Ethical challenges of informed consent, decision-making capacity, and vulnerability in clinical dementia research

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.