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Involving people with dementia

Ethics of dementia research


Involving people with dementia in all aspects of research is increasingly recognised as being essential to good dementia research.  Their involvement as research participants is of paramount importance and recognised as a significant contribution to society. This also reflects their value within society and their equal right to participate in research.

However, research is no longer simply carried out “on” people with dementia but also “with” them. They have a valuable contribution to make to the selection of research topics, the design of studies, issues related to recruitment and those linked to the interpretations and dissemination of the results.  This involvement again reflects their value and is recognition that having dementia means possessing certain knowledge and experience that researchers are interested in learning about. It also reflects changing perceptions within society about people with dementia and the practice of social inclusion.

As people with dementia are equal members of society, they have views to share about a wide range of issues, in the same way as do people with diabetes, cancer or no health problems at all. People with dementia, as the term implies, “have dementia” but each person is different (e.g. might be a public transport user, go shopping, be an ecologist, enjoy skiing etc.) and has something to contribute towards society. The topic of this report is dementia research but clearly, people with dementia should not be excluded from taking part in research about other topics of interest to them just on the basis of their diagnosis.

It is also important to understand that people with dementia are not a homogenous group. Whilst they all have dementia, they are of various ages (but mainly older people), from different cultural groups and social classes and with different levels of education etc.

The term “older people” requires some explanation. Old age is often associated with retirement age but this may be misleading. Retirement, which was initially introduced in Germany by Otto von Bismark in the 1880s, was fixed at 65 as in those days life expectancy at birth was extremely low (Schulz, 1988). Most people therefore worked until they died and very few actually received a pension. With the exception of a few countries (i.e. Norway and Germany), this is still the retirement age in most countries in Europe even though life expectancy is now considerably higher. The term “old-old” is sometimes used to refer to people who are extremely advanced in age. On the other hand, with the cultural emphasis on youth in modern Western society, the term “senior” has been introduced which is usually understood as denoting a person over the age of 50 (and presumably under 65). In the ICH guidelines produced by the European Medicines Agency (EMA [1] ) (1994), the geriatric population is defined as being comprised of people over the age of 65 with further reference being made to an even older population comprised of people over the age of 75. Nevertheless, the mean age in geriatric wards is now 80 to 83 years (European Forum for Good Clinical Practice, in press).

Consequently, when discussing the involvement of older people in research, it is important to bear in mind that we are covering a very wide range of people aged from the albeit arbitrarily defined age of 65 onwards right up to centenarians. Most people who have dementia are over the age of 65. Both prevalence rates and the incidence of Alzheimer’s disease increase dramatically with age, particularly in the 75+ age group.

On the other hand, there are many people with dementia under the age of 65.  This number may increase in line with an increase in early diagnosis but also due to the ageing of groups with a relatively high risk of dementia such as those with intellectual difficulties (especially Down’s syndrome) and those with head injuries. There are groups of people represented in the population of people with dementia such as people from ethnic groups, those with intellectual disabilities and lesbian, gay, bisexual and transsexual (LGBT) people etc. People with dementia from all walks of life have the right to be involved in research.

[1] The abbreviation for the European Medicines Agency changed from EMEA to EMA in 2004. The new abbreviation will be used throughout this document.


Letting people with dementia speak for themselves

Barriers based on communication and understanding the nature of dementia

Even a decade ago, relatively few people with dementia were involved in dementia research (other than clinical trials). Early diagnosis was less common and people were often not informed of the diagnosis. The views and experience of people with dementia were mainly obtained via proxies, mainly carers. This may have been due to negative perceptions of older people, the presumption that they were incapable of communicating their thoughts and feelings and an over-medicalized understanding of the experience of dementia (Hubbard, Downs and Tester, 2003).

The assumption that people with dementia are not capable of communicating their views, feelings and opinions has since been challenged by researchers (Barnett, 2000; Keady, Noland and Gilliard, 1995; Goldsmith, 2002; Wilkinson, 2002). It has also been challenged by people with dementia themselves who have taken part in research, published articles and books, and made speeches at high level European and international conferences (Davis, 1989; McGowin, 1993; McKillop, 2010, 2011). Whilst people with dementia may experience certain difficulties, there may be a tendency to overemphasize “problems” and underestimate the remaining capacities that people have. Talking about her first experience of interviewing older people with dementia, Elisabeth Barnett commented:

“It was quite a shock to discover just how “unproblematic, they actually were. Having arrived freshly armed with new techniques for interviewing confused elderly people, I was confused myself to find that the clients appeared not to be so! (…./….) I became decidedly uncomfortable and wondered if, in fact, their diagnoses were correct, or if everything I thought I knew about dementia was incorrect. In fact, I had merely discovered the enormous range of variation in ability/disability that “dementia” covers” (Barnett, 2000, p. 49).

