[Advance research directives in the context of dementia research: Ethical reflections on the disclosure requirement].

In November 2016, the German Federal Diet adopted an amendment to the German Medicinal Products Act (Arzneimittelgesetz), which permits non-therapeutic biomedical research on incompetent adults under a number of strict conditions. One of these conditions is that the potential research participant has declared her wish to participate in biomedical research in a valid research advance directive. Before completing the research advance directive, the potential research participant must be informed about the circumstances of research participation. It has been argued that the legislature should have omitted the disclosure requirement for research advance directives. In this article, we consider reasons for maintaining such a disclosure requirement. In addition, we propose a practically feasible disclosure standard for research advance directives. According to this standard, potential research participants should be informed about types of biomedical studies rather than about particular studies. © Georg Thieme Verlag KG Stuttgart · New York.