The focus of this part of the study is on cognitively impaired, elderly subjects as potential candidates for participation in biomedical research in Hungary. This implies that the study has special relevance for the field of dementia research. Since there are no acceptable (animal) models for dementia, the necessary research into the causes, prevention and treatment of dementia must be done maily with demented patients themselves. Dementia patients gradually loose their ability to give valid consent to biomedical research. As free and informed consent is a necessary condition for biomedical research with human persons, their participation in biomedical research raises difficult ethical questions. In most countries proxy consent is legally obligatory. There is however no international consensus about the role, responsibilities and authority of proxpy decision makers. Consensus is also lacking about the participation of cognitively impaired elderly subjects in non-therapeutic research. The goal of scientific progress in the cure of dementia will often demand the participation of demented subjects in research which will not benefit them immediately (but may benefit future patients). There is no international consensus with regard to the regulation of this issue, too. This part of the study has the following objectives: 1. inventory and ethical analysis of laws, regulations, guidelines on the conduct of research with these subjects in Hungary*(second objective of the proposal), and 2. participation in expert seminar (third objective of original proposal). Advancement at the European level of ethical acceptable biomedical research with cognitively impaired elderly subjects is of great importance, because of the great societal need for strategies to diagnose, prevent and cure or alleviate the symptoms of dementia. Uniform regulation at the European level is also important, because of the practice of international multi-center trials.
* and the Czech Republic