Module Details

Bioethics in pharmacological trials

MC031

Course
Bioethics in pharmacological trials
Code
MC031
Academic Year
2024/2025
Curriculum Year
2023/2024
Degree Programme
MEDICINE AND SURGERY
Curriculum
000 - CORSO GENERICO
Course coordinator
Credits
1
Lecture Hours
8
Scientific Disciplinary Sector (SSD)
BIO/14 - Pharmacology
Course Type
Single-subject learning activity
Course Delivery
OBB - Obbligatoria
Year
2
Teaching period
Primo Semestre
Campus
NOVARA
Teaching language
Italian
Course Contents
The module will tackle the following items:
1) The importance of research and of evidences to guarantee an appropriate care of patients;
2) Evolution of clinical trials with the perspective of bioethics;
3) Codes and laws that regulate clinical trials;

Bioethics: definitions and fundamental principles
Laws governing clinical research
Informed consent
The rights and the dignity of the ill
Peculiarities of the different Phases of clinical trials and of the different medical areas
Case-studies of ethical issues that have arisen in the last century of clinical trials
Big data and genetics: new challenges in designing ethical trials
Appropriate prescriptions and appropriate choice of medical interventions
Reference Texts
Slides and readings loaded on DIR
Learning Outcomes
Convey to students the need to increase knowledge via clinical trials;
give the student sufficient tools to evaluate the ethical nature of clinical trials with a multidisciplinary vision.
Prerequisites
none
Teaching Methods
Lectures.
Scientific papers concerning the diversity of clinical cases are also discussed and made available to the students.
Additional Information
Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities
Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.
Assessment Methods
Written exam with a single question on which to develop a short assay
Detailed Syllabus
Bioethics: definitions and fundamental principles
Laws governing clinical research
Informed consent
The rights and the dignity of the ill
Peculiarities of the different Phases of clinical trials and of the different medical areas
Case studies of ethical issues arisen in the last 100 years of clinical trials.
Appropriate prescriptions and appropriate choice of medical interventions.
Role of the ethical committee.
Ethic of using placebo
Expected Learning Outcomes
It is expected that students will be able to define the pillars that define an ethical clinical trial, that they will know the main characteristics of a clinica trial, and that they will be able to defend the necessity for experimentation for the progress of science. Furthermore, it is expected that thy will know some of the key clinical trials that brought to the public attention ethics dilemmas.
Last, it is expected that students will be able to read a clinical trial critically for ethical aspects.
Last update:09-09-2026 00:14:31