Law requires institutes using animals for experimental and other scientific or educational purposes to set up an Animal Welfare Body (in particular, 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).

The Animal Welfare Body established at the University of Trento is made up of individuals 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 a Rector’s delegate. The body complies with the principles of replacement, reduction and refinement as required by directive 2010/63/EU.

Replacement principle: to ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure. 

Reduction principle: to ensure that the number of animals used in projects is reduced to a minimum without compromising the objectives of the project. 

Refinement principle: to ensure refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals.

The Animal Welfare Body carries out its functions as required by the above-mentioned legislative decree. Specifically, the task of the Animal Welfare Body is to present motivated technical, scientific and ethical opinions on research projects that use animals for scientific purposes and on any further developments. In order to draft its opinion, the Body assesses the following:

• the correct application of legislative decree no. 26/2014;
• the technical-scientific importance of the project;
• the obligations arising from European and International pharmacopoeias for the development and safety of pharmaceuticals, and from toxicological assays relating to chemical and natural substances;
• the possibility of replacing one or more procedures with alternative methods;
• the proper training and appropriateness of people in roles of responsibility within the project;
• an assessment of damages 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.

Opinion requests

All research projects that include animal experiments must receive an opinion from the Animal Welfare Body. To submit a research project to the Animal Welfare Body and obtain the necessary opinion to activate the experimentation, the Project Manager is required to respect the procedural rules adopted by the Animal Welfare Body and to use the forms that comply with the provisions of Legislative Decree no. 26 of 2014 and the information note of the Ministry of Health containing the operational directions for the fulfilment of the provisions of Regulation 2019/1010/EU and Decision (EU) 2020/569.