The full spectrum of ethical issues in dementia research: findings of a systematic qualitative review

Abstract

Background When including participants with dementia in research, various ethical issues arise. At present, there are only a few existing dementia-specific research guidelines (Committee for Medicinal Products for Human Use in Clinical investigation of medicines for the treatment Alzheimer’s disease (Internet). https://www.ema.europa.eu/en/clinical-investigation-medicines-treatment-alzheimers-disease; Food and Drug Administration, Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry [Internet]. http://www.fda.gov/regulatory-information/search-fda-guidance-documents/alzheimers-disease-developing-drugs-treatment-guidance-industy), necessitating a more systematic and comprehensive approach to this topic to help researchers and stakeholders address dementia-specific ethical issues in research. A systematic literature review provides information on the ethical issues in dementia-related research and might therefore serve as a basis to improve the ethical conduct of this research. This systematic review aims to provide a broad and unbiased overview of ethical issues in dementia research by reviewing, analysing, and coding the latest literature on the topic. Methods We conducted a systematic review in PubMed and Google Scholar (publications in English between 2007 and 2020, no restrictions on the type of publication) of literature on research ethics in dementia research. Ethical issues in research were identified by qualitative text analysis and normative analysis. Results The literature review retrieved 110 references that together mentioned 105 ethical issues in dementia research. This set of ethical issues was structured into a matrix based on the eight major principles from a pre-existing framework on biomedical ethics (Emanuel et al. An Ethical Framework for Biomedical Research. in The Oxford textbook of clinical research ethics, Oxford University Press, Oxford, 2008). Consequently, subcategories were created and further categorized into dementia stages and study phases. Conclusions The systematically derived matrix helps raise awareness and understanding of the complex topic of ethical issues in dementia research. The matrix can be used as a basis for researchers, policy makers and other stakeholders when planning, conducting and monitoring research, making decisions on the legal background of the topic, and creating research practice guidelines.

The Promotion of Health Literacy

“…In this study, we addressed the risk of the potential harm of Alzheimer’s dementia risk prediction, its identity-relevant impact on individuals, their autonomy and self-determination, and their empowerment in decision-making are matters. We wish to reflect on this in light of the ethical guidepost for AD research (Götzelmann et al, 2021; Silva et al, 2020). 18 The ethical issue of potentially harming people with risk information lies within the nature of risk prediction, since communicating a risk entails imposing uncertainty upon a person (Davis, 2017).…”

“…We apprehend ethical considerations of predicting Alzheimer's dementia risk in general, to distillate recommendations for both directions of predictive practice. guidepost for AD research (Götzelmann et al, 2021;Silva et al, 2020). 18 The ethical issue of potentially harming people with risk information lies within the nature of risk prediction, since communicating a risk entails imposing uncertainty upon a person (Davis, 2017).…”

Behaviour-directed interventions for problematic person transfer situations in two dementia care dyads: a single-case design study

“…Due to cognitive impairment and diminished consent capacity of persons in the late stages of dementia, they risk not being included in research that aims to address daily difficulties, such as person transfer situations. Despite these ethical challenges, it is important to study how to improve person transfer situations, which occur frequently and greatly affect the quality of life for a PwD [ 5 ].…”

Challenges of anticipation of future decisions in dementia and dementia research

“…In Germany, ARDs have recently become a necessary condition for the previously prohibited participation of incapacitated people in research with group-benefit with the amendments in the Medicinal Products Act (Deutscher Bundestag, 2016 ). In light of these legal changes and the growing ethical interest in ARDs for dementia research (Heinrichs, 2021 ; Götzelmann et al, 2021 ; Werner & Schicktanz, 2018 ; Davis, 2017 ; Jongsma & van de Vathorst, 2015 ), I argue for the need to reflect on the fact that anticipatory decisions become relevant in this context. Anticipation as such is an important aspect in the context of dementia which, however, has rarely been discussed regarding planning ahead in the field of bioethics.…”

“…The legal debate regarding ARDs in the recent years has predominantly focused on the ethical acceptability under the aspect of the instability of an individual’s preferences and values or on the ethical justification based on concepts of autonomy. From an empirical-ethical perspective, the ethical debate has focused on whether affected individuals are willing to draft and actually use an ARD (Heinrichs, 2021 ; Götzelmann et al, 2021 ; Jongsma et al, 2020 ). However, what is missing in the current debate is a focus on what the concrete challenges are for drafting an ARD, namely referring to the anticipatory aspect of ARDs.…”