Unfortunately, not all researchers have sufficient knowledge of dementia or the openness and self-reflection needed to look beyond stereotypes and misconceptions about complete and global incapacity.

Others may be keen to involve people with dementia but lack the knowledge and necessary skills to involve people with moderate or more advanced dementia. This may result in a disproportionate number of people with early dementia in studies and a lack of research on issues of relevance to people in the more advanced stages of dementia. The increased difficulty in involving the latter results in a lack of equity and a failure to address issues of particular importance for people at different stages of dementia.

Overprotection – balancing risk and benefit in relation to inclusion

One of the reasons for involving proxies instead of people with dementia themselves is that the person with dementia might find the research process disturbing. This may sometimes occur but the solution is not necessarily to exclude people with dementia from research or replace them with carers, but rather to look for ways to reduce the likelihood or consequences of harm (e.g. by having a counsellor available). Methodological issues must be considered in order to make this possible.

An overemphasis on possible harm may lead to the possible benefits of participation being overlooked. Commenting on his own experience of participating in research, McKillop (2011) draws attention to the feeling of empowerment that can result from participating in research and the long-term benefits to other people with dementia. Hellström et al. (2007) conclude that there are serious consequences to not including people with dementia in research and suggests that the question should be not so much whether people with dementia should be included in research, but rather how can we best achieve this and how can we afford not to.

Involving older people in research

The need to involve older people in research

The need to avoid excluding people from clinical research solely on the grounds of age was recognised over 20 years ago, first by the American Food and Drugs Administration (FDA, 1989) and a little later by the European Medicines Agency (EMA):

There is no good basis for the exclusion of patients on the basis of advanced age alone, or because to the presence of any concomitant illness or medication , unless there is reason to believe that the concomitant illness or medication will endanger the patients or lead to confusion in interpreting the results of the study. (FDA, 1989)

Drugs should be studied in all age groups, including the elderly, for which they will have significant utility. Patients entering clinical trials should be reasonably representative of the population that will be later treated by the drug. (EMA, 1994)

Clearly, this practice is not yet widespread as highlighted in a paper produced by the European Forum for Good Clinical Practice (EFGCP) entitled “Ethical considerations for clinical trials in older persons” (EFGCP, in press).

Are older people involved in research?

There is evidence that older people are notably absent from research, particularly clinical trials and pharmacotherapy research (Orwig et a., 2011; Van Spall et al., 2007)). For example, a search of two well-known research databases (PubMed and CINAHL) revealed that only 3 to 6% of clinical trials were based on older populations only (National Center for Biotechnology Information, 2010; EBSCO Publishing/Orwig et al., 2011). Consequently, clinical trials sometimes involve participants who are not representative of those for whom the medication is most likely to be used (Heait et al., 2002).

A comparison by Beswick et al. (2010) of the mean age of participants in 14 randomised control trials of cholinesterase inhibitors, as reported by Birks (2006) in a Cochrane review, revealed that only in three was the average age over 75 (and over 86 in one) and in six, the average age was 73. According to Beswick et al. (2010), the literature on the age of older people in clinical trials for Alzheimer’s disease is limited but for clinical trials to be truly representative, they should include a large percentage of people between the age of 75 and 90. In another review of 109 clinical trials of therapeutic interventions in adults, assessing morbidity or mortality, it was revealed that 20% of studies automatically excluded patients above a certain age (Zulman et al., 2011).

On the other hand, there have been a number of initiatives involving older people such as the many longitudinal and retrospective studies in which their participation has been valuable. An example of an on-going study involving older people is that of the Alzheimer’s Disease Neuroimaging Initiative (ADNI) whose aim is to explore changes of cognition, function, brain structure and function, and biomarkers in older controls, in subjects with mild cognitive impairment, and in subjects with AD (Weiner, 2011). The “nun study” is a good example of the inclusion of older people in research. This was a longitudinal study into healthy ageing and dementia involving 678 Catholic sisters aged between 75 and 107 (Snowdon, 2003). It involved examination of archives, annual examinations and a post mortem analysis of the brain.

