Required in stage
Optional in stage
First term
Second term
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This year
Next year
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Prerequisites
Language of instruction
Duration
Identical coursesEthics and Law in Biomedical Research (B-KUL-E07U9A)
Cannot be taken as part of an examination contract
Dierickx Kris (coordinator) | Dierickx Kris | Lierman Steven Aims
This course wants to make you familiar with the ethical and legal approaches in biomedical research. You will be introduced to the most important ethical-legal guidelines (the Declaration of Helsinki, Good Clinical Practice, Convention Human Rights and Biomedicine, EU Legislation), ethical models and ethical challenges. Eventually, you will study the right argumentation of ethical and legal statements more profoundly and you will learn how to argument in an ethically and legally correct manner.
Previous knowledge
No specific requirements.
Is included in these courses of study
Activities
3 ects. Ethics and Law in Biomedical Research (B-KUL-E07U9a)
Content
The following topics will be discussed:
1. A general introduction to bio-ethics and health law:
a. A general introduction to bio-ethics: the student can distinguish the various ethical argumentation models, explain them, apply them.
b. A general introduction to health law: description and sources of health law (Belgium, Europe, international), with a focus on biomedical research (Declaration of Helsinki, Convention of Human Rights and Biomedicine, Clinical-Trial directive and regulation, Good Clinical Practice Guideline); enforcing the legal norm
2. The student can critically explain the legal aspects of the precautionary principle and biomedical research on test subjects, body material and embryos, with a focus on testing (ethics) committees. The student can name and explain the competences of the European Union in this field. The student can describe and analyze the relevant legislation and case-law.
3. The student can critically explain the ethical aspects of working with human body material
4. The student can critically reflect on the question whether individual research results should (not) be returned and compare the different arguments in different situations
5. The student can give the most important elements of integrity (and misbehaviour) in biomedical research and justify why it is important.
6. The student can describe and analyze the ethical challenges of gene therapy and procreation-oriented cloning
7. The student can name and explain key ethical challenges in biomedical practice in times of globalisation
8. The student can critically reflect on the ethical aspects of clinical trials
Course material
Oral explanation during the oral courses
Course notes will be made available via Medica's course notes service or via Toledo.
Format: more information
Weblectures and class lectures
During the lectures, you are expected to ask questions and participate in discussions.
Evaluation
Evaluation: Ethics and Law in Biomedical Research (B-KUL-E27U9a)
Explanation
The exam is written. It will be verified whether the ethical and legal aspects of biomedical research have been understood and acquired. Both parts will be tested while in addition a well-argued reaction on a statement will be expected. Each part corresponds to half the points.
One global mark will be communicated