Application for animal studies

Applications must be sent electronically in FOTS

Applications submitted in FOTS will be reviewed within 40-55 working days after submission depending on the complexity of the project

All project participant involved in an animal experiments must complete an minimum training program according to the regulation.

You can read more about the training program here.

Below you find links to more useful information in preparing an application in FOTS

Submitted aplllications first to the local Person with Special Control Responsibility (PMSK) for quality check.

Experimental summaries must satisfy the requirements according to the regulation (see below), documentation of training is checked and the Animal Welfare Body give input on the 3Rs

Invoice address must be complete and include PM (UiB) or Merida number (for the Hospital)

Applications to the Food Safety Authority will be processed as quickly as possible and at the latest within 40 or 55 working days, depending on the complexity of the application.

The Norwegian Food Safety Authority has set fees for processing FOTS applications. The rates can be found at: https://lovdata.no/dokument/SF/forskrift/2004-02-13-406?q=mattilsynet%20gebyrer

Invoice address must be complete and include PM (UiB) or Merida number (for the Hospital)

There is no need to apply for permission for use of animals that are only euthanised (using methods in Appendix C) for collection of organs and tissues (§6) as long as the person resonsibility for killing is properly trained (Functions D)

This exemption (according to §6) only appies for the application in FOTS.

All other regulations, like demand to training, housing etc. also apply for these animals as long as they are alive.

Read more about procedures that are exempted from the demand of project authorisation "Hvilke forsøk må du ikke søke om?" at Mattilsynets webpage

The Norwegian Food Safety Authority regards marking by a Single Ear Biopsy NOT to be considered as a procedure that needs project authorization

Breeding a non-harmful phenotype ID-marked with a Single Ear Biopsy does not need authorization from Mattilsynet

To decide whether a phenotype is harmful or not you need to document phenotype for a certain number of animals of both sex, over a certain lifespan and for defined criteria.

We need 10 animals og eah sex from at least 2 different litters, and they must be observed for at least for 40 weeks.

•  Immune deficiency  is regarded as harmful phenotype. Breeding and holding of animals needs approval after application in FOTS

If the animals do not have a harmful phenotype after and evaluation by the clinical veterinarian, you can send a notification to the animal facility instead of an application in FOTS to Mattilsynet

1. Protocol to evaluate phenotype (download) – send to  vetpost@viv.uib.no
2. Notification to animal facility (download document) – send to the local PMSK

After submission in FOTS the application is sent to a local “Person med Særskilt Kontrollansvar” for a quality check of formal failure.

The animal welfare body also give input especially on animal welfare and 3R issues

Applications submitted in FOTS will be reviewed within 40-55 working days after submission depending on the complexity of the project

A new regulation on animal experiments went into force July 1 2015 – see news on new regulation.

More useful information for applicant is available here

Mattilsynet has fixed fees for the application process.

The fees can be found on

https://lovdata.no/dokument/SF/forskrift/2004-02-13-406

FOTS is the elcectronic platform for application for animal resrrach in Norway

When applying for access FOTS for reserach at faculty of medicine, UiB we need:

1. First name
2. Surname
3. Phone (work)
4. Phone (mobile)
5. E-mail address
6. Employment
7. What role should primarily be in the project (project manager, project participant)
8. Highest education
9. When and where you took courses in laboratory animal science (Course in animal experimentation, modules, Theoretical competence may e.g. be described as relevant course modules)
10. Previous experience with animal experiments
11. Animal species and procedures that you have practical experience (cf. § 24, 4th part and appendix E: described. E.g. techniques for injections, handling, anesthesia, surgery.)
12. Further education and updating: Continual further education and updating
13. Have you had access to FOTS earlier? Yes/No

Submit your application to FOTS here

• Applicants and staff and competence of all involved must be documented
• Project summary - according to the requirements of the regulations - see below
• Severity degree evaluation
• Compliance with 3R
• Harm-Benefit assessment
• How many and which animals to use

In addition, one must account for:

• Source of funding
• Scheduled start and end date
• Publicity
• Background and purpose of the experiment
• Rationale for choosing a certain animal model
• If applicable: animals have a different phenotype that affects their well-being
• Anesthesia, pain management and killing
• Calculation of number of animals (experimental groups and group sizes)

Method -  Preparation of the animals before intervention

• Interventions and procedures
• Recordings, observations and sampling
• Follow-up and monitoring
• Method of Sacrifice
• Criteria for human endpoints and measures to be implemented

Non-technical project summaries (NTS) of authorized projects provide information in layman’s terms on where, why and how animals are still being used.
NTS provides context beyond numbers for a better understanding of different scientific use areas and why animals cannot yet be fully replaced in these areas.
Non-technical project summaries will also serve to detect how the three Rs (Replacement, Reduction and Refinement) are applied in current scientific work.
The Non-technical Summary is an important ay of Science Communication

Nontechnical Public Summaries of project applications (“FOTS”) must meet the regulations of § 8 in the Regulation on the use of animals in research (Norw: "Forskrift om bruk av dyr i forsøk).

Project summary should be easily understandable to the public, shall be anonymous and do not contain names and addresses of the user or persons involved.

The project summary shall include:

1.Purpose of the study

2.Expected harm/severity for the animals

3.Expected benefit for science or society

4.How many and what kind of animals will be used (totally in this experiment)

5.How are compliance with the requirements for replacement, reduction and refinement safeguarded

• NTS shall not contain information that is subject to confidentiality obligation under the law on public administration (Forvatningsloven)
• NTS from Norway is published by Mattilsynets on Forsøksdyrsøknader | Mattilsynet
• The European commission will publish NTS on List of results (europa.eu)
• More information on New regulation on the use of animals in experimentation from July 1 2015 | The Laboratory Animal Facility | UiB

EU has made a series of short video explaining why Science Communication is so omportant that can be seen on

What is Science Communication? - The EU Guide to Science Communication - YouTube

• Application for amendments must be sent to the Norwegian Food Safety Authority via FOTS. Remember to update your project summary when you apply for change.
• Changes that do not adversely affect animal welfare are sent as a notification in FOTS

More about changes and admendments

can be adressed to aurora.bronstad@uib.no

What changes were caused by the new regulations