title: Beyond competence: advance directives in dementia research.
abstract: Dementia is highly prevalent and incurable. The participation of dementia patients in clinical research is indispensable if we want to find an effective treatment for dementia. However, one of the primary challenges in dementia research is the patients' gradual loss of the capacity to consent. Patients with dementia are characterized by the fact that, at an earlier stage of their life, they were able to give their consent to participation in research. Therefore, the phase when patients are still competent to decide offers a valuable opportunity to authorize research, by using an advance research directive (ARD). Yet, the use of ARDs as an authorization for research participation remains controversial. In this paper we discuss the role of autonomous decision-making and the protection of incompetent research subjects. We will show why ARDs are a morally defensible basis for the inclusion of this population in biomedical research and that the use of ARDs is compatible with the protection of incompetent research subjects.
authors.affiliation: Department of Medical Ethics and Philosophy of Medicine, Erasmus University Medical Centre Rotterdam, Office NA 21.17, PO box 2040, 3000 CA, Rotterdam, The Netherlands. k.jongsma@erasmusmc.nl.
authors.forename: Karin Rolanda
authors.initials: KR
authors.lastname: Jongsma
authors.affiliation: Department of Medical Ethics and Philosophy of Medicine, Erasmus University Medical Centre Rotterdam, Office NA 21.17, PO box 2040, 3000 CA, Rotterdam, The Netherlands. s.vandevathorst@erasmusmc.nl.
authors.forename: Suzanne
authors.initials: S
authors.lastname: van de Vathorst
mesh_terms: D024362:Advance Directive Adherence / Q000941:ethics / Q000331:legislation & jurisprudence; D016223:Advance Directives / Q000941:ethics* / Q000331:legislation & jurisprudence; D000544:Alzheimer Disease / Q000175:diagnosis*; D004992:Ethics, Medical; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D016743:Mental Competency / Q000331:legislation & jurisprudence*; D009014:Morals; D009426:Netherlands; D026684:Personal Autonomy; D019727:Proxy / Q000331:legislation & jurisprudence
keywords: Advance directives; Dementia; Informed consent; Research ethics