Ateneo - UPO

The course examines the legal and ethical framework governing the profession of Biologist in Italy. Topics covered include professional regulations (Law 396/1967, Presidential Decree 328/2001), the role of Regional and National Professional Orders (FNOB), the Code of Conduct, and legal/disciplinary responsibilities. Detailed attention will be given to sector-specific legislation (healthcare, laboratory diagnostics, environmental protection, food safety, and nutrition), data privacy (GDPR and Electronic Health Records FSE 2.0), social security and pension rules (ENPAB), and the biologist's role within the National Health Service (SSN).

No commercial textbooks are required. The essential study material consists of lecture notes, slides, and regulatory texts provided directly by the instructor via the University e-learning portal (DIR/Moodle).

The course aims to equip students with the theoretical and legal tools required to practice as a professional Biologist in compliance with current legislation and professional ethics, whether in private practice or as employees in public/private institutions. (4 ECTS = 32 hours of face-to-face lectures).

No formal prerequisites are required. A basic understanding of public institutions and the National Health Service structure is recommended.

The course consists of 32 hours of lectures supplemented by case study analysis (e.g. ethical disputes, legal liability, health data privacy) aimed at promoting active participation and critical thinking.

Students with disabilities, Specific Learning Disabilities (SLD/DSA), or Special Educational Needs (SEN) may request dedicated support and modifications for lectures and exams by contacting the University Disability Office (⁠[https://uniupo.it/it/servizi/servizi-studentesse-e-studenti-condizione-di-disabilità-e-dsa](https://uniupo.it/it/servizi/servizi-studentesse-e-studenti-condizione-di-disabilità-e-dsa)⁠) and informing the professor at the beginning of the course.

The final evaluation consists of an oral examination focusing on 3 main questions: professional law and ethics, sector regulations (health, environment, privacy), and freelancing/ENPAB pension system. Grading scale ranges from 18/30 (basic pass) to 30/30 cum laude (full mastery, critical analysis, and flawless legal-scientific terminology).

Module 1: Legal Framework and Professional Body (8 hours) — Law 396/1967, DPR 328/2001, state examination, and registration with the Order (FNOB).
Module 2: Ethics and Legal Responsibility (8 hours) — Code of conduct, professional secrecy, continuing medical education (CME), disciplinary procedures, and civil/criminal liability.
Module 3: Sectoral Legislation (10 hours) — Biologist's role in healthcare, food safety (HACCP), environmental regulation, GDPR, and Electronic Health Records (FSE 2.0).
Module 4: Social Security and Freelancing (6 hours) — Pension rules (ENPAB), opening a practice, VAT, and contract management.
Gender Dimension Integration: A dedicated section covers maternity/paternity support and equal opportunity policies for self-employed female biologists.

(Formulated according to the Dublin Descriptors )
Knowledge and understanding:
By the end of the course, students must demonstrate an in-depth knowledge of the regulatory framework governing the profession, ethical rules, professional secrecy obligations, and the social security and welfare protections managed by ENPAB.
Applying knowledge and understanding:
Students must be able to independently identify the correct laws and procedures applicable to various professional scenarios (e.g., setting up a private practice, managing data privacy and informed consent, reporting CME/ECM credits).
Making judgements:
Ability to evaluate and resolve ethical and regulatory dilemmas in biological practice, identifying potential criminal, civil, or disciplinary liabilities.
Communication skills:
Ability to present legal rules and ethical principles with appropriate, precise legal and healthcare terminology to both specialist and non-specialist audiences.
Learning skills:
Ability to independently locate and consult regulatory sources, ministerial circulars, and ethical updates issued by the Order of Biologists to ensure continuous professional development throughout their career.