7  Legal & ethical considerations

There are many legal and ethical aspects to responsible preclinical research. This chapter lists important resources, in particular relating to the situation in Switzerland. We recommend consulting the relevant guidelines early, ideally in the planning phase of a project. Also, whenever possible, we recommend following any standard for transparency agreements and lab procedures. We suggest considering such frameworks as resources enshrining expert and societal consensus on responsible research.

7.1 Legislation

In Switzerland, the «dignity of living beings» has been enshrined in the Federal Constitution (Art. 120 para. 2) since 1992, and the «dignity of animals» in the Animal Welfare Act (Art. 1 in conjunction with Art. 3 let. a) since 2008. For more details, consult the regulatory framework summary by Swissuniversities.

Laws and ordinances

  • Animal Welfare Act (AniWA; 455)
    • Protects animal dignity and ensures animal welfare.
  • Ordinance on Animal Protection (TSchV/OPAn; 455.1)
    • Defines rules on animal handling, use, and housing.
    • Regulates how interventions are performed on animals (e.g., authorized and forbidden procedures, analgesia, housing infrastructure requirements).
  • Animal Experimentation Ordinance (AEO; 455.163)
    • Defines rules on laboratory animal breeding.
    • Regulates genetically modified animals.
    • Specifies requirements for laboratory animal breeding announcements and animal experimentation.
  • Animal Welfare Training Ordinance (AWTO; 455.109.1)
    • Defines the basic education needed for persons working with animals.
    • Establishes content and minimal duration of education and training courses.
    • Specifies requisite continuing education for persons working with animals.
  • Ordinance on Electronic Management of Animal Experiments (VerTi-V/O-SIGEXPA; 455.61)
    • Regulates the operation of the management information system for animal experimentation.
    • Covers reports, basic training, and continuing education certificates.
  • Containment Ordinance (ContainO 814.912)
    • Regulates “the handling of organisms, in particular genetically modified, pathogenic or alien organisms, in contained systems.”

7.2 Authorization of animal experiments in Switzerland

The AniWA stipulates that every animal experiment and the keeping of laboratory animals in Switzerland must be authorised.

A weighing of interests is carried out for each application. Applicants need to consider ethical as well as scientific aspects. The expected gain in knowledge is weighed against the burden on the animals to keep the number of animals as low as possible, to protect the animals from excessive stress and to define appropriate termination criteria. In addition, those conducting experiments are obliged to report the number of times they have used laboratory animals and to report on completed experiments.

The Ethics Committee for Animal Experimentation (ECAE) of the Swiss Academies has published an extensive guideline to help researchers carry out the weighing of interestes for any proposed animal experiment (2nd Edition from 2022).

7.3 Swiss Transparency Agreement on Animal Research (STAAR)

Swissuniversities has set up the STAAR Commission to improve communication and transparency regarding the use of animals in research. The signatory organizations agree to the following commitments):

  • We will be clear about how and why we use or support the use of animals in research,
  • We will enhance our communication with the public and the media about our involvement with research using animals,
  • We will be proactive in providing opportunities for the public to find out about our involvement with research using animals,
  • We will report on progress annually and share our experiences

The specific objectives of STAAR are defined each year (see STAAR standards).

7.4 Ethics

7.5 Good Laboratory Practices (GLP)

The goal of GLPs is to ensure quality of the process and conditions under which studies are planned, performed, monitored, recorded, archived and reported.

Animal tests carried out in accordance with GLP for chemicals, therapeutic products (human and animal), plant protection products and biocidal products in Switzerland are internationally recognised. This means that the tests do not have to be repeated for each country, thus unnecessary animal tests can be avoided (principle of reduction).

Other relevant GLP authorities are: