- 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? For animal research in the EU, this threshold has been defined in Directive 2010/63. Is there justification for applications for exemptions from requirements in the Directive?
- Are there specific statements in the legislation concerning this type of research which must be attended to? Examples of these housing requirements, harm-benefit assessment and the use of genetically altered animals or micro-organisms (Norwegian GMO legislation).
- 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? In the case of non-laboratory animal research, a number of additional points will arise, such as the need for permits from park authorities, approval by land-owners, or informed consent from the owners of privately owned animals.
- 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? Has the EU Guidance on Project Evaluation and Retrospective Assessment been followed? There is also guidance available from the LASA Ethics & Training Group and guidance from the Irish authorities (HPRA) on filling out their Retrospective Assessment Report form.
Mark d'Alton, Designated Veterinarian at University College Dublin, has provided Norecopa with two related forms: an End of Study Report Form and an Unforeseen Events Report Form.
- Is there sufficient information available to complete an application form for permission to conduct the research?