Capacity to Consent of People with Dementia: a Narrative Review from an Ethical Perspective

Urfa Khairatun Hisan; Nurul Qomariyah; Kristina Elizabeth

doi:10.33533/jpm.v16i2.4744

Authors

Urfa Khairatun Hisan - Faculty of Medicine, Universitas Ahmad Dahlan Yogyakarta. - Bioethics Master Study, Unversitas Gadjah Mada http://orcid.org/0000-0003-4952-3542
Nurul Qomariyah Aff 1: Faculty of Medicine, Universitas Ahmad Dahlan, Yogyakarta, Indonesia Aff 2: Research Ethics Committee, Universitas Ahmad Dahlan, Yogyakarta, Indonesia
Kristina Elizabeth Aff 1: Graduate School of Health Law, Universitas Katolik Soegijapranata, Semarang, Indonesia Aff 2: Sector of Medical and Health Service, Resort Police Force of Yogyakarta, Indonesia

DOI:

https://doi.org/10.33533/jpm.v16i2.4744

Keywords:

Capacity to Consent, Decision-making Capacity, Dementia, Research Ethics

Abstract

People with dementia have impairment to execute daily life activities by presenting as a deterioration of mental processes, such as memory, thinking, reasoning, and judgment. Many participants in dementia research may lack the capacity to provide informed consent. Additional safeguards are needed for dementia research participants’ protection because of their vulnerability. Only after carefully weighing the risks and possible benefits for the participants in the research may it be decided to use vulnerable participants. The intention to prevent harm pushes against the removal of autonomy. This dilemma is the driving force behind this article's narrative review of the capacity to consent problems in dementia research. For this critical narrative review, we conducted a thorough search of Scopus, PubMed, and Wiley Open Library for literature addressing the ethical and legal issues on the capacity to consent of people with dementia. We outline the dilemmas and difficulties that surround them including the related ethical principles, the informed consent process, capacity to consent, and safeguards for the participant in research involving people with dementia.

Author Biography

Urfa Khairatun Hisan, - Faculty of Medicine, Universitas Ahmad Dahlan Yogyakarta. - Bioethics Master Study, Unversitas Gadjah Mada

Urfa Khairatun Hisan is a lecturer at the Faculty of Medicine, Universitas Ahmad Dahlan, and a graduate student of the Department of Bioethics, Universitas Gadjah Mada. She received her B.Med. and M.D. degrees from the Faculty of Medicine, Universitas Gadjah Mada, Yogyakarta, Indonesia, in 2017 and 2019, respectively. Her research interests include public health and bioethics in medicine. She can be contacted at email: urfa.khairatun.h@mail.ugm.ac.id or urfa.hisan@med.uad.ac.id.

References

Organisation WH. Global action plan on the public health response to dementia 2017 - 2025 [Internet]. Geneva: World Health Organization. 2017. 52 p. Available from: http://www.who.int/mental_health/neurology/dementia/action_plan_2017_2025/en/

World Health Organization. Public health response to dementia [Internet]. Geneva: World Health Organization. 2021. 137 p. Available from: https://www.who.int/publications/i/item/9789240033245

Warner J, McCarney R, Griffin M, Hill K, Fisher P. Participation in dementia research: rates and correlates of capacity to give informed consent. J Med Ethics. 2008 Mar;34(3):167–70.

Lai JM, Karlawish J. Assessing the capacity to make everyday decisions: a guide for clinicians and an agenda for future research. Am J Geriatr psychiatry Off J Am Assoc Geriatr Psychiatry. 2007 Feb;15(2):101–11.

Jackson E, Warner J. How much do doctors know about consent and capacity? J R Soc Med. 2002 Dec;95(12):601–3.

Cacchione PZ. People with dementia: capacity to consent to research participation. Vol. 20, Clinical nursing research. United States; 2011. p. 223–7.

The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research. J Am Coll Dent. 2014;81(3):4–13.

Soofi H. Respect for Autonomy and Dementia Care in Nursing Homes: Revising Beauchamp and Childress’s Account of Autonomous Decision-Making. J Bioeth Inq. 2022 Sep;19(3):467–79.

