An innovative approach to enhance the informed consent process for people with dementia: the ensure project

Background: People with dementia have the right to decide whether or not they want to participate in clinical research and to give their free, prior and informed consent. However, as dementia progresses, they can lose their ability to give informed consent to complex medical research because of an increasing loss of cognitive functions. At first sight, it seems ethically problematic to involve dementia patients in research, as people with impaired mental capacity must be protected against the risks of research participation. In contrast to informed consent to medical treatment, an individual benefit from participation in research can rarely be taken for granted. However, people with dementia also have a right to benefit from medical research in particular, so their categorical exclusion would appear to be ethically problematic too. Methods: The international, interdisciplinary ENSURE project (Enhancing the informed consent process: Supported decision-making and capacity assessment in clinical dementia research) aims to provide interdisciplinary recommendations to support the development of an action model of an informed consent process in clinical dementia research that 1) enhances the capacity to consent of people with dementia, 2) improves the assessment of decision-making capacity, 3) protects those who do not have the capacity to consent, and 4) guarantees the ethically justified inclusion of research subjects in clinical dementia research. To achieve this, four international project partners cooperate on four interdisciplinary interlinked subprojects. The disciplines involved are gerontology, ethics and law. Results: A flow-chart of ENSURE and an overview of the first results of the subprojects will be presented. Conclusions: Implications for practical use in informed consent procedures will be discussed.