In psychosocial studies too, researchers are increasingly aware of the need to involve older people and to avoid discriminating on the basis of age. Hubbard et al. (2003) draw attention to the importance of both verbal and non-verbal communication when trying to involve older people with dementia in research. Sometimes age is associated with a more advanced stage of dementia. They caution against categorizing people into different stages, suggesting rather the need to focus on specific impairments and to use methods suited to the individual, irrespective of the duration or severity of dementia.

General barriers to participation

Possible barriers to the involvement of older people in research of all kinds include physical and cognitive impairments, lack of transport, a lower threshold for burden, distrust, changes in routine and negative beliefs about medication (Modey et al., 2008; Orwig et al., 2011). However, such factors do not apply to all older people and are not limited to older people. Suggesting that they do would amount to stereotyping. Higher costs linked to the recruitment and maintenance of older people in studies have also been cited as possible barriers to their participation in research(Cherubini et al., 2010). 

With the necessary time, effort and perhaps financial investment, such factors could often be overcome. Adherence to recruitment methods and study protocols, which do not take into account the specific needs of older people (with or without dementia) as well as failure to build in additional costs into the design of studies for the recruitment of older people, could be considered as examples of ageism and structural discrimination. This is also not in keeping with the principles of dignity, respect and social inclusion.  

Specific issues linked to the exclusion of older people from clinical trials 

Failure to include older people in clinical and epidemiological studies may lead to inequities in healthcare (Choo, 1994). However, it has been suggested that people with poor health and older people may be particularly difficult to recruit in clinical trials. As Prof. Tom MacDonald from the University of Dundee’s Medicines Monitoring Unit points out, “We can’t get the people who are unhealthy to take part, and we can’t get older people to take part. But they are the ones who need all the drugs” (quoted in Reynolds, 2001, p. 1338 – BMJ, 342, 2011).

The difference between older people and younger people participating in clinical trials is not simply numerical (i.e. the number of years’ difference in age). Rather, it is the implications or consequences of age which are often perceived in a negative light due to comparison with the socially defined norm of the younger person. There may be differences between younger and older people with regard to:

  •  adherence (whether the person actually takes the medication as recommended),
  • adverse reactions,
  • pharmacokinetics and pharmacodynamics (biological effects in this case linked to age e.g. affecting metabolism and sensitivity to medication),
  • comorbidities (having additional acute illnesses and chronic conditions – such as dementia),
  • polypharmacy (increased use of medication/older people taking several different drugs each day) (EFGCP, in press; Orwig et al., 2011).

The above age-related differences often contribute towards the exclusion of older people from clinical trials. However, these are the characteristics of the majority of older people who will eventually be taking the drugs which hopefully will result from the clinical trials from which they were excluded. They are not the characteristics of the majority of those who took part in the study.

Another possible reason for excluding older people from clinical trials is that their inclusion might dilute the active treatment effect, thereby resulting in results which are not statistically significant (Cherubini et al., 2010). This has obvious implications for the development of marketable drugs but at the same time for fairness to the hundreds or thousands of participants who dedicate their time and energy to a study which may be inconclusive. Nevertheless, Sox and Greenfield (2009) criticise randomised clinical efficacy trials for attempting to create near ideal circumstances in order to determine whether the intervention could possibly work as this may result in many people (e.g. older people with comorbidities) being excluded and does not reflect the conditions in real clinical practice.

The scientific validity of research into the use of existing or experimental drugs which have not been tested on the populations using them is questionable. As Loewy (2007) points out, it would be inappropriate scientifically (and hence unethical as good ethics must start with good facts) to extrapolate the conclusions of a study based, for example, on 20 to 30 year old white males to a 70-year-old black woman. People with dementia are entitled to have access to drugs which were tested on people of a similar age because the physiology of younger people (even younger people within the older age group) is likely to be different and therefore side effects and tolerability may be different. The EFGCP (in press) recently advised in their paper on the Ethical Considerations for Clinical Trials in Older Persons that all medicines be tested on our real, very old, frail and multi-morbid patients. They further suggest that extrapolation on other patients and conditions is scientifically unsound and has to be abandoned as soon as possible.

If older people with dementia are excluded from research, they are denied the same opportunity as other members of society to participate in and contribute towards society, to express their views and ultimately, to benefit from drugs which have been scientifically tested on people with similar characteristics to themselves (contrary to most other groups in society). This is not in keeping with the principles of equity, solidarity and autonomy, and amounts to exclusion and discrimination. However, there is a growing awareness of the need to include them and of their right to be involved.

