Ethical Dilemmas in Research in the Age of Learning Healthcare Systems

Learning healthcare systems undermine the existing conceptual and ethical framework of biomedical research. The distinction between research and practice, and the necessity of informed consent requirement are brought into question. Some try to extend the concept of research participant in such a way that it embraces physicians and healthcare institutions. It is thought that research regulations should no longer only protect individual against research, but also nudge individuals to participate. Individuals have a duty to contribute to the research enterprise. Therefore, transformation of healthcare system into a learning one challenges the existing research ethics paradigm. In my presentation I discuss the main ethical challenges of embedded research and possible limitations of a new ethical framework for learning healthcare systems.