Ethical Challenges of Informed Consent, Decision-Making Capacity, and Vulnerability in Clinical Dementia Research
Ethics and Integrity in Health and Life Sciences Research
ISBN: 978-1-78743-572-8, eISBN: 978-1-78743-571-1
Publication date: 6 December 2018
Abstract
This chapter aims to provide an overview of the ethical framework and decision-making in clinical dementia research, and to analyze and discuss the ethical challenges and issues that can arise when conducting clinical dementia research.
Informed consent is the most scrutinized and controversial aspect of clinical research ethics. In clinical dementia research, assessing decision-making capacity may be challenging as the nature and progress of each disease influences decision-making capacity in diverse ways. Persons with dementia represent a vulnerable population deserving special attention when developing, implementing, and evaluating the informed consent process. In this chapter, particular attention will be given to vulnerability categories and how these influence decision-making capacity. Ethical frameworks with a pragmatic contour and implication are needed to protect vulnerable patients from potential harms and ensure their optimal participation in clinical dementia research.
In addition, this chapter analyses important ethical challenges and issues in clinical dementia research. If handled thoughtfully, they would not pose insuperable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and cause harm to research participants. Ethical considerations in research involving persons with dementia primarily concern the representation of the interests of the participants with dementia and protection of their vulnerabilities and rights.
A core set of ethical questions and recommendations are drawn to aid researchers, institutional review boards and potential research participants in the process of participating in clinical dementia research.
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Acknowledgements
Acknowledgment
This chapter was written during the duration of Subproject ETHICS II of Project ENSURE “Enhancing the Informed Consent Process: Supported Decision-Making and Capacity Assessment in Clinical Dementia Research.” The authors would like to thank ERA-NET NEURON II, ELSA 2015, European Commission, and Fundação para a Ciência e a Tecnologia (FCT), Ministério da Ciência, Tecnologia e Ensino Superior, Portugal, for their financial support to the Subproject ETHICS II of Project ENSURE. The funders had no role in the design and writing of this chapter.
Citation
Hernández-Marrero, P., Martins Pereira, S., Araújo, J. and Sofia Carvalho, A. (2018), "Ethical Challenges of Informed Consent, Decision-Making Capacity, and Vulnerability in Clinical Dementia Research", Ethics and Integrity in Health and Life Sciences Research (Advances in Research Ethics and Integrity, Vol. 4), Emerald Publishing Limited, Leeds, pp. 147-168. https://doi.org/10.1108/S2398-601820180000004010
Publisher
:Emerald Publishing Limited
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