D0213 - FUNZIONI MINISTERIALI NELLA SPERIMENTAZIONE ANIMALE

Learning outcomes

"At the end of the course, the student will be familiar with and able to apply the ethical and regulatory principles governing the protection of animals used for scientific purposes, including the concepts of the 3Rs (Replacement, Reduction, Refinement) and the proper management of animals in animal facilities. The student will also be familiar with procedures for the handling, restraint, and care of animals, the main experimental techniques and methods of substance administration, as well as methods for recognizing pain, distress, and clinical signs of suffering. Finally, the student will acquire knowledge of humane methods of euthanasia and the criteria for ensuring animal welfare throughout all stages of experimental procedures, in compliance with regulatory requirements and good laboratory practices (Italian Legislative Decree 26/2014 and the relevant ministerial decree on training for carrying out functions a), b), c), and d) in the use of animals for scientific purposes).

Course contents

The course is organized in accordance with the Decree of the Italian Ministry of Health of 5 August 2021, which regulates the training of personnel performing the tasks and functions referred to in Article 23(2) of Legislative Decree No. 26 of 4 March 2014 on the protection of animals used for scientific purposes.

Each teaching module integrates one or more training modules established by the Decree of the Italian Ministry of Health of 5 August 2021. The correspondence between the course teaching modules and the ministerial training modules is reported below. For the purpose of accreditation for Functions a), b), c), and d), each teaching module includes all the learning objectives and minimum contents required by the Decree for the corresponding ministerial training modules.

The course provides training for rodents (mouse and rat), pigs, zebrafish, and other fish species.

MODULE 1 – Luca Lorenzini

Legislation and Ethics: 10 h

The programme integrates the contents of Modules 1 (National Legislation), 2 (Ethics, Animal Welfare and the 3Rs – Level 1), and 9 (Ethics, Animal Welfare and the 3Rs – Level 2) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes national and European legislation, the roles and responsibilities of personnel involved in animal experimentation, the Animal Welfare Body (OPBA), project authorization procedures, the principles of the 3Rs, harm-benefit analysis, the culture of care, alternative methods, and the ethical evaluation of research protocols.

MODULE 2 – Luciana Giardino

Design of Procedures and Projects: 9 h

The programme integrates the contents of Modules 10 (Design of Procedures and Projects – Level 1) and 11 (Design of Procedures and Projects – Level 2) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes the principles of experimental design, selection of the appropriate animal model, definition of experimental and humane endpoints, statistical aspects of experimental design, methodological quality and reproducibility, the ARRIVE Guidelines, and the integration of the principles of the 3Rs into experimental design.

MODULE 3 – Domenico Ventrella

Basic Biology, Animal Care, Health and Management: 9 h

The programme integrates the contents of Modules 3.1 (Species-specific Basic Biology) and 4 (Animal Care, Health and Management) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes comparative anatomy, physiology, and species-specific behaviour, the biological and ethological needs of the principal laboratory animal species, as well as the principles of housing, nutrition, environmental enrichment, health management, microbiological monitoring, biosecurity, and good laboratory animal facility practices.

MODULE 4 – Carlotta Lambertini

Basic Biology, Animal Care, Health and Management: 8 h

The programme integrates the contents of Module 3.2 (Species-specific Basic Biology – Practical Training) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes anatomical identification of the principal laboratory animal species, recognition of major anatomical landmarks, observation of normal and species-specific behaviour, clinical assessment of animals, and practical application of the principles of laboratory animal care and management.

MODULE 5 – Luciana Giardino

Management and Welfare of the Mouse Model: 4 h

The programme integrates the contents of Module 5 (Recognition of Pain, Suffering and Distress), Module 6.1 (Humane Methods of Killing – Theory), and Module 7 (Minimally Invasive Procedures without Anaesthesia – Theory) of the Decree of the Italian Ministry of Health of 5 August 2021, with specific reference to the mouse model.

It therefore includes recognition of pain, suffering, and distress, the use of clinical scoring systems, severity assessment, definition of humane endpoints, principles of humane killing, handling and restraint techniques, administration and sampling procedures, and refinement strategies applicable to laboratory mice.

MODULE 6 – Luca Lorenzini

Management and Welfare of the Mouse Model: 6 h

The programme integrates the contents of Module 6.2 (Humane Methods of Killing – Practical Skills) and Module 8 (Minimally Invasive Procedures without Anaesthesia – Practical Skills) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes practical training on rodent handling and restraint, individual identification techniques, administration and biological sampling procedures, application of humane methods of killing, confirmation of death, and assessment of technical competence.

MODULE 7 – Nicola Facchinello

Management of Zebrafish and Other Fish Models: 8 h

The programme integrates, for fish species, the contents of Modules 3.1 (Species-specific Basic Biology), 4 (Animal Care, Health and Management), 5 (Recognition of Pain, Suffering and Distress), 6.1 (Humane Methods of Killing – Theory), and 7 (Minimally Invasive Procedures without Anaesthesia – Theory) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes the biology and physiology of zebrafish and other fish models, husbandry and management, animal welfare assessment, recognition of pain, suffering, and distress, experimental procedures, humane methods of killing, and refinement strategies applicable to fish models.

MODULE 8 – Nicola Facchinello

Management of Zebrafish and Other Fish Models – Practical Training: 4 h

The programme integrates, for fish species, the contents of Module 3.2 (Species-specific Basic Biology – Practical Training), Module 6.2 (Humane Methods of Killing – Practical Skills), and Module 8 (Minimally Invasive Procedures without Anaesthesia – Practical Skills) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes practical training using models and simulators covering animal handling and restraint, anaesthesia techniques, administration and biological sampling procedures, humane methods of killing, confirmation of death, and assessment of the practical competences required for the use of zebrafish and other fish models.

