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.

Personal data management according to the GDPR.

As part of the course, 8 hours of laboratory will be dedicated to the critical analysis 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 in the preparation of the information sheet for participation in a clinical trial (the protocol will be provided during the couse). Information sheets that demonstrates the acquisition of the ethical principles of clinical trials and of the formal and substantive elements necessary to adequately inform potential research participants will be positively evaluated. In particular, the information sheets that will present all the essential  information, in graphic form and with a language that allow maximum readability and comprehensibility by potential participants, will obtain the maximum vote. The poor overall readability and comprehensibility of the information as well as the presence of useless or redundant, incorrect or confusing information and the use of captivating techniques will be evaluated negatively, and therefore will result in a progressively lower evaluation.

Teaching tools

Video projector, PPT.

Office hours

See the website of Francesca Ingravallo