Organisation responsible for animal welfare

The Organisation responsible for animal welfare (OPBA), in accordance with Legislative Decree 26/2014, issues opinions on research projects involving the use of animals for scientific purposes.

In carrying out its activities, the OPBA pays particular attention to ensuring that the 3Rs principle – replacement (replacement), reduction (reduction) and refinement (refinement) – is applied in such experimental activities. In particular, the researcher must:

1. endeavour, to the greatest extent possible, to replace their animal model with an alternative model;
2. subsequently seek to reduce as far as possible the number of animals used in the experimental protocol;
3. and finally, carry out “refinement” – the process of refining, or improving, the experimental conditions to which the animals are subjected.

The project leader must submit a request for an opinion to the OPBA by completing the specific forms.

The project submitted to the OPBA must first be analysed and assessed by the OPBA’s statistics expert and the veterinary surgeon at the animal facility.

Each application must consist of:

• Form extracted from the Ministry’s website;
• Form Stab. 01 – Research project;
• Form Stab. 02 – Research project proposal;
• Form Stab. 03 – Non-technical summary;
• Form Stab. 04 – Declaration by the project leader confirming the absence of any final convictions for any of the offences referred to in Articles 544-bis and 544-ter and 727 of the Criminal Code, as well as those referred to in Articles 4 and 5 of Law No. 201 of 4 November 2010;
• A signed copy of the project manager’s identity card;
• Documentation, issued by the funding body and/or the home organisation, confirming that the project has been funded and demonstrating financial coverage for the entire duration of the research.
• Form Stab. 05 – Self-certification of training relating to the functions referred to in points (a), (b), (c) and (d) by means of a declaration in lieu of certification and/or an affidavit, made in accordance with Articles 46 and 47 of Presidential Decree No. 445 of 28 December 2000.

The OPBA will notify the project manager of its reasoned opinion and forward the application for authorisation to the Ministry of Health via the new web platform.

Furthermore, pursuant to Legislative Decree No. 26 of 4 March 2014, every Research Project Manager must carry out, by the date specified in the Ministerial authorisation, the final and/or interim assessment for all research projects involving the handling of laboratory animals for experimental purposes. To this end, Form Stab. 07 must be completed and a request made to the OPBA:

• for the opinion on the final and/or interim assessment;
• for an extension of the project in order to submit the assessment to the Ministry.

The OPBA will submit the final/interim assessment via the new web platform to the Ministry of Health.