European journal of neurology : the official journal of the European Federation of Neurological Societies
-
Across Europe the protection of research subjects with dementia has to meet a variety of national legislation and ethical codes. This research project compared how in different EU countries one single descriptive multinational study on dementia treatment strategies was evaluated by medical ethical committees and how the issues of informed consent and capacity to consent were dealt with. The study that was evaluated is the ICTUS study, which studies the impact of treatment with acetylcholinesterase inhibitors (AChE-I) on Europeans with mildly or moderately severe Alzheimer's disease (AD). ⋯ There was no formal informed consent procedure required by the ethical committees. The data from this survey suggest that there should be more consensus across the EU about which studies or interventions do and which do not require approval of an ethics committee. Procedures for the assessment of informed consent in dementia research should be harmonized by central national or European bodies.