B0444 - Veterinary Bioethics and Quality Systems for Controlling the Reproducibility of Results

Learning outcomes

The aim of the course is to provide the basis for a discussion on ethical issues related to animal welfare, from the implications in the work of veterinarian and  researcher, to the ethical controversies that coexist with the technical advancements of science.
The second part will address the issues related to the reproducibility of the experimental data and how to deal with the problem, also through the quality management systems used in the drug development process and applicable to all research systems.

Course contents

We will develop the course in two modules.

Module 1: Veterinary bioethics and ethics of the responsible research

During the course, various topics will be addressed starting from how the modern scientific method has developed, the ethics of responsible research, issues related to animal welfare and animal experimentation, to the discussion on xenografts,the use of stem cells and to regenerative medicine, up to the theme of euthanasia as an ethical act of the veterinarian. The issue of science communication will also be addressed and the tools to carry out a cost / benefit and harm / benefit analysis will be provided. It will also address an interactive path on the construction of an experimental protocol, informed consent, and its ethical review process in the field of research with laboratory and non-laboratory animals.

Module 2: Quality management systems as a tool to guarantee rights and reproducibility of results
During this module, topics related to the management and organization system of the laboratories that operate for the production of data on the safety of chemical and medical products will be addressed. The issues of certifications and logical and technical paths will then be addressed to achieve certain standards of safety, quality and reproducibility of results.

Main contents of the two modules will be:

The scientific method: birth and evolution

Scientific fraud, economic and social costs

Research integrity and guidelines

Considerations on major issues such as:
Animal experimentation
Genetic signature of the patient and personalized medicine
Transplants and xenotransplants
Regenerative Medicine and Stem Cells

Tools for ethical analysis:
The precautionary principle
Ethics of animal welfare and research with animals
The design of the experimental protocols
The Ethics Committees: functioning and evaluation process of the experimental protocols

Quality management systems in a laboratory:
Concepts of Good Laboratory Practices
Concepts of Good Clinical Practices
Medication or medical device?

Readings/Bibliography

Reichlin M. Fondamenti di Bioetica. Ed. Il Mulino (2021)

Magni SF. Bioetica. Ed.Carocci (2011)

Songhorian S. Etica e scienze cognitive. Ed. Carocci (2020)

Rollin BE, DeMori B. Gli altri animali. Ed. Mimesis (2020)

Teaching methods

lectures and group exercises

Assessment methods

oral exam

Teaching tools

The teaching material presented will be available to the student

Office hours

See the website of Luca Lorenzini

See the website of Luciana Giardino