Areas where appropriate research involving or of relevance to older people is lacking

An important avenue of research, currently being developed, is that of pharmacogenomics. Pharmacogenomics is the field of research which focuses on the effect of genes on individual responses to medicines in terms of effectiveness and toxicity. For this reason, some pharmaceutical companies collect DNA samples which they then analyse alongside the results of clinical trials. This has led to advances, for example, in the effective treatment of HIV (where a genotyping kit has been developed) and in the domain of cancer (in connection with the breast cancer drug Herceptin ®) (NIGMS, 2011). Further progress is needed in conditions predominantly affecting older people (e.g. in the domain of neuro-degenerative diseases such as dementia).

Another area of research attracting interest is comparative effectiveness research, which compares different available treatments or examines their impact on particular sub-populations such as people with other existing medical conditions or of the same age, sex or ethnic group as a particular patient. This can be helpful because as Tinetti and Studenski (2011) point out, there are an infinite number of combinations of diseases and treatments and this makes the identification of a truly representative population very difficult. Comparative effectiveness research can be meaningful to doctors when trying to make a decision about or with a specific patient, particularly when treatments which are effective for one condition may exacerbate another condition in the same patient (Tinetti and Studenski, 2011; Institute of Medicine of the National Academies, 2009).  

Pharmacogenomics and comparative effectiveness research are relatively new areas of research which could be beneficial to older people with dementia. In the interests of equity but also to avoid age-based discrimination, adequate funding must be provided for this particular population.

Reactions of patients towards failure to include older people in research

The PREDICT study (2000), which aimed at increasing the participation of older people in clinical trials, investigated how the low number of older people involved such research was interpreted by lay people. A series of focus groups were held in which people with stroke, depression, heart failure, cancer, diabetes or dementia and their carers were asked about participation in clinical trials (Bartlam et al., 2010). Most people felt that leaving older people out of clinical trials amounted to ageism and a devaluation of older people in both scientific and social communities. Some were shocked that it was even possible for certain drugs, typically used for older people, to have been clinically tested on much younger populations. Other points raised in the PREDICT study, which could equally apply to other forms of research, is that older people are devalued  and stereotyped as vulnerable (perhaps leading to over-protection) (Bartlam et al., 2010). This undermines their right and ability to take part in research.

Involving older people in all kinds of research and at all stages of the research

At the same time, it is important not only to involve older people in research but to involve them in research which results in knowledge that is meaningful to them and their doctors, such as comparative effectiveness research, bearing in mind that older people with comorbidities may have different priorities when it comes to outcome measures compared to those of the researchers. In a review of over 100 studies into conditions which are common in older people, only 27% mentioned outcomes which were of relevance to the older people such as quality of life or functional status (Covinsky, 2011). Whereas researchers may place their emphasis on disease specific outcomes, older people with multiple conditions may prioritize outcomes of a more individual or personal nature.

Involving people from ethnic minority and other “racialised” groups in research

According to the principle of justice, participants should have an equal opportunity to participate in research (Fondation Médéric Alzheimer, 2011). This means that they should not be systematically excluded on the basis of race, gender, religion or other personal characteristics unless this can be justified due to the nature of the research question (Fawcett and Garity, 2009). For example, it would be justifiable to exclude “white/European” or Indian immigrant carers from a study into the attitudes of Chinese immigrant carers towards state support but it would not be justifiable to exclude same-sex Chinese immigrant partners who are carers from that study.

Language barriers may prevent some people from ethnic minority groups or immigrants from participating in research. Researchers could be encouraged to take necessary steps to overcome this barrier (e.g. having interpreters or participant information sheets and consent forms in the language of potential participants from such groups). However, this would incur extra time and costs, which they might not have. It would be impossible to translate research materials into every possible language and each translation would ideally have to be translated and then back-translated (to see whether the translated version when translated back into English is very close to the original version).  With some research materials, such as cognitive tests or other research tools (sometimes called research instruments), this would not be sufficient as the materials should ideally be validated and this would involve a study in itself. Certain well-known tests may already exist in other languages and already be validated but may be difficult to obtain.

In some countries, sign language is recognised as a language and in New Zealand, it is one of three official languages of the country (New Zealand Government, 2006). However, researchers may find it even more difficult to involve people with dementia who use sign language in research due to difficulties communicating and a lack of tools adapted to this particular group of people.

