{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T23:16:58Z","timestamp":1767050218251,"version":"3.48.0"},"reference-count":95,"publisher":"Emerald Publishing Limited","isbn-type":[{"type":"print","value":"9781787435728"},{"type":"electronic","value":"9781787435711"},{"type":"electronic","value":"9781787439184"}],"license":[{"start":{"date-parts":[[2018,12,6]],"date-time":"2018-12-06T00:00:00Z","timestamp":1544054400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.emeraldinsight.com\/page\/tdm"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,12,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1108\/s2398-601820180000004010","type":"book-chapter","created":{"date-parts":[[2018,11,14]],"date-time":"2018-11-14T10:32:44Z","timestamp":1542191564000},"page":"147-168","source":"Crossref","is-referenced-by-count":2,"title":["Ethical Challenges of Informed Consent, Decision-Making Capacity, and Vulnerability in Clinical Dementia Research"],"prefix":"10.1108","author":[{"given":"Pablo","family":"Hern\u00e1ndez-Marrero","sequence":"first","affiliation":[]},{"given":"Sandra","family":"Martins Pereira","sequence":"additional","affiliation":[]},{"given":"Joana","family":"Ara\u00fajo","sequence":"additional","affiliation":[]},{"given":"Ana","family":"Sofia Carvalho","sequence":"additional","affiliation":[]}],"member":"140","reference":[{"issue":"9","key":"2025122918045541100_s2398-601820180000004010_9.bib1","doi-asserted-by":"crossref","first-page":"801","DOI":"10.1002\/(SICI)1099-1166(199609)11:9<801::AID-GPS379>3.0.CO;2-H","article-title":"Ethics of \u2018informed consent\u2019 in dementia research \u2013 the debate continues","volume":"11","author":"Agarwal","year":"1996","journal-title":"International Journal of Geriatric Psychiatry"},{"issue":"3","key":"2025122918045541100_s2398-601820180000004010_9.bib2","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1097\/01.wad.0000137520.23370.56","article-title":"Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators","volume":"18","author":"Alzheimer\u2019s Association","year":"2004","journal-title":"Alzheimer Disease & Associated Disorders"},{"issue":"2","key":"2025122918045541100_s2398-601820180000004010_9.bib3","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1097\/00019442-200203000-00002","article-title":"Involving decisionally impaired subjects in research: The need for legislation","volume":"10","author":"Appelbaum","year":"2002","journal-title":"American Journal of Geriatric Psychiatry"},{"issue":"18","key":"2025122918045541100_s2398-601820180000004010_9.bib4","doi-asserted-by":"publisher","first-page":"1834","DOI":"10.1056\/NEJMcp074045","article-title":"Clinical practice. Assessment of patients\u2019 competence to consent to treatment","volume":"357","author":"Appelbaum","year":"2007","journal-title":"New England Journal of Medicine"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib5","doi-asserted-by":"publisher","first-page":"367","DOI":"10.1007\/s11910-010-0123-5","article-title":"Consent in impaired populations","volume":"10","author":"Appelbaum","year":"2010","journal-title":"Current Neurology and Neuroscience Reports"},{"issue":"25","key":"2025122918045541100_s2398-601820180000004010_9.bib6","doi-asserted-by":"publisher","first-page":"1635","DOI":"10.1056\/NEJM198812223192504","article-title":"Assessing patients\u2019 capacities to consent to treatment","volume":"319","author":"Appelbaum","year":"1988","journal-title":"New England Journal of Medicine"},{"issue":"2","key":"2025122918045541100_s2398-601820180000004010_9.bib7","doi-asserted-by":"crossref","first-page":"105","DOI":"10.1007\/BF01499321","article-title":"The MacArthur treatment competence study: I, mental illness and competence to consent to treatment","volume":"19","author":"Appelbaum","year":"1995","journal-title":"Law and Human Behaviour"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib8","first-page":"1","article-title":"Ethical issues in conducting research with persons with dementia","volume":"9","author":"Aselage","year":"2009","journal-title":"Southern Online Journal of