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Application for animal studies

Application to Mattilsynet for studies in animals

To do research in animals you must obtain permission from the animal experimentation administration (Forsøksdyrforvaltningen - FDF) in Norwegian Food Safety Authority (NFSA).

FOTS
Forsøksdyrforvaltningens tilsyns- og søknadssystem FOTS
Photo:
Aurora Brønstad

Main content

Permission for experiments on animals in reserach must be obtained from Mattilsynet.

Permission for experiments on animals

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

Administrative procedure of FOTS applications

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.

Application Fees

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)

Procedures that not need authorization from Mattilsynet

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

Breeding non-harmful phenotypes does not need authorization from Mattilsynet

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.

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

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

Fees

Mattilsynet has fixed fees for the application process.

The fees can be found on

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

Access to FOTS

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

General requirements for the application

  • 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 Public Summary (NTS)

The NTS shall be anonymous and shall not contain the names and addresses of the user or persons involved.

The NTS shall also not contain information subject to the duty of confidentiality under the Public Administration Act.

NTS should be easily understandable to the general public and should describe

  1. Purpose of the experiment
  2. Expected adverse effects on the animals
  3. Expected scientific or societal benefit
  4. How many and what animals to use
  5. How to meet the requirements for replacement, reduction and refinement

Non Technical Public Summary (NTS) will be published on Mattilsynets web page.

The Non-technical Summary is an important ay of Science Communication

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

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

Changes of an approved protocol

  • 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

Further questions

can be adressed to aurora.bronstad@uib.no

New regulations from 1 july 2015