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FDU’s ref.:
NORWEGIAN ANIMAL RESEARCH AUTHORITY
Forsøksdyrutvalget (FDU), P.O. Box 383, 2381 Brumunddal
Telephone / Telefax: 23 21 66 48 / 23 21 68 01
e-mail: postmottak@mattilsynet.no
http://www.fdu.no
APPLICATION FORM FOR PERMISSION TO CONDUCT
RESEARCH ON ANIMALS
Type of experiment/application:
New exp.
Pilot study
Continuance/modification
Block application
Field exp.
For use by person in charge of animal unit (ansvarshavende):
NB! Field experiment: State as accurately as possible, the location of the animal experiment.
Name of institution/location where the experiment will take place:
Animal unit’s no.:
Animal unit’s reference no.:
Name of person in charge of animal unit:
Address:
Tlf.:
Post code.:
Place:
Fax.:
E-mail:
Type of exp. (A-F):
Species and strain of
exp. animals*:
Are anaesthetics/
analgesics used?
Yes
No
No. of animals:
Have similar
Have similar exp.
experiments been
been performed by
performed at the unit? the applicant?
Start (month/year):
End (month/year):
No. of animals reused Is the application fully or
(Regulation § 15):
partly confidential?
Yes
No
Is the project leader’s competence in accordance
with existing legislation?
Yes
No
Yes
No
Yes
EC-statistics (including field experiments):
Tab. 1 (source): Tab. 2 (purpose): Tab. 3 (for 2.4):
No
Tab. 4 (disease): Tab. 5 (required by
law) :
* ID no. must be declared for dogs and cats:
Approved. Copy sent to Norwegian Animal Research Authority.
Rejected/forwarded to Norwegian Animal Research Authority for assessment. State the
reasons for the rejection.
Submitted to Norwegian Animal Research Authority for assessment. State the reason reasons
for the submission.
Date of approval:
Expiry of approval:
Signature of person in charge of animal unit:
Date sent FDU:
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For use by the applicant:
1. Information on the applicant (project leader).
Name and position:
Address at work place:
Education:
Experience with similar
experiments?:
Yes
No
Experience with the
selected species?:
Tlf.:
Fax.:
E-mail:
Completed course in laboratory animal science?:
Yes
No
Institution where the course
was completed:
Yes
No
Co-workers dealing with the animals
Name:
Position and education:
Course name:
Year completed:
Laboratory animal
science course?
Yes
No
Yes
No
Yes
No
Yes
No
Telephone no.:
2. Public access
Does the application include confidential information not suited for the general public (Freedom of
information act of 19 June 1970 No. 69)?
Yes
No
If yes, enclose a short explanation, and identify the confidential information.
3. General information
Title of the experiment:
Use two sentences to describe the experiment. The sentences will be made available to the general
public (annual reports, internet etc.):
Duration of the
experiment
(days/months):
Planned start
(month/year):
Planned end
(month/year):
Duration for each animal:
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4. Description of selected animals:
Species
Strain
Sex
Age/weight Number of animals needed
No. of animals for reuse, in accordance with the Regulations on animal experiments § 15:
Are any negative physiological changes to be expected as a result of the treatment/gene
modification (reproduction disorders, CNS symptoms, reduced immunity, alopecia)?
If any, which measures are to be taken to counter the expected effects of the physiological changes?
(Soaking of feed, feeding on the bottom of cages, euthanasia, wiping of eyes, reduced light
intensity, reduce/increase room temperature, special handling, etc.)
Gene modified animals:
Yes
No
Are the animals to be bred at the institution?
Yes
No
Date of notification to the Directorate of Health and Social Affairs
Date of notification to the Directorate of Nature Management
(transportation/relocation only)
5. Reasons for selected animal model:
Explain on what grounds you have selected the chosen animal model, in accordance with the
Regulations on animal experiments § 8 (species, line, special qualities, gene modifications):
6. Alternatives to animal experiments:
Always consider alternative, scientifically satisfactory, methods to the use of living animals. Give
an account for which alternatives exist and why you have rejected them. Concider the 3 Rs:
Replacement:
Refinement:
Reduction:
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Project protocol
7. Background and purpose
Give a short description, in commonly understood terms, of the background and purpose of the
experiment, and if any, state the hypothesis to be tested. State specifically procedures that are
required by law, or if the tests are demanded by public authorities.