Nursing Research"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib9","doi-asserted-by":"crossref","first-page":"79","DOI":"10.1007\/BF03324536","article-title":"Informed consent for research participation in frail older persons","volume":"16","author":"Barron","year":"2004","journal-title":"Aging Clinical Experiment Research"},{"issue":"9","key":"2025122918045541100_s2398-601820180000004010_9.bib10","doi-asserted-by":"publisher","first-page":"956","DOI":"10.1176\/ps.47.9.956","article-title":"Clinicians\u2019 judgement of capacity of nursing home patients to give informed consent","volume":"47","author":"Barton","year":"1996","journal-title":"Psychiatric Services"},{"key":"2025122918045541100_s2398-601820180000004010_9.bib11","volume-title":"Principles of biomedical ethics","author":"Beauchamp","year":"2013","edition":"7th edition"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib12","doi-asserted-by":"publisher","first-page":"6","DOI":"10.3928\/19404921-20090101-04","article-title":"Challenges in conducting qualitative research with persons with dementia","volume":"2","author":"Beuscher","year":"2009","journal-title":"Research in Gerontological Nursing"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib14","first-page":"83","article-title":"Predictors of providing informed consent or assent for research participation in assisted living residents","volume":"16","author":"Black","year":"2008","journal-title":"American Journal of Psychiatry"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib13","doi-asserted-by":"publisher","first-page":"355","DOI":"10.1016\/j.jagp.2012.11.009","article-title":"Decision making for participation in dementia research","volume":"21","author":"Black","year":"2013","journal-title":"American Journal of Geriatric Psychiatry"},{"year":"2018","author":"Bravo","key":"2025122918045541100_s2398-601820180000004010_9.bib15"},{"issue":"2","key":"2025122918045541100_s2398-601820180000004010_9.bib16","doi-asserted-by":"crossref","first-page":"31","DOI":"10.1353\/hcr.0.0113","article-title":"Choosing for another: Beyond autonomy and best interests","volume":"39","author":"Brudney","year":"2009","journal-title":"Hastings Center Report"},{"issue":"3","key":"2025122918045541100_s2398-601820180000004010_9.bib17","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1177\/082585979401000302","article-title":"Ethical issues in palliative care research","volume":"10","author":"Bruera","year":"1994","journal-title":"Journal of Palliative Care"},{"issue":"8","key":"2025122918045541100_s2398-601820180000004010_9.bib18","doi-asserted-by":"publisher","first-page":"701","DOI":"10.1136\/medethics-2014-102024","article-title":"Advance consent, critical interests and dementia research","volume":"41","author":"Buller","year":"2015","journal-title":"Journal of Medical Ethics"},{"issue":"3","key":"2025122918045541100_s2398-601820180000004010_9.bib19","doi-asserted-by":"crossref","first-page":"223","DOI":"10.1177\/1054773811415810","article-title":"People with dementia: Capacity to consent to research participation","volume":"20","author":"Cacchione","year":"2011","journal-title":"Clinical Nursing Research"},{"issue":"6","key":"2025122918045541100_s2398-601820180000004010_9.bib20","doi-asserted-by":"publisher","first-page":"550","DOI":"10.1001\/archinternmed.2011.31","article-title":"The persistent exclusion of older patients from ongoing clinical trials regarding heart failure","volume":"171","author":"Cherubini","year":"2011","journal-title":"Archives of Internal Medicine"},{"issue":"3","key":"2025122918045541100_s2398-601820180000004010_9.bib21","first-page":"353","article-title":"Decision-making capacity for informed consent in the older population","volume":"23","author":"Christensen","year":"1995","journal-title":"Journal of the American Academy of Psychiatry and the Law Online"},{"key":"2025122918045541100_s2398-601820180000004010_9.bib101","doi-asserted-by":"publisher","first-page":"61","DOI":"10.1016\/j.ijlp.2015.01.008","article-title":"Supported decision making: A review of the international