MODULE 9 – Domenico Ventrella

Management and Use of the Pig Model in Preclinical Research: 4 h

The programme integrates, for the pig model, the contents of Modules 3.1 (Species-specific Basic Biology), 4 (Animal Care, Health and Management), 5 (Recognition of Pain, Suffering and Distress), 6.1 (Humane Methods of Killing – Theory), and 7 (Minimally Invasive Procedures without Anaesthesia – Theory) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes the biological and physiological characteristics of the pig model, animal care and welfare, recognition of pain, suffering, and distress, experimental procedures, humane methods of killing, and refinement strategies applicable to preclinical research involving pigs.

MODULE 10 – Carlotta Lambertini

Management and Use of the Pig Model in Preclinical Research – Practical Training: 6 h

The programme integrates, for the pig model, the contents of Module 3.2 (Species-specific Basic Biology – Practical Training), Module 6.2 (Humane Methods of Killing – Practical Skills), and Module 8 (Minimally Invasive Procedures without Anaesthesia – Practical Skills) of the Decree of the Italian Ministry of Health of 5 August 2021.

It therefore includes practical training using simulators on animal handling and restraint, training and habituation techniques, administration and biological sampling procedures, application of humane methods of killing, confirmation of death, and assessment of the practical competences required for the use of the pig model in preclinical research.

Readings/Bibliography

Course materials are available on the University of Bologna's Virtual Learning Environment (Virtuale) (https://virtuale.unibo.it/ ).

Required reading

• National Research Council. Guide for the Care and Use of Laboratory Animals. 8th ed. National Academies Press.

• Hubrecht R, Kirkwood J (Eds.). The UFAW Handbook on the Care and Management of Laboratory and Other Research Animals. 9th ed. Wiley-Blackwell.

• Fox JG, Suckow MA, Pritchett-Corning KR, Metcalf Pate K, Hankenson FC. Laboratory Animal Medicine. 4th ed. Elsevier, 2025.

Recommended reading

• FELASA. A Working Document on the Development of a Common Education and Training Framework to Fulfil the Requirements under the EU Directive 2010/63/EU. Federation of European Laboratory Animal Science Associations (latest available version).

• Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes.

• Italian Legislative Decree No. 26/2014 implementing Directive 2010/63/EU.

• Decree of the Italian Ministry of Health of 5 August 2021 concerning the training of personnel involved in the care and use of animals for scientific purposes.

• ARRIVE Guidelines 2.0: Updated Guidelines for Reporting Animal Research.

• PREPARE Guidelines: Planning Research and Experimental Procedures on Animals – Recommendations for Excellence.

Teaching methods

Teaching is delivered through face-to-face lectures supported by PowerPoint presentations. Whenever appropriate, lectures combine theoretical explanations with the discussion of practical examples, case studies, and real-life scenarios in the field of laboratory animal science, with the aim of promoting critical thinking and active student participation. Selected images, videos, and additional educational resources are used to illustrate species-specific handling techniques, housing systems, animal welfare assessment, and the main experimental procedures. Practical training activities are carried out, whenever possible, using simulators, training models, and other educational tools that enable students to acquire technical skills in accordance with the principles of the 3Rs (Replacement, Reduction and Refinement). Direct observation of animal procedures is included only where permitted by current legislation and in compliance with the provisions of the Italian Ministry of Health Decree of 5 August 2021. Course materials are made available through the University of Bologna's Virtual Learning Environment (Virtuale).

Assessment methods

The assessment consists of a written examination designed to evaluate the achievement of the course learning outcomes and the acquisition of the competences required by the Italian Ministry of Health Decree of 5 August 2021.

The examination consists of 72 multiple-choice questions, distributed across the 10 teaching modules in proportion to the number of teaching hours allocated to each module. Each question may have one or more correct answers.

The scoring system is as follows:

• Fully correct answer: 1 point;

• Partially correct answer: 0.5 points;

• Incorrect answer: 0 points;

• Blank answer: 0 points.

The time allowed for the examination is 90 minutes.

A minimum score of 43 out of 72 is required to pass the examination. In addition, students must achieve the minimum passing threshold in each teaching module, proportionate to the number of questions assigned to that module, in order to demonstrate adequate knowledge across all areas covered by the training programme.

The final grade is expressed on the Italian 30-point grading scale. Provided that the minimum passing threshold has been achieved in all teaching modules, the overall score obtained in the examination is converted into a mark out of 30 using a proportional scale, in which 43/72 corresponds to 18/30 and 72/72 corresponds to 30/30. The final grade and any rounding are determined by the Examination Board on the basis of the candidate's overall performance.

During the examination, the use of textbooks, notes, or electronic devices (including calculators, tablets, smartwatches, and computers) is not permitted unless explicitly authorised by the Examination Board.

The results of the written examination will be published within five working days on the University of Bologna's Virtual Learning Environment (Virtuale).

Teaching tools

Teaching activities make use of PowerPoint presentations, images, educational videos, and interactive in-class quizzes to assess learning and stimulate discussion of the main course topics. Scientific articles, legislative documents, and national and international guidelines are also used as supporting educational resources. Course materials, including the presentations used during lectures and additional learning resources, are made available through the University of Bologna's Virtual Learning Environment (Virtuale).

In case of difficulty understanding the course content, the instructor is available for clarification meetings, which must be scheduled in advance by email

Office hours

See the website of Luca Lorenzini

See the website of Luciana Giardino

See the website of Domenico Ventrella

See the website of Carlotta Lambertini

See the website of Luciana Giardino

See the website of Nicola Facchinello

See the website of Nicola Facchinello

See the website of Domenico Ventrella

See the website of Carlotta Lambertini