Informed Consent for Research Involving People with Dementia: A Grey Area
Cubit, Katrina, Contemporary Nurse : a Journal for the Australian Nursing Profession
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
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, 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% 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.
DEMENTIA AS A RESEARCH PRIORITY
In Australia dementia was recognised as a National Health Priority in 2005 (Commonwealth Department of Health & Ageing, 2005). This resulted in a Federal Budget initiative by the then Coalition Government which provided funding of $320.6 million over 5 years for the purpose of enhancing dementia research, primary care and early intervention opportunities.
Since then, Alzheimer's Disease International identified the need for collaborative dementia research in the Asia Pacific region (Access Economics, 2006). In the same year, the National Framework for Action on Dementia 2006-2010 (AHMC, 2006) flagged dementia research as one of five key priority areas for action. Interestingly, in the challenges identified, the potential difficulties in obtaining informed consent from people with dementia were not recognized.
When people with dementia are to be considered as research participants, great care must be taken to ensure their human rights are maintained. Responsible researchers must preserve the dignity and respect of participants, ensure cultural differences are acknowledged and that the potential for causing harm to participants is avoided (National Health & Medical Research Council; Australian Research Council & Universities Australia, 2007). In Australia, guidelines are available for conducting responsible and ethical human research. These include The National Statement on Ethical Conduct in Human Research 2007 and the Australian Code for the Responsible Conduct of Research (NH&MRC, ARC & Universities Australia, 2007). These guidelines acknowledge that all kinds of research involving or impacting upon humans should conform to the highest standards of academic integrity and ethical practice. To adhere to these guidelines, researchers have an obligation to: understand and comply with ethical principles of integrity; respect for persons; justice and beneficence; and where required, gain written approval for research from a Human Research Ethics Committee (HREC). …