literature","volume":"38","author":"Davidson","year":"2015","journal-title":"International Journal of Law and Psychiatry"},{"issue":"12","key":"2025122918045541100_s2398-601820180000004010_9.bib22","doi-asserted-by":"publisher","first-page":"852","DOI":"10.1136\/medethics-2016-103392","article-title":"Ethical issues in Alzheimer\u2019s disease research involving human subjects","volume":"43","author":"Davis","year":"2017","journal-title":"Journal of Medical Ethics"},{"issue":"8","key":"2025122918045541100_s2398-601820180000004010_9.bib23","doi-asserted-by":"publisher","first-page":"636","DOI":"10.1634\/theoncologist.10-8-636","article-title":"Informed consent for medical treatment and research: A review","volume":"10","author":"del Carmen","year":"2005","journal-title":"Oncologist"},{"volume-title":"Essentials of nursing law and ethics","year":"2009","author":"Dempski","key":"2025122918045541100_s2398-601820180000004010_9.bib24"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib25","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1177\/1471301207075625","article-title":"Participatory research: A method for process consent with persons who have dementia","volume":"6","author":"Dewing","year":"2007","journal-title":"Dementia"},{"issue":"7","key":"2025122918045541100_s2398-601820180000004010_9.bib26","doi-asserted-by":"publisher","first-page":"925","DOI":"10.1001\/jama.1984.03350070043021","article-title":"Competency to give an informed consent. A model for making clinical assessments","volume":"252","author":"Drane","year":"1984","journal-title":"Journal of the American Medical Association"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib29","doi-asserted-by":"publisher","first-page":"337","DOI":"10.1016\/j.jagp.2012.11.014","article-title":"\u201cThinking about it for somebody else\u201d: Alzheimer\u2019s disease research and proxy decision makers\u2019 translation of ethical principles into practice","volume":"21","author":"Dunn","year":"2013","journal-title":"American Journal of Geriatric Psychiatry"},{"issue":"2","key":"2025122918045541100_s2398-601820180000004010_9.bib27","doi-asserted-by":"publisher","first-page":"395","DOI":"10.1016\/j.psc.2009.03.007","article-title":"Research ethics issues in geriatric psychiatry","volume":"32","author":"Dunn","year":"2009","journal-title":"Psychiatric Clinics of North America"},{"issue":"8","key":"2025122918045541100_s2398-601820180000004010_9.bib28","doi-asserted-by":"publisher","first-page":"1323","DOI":"10.1176\/ajp.2006.163.8.1323","article-title":"Assessing decisional capacity for clinical research or treatment: a review of instruments","volume":"163","author":"Dunn","year":"2006","journal-title":"American Journal of Psychiatry"},{"issue":"20","key":"2025122918045541100_s2398-601820180000004010_9.bib30","doi-asserted-by":"publisher","first-page":"2701","DOI":"10.1001\/jama.283.20.2701","article-title":"What makes clinical research ethical?","volume":"283","author":"Emanuel","year":"2000","journal-title":"Journal of the American Medical Association"},{"issue":"8","key":"2025122918045541100_s2398-601820180000004010_9.bib31","doi-asserted-by":"publisher","first-page":"462","DOI":"10.1111\/pcn.12289","article-title":"Informed consent procedures with cognitively impaired patients: A review of ethics and best practices","volume":"69","author":"Fields","year":"2015","journal-title":"Psychiatry and Clinical Neurosciences"},{"issue":"10","key":"2025122918045541100_s2398-601820180000004010_9.bib32","doi-asserted-by":"crossref","first-page":"1813","DOI":"10.1176\/ajp.2006.163.10.1813","article-title":"Capacity of persons with mental retardation to consent to participate in randomized clinical trials","volume":"163","author":"Fisher","year":"2006","journal-title":"American Journal of Psychiatry"},{"issue":"3 Suppl","key":"2025122918045541100_s2398-601820180000004010_9.bib33","doi-asserted-by":"crossref","first-page":"S100","DOI":"10.1016\/j.jamda.2005.03.021","article-title":"Ten myths about decision-making capacity","volume":"6","author":"Ganzini","year":"2005","journal-title":"Journal of the American