B8779 - Bioethics and Biotechnology Law

Learning outcomes

Upon completion of the course, students will understand the regulations applicable to Animal Biotechnology and the use of animals in research, including authorization and oversight procedures. They will also understand the development of the modern scientific method, the principles of responsible research ethics, cost-benefit analysis tools applied to research projects, and the development of key bioethical theories and their practical application in various contexts, including experimentation on human and animal subjects, gene therapy, neuroethics, and euthanasia. They will be able to use legal terminology, issue compliance judgments, and manage authorization processes without risk to themselves or the organization. They will be able to guide professionals toward regulatory compliance in biotechnology and animal research projects.

Course contents

 

MODULE 1 – Giampaolo Peccolo

The program is structured as follows:

1) Fundamental legal principles

• Law, regulatory function, and administrative function
• Biotechnology in international law
• The European Union, sources of European law, and European policy in the sector
• Animals and their legal status in national and European law
• Crimes against animals in national criminal law
  

2) Legal aspects relating to the use of animals for scientific purposes and genetically modified organisms

• Regulation of animal testing
• Contained use
• Deliberate release
• Intellectual Property
• Environmental liability
• Cartagena Protocol on Biosafety

 

MODULE 2 – Luca Lorenzini

The program is structured as follows:

1. Introduction to the Scientific Method and Research Ethics – 2 hours

• The Scientific Method: Origin, Evolution, and Impact on Biomedical Research Research
• Ethics and Scientific Integrity: The Scientist's Responsibility

2. Normative and Applied Ethics – 3 hours

• Definition and comparison of normative (theoretical) ethics and applied ethics
• Ethical models: deontology, utilitarianism, virtue ethics
• Practical application of ethical models in scientific research

3. From Medical Ethics to Bioethics – 3 hours

• Historical evolution: from Clinical Ethics to modern Bioethics
• Critical themes: beginning and end of life, Personalized Medicine, Human Enhancement
• Bioethics as an Autonomous Discipline

4. Ethics of animal testing - 2 hours

• Ethical and scientific references to animal testing
• The principles of the 3Rs and the concept of animal welfare

5. Tools for ethical analysis and risk assessment - 3 hours

• How to design an ethically sustainable protocol
• Ethics Committees work and evaluation processes
• Precautionary principle and the lesser evil principle cost/benefit and harm/benefit assessment

6. Practical sessions and guided exercises - 3 hours

Readings/Bibliography

The course materials are available on the Virtuale platform (https://virtuale.unibo.it/).

Required readings:

• G. Peccolo, Nozioni Giuridiche Fondamentali, CLEUP editore
• art. 544 bis e art. 544 ter del Codice Penale
• decreto legislativo 4 marzo 2014, n. 26
• decreto legislativo 12 aprile 2001, n. 206
• decreto legislativo 8 luglio 2003, n. 224
• legge 22 febbraio 2006, n. 78

Further bibliography:

• Magni, S. F. (2011). Bioetica. Roma: Carocci.
• Reichlin, M. (2021). Fondamenti di bioetica. Bologna: Il Mulino
• De Mori, B. (2013). Che cos’è la bioetica animale. Roma: Carocci (collana “Bussole”).)
• Pollo, S. (2016). Umani e animali: questioni di etica. Roma: Carocci.
• DeGrazia, D., & Beauchamp, T. L. (2020). Principles of Animal Research Ethics. New York: Oxford University Press.
• Singer, P. (2024). Nuova liberazione animale. Milano: Il Saggiatore.

Teaching methods

Courses consist of theoretical lessons, and group work for case study solutions

Assessment methods

The learning assessment consists of an oral exam, consisting of two questions on each of the two modules that comprise the course. The grade will be the average of the respective scores.

In their assessments, teachers will use the following learning assessment scale:

• Knowledge of a very limited number of topics covered in the course and analytical skills that emerge only with the instructor's assistance, using generally correct language → 18-22;
• Knowledge of a limited number of topics covered in the course and independent analytical skills only on purely executive questions, using correct language → 23-26;
• Knowledge of a large number of topics covered in the course, ability to make independent critical analysis choices, mastery of specific terminology → 27-29;
• Essentially comprehensive knowledge of the topics covered in the course, ability to make independent critical analysis and connection choices, full mastery of specific terminology, and ability for argumentation and self-reflection → 30-30L.

The oral exam grade will be communicated at the end of the interview.

A minimum score of 18/30 is considered a pass. A negative grade does not result in a grade, but only a judgment (withdrawn or rejected) recorded on the electronic transcript compiled on AlmaEsami. Therefore, it does not affect the student's academic career.

The student may reject the grade by notifying the recording instructor via email within 5 working days.

The recording teacher for this course is Professor Giampaolo Peccolo.

Students can register for exam sessions through AlmaEsami (http://almaesami.unibo.it/). Exam sessions are offered within the timeframes indicated in the academic calendar. Students are advised to always contact their teachers via email to find out about any additional exam sessions that may be available.

Students with DSA or temporary or permanent disabilities: please contact the relevant University office promptly. They will be responsible for suggesting any adjustments to the affected students. These adjustments must be submitted to the teacher for approval 15 days in advance, who will evaluate their suitability, also taking into account the course's learning objectives.

 

Teaching tools

PowerPoint presentations, regulatory acts, scientific articles, and guidelines.

If students have difficulty understanding contents, teachers are available to meet with them for a clarification meeting, which can be requested via email. (see teachers' websites)

Office hours

See the website of Giampaolo Peccolo

See the website of Luca Lorenzini