Course ObjectiveAt 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
• 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
Course ContentAfter 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
Method of AssessmentWritten exam (50%), paper (50%).
Entry RequirementsBachelor in a health care related subject or a Bachelor in philosophy.
LiteratureEuropean Commission, Directorate-General for Research, Science, Economy
and Society (2010). European Textbook on Ethics in Research. Brussels,
Belgium: European Union.
Target AudienceMaster 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 InformationAttendance 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.
|Language of Tuition||English|
|Faculty||Faculty of Humanities|
|Course Coordinator||prof. dr. L.M. Bouter|
|Examiner||prof. dr. L.M. Bouter|
prof. dr. L.M. Bouter
dr. M.J.P.A. Janssens
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