84260 - Ethics and Forensic Medicine

Learning outcomes

At the end of the course the student should know the principles of the ethics of biomedical research and the main ethical and medico-legal issues of research involving human subjects, with particular regard to information, consent and involvement of vulnerable subjects.

Course contents

Introduction to biomedical research ethics, historical overview, and main national and international sources.

Ethical requirements for clinical research: scientific and social value, methodological validity, fair selection of participants, risk-benefit ratio, independent review, informed consent, and respect for research participants.

Main ethical issues in research involving human participants: therapeutic misconception, involvement of minors, individuals lacking decision-making capacity, and other vulnerable populations, and research in emergency situations.

Ethical issues in randomised controlled trials: equipoise, randomisation, blinding, placebo use, and non-inferiority studies.

Informed consent: decision-making capacity, timing and procedures for obtaining consent, essential information, and the readability and comprehensibility of participant information sheets.

Overview of insurance, personal data processing, and the GDPR.

Digital health, artificial intelligence, and Patient and Public Involvement will be addressed throughout the course, with particular attention to the involvement of patients and members of the public in the design, conduct, and evaluation of research.

Eight hours will be devoted to laboratory activities involving the critical analysis of cases, documents, research protocols, participant information sheets, and informed consent forms.

Readings/Bibliography

Nuremberg Code.

Belmont Report.

Declaration of Helsinki.

Good Clinical Practice Guidelines – GCP.

Convention on Human Rights and Biomedicine – Oviedo Convention.

Council for International Organizations of Medical Sciences – CIOMS, International Ethical Guidelines for Health-related Research Involving Humans.

Emanuel E.J., Wendler D., Grady C., “What Makes Clinical Research Ethical?”, JAMA, 2000; 283(20):2701–2711. DOI: 10.1001/jama.283.20.2701.

Slides, documents, research protocols, case studies, participant information sheets, informed consent forms, and any additional materials made available by the lecturer on the VIRTUALE platform.

Teaching methods

Lectures

Presentation and discussion of case studies

Guided reading of ethical and regulatory documents

Analysis of scientific articles

Individual and small-group exercises

Critical analysis of research protocols, participant information sheets, and informed consent forms

Structured discussions of controversial issues

Laboratory activities are an integral part of the learning experience and enable students to apply theoretical content to documents and real-life situations. These activities also include exercises on the responsible use and critical evaluation of artificial intelligence tools.

Assessment methods

The exam consists of an individual 30-minute written test, comprising:

-5 multiple-choice questions, worth 2 points each for a correct answer and 0 points for an incorrect or unanswered question;

-2 restricted open-ended questions, requiring a total of 7 answers. Each correct answer is worth 2 points; incorrect or omitted answers are worth 0 points;

-1 extended open-ended question, worth up to a maximum of 7 points, assessed on the basis of:

• accuracy and completeness of the content;
• relevance to the question;
• ability to define and apply concepts;
• ability to provide appropriate examples;
• clarity of presentation;
• correct use of subject-specific terminology.

The score awarded for each question is indicated next to it. The maximum score is 31 points. The examination is passed with a minimum score of 18 points. A score of 31 corresponds to 30/30 with honours, while scores from 18 to 30 correspond to the respective mark expressed out of 30.

During the examination, the use of books, notes, electronic devices, or artificial intelligence tools is not permitted, except for accommodations authorised in advance for students with specific learning disabilities or disabilities.

Teaching tools

Video projector, PPT, VIRTUALE, ChatGPT.

Office hours

See the website of Francesca Ingravallo