"Enhancing the Informed Consent Process in Clinical Dementia Research"

Persons involved: PD Dr. Julia Haberstroh, Prof. Dr. Frank Oswald, Prof. Dr. Johannes Pantel, Dr. Maren Knebel, Dr. Valentina Tesky, Theresa Wied, M. Sc., (Goethe-Universität Frankfurt am Main, Germany), Prof. Dr. Dr. Jochen Vollmann, Dr. Jakov Gather, Dr. Matthé Scholten (Ruhr-Universität Bochum, Germany), Prof. Dr. José Antonio Seoane , Prof. Dr. Natalia Álvarez Lata (University of A Coruña, Spain), Prof. Dr. Ana Sofia Carvalho, Pablo Hernández Marrero, Phd. (Catholic University of Portugal)

Funding: Federal ministry of Education and Research (Germany), National Institute of Health Carlos III. (Spain), Fundação para a Ciência e Tecnologia (Portugal)

Project term: 01.06.2016 - 31.05.2019

Keywords: Informed Consent, dementia research, ethics, substitute and supported decision-making

Enhancing the Informed Consent Process: Supported decision-making and capacity assessment in clinical dementia research (ENSURE)

Demographic change is expected to increase the number of people suffering from dementia significantly in European countries and elsewhere in the coming decades. No established pharmacological treatments are currently available that can reverse or even halt the neurodegenerative process, and dementia is a considerable burden on patients and caregivers, as well as on societies as a whole. For this reason, there is a substantial need for further medical dementia research. 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 and decreasing communicative skills. 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. Furthermore, in contrast to informed consent to medical treatment, an individual benefit from participation in research can rarely be taken for granted. However, people suffering from dementia also have a right to benefit from research, so their categorical exclusion would appear to be ethically problematic. High standards for the informed consent process and a thorough assessment of mental capacity are therefore important for the protection of research participants. The international, interdisciplinary project ENSURE aims to contribute towards achieving an adequate balance between autonomy and the protection of dementia patients in clinical research.

ENSURE aims to provide interdisciplinary recommendations to support the development of an action model of an informed consent process in clinical dementia research that a) enhances the capacity to consent of people with dementia, b) improves the assessment of decision-making capacity, c) protects those who do not have the capacity to consent, and d) guarantees the ethically justified inclusion of research subjects in clinical dementia research. To achieve this, four international European project partners from three countries (Germany, Portugal, Spain) cooperate on four interdisciplinary interlinked subprojects to be conducted in three successive phases. The disciplines involved are gerontology, ethics and law.

We have developed an online-survey to ask persons with dementia and caregivers who are involved in dementia research about actual conditions and needs in informed consent procedures


Subproject LAW: Legal framework of mental capacity and decision-making process in the light of the UN-CRPD

Subproject ETHICS I: Ethical concepts of decision-making capacity

Subproject ETHICS II: Capacity Assessment in people with dementia

Subproject GERONTOLOGY: Supported decision making and person-environment (p-e) fit