This is a course about history, ethics, and policies of biomedical research involving human beings. Students will be introduced to evolution of social attitudes towards research enterprise. We follow the development of research ethics from researcher paternalism, through scandals and tragedies, to the most recent call for learning healthcare systems.
The course will present the most important questions of research ethics: What are the basic ethical principles for biomedical research? What constitutes informed consent? How to justly enroll participants into biomedical research? What is exploitation in the context of medical experimentation? Should research be an instrument of social justice in the world of inequalities? What is the age of consent/assent in case of research participation? What are the additional ethical considerations in low-income settings? Do researchers have the same moral obligations as physicians? What is the difference between research and practice of medicine?
Students will also be introduced to the legal regulations of research involving humans in the EU and the US, as well as to the most influential ethical guidelines concerning research (e. g. the Declaration of Helsinki, the Belmont Report, the Oviedo Convention, CIOMS Guidelines). The course is designed so that students will not only acquire knowledge and information, but also enhance their discussion and presentation skills, reading with understanding, and logical reasoning skills.