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

FUNDING:

ENSURE is funded by the German Ministry for Education and Research (BMBF).
Grant number: 01GP1623B
Duration: 2016-2019

SUMMARY:

As a result of an ageing population, the already high number of people suffering from dementia will significantly increase in European countries in the coming decades. 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 on the basis of their free informed consent. High standards for the informed consent process and the assessment of decision-making capacity are important to protect potential research participants.

ENSURE is an international and interdisciplinary collaboration involving the following project partners:

• The Frankfurt Forum for Interdisciplinary Ageing Research, Goethe University Frankfurt
• The Institute for Bioethics, Catholic University of Portugal
• The Department of Philosophy of Law, School of Law, University of A Coruña

ENSURE involves researchers from gerontology, psychology, psychiatry, law and medical ethics. The project aims to enhance the capacity to consent of people with dementia, to improve the assessment of decision-making capacity, to protect those who do not have the capacity to consent, and to ensure that the inclusion of people with dementia in neuroscientific and medical research is ethically justifiable. The Bochum subproject focuses on ethical and conceptual questions regarding informed consent and decision-making capacity.

Within the thematic context of ENSURE, Jochen Vollmann and Jakov Gather serve as trustees of the German Academy for Ethics in Medicine and Matthé Scholten and Astrid Gieselmann as experts for the AMWF S2k clinical guideline “Informed consent to medical treatment for persons with dementia.”

RESEARCHERS:

• Jakov Gather (Projektleitung)
• Matthé Scholten
• Prof. Dr. Dr. Jochen Vollmann (Projektleitung)

Psychiatric Advance Directives

Project description:

Advance directives are documents that enable patients to articulate their treatment choices for later periods of incompetence. In psychiatry, advance directives are particularly helpful for service users who suffer from disorders that may entail recurrent phases of temporary incompetence, such as bipolar, depressive and schizophrenic disorders. Psychiatric advance directives can strengthen the autonomy of psychiatric service users and increase their share in medical decision-making. In addition, they can lead to a reduction of involuntary treatment and coercion rates.

The implementation of psychiatric advance directives raises several fundamental ethical concerns. How, for example, should mental health professionals deal with advance directives in which patients indiscriminately reject all forms of psychiatric treatment? Should psychiatric advance directives be revocable at any time or should psychiatric service users have the right to exclude the possibility of revocation under conditions of incompetence?

Besides the ethical questions that arise in the context of advance directives, their implementation in clinical practice also raises several empirical issues. Although many psychiatric service users express interest in advance directives, in practice few of these documents are actually completed. This may be caused by barriers to the implementation of psychiatric advance directives such as limited time resources in psychiatric practice and lack of access to completed directives.

A dissertation project will identify the institutional barriers and difficulties in the implementation process of advance directives. By means of a nationwide quantitative questionnaire, the attitudes, knowledge and experience of psychiatrists with regard to various forms of psychiatric advance care planning will be investigated. The data will be analyzed by means of descriptive statistics.

RESEARCHERS:

• Jakov Gather
• Astrid Gieselmann
• Prof. Dr. Dr. Jochen Vollmann

Ethical expertise in clinical practice: An empirical-ethical inquiry into normative competence in value conflicts in psychiatry

Ruhr University Bochum
Researchers: Joschka Haltaufderheide und Prof. Dr. Dr. Jochen Vollmann
2017-2018

Winter school: Beneficial coercion in medicine? Foundations, areas of conflict, prevention

German Ministry of Education and Research
Grant program ethical, legal and social aspects of the modern life sciences
Researchers: Jakov Gather, Tanja Henking, Alexa Nossek und Prof. Dr. Dr. Jochen Vollmann
2016-2017

Implementation and evaluation of advance directives in the hospital

German Ministry of Education and Research
Grant number: 1711701
Prof. Dr. Dr. Vollmann
2001-2003

Ethicists and Practitioners in Collaboration on Capacity (EPICC)

European Commission
European Fifth Framework
Grant number: QLG6-CT-2001-00037
Prof. Dr. Dr. Vollmann
2002-2003

Empirical studies on competence and the process of informed consent for mentally disordered persons

German Research Foundation (DFG)
Grant number: Az. Vo 625/2-1
Prof. Dr. Dr. Vollmann
1998-2001

Ethical, legal, and social aspects of brain research

European Commission
Biotechnology Program (BIOTECH II)
Förderkennzeichen: BIOTECH 2B104 CT97 2264
Prof. Dr. Dr. Vollmann
1997-1999

Ethical problems concerning informed consent in health care, as exemplified by persons with dementia

German Research Foundation (DFG)
Grant number: Az. Vo 625/1-3
Prof. Dr. Dr. Vollmann
1994-1996