Medical Directors Association"},{"issue":"11","key":"2025122918045541100_s2398-601820180000004010_9.bib34","doi-asserted-by":"publisher","first-page":"611","DOI":"10.1038\/nrneurol.2010.148","article-title":"Decision-making cognition in neurodegenerative diseases","volume":"6","author":"Gleichgerrcht","year":"2010","journal-title":"Nature Reviews Neurology"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib35","doi-asserted-by":"crossref","first-page":"196","DOI":"10.12968\/jpar.2009.1.5.42062","article-title":"Elements of a valid consent to treatment in capable adults","volume":"1","author":"Griffith","year":"2009","journal-title":"Journal of Paramedic Practice"},{"key":"2025122918045541100_s2398-601820180000004010_9.bib36","doi-asserted-by":"crossref","DOI":"10.1093\/oso\/9780195103724.001.0001","volume-title":"Assessing competence to consent to treatment","author":"Grisso","year":"1998"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib37","doi-asserted-by":"crossref","first-page":"18","DOI":"10.7748\/nop2004.06.16.4.18.c2314","article-title":"Using negotiated consent in research and practice","volume":"16","author":"Grout","year":"2004","journal-title":"Nursing Older People"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib38","doi-asserted-by":"publisher","first-page":"258","DOI":"10.1016\/j.trci.2016.09.001","article-title":"Measuring informed consent capacity in an Alzheimer\u2019s disease clinical trial","volume":"2","author":"Guarino","year":"2016","journal-title":"Alzheimers\u2019s and Dementia: Translational Research & Clinical Interventions"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib39","doi-asserted-by":"publisher","first-page":"26","DOI":"10.4103\/2229-3485.106373","article-title":"Informed consent in clinical research: Revisiting few concepts and areas","volume":"4","author":"Gupta","year":"2013","journal-title":"Perspectives in Clinical Research"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib40","doi-asserted-by":"publisher","first-page":"608","DOI":"10.1177\/0969733007080206","article-title":"Ethical and methodological issues in interviewing persons with dementia","volume":"14","author":"Hellstr\u00f6m","year":"2007","journal-title":"Nursing Ethics"},{"issue":"8","key":"2025122918045541100_s2398-601820180000004010_9.bib41","first-page":"20","article-title":"Involving people with dementia in research","volume":"109","author":"Higgins","year":"2013","journal-title":"Nursing Times"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib42","doi-asserted-by":"publisher","first-page":"25","DOI":"10.7748\/nr.22.4.25.e1308","article-title":"Ethical issues when involving people newly diagnosed with dementia in research","volume":"22","author":"Holland","year":"2015","journal-title":"Nurse Research"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib43","first-page":"531","article-title":"Cognitive functions in the informed consent evaluation process: A pilot study","volume":"25","author":"Holzer","year":"1997","journal-title":"Journal of the American Academy of Psychiatry and the Law"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib44","doi-asserted-by":"publisher","first-page":"36","DOI":"10.1080\/15265160590927732","article-title":"Waste not, want not: Cognitive impairment should not preclude research participation","volume":"5","author":"Hougham","year":"2005","journal-title":"American Journal of Bioethics"},{"issue":"5\u20136","key":"2025122918045541100_s2398-601820180000004010_9.bib45","first-page":"47","article-title":"Informed consent, participation in research, and the Alzheimer\u2019s patient","volume":"9","author":"Howe","year":"2012","journal-title":"Innovations in Clinical Neuroscience"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib46","doi-asserted-by":"publisher","first-page":"351","DOI":"10.1080\/1360786031000150685","article-title":"Including older people with dementia in research: Challenges and strategies","volume":"7","author":"Hubbard","year":"2003","journal-title":"Aging & Mental