2-Legal issues

1. Does the project involve procedures at or above the threshold for a regulated procedure, or can these procedures be refined to bring them under the threshold, for example by refining methods of identification?
2. Are there specific statements in the legislation concerning this type of research which must be attended to?
3. Is the project also affected by other legislation, for example animal transport, the use of genetically altered animals, infectious agents, ionising radiation or carcinogens, and the treatment of hazardous waste?
4. Are there already local, national, regional or international guidance documents or ethical statements on the implementation and legal issues related to this type of research?

Dialogue with local competent persons and, if necessary, with the regulatory authorities, is an important part of this step, not least in order to allocate responsibility for attending to these issues.

Relevant resources

• EU legislation in animal research
• Norwegian legislation on animal research
• Guidance documents and regulatory advice from ASRU (Animals in Science Regulation Unit, UK). This includes
  • household products testing ban
  • guidance on the use of human material in animals
  • use, keeping alive and re-use
  • harm-benefit analysis
  • re-homing and setting free
  • working with animals taken from the wild
  • code of practice for the care and accommodation of animals
  • efficient breeding of genetically altered animals
  • severity classification of genetically altered animals
  • recording and reporting the actual severity of regulated procedures
  • process and standards for establishment full system audits
  • Standard genetically altered rodents protocols
  • standard genetically altered zebrafish protocols
  • guidance on the use of standard genetically altered animals protocols
  • guidance for project licence applications
• EARA working group on Non-Technical Summaries
• Writing non-technical summaries: a researcher's guide
• Meta-analysis of non-technical project summaries identifies research areas for 3R development (webinar, 25 October 2018)
• Checklists to support the assessment of welfare standards in overseas research
• Guidelines for the establishment and functioning of Animal Ethics Commitees (Institutional Animal Care and Use Committees) in Africa

This page was updated on 08 March 2024