In Sweden every experiment with laboratory animals must be approved by an regional ethics committee , i.e., an ethical permit is issued.
An ethical approval is required for studies on mammals, birds, reptiles, amphibians, fish and cyclostomes. Even experiments on embryos in the later part of development are covered. No approval is needed for ringing birds, nor feeding trials conducted on conventional livestock.
The Regional Ethics Committee should in principle decide if the value of the experiment is greater than the suffering animals can be exposed to, and experiments on animals are not allowed to be conducted if there is an equal good alternative (i.e., animal-free) to experiments on laboratory animals.
All ethical applications are preceded by a dialogue between the applicant, University veterinarian and named animal care and welfare officer (NACWO) within Umeå University's organization. The dialogue continue during the application procedure. When the application is completed and the content approved by the NACWO and University veterinarian, it can be sent to the Regional Ethics Committee.
Regional Ethics Committee
Sweden has six regional ethics committees (situated in Court of Appeal) in charge of weighing the benefits of the trials against animal suffering. The Regional Ethics Committees are responsible for the respective Swedish region, one of them is in Court of Appeal for Northern Norrland in Umeå.
The Regional Ethics Committee each have 14 members and meet about once a month. Each regional ethics committee is divided into several panels, which ensure that the applications are accurate, understandable and complete. This means that when the applications are on the table at the board meeting, most ambiguities should be resolved. This is one explanation for the fact that the refusals are so rare.
The Regional Ethics Committee decision is legally binding but may be appealed to the Central Ethics Committee. The Central Ethics Committee should also evaluate ex-post animal experiments.
Application procedure
The application procedure for ethical approval is executed, as of March 2023, on a new e-service at Jordbruksverket (website in Swedish) and must be written in Swedish.
The non-technical project summery should be written i Swedish and submitted through the EU e-service ALURES at Jordbruksverket.
To ease the application process, read our tips about the e-service and the application procedure available at our information site (only available for employees at Umeå University).
Start trials
The trials are not allowed to start before the Regional Ethics Committee have approved the experiments, signed an ethical permit and UCCB have gotten the decision in writing.
Evaluation of ex-post animal experiments
In accordance with the EU directive 20101/63/EU and § 21 fourth paragraph of the Animal Welfare Act (1988:534), certain experiments are evaluated in retrospect.
Evaluation should be performed on:
all experiments using primates
all procedures classified as severity "substantial" and
other experiments that the regional animal ethics committee has decided to evaluate.
If the Regional Ethics Committee decide that an ex-post evaluation should be performed it must be stated on the approved ethical permit.
The evaluation is conducted by the Central Ethics Committee.
To make amendments in approved ethical permit
There are two possible ways to make amendments in approved ethical permits
A. If the number of animals increase and/or the animal welfare is adversely affected
If the amendment result in increased numbers of animals or adversely affect the animal welfare the Regional Ethics Committee should handle the application. Contact the NACWO for tips.
B. If neither the animal number nor animal welfare are affected
If the amendment do not result in increased animal numbers nor affect the animal welfare the local Animal Welfare Body (AWB, or Djurskyddsorganet in Swedish) can approve the application provided that the changes/amendments:
does not run the risk of adversely affecting animal welfare
does not lead to an increase in number of experimental animals
does not affect the ability to achieve the purpose or goal of the experiment
does not adversely affect
a) the severity of the experiment,
b) experimental end or human end point,
c) time points of experimental set ups,
d) monitoring of the animals during the animal experiment, as well as
e) husbandry, maintenance or marking of animals that requires
an approval of the Regional Ethical Committee
Examples of changes that AWB may consider:
Change of administrative nature such as change of research leader (main applicant), change of manager and change of animal research facility
Change of anaesthetic drugs
Change of anaesthetic method if it causes less suffering or is equivalent to that approved in the basic condition
Changing the dosage if this does not lead to increased suffering, application for such a change requires documentation that substantiates the request.
Change of species within the same taxa (animal species) but for rodents you can not change to transgenic animals
The application should be written on a special form, the form and more information are found on our information site (only available for staff at Umeå University).
If the animal welfare body decides that the change of the ethical approval does not meet the conditions, the animal welfare body will reject the application.
If the animal welfare body rejects the application, the applicant can apply for amendments at the Regional Ethics Committee, see point A.
If you want to make an amendment, contact the NACWO for advise.
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