Health"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib47","doi-asserted-by":"publisher","first-page":"191","DOI":"10.1111\/j.1467-8519.2008.00631.x","article-title":"Vulnerability in research and health care; describing the elephant in the room?","volume":"22","author":"Hurst","year":"2008","journal-title":"Bioethics"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib48","doi-asserted-by":"publisher","first-page":"28","DOI":"10.1080\/00332747.2017.1324697","article-title":"Supported decision making in serious mental illness","volume":"81","author":"Jeste","year":"2018","journal-title":"Psychiatry"},{"issue":"10","key":"2025122918045541100_s2398-601820180000004010_9.bib49","doi-asserted-by":"publisher","first-page":"1635","DOI":"10.1017\/S1041610215000848","article-title":"A review of ethical issues in dementia","volume":"27","author":"Johnson","year":"2015","journal-title":"International Psychogeriatrics"},{"issue":"2\u20133","key":"2025122918045541100_s2398-601820180000004010_9.bib50","doi-asserted-by":"publisher","first-page":"167","DOI":"10.1007\/s40592-015-0034-y","article-title":"Beyond competence: advance directives in dementia research","volume":"33","author":"Jongsma","year":"2015","journal-title":"Monash Bioethics Review"},{"issue":"8","key":"2025122918045541100_s2398-601820180000004010_9.bib51","doi-asserted-by":"publisher","first-page":"708","DOI":"10.1136\/medethics-2014-102445","article-title":"Dementia research and advance consent: it is not about critical interests","volume":"41","author":"Jongsma","year":"2015","journal-title":"Journal of Medical Ethics"},{"issue":"39","key":"2025122918045541100_s2398-601820180000004010_9.bib52","doi-asserted-by":"publisher","first-page":"38","DOI":"10.7748\/ns.30.39.38.s43","article-title":"Promoting participation of people with dementia in research","volume":"30","author":"Juaristi","year":"2016","journal-title":"Nursing Standard"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib53","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1159\/000109763","article-title":"Measuring decision-making capacity in cognitively impaired individuals","volume":"16","author":"Karlawish","year":"2008","journal-title":"Neurosignals"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib54","doi-asserted-by":"crossref","first-page":"S14","DOI":"10.1016\/S0885-3924(03)00098-8","article-title":"Conducting research that involves subjects at the end of life who are unable to give consent","volume":"25","author":"Karlawish","year":"2003","journal-title":"Journal of Pain and Symptom Management"},{"issue":"6","key":"2025122918045541100_s2398-601820180000004010_9.bib55","doi-asserted-by":"crossref","first-page":"789","DOI":"10.1212\/WNL.56.6.789","article-title":"How do AD patients and their caregivers decide whether to enroll in a clinical trial?","volume":"56","author":"Karlawish","year":"2001","journal-title":"Neurology"},{"issue":"30","key":"2025122918045541100_s2398-601820180000004010_9.bib56","doi-asserted-by":"publisher","first-page":"38","DOI":"10.7748\/ns.30.30.38.s45","article-title":"Supported decision making: the rights of people with dementia","volume":"30","author":"Keeling","year":"2016","journal-title":"Nursing Standard"},{"issue":"2","key":"2025122918045541100_s2398-601820180000004010_9.bib58","doi-asserted-by":"publisher","first-page":"149","DOI":"10.1212\/01.wnl.0000339039.18931.a2","article-title":"Surrogate consent for dementia research","volume":"72","author":"Kim","year":"2009","journal-title":"Neurology"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib59","doi-asserted-by":"publisher","first-page":"797","DOI":"10.1176\/appi.ajp.161.5.797","article-title":"Proxy and surrogate consent in geriatric neuropsychiatric research: Update and recommendations","volume":"161","author":"Kim","year":"2004","journal-title":"American Journal of Psychiatry"},{"key":"2025122918045541100_s2398-601820180000004010_9.bib60","doi-asserted-by":"publisher","first-page":"410","DOI":"10.1038\/nrneurol.2011.76","article-title":"The ethics of informed consent in Alzheimer disease research","volume":"7","author":"Kim","year":"2011","journal-title":"Nature Reviews