People from ethnic minority groups are poorly represented in published clinical trials (Mason et al., 2003). Their inclusion in other types of research is probably also low (Hulko, 2004). Some cultural groups (e.g. travellers [1] ) may be even more absent from research, perhaps based on a combination of factors such as accessibility, patterns of mobility, language and stigma.

It is debatable whether the voices of people with dementia are really being heard in the domain of research or whether the voices of certain groups of people (which Hulko describes as “racialised” people) such as older and disabled people, LGBT people, people on a low income and those with little or no education, are being ignored. (Younger people may also be somewhat excluded from dementia research as dementia is typically associated with older people and as younger people may be difficult to reach.)

Hulko (2004) points out that where these groups have been included in research, the focus has tended to be on comparative risk, incidence and prevalence, challenges in assessment and diagnosis, service provision and the meanings of dementia. There are very few accounts of their subjective experiences of dementia as the focus tends to be on the subjective experiences of white, middle-aged, well-educated people in the early stages of dementia with a supportive family (also, Phinney, 2008).

People with dementia from ethnic groups should be involved in the design of studies and the dissemination of the results as well as in their capacity as a research participant. It has been suggested that in the case of studies involving people from different cultures, researchers should seek the advice of community leaders. However, others warn against assuming that the opinions of minority scholars and community leaders truly reflect those of all members of that community, suggesting that this amounts to paternalism (Fisher, 2006).

The very use of terms such as “race” and “ethnicity” fails to challenge racial stereotypes or examine the significance of these socially constructed labels (Standfield, 1993; Fisher, 2006). It also strips people of their personal identity, as they become a mere representative of a particular “race” to which they may even have little sense of belonging (Heath, 1995). For example, a British participant, who was born and educated in England, whose mother was French and father Pakistani, might be classed as “mixed Asian” in a particular study but she might consider herself as international, British, mixed British, Asian or British Asian. 

Involving people from minority communities in research should also extend to the choice of research topic. Tyack (1995) points out that research into issues relating to various minority groups often reflects topics chosen by or identified as being problematic by people who are not members of those groups and often for economic or political reasons.

Involving people dying with or from dementia in research

Research with patients at the end of their lives can be extremely difficult. Morse (2000) described qualitative studies with seriously ill patients as “being the most difficult type of qualitative research because of the immediacy of their symptoms and fluctuating nature of their own personal realities.” Nevertheless, it has been suggested that excluding patients who are at the end of their lives from clinical research is unethical and runs counter to the Declaration of Helsinki and that instead of asking whether they should be included in research, we should be asking on what grounds, if any, would it be considered ethical to exclude them (Alexander, 2010; Bradburn and Maher, 2005; Krouse et al., 2003).

It is important that research into end-of-life care is conducted amongst a group of participants with the same characteristics as those for whom the improvements in care are envisaged (Carasret et al., 2001). Studies involving people who do not have dementia or are not receiving end-of-life care would be unlikely to contribute towards the development or improvement of services for that group. For this reason, the participation of people who are dying with or from dementia is greatly needed. Furthermore, depriving them of the opportunity to take part in research could be construed as paternalism or injustice.

It has been suggested that participants in end-of-life research cannot benefit from the results of the research as they will no longer be around to do so and that they should therefore be left in peace. This presumes that they will not benefit from an intervention that is being studied during the study or from the personal satisfaction of being able to benefit others. Alexander (2010) suggests that such presumptions, for which there is no supporting empirical evidence, may have hindered the development of appropriate palliative care to vulnerable groups.

Moreover, people with a limited prognosis are still people and as far as we know, have the same views about the potential value to the community of participating in research as do other people (Addington-Hall, 2002). Consequently, a person’s prognosis should not be used as an excuse to deprive them of the right to decide whether or not to participate in such studies.

Reciprocity has been described as a universal element in sustaining human relationships (Gouldner, 1960) and as a basic social need which is largely ignored but may contribute towards self-esteem and dignity, as well as respecting autonomy (Vernooij-Dassen et al., 2011). As the disease progresses, it may become increasingly difficult to find opportunities to give something back to others or to society at large, particularly in the end stage when many people are dependent on others for their care. It would therefore be unethical to deny them this opportunity.

