Legislative Decree no. 26, of 4 March 2014, “Implementing directive 2010/63/EU on the protection of animals used for scientific purposes”, published in the Italian Official Journal on 14 March 2014, requires institutes using animals for experimental and other scientific/educational purposes to set up an “Animal-welfare body”.
The Animal-welfare body established at the University of Trento is made up of members responsible for the welfare of animals, veterinarians responsible for animal enclosures, an expert from the scientific community with deep knowledge of animal experimentation, an expert in bioethics, an expert in biostatistics, and the Rector’s delegate.
The Body for Animal Welfare carries out its functions as required by art. 26 of legislative decree no. 26/2014. Specifically, the task of the Body for Animal Welfare is to present motivated technical, scientific and ethical opinions on research projects that use animals for scientific purposes and on any further modification of the projects. Under the above mentioned art. 26, in order to draft its opinion, the Body for Animal Welfare assesses the following:
- the correct implementation of legislative decree no. 26/2014;
- the technical-scientific importance of the project;
- the requirements of European and international law; pharmacopoeias used for the development and safety of medicines; toxicology tests on natural and chemical substances;
- the replacement of one or more procedures, if possible, with alternative methods;
- the suitable training and appropriateness of people in roles of responsibility within the project;
- an assessment of damage and benefits.
In the specific case of projects that do not require the use of non-human primates to satisfy regulatory requirements with established methods and procedures classified as “non-recovery”, “mild”, “moderate”, the principle of consent by silence applies, as per art. 33 of legislative decree no. 26/2014. Research projects that require the use of animals can be carried out only once the Ministry has given its authorization, which will be granted under art. 31, paragraph 7, of the same legislative decree (within 40 working days from the day of receipt of the application).
Requesting an opinion
All research projects that include animal experimentation must obtain a positive opinion from the Body for Animal Welfare.
To submit projects to the Body for Animal Welfare and receive a positive opinion to carry out the experimentation, the Principal investigator has to respect the procedure adopted by the Body and use the appropriate forms as required by legislative decree no. 26/2014. All documents and forms are available in the Download box.
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