Neurology"},{"key":"2025122918045541100_s2398-601820180000004010_9.bib57","doi-asserted-by":"publisher","first-page":"712","DOI":"10.1176\/appi.ajp.158.5.712","article-title":"Assessing the competence of persons with Alzheimer\u2019s disease in providing informed consent for participation in research","volume":"158","author":"Kim","year":"2001","journal-title":"American Journal of Psychiatry"},{"key":"2025122918045541100_s2398-601820180000004010_9.bib61","article-title":"Vulnerability in research subjects: A bioethical taxonomy","volume":"2","author":"Kipnis","year":"2001","journal-title":"Ethical and policy issues in research involving human participants"},{"issue":"10","key":"2025122918045541100_s2398-601820180000004010_9.bib62","first-page":"237","article-title":"Incompetent patients, substitute decision making, and quality of life: Some ethical considerations","volume":"10","author":"Kluge","year":"2008","journal-title":"The Medscape Journal of Medicine"},{"issue":"8","key":"2025122918045541100_s2398-601820180000004010_9.bib63","doi-asserted-by":"publisher","first-page":"e1001498","DOI":"10.1371\/journal.pmed.1001498","article-title":"Inclusion of ethical issues in dementia guidelines: A thematic text analysis","volume":"10","author":"Kn\u00fcppel","year":"2013","journal-title":"PLoS Medicine"},{"issue":"10","key":"2025122918045541100_s2398-601820180000004010_9.bib64","doi-asserted-by":"crossref","first-page":"949","DOI":"10.1001\/archneur.1995.00540340029010","article-title":"Assessing the competency of patients with Alzheimer\u2019s disease under different legal standards. A prototype instrument","volume":"52","author":"Marson","year":"1995","journal-title":"Archives of Neurology"},{"volume-title":"The UNESCO Universal Declaration on Bioethics and Human Rights: Background, Principles and Application","year":"2009","author":"Martin","key":"2025122918045541100_s2398-601820180000004010_9.bib65"},{"issue":"3","key":"2025122918045541100_s2398-601820180000004010_9.bib66","doi-asserted-by":"publisher","first-page":"285","DOI":"10.1176\/ajp.134.3.285","article-title":"Toward a model of the legal doctrine of informed consent","volume":"134","author":"Meisel","year":"1997","journal-title":"American Journal of Psychiatry"},{"issue":"15","key":"2025122918045541100_s2398-601820180000004010_9.bib67","doi-asserted-by":"publisher","first-page":"1528","DOI":"10.1212\/01.wnl.0000277639.90611.d9","article-title":"Medical decision-making capacity in patients with mild cognitive impairment","volume":"69","author":"Okonkwo","year":"2007","journal-title":"Neurology"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib68","doi-asserted-by":"crossref","first-page":"46","DOI":"10.1212\/01.WNL.0000073623.84147.A8","article-title":"Subacute meningoencephalitis in a subset of patients with AD after Abeta42 immunization","volume":"61","author":"Orgogozo","year":"2003","journal-title":"Neurology"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib69","doi-asserted-by":"publisher","first-page":"623","DOI":"10.1016\/j.socscimed.2009.10.037","article-title":"A changing landscape for advance directives in dementia research","volume":"70","author":"Pierce","year":"2010","journal-title":"Social Science & Medicine"},{"key":"2025122918045541100_s2398-601820180000004010_9.bib70","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1186\/s12910-018-0249-6","article-title":"Advance directives as a tool to respect patients\u2019 values and preferences: discussion on the case of Alzheimer\u2019s disease","volume":"19","author":"Porteri","year":"2018","journal-title":"BMC Medical Ethics"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib71","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1016\/j.jalz.2012.11.007","article-title":"The global prevalence of dementia: a systematic review and metaanalysis","volume":"9","author":"Prince","year":"2013","journal-title":"Alzheimer\u2019s & dementia: the journal of the Alzheimer\u2019s Association"},{"volume-title":"Research Methods in Palliative