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 rontrolled trials.

Personal data management according to the GDPR.

As part of the course, 4 hours of laboratory will be dedicated to the critical analysis of the ethical aspects of research protocols and 4 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 drafting of the part dedicated to the ethical aspects of the protocols presented for the verification of the other courses of the IC and of the information sheets for participation in a study. At the beginning of the course, the exam sessions and the deadlines for the delivery of the written exam, which will be discussed on the day of the exam itself, will be communicated.

Written exames that demonstrates the acquisition of the ethical principles of clinical research and the formal and substantive elements necessary to adequately inform potential research participants will be positively evaluated. In particular, the papers presenting:

- for the part concerning the protocol: an adequate evaluation of the ethical aspects and all the information regarding the methods for obtaining informed consent;

- for information sheets: all essential information, in graphic form and in a language that allows maximum readability and comprehensibility by potential participants.

The inadequate treatment of the ethical aspects in the protocol and the poor overall readability and understanability  of the information as well as the presence of useless or redundant, incorrect or confusing information and the use of attractive 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