experimental procedures and assessments of degrees of seriousness. This requires centralizing and disseminating existing good practices guidelines and guides. These documents should also play an educational role and are important for harmonizing the assessments by the numerous CEEAs. These documents should also simplify/accelerate DAP assessments, by limiting exchanges between designers and CEEAS, if a procedure is carried out according to a recognized good practice reference system/guide.
5. To simplify and harmonize the practical organization of the authorization of project application assessment, in particular the exchanges between designers, User Establishments (UEs), CEEA, and MESR, thanks to an integrated tool allowing the entire process to be traced from the submission of the project by a designer to its authorization by the MESR, including evaluation by the CEEA. Such an organization would allow to monitor the duration of the entire process, which the law stipulates should not exceed 8 weeks. Harmonization of submission procedures will be possible by publishing the submission and management rules/procedures of project authorization applications on the MESR website. Such a system could reduce the administrative tasks incumbent on the CEEAs.
6. To increase exchanges between CEEAs and designers by multiple means (videoconferences or face-to-face meetings, exchange of documents, exchange platforms, etc.) to move from a submitter/jury logic to a collaborative spirit, respectful of each other’s expertise, allowing the improvement of experimental protocols for the benefit of animals and objectives of the research project.
7. To strengthen the visibility and actions of animal welfare management structures by involving more often experimenters and validating the skills of their members.
8. To create a national IT tool allowing a modern feedback accessible in particular to designers,
9. To clarify the retrospective evaluation circuit and its use to promote 3Rs.
10. To include designers and users (researchers, toxicologists, industrialists, etc.) and learned societies in constructive discussions when organizing changes to procedures related to the use of animals for scientific purposes.
11. To replace the term ‘animal experimentation ethics committees’ by ‘ethics and protection committees for animals used for scientific purposes’ in order to emphasize their important role in animal protection.