Care","year":"2009","author":"Reyna","key":"2025122918045541100_s2398-601820180000004010_9.bib72"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib73","doi-asserted-by":"publisher","first-page":"705","DOI":"10.1176\/appi.ajp.159.5.705","article-title":"Informed consent and the capacity for voluntarism","volume":"159","author":"Roberts","year":"2002","journal-title":"American Journal of Psychiatry"},{"year":"2015","author":"Rubinstein","key":"2025122918045541100_s2398-601820180000004010_9.bib74"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib75","first-page":"37","article-title":"Proxy consent to research: The legal landscape","volume":"8","author":"Saks","year":"2008","journal-title":"Yale Journal of Health Policy Law Ethics"},{"issue":"3","key":"2025122918045541100_s2398-601820180000004010_9.bib102","doi-asserted-by":"publisher","first-page":"328","DOI":"10.1159\/000479426","article-title":"Advance directives as support of autonomy for persons with dementia? A pilot study among persons with dementia and their informal caregivers","volume":"7","author":"Schmidhuber","year":"2017","journal-title":"Dementia and Geriatric Cognitive Disorders EXTRA"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib76","doi-asserted-by":"publisher","first-page":"226","DOI":"10.1136\/medethics-2017-104414","article-title":"Adverse consequences of article 12 of the UN Convention on the Rights of Persons with Disabilities for persons with mental disabilities and an alternative way forward","volume":"44","author":"Scholten","year":"2018","journal-title":"Journal of Medical Ethics"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib77","doi-asserted-by":"publisher","first-page":"420","DOI":"10.1001\/jama.2011.1023","article-title":"Does this patient have medical decision-making capacity?","volume":"306","author":"Sessums","year":"2011","journal-title":"Journal of the American Medical Association"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib78","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1186\/s12910-016-0138-9","article-title":"Research involving adults lacking capacity to consent: the impact of research regulation on \u2018evidence biased\u2019 medicine","volume":"17","author":"Shepherd","year":"2016","journal-title":"BMC Medical Ethics"},{"issue":"2","key":"2025122918045541100_s2398-601820180000004010_9.bib79","doi-asserted-by":"crossref","first-page":"235","DOI":"10.1097\/00003246-200102000-00002","article-title":"Variability among institutional review boards\u2019 decisions within the context of a multicenter trial","volume":"29","author":"Silverman","year":"2001","journal-title":"Critical Care Medicine"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib80","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1164\/rccm.200303-430CP","article-title":"Protecting subjects with decisional impairment in research: The need for a multifaceted approach","volume":"169","author":"Silverman","year":"2004","journal-title":"American Journal of Respiratory Critical Care Medicine"},{"issue":"1","key":"2025122918045541100_s2398-601820180000004010_9.bib81","doi-asserted-by":"publisher","first-page":"27","DOI":"10.1177\/0969733007071355","article-title":"Consent and assent to participate in research from people with dementia","volume":"14","author":"Slaughter","year":"2007","journal-title":"Nursing Ethics"},{"issue":"6","key":"2025122918045541100_s2398-601820180000004010_9.bib82","doi-asserted-by":"publisher","first-page":"400","DOI":"10.1192\/bjp.bp.112.116335","article-title":"The full spectrum of ethical issues in dementia care: systematic qualitative review","volume":"202","author":"Strech","year":"2013","journal-title":"The British Journal of Psychiatry"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib83","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1111\/j.1532-5415.1998.tb02477.x","article-title":"Getting meaningful informed consent from older adults: a structured literature review of empirical research","volume":"46","author":"Sugarman","year":"1998","journal-title":"Journal of the American Geriatrics