Recruitment and the involvement of third parties

Many studies are based on convenience samples or purposive sampling. This means that the participants are chosen on the basis of availability (i.e. because it was possible to reach them) or for theoretical or practical reasons and that they were not randomly selected. These are acceptable ways of recruiting participants and commonly used in qualitative studies where the need for a large, random sample is not necessary (i.e. for statistical purposes). Some quantitative studies also use convenience samples but this approach has implications for statistical analysis and the perceived value of the results.

However, such recruitment strategies may also have ethical implications. For example, gaining access to people in specific settings may necessitate the involvement of other people such as health and social care professionals and staff but these people may not be aware of or entitled to give information about people’s diagnoses to third parties. Some may nevertheless do this, thereby violating the right to privacy and confidentiality. If they limit themselves to identifying people with memory problems, such people cannot be considered as necessarily having dementia as the two are not synonymous.

Alternatively, they may block access to potential participants. Managers in care homes, for example, might refuse permission based on concerns about disturbing residents or the belief that they would not be interested (Fisk and Wigley, 2000; Sherratt et al., 2007). Alternatively, refusals to cooperate may be based on stereotypes about dementia, concerns about how they or their staff might be affected by the study and paternalism. In a recent phenomenological study, for example, into the experience of patients with malignant wounds receiving palliative care, some patients were excluded from the study based on the unilateral decision of healthcare professionals who felt that it would be detrimental to their wellbeing. Yet those who did take part in the study all commented that it was a positive experience and that they appreciated having been able to tell their story (Alexander, 2010).

Addington-Hall (2002) suggests that such practices may limit participation in end-of-life research to a particular type of person and deprive others of the right to be heard. Even research which does not aim at representativeness in the statistical sense may strive to represent a diversity of views and therefore such interference with the selection process could adversely affect the results.

The involvement of third parties can also be positive in that it may help to reduce feelings of anxiety, prevent coercive measures being used to recruit participants and facilitate access to certain groups of people with dementia (e.g. those living in residential care or institutions, those with Down’s Syndrome and those from ethnic minority groups).

Attempts to recruit people with dementia for studies into end-of-life care may be upsetting to potential participants and their close family and friends if they had not realised that this is what they were receiving. Healthcare professionals may have been avoiding using these terms in order to help those concerned retain hope or cope emotionally. It is not always possible for researchers responsible for the initial contact to understand how someone interprets the treatment or care they are receiving. Even if a person has been told, they might not have taken in the implications of what was said. Healthcare professionals with experience interacting with people dying with or from dementia could be helpful in advising researchers on how to approach this topic with individual patients.   

The involvement of third parties may therefore be beneficial in some cases, protecting the wellbeing of potential participants and hinder the recruitment process in others, depriving some people with dementia of their autonomy and disempowering them.

Involving carers

It is considered good practice to involve carers in studies in which people with dementia are participants. Advantages include ensuring the wellbeing of the person with dementia by preventing possible psychological harm, helping the person with dementia to communicate his/her views, helping ensure that informed consent is obtained and providing another perspective on the research topic (sometimes called triangulation). However, not all people with dementia and carers have harmonious relationships. There may be underlying power issues, the presence of the carer may hamper the person with dementia in expressing his/her views and insistence on involving carers may be interpreted as a devaluation of the contribution made by the person with dementia. Some people with dementia may want to participate in a study and object to the assumption that they will be accompanied (Pratt, 2002). In some cases, the involvement of the carer may amount to paternalism which erodes the personhood of the person with dementia (Cowdell, 2006). 

Disclosure of the diagnosis through research and confidentiality issues

People may be involved in a study based on consent given by a third party and are not aware that they are taking part in the study. Whilst they may not be disturbed by the study, if other residents in group living arrangements are aware of the study and the topic of the study is sensitive (e.g. aggression, sexually inappropriate behaviour or incontinence), they may devalue or even ridicule the participant. The consequences of this may be disturbing to the participant and this raises issues about the protection of the dignity of participants.

It is possible that researchers, simply by approaching somebody about possible participation in a study, may inadvertently disclose a diagnosis of dementia to a person who was not aware that they had dementia, and in some cases, such information may in addition be incorrect (Cowdell, 2006). In group living arrangements, depending on how people are approached and what is known by residents about the study, some people may feel devalued or stigmatized, either for having been approached or for not having been approached. Some residents who are not involved may perceive the participants as having more power or as receiving more attention and this may be psychologically disturbing.

