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

Research ethics: national and supranational legislation and guidelines.

Ethical Issues of research involving human subjects: general questions and questions concerning randomized controlled trials.

Other medical-legal aspects

As part of the course, 8 hours of laboratory will be dedicated to the critical analysis of documents and of the ethical aspects of research protocols and to information for participation in the study.

Readings/Bibliography

Nuremberg Code

Declaration of Helsinki

Belmont Report

EU Guidelines of Good Clinical Practice (GCP)

Oviedo Convention

International Ethical Guidelines for Biomedical Research involving Human Subjects, Council for Intemational Organizations of Medical Sciences (CIOMS)

Other material provided by the teacher during the course. Edit

Teaching methods

Lectures, plenary discussions, work in small groups.

Assessment methods

The exam will be written and will consist of drafting an information sheet for participation in a study, the protocol of which will be provided at the end of the lessons. The papers must be delivered via Virtuale by the agreed deadlines. Papers that demonstrate the acquisition of the ethical principles of clinical trials and the formal and substantial elements necessary to adequately inform potential research participants will be positively evaluated.

Final grade grading:

Information sheets that present all the essential information, in graphic form and with a language that allows maximum readability and comprehensibility by potential participants → 30-30L.

Information sheets that present most of the essential information and good readability and comprehensibility → 27-29.

Information sheets that present most of the essential information with a fair readability and comprehensibility, with frequent use of pseudo-technical terms or unexplained technical terms → 24-26.

Information sheets that present part of the essential information with a low readability and comprehensibility, with frequent use of pseudo-technical terms or unexplained technical terms → 18-23.

Information sheets that present few of the essential information with a low readability and comprehensibility, with frequent use of pseudo-technical terms or unexplained technical terms → insufficient.

Teaching tools

Video projector, PPT.

Office hours

See the website of Francesca Ingravallo