Ethics of Medical Research

2019-2020

Course Objective

At the end of this course, the student will be able to:
• describe the (Dutch and European) regulations, policies, statutes, and
guidelines with regard to research integrity in general, and research
involving human subjects in particular;
• describe the methodological, legal, and moral issues regarding medical
research involving human and animal subjects;
• identify the ethical issues concerning scientific research in general;
• recognize the issues and problems regarding patient autonomy, and
informed consent;
• value the assessment of research protocols, in particular the
assessment of riskbenefit ratios, subsidiarity and medical progress;
• produce sound and valid reasoning on ethical issues regarding medical
scientific research;

Course Content

After giving an overview of the history of the ethics of medical
research and of the framework of the ethics of medical research, the
course tackles issues such as the methodological soundness and the
integrity of research. Since ethical reflection on, and regulation of
medical research involving human subjects cannot be left to the good
will of researchers, ethical principles and procedures have been
institutionalized in national and supranational laws and in non-legal
ethical codes. Given that a large part of medical research involves
human subjects, students are required to study the moral background,
principles and procedures of informed consent as well as the principles
related to the research protocol itself. The assessment of the balance
between the burdens and the benefits will be discussed. Furthermore,
students will learn hands-on how Institutional Review Boards operate,
and how effective the work of these committees is. The course will also
cover the ethical principles, rules and regulations of animal research
and the use of biobanks for scientific purposes.

Teaching Methods

(Guest) lectures, study of literature, assignments, group discussions,
presentations, analysing research protocols (in a group), writing a
paper.

Method of Assessment

Written exam (50%), paper (50%).

Entry Requirements

Bachelor in a health care related subject or a Bachelor in philosophy.

Literature

European Commission, Directorate-General for Research, Science, Economy
and Society (2010). European Textbook on Ethics in Research. Brussels,
Belgium: European Union.

Target Audience

Master students Philosophy, Bioethics and Health and Master students
Philosophy of Neuroscience; students from other health-related masters
(e.g. Health Sciences, Medicine, Psychology, Biomedical Sciences)
interested in medical research ethics.

Additional Information

Attendance of the face-to-face sessions is obligatory. A student can be
absent with a valid reason for a maximum of 5 lectures. When a student
is absent for more than 5 lectures, they will be excluded from the
course. If students miss more than 3 lectures they will have to hand in
an extra assignment.

General Information

Course Code W_MASP_PBH2
Credits 6 EC
Period P1
Course Level 500
Language of Tuition English
Faculty Faculty of Humanities
Course Coordinator prof. dr. L.M. Bouter
Examiner prof. dr. L.M. Bouter
Teaching Staff prof. dr. L.M. Bouter
dr. M.J.P.A. Janssens
K. Labib

Practical Information

You need to register for this course yourself

Last-minute registration is available for this course.

Teaching Methods Lecture
Target audiences

This course is also available as: