Abstract
BackgroundWhen 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.MethodsWe 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.ResultsThe 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.ConclusionsThe 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.
Highlights
When including participants with dementia in research, various ethical issues arise
Research conducted with participants living with dementia raises important ethical questions, such as how to protect cognitively impaired persons against exploitation, how to design informed consent (IC) procedures with proxies, how to disclose risk-factors for dementia given the lack of evidence for their reliability, and how to apply risk–benefit considerations in such cases [3]
References and journals The literature search in PubMed and Google Scholar revealed a total set of 594 references, 110 of which were included in the analysis, published between 2007 and 2020 in 64 different journals
Summary
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. 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. Out of fear of not being able to fulfil the ethical obligations required when conducting research with incapacitated persons, some might suggest the overall exclusion of cognitively impaired persons, or even of all individuals affected by dementia, from research. This caution may lead to the abandonment of meaningful research on dementia and would exclude dementia research from medical progress, leaving affected persons and their relatives orphaned
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