Society"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib84","doi-asserted-by":"publisher","first-page":"18","DOI":"10.5334\/ijic.2497","article-title":"Achieving Prudent Dementia Care (Palliare): An International Policy and Practice Imperative","volume":"16","author":"Tolson","year":"2016","journal-title":"International Journal of Integrated Care"},{"issue":"3","key":"2025122918045541100_s2398-601820180000004010_9.bib85","doi-asserted-by":"publisher","first-page":"184","DOI":"10.1016\/j.jamda.2010.12.013","article-title":"International Association of Gerontology and Geriatrics: A global agenda for clinical research and quality of care in nursing homes","volume":"12","author":"Tolson","year":"2011","journal-title":"Journal of the American Medical Directors Association"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib86","doi-asserted-by":"publisher","first-page":"360","DOI":"10.1177\/1533317514539377","article-title":"Cognitive fluctuations as a challenge for the assessment of decision-making capacity in patients with dementia","volume":"30","author":"Trachsel","year":"2015","journal-title":"American Journal of Alzheimer\u2019s Disease & Other Dementias"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib87","doi-asserted-by":"publisher","first-page":"503","DOI":"10.1177\/1740774515597701","article-title":"The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials","volume":"12","author":"Welch","year":"2015","journal-title":"Clinical Trials"},{"issue":"7","key":"2025122918045541100_s2398-601820180000004010_9.bib89","doi-asserted-by":"publisher","first-page":"515","DOI":"10.1111\/bioe.12367","article-title":"A pragmatic analysis of vulnerability in clinical research","volume":"31","author":"Wendler","year":"2017","journal-title":"Bioethics"},{"issue":"7","key":"2025122918045541100_s2398-601820180000004010_9.bib88","doi-asserted-by":"crossref","first-page":"514","DOI":"10.7326\/0003-4819-135-7-200110020-00011","article-title":"Core safeguards for clinical research with adults who are unable to consent","volume":"135","author":"Wendler","year":"2001","journal-title":"Annals of Internal Medicine"},{"issue":"4","key":"2025122918045541100_s2398-601820180000004010_9.bib90","doi-asserted-by":"publisher","first-page":"678","DOI":"10.1093\/ageing\/afw250","article-title":"Operationalising ethical challenges in dementia research-a systematic review of current evidence","volume":"46","author":"West","year":"2017","journal-title":"Age and Ageing"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib91","doi-asserted-by":"publisher","first-page":"423","DOI":"10.1080\/13607860500143125","article-title":"Awareness in dementia: Ethical and legal issues in relation to people with dementia","volume":"9","author":"Woods","year":"2005","journal-title":"Aging & Mental Health"},{"year":"2015","author":"World Health Organization","key":"2025122918045541100_s2398-601820180000004010_9.bib92"},{"issue":"5","key":"2025122918045541100_s2398-601820180000004010_9.bib93","doi-asserted-by":"publisher","first-page":"40","DOI":"10.1186\/alzrt143","article-title":"Dementia: a global health priority - highlights from an ADI and World Health Organization report","volume":"4","author":"Wortmann","year":"2012","journal-title":"Alzheimer\u2019s Research & Therapy"}],"container-title":["Ethics and Integrity in Health and Life Sciences Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.emeraldinsight.com\/doi\/full-xml\/10.1108\/S2398-601820180000004010","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.emerald.com\/books\/edited-volume\/chapter-pdf\/9404726\/s2398-601820180000004010.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,29]],"date-time":"2025-12-29T23:12:13Z","timestamp":1767049933000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.emerald.com\/books\/book\/15786\/chapter\/87433481\/Ethical-Challenges-of-Informed-Consent-Decision"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,12,6]]},"ISBN":["9781787435728","9781787435711","9781787439184"],"references-count":95,"URL":"https:\/\/doi.org\/10.1108\/s2398-601820180000004010","relation":{},"subject":[],"published":{"date-parts":[[2018,12,6]]}}}