Regulation of Biomedical Research with Human Participants

This lecture covers the general framework of regulations for biomedical research involving human subjects, focusing on the balance between innovation, medical progress, and subject protection. It explains the objectives of biomedical research, the distinction between research and medical practice, and the legal frameworks in Switzerland and other countries. The lecture also delves into the ethical considerations, international norms, and the authorization process for research projects involving human subjects. It discusses the types of research projects requiring authorization, the classification of risks, and the legal aspects of using biological material for research purposes. The lecture concludes with a reflection on the importance of progress in research while upholding ethical standards.