HPRA Guidelines - School of Natural Sciences Research Ethics
Animal (vertebrate) research:
The Health Products Regulatory Authority Guide to Practices outside the Scope of Scientific Animal Protection Legislation can be downloaded here. Please note the following text from that document which outlines research which does not fall under the scope of the legislation:
“When conducted in isolation, practices undertaken for a scientific or educational purpose which do not reach a threshold of pain, suffering, distress or lasting harm equivalent to or higher than that caused by the introduction of a needle according to Good Veterinary Practice do not fall within the scope of the legislation. Some examples include monitoring ECG with non-invasive techniques with minimal or no restraint of habituated animals and breeding genetically altered animals which are expected to have no clinically detectable adverse phenotype.
Annex VIII of the Directive provides other examples for procedures that do not fall within the scope of the legislation. It is important to note that a series or combination of ‘below threshold’ procedures together may have the effect of causing an animal pain, suffering, distress or lasting harm which is equal to or exceeds the threshold, and therefore would fall under the scope of the legislation. However this is reviewed on a case-by-case basis. Although not mentioned specifically in the legislation, the HPRA regards the following practices as outside the scope of the legislation and therefore does not require a project authorisation:
- The use of choice chamber tests and food-preference tests for animal behaviour studies.
The use of non-human vertebrate animals for food preference tests would also fall outside the scope of this legislation, provided the activity did not have the capacity of causing pain, suffering, distress or other lasting harm and that the animals concerned were not taken from the wild.
- The hatching of chicks from eggs kept in an incubator.
Although chicks are included as ‘animals’ under the legislation, the observation and monitoring of such animals (including hatching) while housed under conditions of good husbandry would be out of scope of the legislation as no procedure with the likelihood of causing pain, suffering, distress or lasting harm would be considered to have taken place. Again, care should be taken that animals are not handled in a way that is harmful to their development or causes them fear and anxiety. Chicks that are bred from genetically modified lines or where eggs are manipulated to introduce new genes fall within the scope of the legislation and require a project authorisation.
- The use of frog spawn in glass tanks to facilitate observational studies.
Some species of frogs (Xenopus laevis, Xenopus tropicalis, Rana temporaria and Rana pipiens) come under the scope of the legislation at the stage that the larvae become capable of independent feeding. However, the observation of spawning in a situation similar to a natural pond is considered to be out of scope of the legislation.
- The use of an aquarium or vivarium or small mammal cage in laboratories for direct observation of animal behaviour including species of fish, reptile, amphibia, arthropod or small mammal such as hamster. The observation and monitoring of fish in an aquarium or animals in small cages that are housed under natural conditions would not constitute a ‘procedure’ under the legislation and so would fall outside the scope of this legislation.“