World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov;310(20):2191–4.

Agarwal MR, Ferran J, Ost K, Wilson KCM. Ethics of “informed consent” in dementia research -- the debate continues. Int J Geriatr Psychiatry. 1996 Sep;11(9):801–6.

Fields LM, Calvert JD. Informed consent procedures with cognitively impaired patients: A review of ethics and best practices. Psychiatry Clin Neurosci. 2015 Aug;69(8):462–71.

Woods B, Pratt R. Awareness in dementia: ethical and legal issues in relation to people with dementia. Aging Ment Health. 2005 Sep;9(5):423–9.

Schuklenk U, Ashcroft R. International research ethics. Bioethics. 2000 Apr;14(2):158–72.

Black BS, Brandt J, Rabins P V, Samus QM, Steele CD, Lyketsos CG, et al. Predictors of providing informed consent or assent for research participation in assisted living residents. Am J Geriatr psychiatry Off J Am Assoc Geriatr Psychiatry. 2008 Jan;16(1):83–91.

Forrester K, Griffiths D. Essentials of Law for Health Professionals-eBook. Elsevier Health Sciences; 2014.

Cubit K. Informed consent for research involving people with dementia: a grey area. Contemp Nurse. 2010;34(2):230–6.

Karlawish J. Measuring decision-making capacity in cognitively impaired individuals. Neurosignals. 2008;16(1):91–8.

Gilbert T, Bosquet A, Thomas-Antérion C, Bonnefoy M, Le Saux O. Assessing capacity to consent for research in cognitively impaired older patients. Clin Interv Aging. 2017;12:1553–63.

Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients’ capacities to make treatment decisions. Psychiatr Serv. 1997 Nov;48(11):1415–9.

Pennington C, Davey K, Ter Meulen R, Coulthard E, Kehoe PG. Tools for testing decision-making capacity in dementia. Age Ageing. 2018 Nov;47(6):778–84.

Etchells E, Darzins P, Silberfeld M, Singer PA, McKenny J, Naglie G, et al. Assessment of patient capacity to consent to treatment. J Gen Intern Med. 1999 Jan;14(1):27–34.

Lai JM, Gill TM, Cooney LM, Bradley EH, Hawkins KA, Karlawish JH. Everyday decision-making ability in older persons with cognitive impairment. Am J Geriatr psychiatry Off J Am Assoc Geriatr Psychiatry. 2008 Aug;16(8):693–6.

Schmand B, Gouwenberg B, Smit JH, Jonker C. Assessment of mental competency in community-dwelling elderly. Alzheimer Dis Assoc Disord. 1999;13(2):80–7.

Olde Rikkert MG, Verweij MF, Hoefnagels WH. [Informed consent and mental competence of the elderly in medical-scientific studies]. Tijdschr Gerontol Geriatr. 1995 Aug;26(4):152–62.

Kim SYH, Karlawish JHT, Caine ED. Current state of research on decision-making competence of cognitively impaired elderly persons. Am J Geriatr psychiatry. 2002;10(2):151–65.

Slaughter S, Cole D, Jennings E, Reimer MA. Consent and assent to participate in research from people with dementia. Nurs Ethics. 2007 Jan;14(1):27–40.

Research consent for cognitively impaired adults: recommendations for institutional review boards and investigators. Alzheimer Dis Assoc Disord. 2004;18(3):171–5.

Berghmans RLP, ter Meulen RHJ. Ethical issues in research with dementia patients. Int J Geriatr Psychiatry. 1995 Aug;10(8):647–51.

Artal R, Rubenfeld S. Ethical issues in research. Best Pract Res Clin Obstet Gynaecol. 2017 Aug;43:107–14.

Meulenbroek O, Vernooij-Dassen M, Kessels RPC, Graff MJL, Sjögren MJC, Schalk BWM, et al. Informed consent in dementia research. Legislation, theoretical concepts and how to assess capacity to consent. Eur Geriatr Med. 2010;1(1):58–63.