8. Description of method
Preparation of the animals before the experiment (including identification method):
Treatment during the experiment (enclose drawing of any surgical interventions):
Parameters that are measured in the experiment:
Give a short description of the experimental groups and their controls:
Supervision during the experiment, emergency precautions:
Method of euthanasia:
Give criteria for humane endpoints (when will the animals be killed if they suffer more than
described under item 10):
9. Sedation, anaesthetics and analgesics
If the experiment is presumed to inflict pain, analgesics are normally to be used (according to the
Regulations on animal experiments §§ 8 & 14). In experiments requiring surgery, followed by
postoperative observation, give a detailed description of the postoperative pain control and
supervision. Approval of an experiment where the animals are inflicted with continuous or
considerable pain can only be given by the Norwegian Animal Research Authority.
Not relevant
Anaesthetics (substance, dose)
Analgesics (substance, dose)
Euthanasia (substance, dose)
Other medication (substance, dose).
If neuromuscular blocking agents are used, mention this in particular with a short justification.
Not relevant
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10. Pain and discomfort:
State the intensity of the maximum pain animals are expected to experience:
no pain
very mild
Duration of the pain:
seconds
minutes
mild
hours
moderate
days
strong‡
very strong‡
weeks
11. Number of animals used
Explain the reasoning behind the number of animals to be used. If there is uncertainty concerning
the number of animals needed, a pilot study must be carried out, according to the Regulation’s § 13.
(You are advised to seek assistance from a statistician, if you do not feel competent to do the
calculations yourself). Describe the experimental groups and the sizes of the groups.
Method used for calculating the group sizes:
Power analysis
Resource equation
Other methods, describe:
Not relevant, give a justification:
Deviations from this application must be reported to the person in charge of the animal unit
(ansvarshavende) or the National Animal Research Authority for approval. The National Animal
Research Authority must receive notification when the experiment is ended. For projects of long
duration, a short report on the current status must be delivered annually to the person in charge of the
animal unit or the National Animal Research Authority. The National Animal Research Authority is
primarily interested in information concerning animal welfare during the experiment and whether the
results can justify any discomfort to the animals.
Place and date:
The applicant’s signature:
Signature of project leader when other than applicant:
‡
The competent person cannot approve experiments in these categories.
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INFORMATION FROM THE NATIONAL ANIMAL RESEARCH AUTHORITY
Please read the following in order to avoid unnecessary delay in the application process!
The National Animal Research Authority’s (Forsøksdyrutvalget) is authorised to assess, approve and
control experiments using animals, in accordance with the Animal Welfare Act (dyrevernloven) and the
Regulation of animal experiments (forskrift om forsøk med dyr). Their mandate is to ensure that
experiments using animals is conducted in an acceptable way in regard to animal welfare.
General requirements for permission to experiment (in accordance with Regulation of animal
experimentation §8):




Experiments with animals may only be carried out for the acquisition of knowledge, taking
legitimate scientific or social considerations.
For experiments that may be assumed to cause pain, and where the goal of the experiment is such
that the use of anaesthesia or analgesic preparations is not possible, special demands on the
scientific or practical value of the experiment must be made.
Permission for the use of animals in experimentation must only be given if other scientifically
acceptable methods that do not require the use of animals are not possible in practice.
An applicant for an experiment that will use animals is required to document the alternative
methods that exist and to describe these in the application.
The National Animal Research Authority or the person approved to be in charge of the animal unit
(ansvarshavende) must receive the application form in due time, preferably three months before the
experiment is planned to start. The National Animal Research Authority meet once a month, except in the
month of July.
Assessments of the applications to conduct animal experiments are heavily based on the information
given in the application. Many applications to the National Animal research Authority are poorly or
incorrectly filled out, making assessment impossible. By filling out the form thoroughly, you will save
yourself and the National Animal Research Authority time and resources. Enclosed information and
references can support, but not replace essential facts to be given in the application.
Both specialists and laypeople are represented in the National Animal Research Authority. It is therefore
important that the content of the application is clear, concise and readable. Please use commonly
understandable words with the necessary professional terminology in brackets. Please use a computer or a
typewriter when filling in the application form.
The National Animal Research Authority’s members do not necessarily have previous knowledge on the
animals or techniques you want to use. It is therefore important to thoroughly describe all aspects of the
experiment where animals are subjected to discomfort, stress, pain or similar unpleasant experiences. You
are also asked to account for any risk that animals will encounter unpleasant experiences (in accordance
with the Animal Welfare Act § 2).
You can find the relevant legislation for animal experimentation, other relevant information and this
application form on the internet: http://www.fdu.no/
Please do not enclose this page with your application.