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Legal aspects

Zebrafish in Biomedical Research – Animal Experimentation for the Benefit of Mankind

Zebrafish is an excellent biological model for scientific investigation of numerous human diseases. However, the use of Zebrafish as experimental model requires an authorisation of the local competent authorities. The authorisation has to cover any experimental treatment, that could potentially cause pain, suffering, or harm to the animals. Their use for the respective experimental purposes is subject to regulatory approval. No matter, if the animals will actually experience a burden. For instance, even a temporary singly housing (one animal per tank) of the schooling Zebrafish could induce isolation stress and is thus subject to authorisation. Any scientist, who wants to perform animal experiments and to prepare an application, has to make sure, that all parts of the respective project are in full compliance with the principles of the 3R. The 3R stand for Replacement, Reduction and Refinement.



The use of animals for experimental purposes is authorised in cases where no satisfactory substitute method exists. Otherwise alternative methods have to be applied (Replacement). The number of animals used in a project must be reduced to a minimum (Reduction) without however compromising the objectives of the project. Refinement requires the application of procedures that are least burdening for the animals. Practically it requires e.g. the application of an effective analgesia during painful procedures or singly housed Zebrafish should have visual contact with conspecifics in nearby tanks to reduce isolation stress.

Once these requirements have been considered, the investigators are ready to work on the actual application. Project-related: the project must be scientifically justified and the essential character and ethical defensibility demonstrated. After completion of the application, the competent animal welfare officer hast to evaluate it and deliver the application together with a written assessment to the authorities.


The competent authority reviews the application documents and examines the contents of the application. The competent authority is advised by the so called §15 commission, which consists of 6 members. Four of them are scientists with a comprehensive knowledge and experience in experimental medicine, while two members are delegated by animal welfare groups.

Each application is examined and evaluated intensely by the commission and members of the authority. In case of full agreement with the application, the authorisation will be given to the applicants. However, the authority can impose additional conditions as it seems necessary. Such as lower number of animals or less burdening procedures. In special cases an application can be rejected, if it does not meet the necessary requirements at all.

All individuals interacting with the animals and being involved in experimental procedures are noted namely in the application. They must have the appropriate training and practice while being observed by a supervisor during their practical work. The competent animal welfare officer usually accompanies the experimental processes on a regular basis.

Each step of the animal experiment must be recorded in detail, records must be available to members of the competent authorities, if required. At the end of a year the actual number of animals used for a certain project is given to the authorities. The actual burdening of the animals, compared to the evaluation in the written application, has to be re-examined.




Literature/Source: https://www.tierversuche-verstehen.de/genehmigungsverfahren/