Informed consent for research involving people with dementia: A grey area
Katrina Cubit
School of Nursing & Midwifery, University of Tasmania, Launceston TAS
PP: 230 - 236
Abstract
Research involving people with dementia has been flagged as a key priority by Alzheimer's International. Dementia has been an Australian National Health Priority since 2005, yet there are no clear guidelines for seeking and obtaining informed consent from people with dementia to participate in observational research. Informed consent is an ethical requirement for the conduct of research involving humans. Although many people with dementia are able to express a desire to be involved in research, the insidious progression of the disease reduces a person's ability to understand and appreciate the consequences of involvement. This paper explores the author's journey of seeking and obtaining informed consent for a mixed methods study which involved the observation of older people with dementia.
Keywords
Nursing, mixed methods research, dementia, consent
Article Text
As the population ages, governments, health care providers, communities and families are faced with the significant burden of caring for people with dementia. Dementia is becoming increasingly prevalent in ageing populations worldwide (Access Economics Pty Limited 2005). In 2003, the number of people with dementia in Australia was estimated to be 173,000. The total health and welfare system expenditure for dementia in the same year was estimated at $1.4 billion (AIHW 2007a). Predictions are that by 2050 more than 730,000 Australians (2.8 per cent of the projected population) will have dementia (Access Economics 2005). As a cure for dementia is not yet on the horizon, there is a growing imperative to conduct research into finding ways of slowing the dementia process and for managing the behavioural and other associated symptoms.
Conducting research involving people with cognitive decline associated with dementia is however fraught with difficulties. The most problematic of these is the arduous process of seeking and obtaining informed consent in a moral and ethical way. Informed consent can be difficult to obtain due to the nature of the disease process which may preclude people from providing consent for themselves.
References
Access Economics (2006) Dementia in the Asia Pacific region: the epidemic is here. Report for Asia Pacific Members of Alzheimer's Disease International. Retrieved 4 March 2009 from http://www.alzheimers.org.au/upload/AsiaPacificEpidemicSept06.pdf.
Access Economics Pty Limited (2005) Dementia estimates and projections: Australian states and territories. Alzheimer's Australia. Canberra.
AHMC (2006) National Framework for Action on Dementia 2006-2010. Australian Health Ministers' Conference, New South Wales Department of Health. North Sydney. Retrieved 4 March 2009 from http://www.health.gov.au/internet/main/publishing.nsf/Content/D64BD892C6FDD167CA2572180007E717/$File/nfad.pdf.
AIHW (2003) Australia's Welfare 2003. Australian Institute of Health and Welfare. Canberra.
AIHW (2007a) Dementia in Australia: National data analysis and development. Australian Institute of Health and Welfare. Canberra.
AIHW (2007b) Older Australians at a glance (4th edn) AIHW and the Office for Older Australians, Commonwealth Department of Health and Aged Care. Canberra. Retrieved 18 June 2009 from http://www.aihw.gov.au/publications/index.cfm/title/10402.
Bartlett H and Martin W (2002) Ethical issues in dementia care research. The perspectives of people with dementia: research methods and motivations. H. Wilkinson. London Jessica Kingsley: 47-61.
Brodaty H (2007) Six reasons why the early diagnosis of dementia does not occur but ten reasons why it is important. South Eastern Sydney Division of General Practice (Supplement to March/April Newsletter).
Carpenter B and Dave J (2004) Disclosing a dementia diagnosis: a review of opinion and practice, and a proposed research agenda. The Gerontologist 44(2): 149-158.
Cohen-Mansfield J (2003) Consent and refusal in dementia research: conceptual and practical considerations. Alzheimer Disease & Associated Disorders 17(Suppl. 1): S17-S25.
Commonwealth Department of Health and Ageing. (2005) Ageing Factsheet 1 - Helping Australians with dementia, and their carers - making dementia a National Health Priority. Retrieved 25 April 2008 from http://www.health.gov.au/internet/budget/publishing.nsf/Content/health-budget2005-abudget-afact1.htm.
Cubit KA (2009) Dementia and physically aggressive behaviour in residential aged care. School of Nursing & Midwifery. Launceston, University of Tasmania. Unpublished PhD thesis.
Foley JM and Post SG (1994) Ethical issues in dementia. Handbook of Dementing Illnesses. JC Morris New York, Marcel Dekker Inc.: 3-22.
Forrester K and Griffiths D (2001) Essentials of law for health professionals. Sydney, Harcourt.
Goodwin JS (2002) Language and medicine: thinking and talking about Alzheimer's Disease. The Gerontologist 42(3): 293-296.
Hellström I, Nolan M, Nordenfelt L and Lundh U (2007) Ethical and methodological issues in interviewing persons with dementia. Nursing Ethics 14(5): 608-619.
Hougham GW (2005) Waste not, want not: cognitive impairment should not preclude research participation. The American Journal of Bioethics 5(1): 36-37.
Lai JM and Karlawish J (2007) Assessing the capacity to make everyday decisions: A guide for clinicians and an agenda for future research. American Journal of Geriatric Psychiatry 15: 101-111.
Mocellin R, Scholes A and Velakoulis D (2008) Quality dementia care: understanding younger onset dementia. Alzheimer's Australia. Hawker, ACT.
Moye J, Karel MJ, Azar AR and Guerra RJ (2004) Capacity to consent to treatment: empirical comparison of three instruments in older adults with and without dementia. The Gerontologist 44(2): 166-175.
National Dementia Behaviour Advisory Service (2003) ReBOC: Reducing behaviours of concern - a hands on guide. Glenside, Alzheimer's Association (SA) Inc.
National Health & Medical Research Council; the Australian Research Council and Universities Australia (2007) National statement on ethical conduct in research involving humans. Commonwealth of Australia. Canberra, ACT. Retrieved 18 March 2009 from http://www.nhmrc.gov.au/publications/synopses/_files/e72.pdf.
National Health and Medical Research Council (2006) Challenging ethical issues in contemporary research on human beings. Australian Government. Canberra. Retrieved 18 June 2009 from http://www.nhmrc.gov.au/PUBLICATIONS/synopses/_files/e73.pdf.
National Health and Medical Research Council; the Australian Research Council and Universities Australia (2007) Australian code for the responsible conduct of research. Canberra, ACT, Revision of the joint NHMRC/AVCC statement and guidelines on research practice.
Pond D and Brodaty H (2004) Diagnosis and management of dementia in general practice. Australian Family Physician 33(10): 789-793.
Slaughter S, Cole D, Jennings E and Reimer MA (2007) Consent and assent to participate in research from people with dementia. Nursing Ethics 14(1): 27-40.
Teel CS (2004) Rural practitioners' experiences in dementia diagnosis and treatment. Aging & Mental Health 8(5): 422-429.
Williams K (2007) Understanding capacity. Australian General Practice Network. Retrieved 6 March 2009 from http://www.gppartners.com.au/content/Document/resource_capacity.pdf.
Yarborough M (2002) Adults are not big children: examining surrogate consent to research using adults with dementia. Cambridge Quarterly of Healthcare Ethics 11(2): 160-168.
eContent Home
