Regulation on the Use of Animals in Research (Forskrift om bruk av dyr i forsøk)

Flashcards covering key definitions, roles, classification levels, and legal requirements from the Norwegian Regulation on the use of animals in research (FOR-2015-06-18-761).

Forsøksdyr (Experiment)

Any use of animals for scientific or educational purposes, or in medical activities, which may cause the animal pain, fear, permanent damage, or other suffering equivalent to or greater than the insertion of a needle according to good veterinary practice.

Replacement (Erstatning)

The principle that live animals shall not be used in experiments if the purpose can be achieved by replacing such use with alternative methods or test strategies.

Reduction (Reduksjon)

The principle that no more animals shall be used in an experiment than is necessary to achieve the specific purpose of the study.

Refinement (Forbedring)

What might happen? Optimise the experiment in terms of animal welfare. How can harm and suffering be minimized?

Forsøkssammendrag (Non-technical summary)

An anonymous summary, understandable to the general public, describing the experiment's purpose, expected harm to animals, scientific or social benefit, types/numbers of animals, and how the 3Rs are met.

Humane endepunkter (Humane endpoints)

Defined STOP-points. Endpoint in which action will be taken. This includes stopping an experiment if an animal experiences significant suffering or distress above the expected level, ensuring humane treatment throughout the research. These endpoints should be concise and clear guidelines that define when to intervene. There should not be question about the criteria for intervention to ensure the animals' welfare is prioritized. Death should not be the endpoint. Earlier endpoints should be utilized to minimise suffering. If death inevitable, it should be done as painfree as possibly ASAP to minimise suffering. As few animals as possible should die.
Must be measurable, quantifiable, Directional for adequate actions, BINDING.

Terminale forsøk (Non-recovery/Terminal experiments)

Experiments carried out entirely under general anesthesia where the animal is not intended to regain consciousness before being killed.

Eksamples: invasive surgery, drug testing, or toxicological studies that evaluate the effects of substances, where the animal is euthanized immediately after the procedure.

Mild (Mildly experiments)

Experiments likely to cause short-term mild pain, fear, or distress, or those with no significant impairment of the animals’ well-being or general condition. Keep in mind that the criteria for it to be defined as an animal experiment requires that animals experience some harm equal to at least the introduction of a needle.
EXAMPLES: Singular dose of substance, limited amount of blood samples, and substance is not thought to give any harmful effects. Biopsies, feeding diets that doesnt cover the animals dietary needs

Moderat (Moderate experiments)

Experiments likely to cause short-term moderate pain, fear, or distress, or long-term mild distress, or moderate impairment of general condition.
EXAMPLES: Repeated use of testsubstance that gives averse effect, surgical prosedures assosiated with pain, or reduced general condition.

Betydelige forsøk (Severely burdensome experiments)

Experiments likely to cause severe pain, fear, or distress, or long-term moderate distress, or severe impairment of the animals’ well-being or general condition.
Eksamples: Toxisitytesting resulting in death, testing of equipments that kan result in severe pain, fear or death.

Dyrevelferdsenhet (Animal Welfare Body)

A mandatory internal unit for breeders, intermediaries, and users that advises on welfare, the 3Rs, and establishes procedures for monitoring and reporting animal well-being.

Navngitt veterinær eller fiskehelsebiolog (Named veterinarian or fish health biologist)

An individual with specific knowledge in laboratory animal medicine who provides mandatory advice on the welfare and treatment of animals within the facility.

Feltforsøk (Field experiment)

An experiment conducted outside of approved premises, which can be approved for a maximum duration of $2$ years.

Vedlegg D (Annex D)

A specific list of species, including mice, rats, dogs, and cats, that must be specifically bred for research use unless a scientific exception is granted.

Pilotforsøk (Pilot study)

A small-scale experiment required if methods are previously unused or if the quantity of animals required is uncertain.

Gjenbruk (Reuse)

The use of an animal in a new experiment after it has already completed one, permitted only if previous actual distress was mild or moderate and the animal's health is fully restored.

Dyrejournal (Animal log)

A general record kept by facilities for at least $5$ years detailing animal origins, acquisition dates, deaths, and the types of experiments conducted.

Individuell journal (Individual log)

A mandatory life-long record for every dog, cat, and primate detailing identity, birth, veterinary history, and social behavior, kept for $3$ years after the animal's death.

Årsrapport (Annual report)

A statistical report users must submit to Mattilsynet by $1$ March each year containing data on animal use from the preceding calendar year.

Mattilsynet (Norwegian Food Safety Authority)

The government body responsible for supervising the regulation and granting approvals for personnel, facilities, and specific experimental protocols.

Forsøksansvarlig (Person responsible for the experiment)

The individual designated to ensure experiments are performed according to approval and that any unnecessary pain or distress is removed immediately.

Vedlegg C (Annex C)

The annex specifying permitted euthanasia methods, including physiological requirements to confirm death such as permanent cessation of circulation or destruction of the brain.

Tillatte avvlivningsmetoder

The methods of euthanasia should ensure that the animal is unconscious and should not wake up during the prosess.
To make sure that the animal is dead the following methods should be practised: Making sure sirculation has stopped, destructing of the brain, dislocation of the neck, excanguation, declear that rigor mortis has set in.

Which animals are protected by the legislation?

All vertabrates (virveldyr), cephalopods (blekksprut), decapoda (Tifotkrepser), as well as defined developemental stages of these species. Mammals: 3rd tirmester, birds/reptiles: 2/3rd of incubation, Larve: when they are independently feeding. “When senses apparatus is equivalent to the lvl in a matur animal

Re-use of animals

Generally not allowed to re-use animals that has been included in experiments before. However, it is allowed if the following is true: The severity of the previous procedures was mild or moderate, the animals general state of health and general well being is fully restored, the new experiment is classified as mild, moderate or non-recovery and it is in accordance with vet advice.