Including people at all stages and types of dementia in research

A great deal of research involving people with dementia has involved relatively articulate people in the early stages of Alzheimer’s disease. Those with other forms of dementia and in the more advanced stage of dementia have been largely excluded. This is perhaps as it requires much more effort to include them (Phinney, 2008) in terms of communication, consent and access.  Yet their views, experience, behaviour and reactions are important. Standard methods for collecting data such as the interview or questionnaire may be difficult for people with more advanced dementia but excluding them from research fails to respect the principle of equity. Excluding people with lower scores on cognitive tests such as the Mini-Mental State Examination (MMSE) is not justifiable, as a lower score does not necessarily indicate the inability to communicate one’s views (Cowdell, 2006).

Clearly, the choice of participants must be linked to the research question/hypothesis. For example, if researchers are interested in some aspect of the disease biology in people with mild dementia, they would legitimately want to recruit people with mild dementia for their study. The problem arises when the initial choice of topic is determined by obstacles which could in many cases be overcome.

Different approaches may be necessary to facilitate the participation of people with more advanced dementia in research. One such approach is that of observation in a natural setting. Kitwood (1997) advocated carefully attending to what people do and say as they go about their daily lives. This might involve interacting with them (e.g. accompanying them on a walk or carrying out a certain task such as preparing a meal with them). Such an approach could be used in the context of assessing people’s needs with the aim of providing support but has also been used in the context of research (Sheehan et al., 2006) for which video or monitoring devices may be useful for the collection and analysis of the information obtained (Cook, 2003).

There is a need to be creative in the search for novel ways to include people with different levels of dementia in research. Finding new approaches to data collection is likely to involve addressing additional ethical issues (e.g. linked to privacy, confidentiality, trust and consent). 

[1] The term traveller is a generic term used in England which refers to people from a range of different ethnicities, cultural groups and lifestyles including gypsies, traditional and new travellers, boat dwellers, and fairground and circus people. In other countries, a different term might be preferred. For further information, please refer to: http://gypsyromatraveller.com/gypsy-roma-traveller-culture.html


General involvement

  • People with dementia should be consulted during the design phase of research projects, in the definition of meaningful outcome measures and, if appropriate, concerning the initial choice of topic.
  • Such involvement should be meaningful and not merely a token gesture.
  • Depending on the nature of the research, researchers should consider involving people with dementia not only as participants but also as consultants and co-researchers.
  • Research should be encouraged involving people at all stages of dementia (from early to end-stage dementia) and with different types of dementia (including rare forms of dementia).
  • All participants in dementia research should be equally valued and respected.

Involvement of older people with dementia

  • Attempts should be made to include people with dementia from the older age group in all types of research.
  • When trying to recruit older people for research (including those who lack the capacity to consent), researchers should explain to those people, their carers, legal representatives or possible “gatekeepers” why it is important to include older people in research and why the same research could not be achieved with younger people or just with people who have the capacity to consent.
  • Study designs for medical research (e.g. clinical trials for drugs to be used in the treatment of dementia), which do not include an appropriate proportion of older people with dementia, should be challenged by funders, research ethics committees and peer reviewers of such research.
  • Clinical trials for drugs, targeted for future use by people with dementia, should be tested on samples which are truly representative of that group of people.
  • More research into comparative effectiveness and pharmacogenomics linked to dementia should be carried out.

Involvement of other specific groups of people with dementia

  • Attempts should be made to include people with dementia from ethnic minority or other “racialised groups”, and people with dementia with visual, auditory and intellectual impairments or with less common forms of dementia in research.
  • Researchers should draw up a plan of proposed actions or measures to ensure the recruitment of older people and other sub-groups of the population with dementia.
  • As such actions and measures may involve extra costs and time (e.g. for facilitators, interpreters and transport) this should be considered during the design phase.
  • As people have multiple identities, with various degrees of emphasis on different aspects of their identity, the relationship and dynamics between and within various racialised identities and people should be considered.
  • People from ethnic minority and other racialised groups involved in research should be recognised as representing more than their perceived ethnic or racialised characteristics (i.e. they may have many similarities with other people with dementia who do not share the same characteristics).
  • People from ethnic minority and other “racialised” groups should be included in a broad range of research topics.
  • Unless there are good reasons for not doing so, researchers should, where possible, translate research materials into other languages if this would facilitate the inclusion of people from ethnic minority or immigrant groups.

Involvement of third parties

  • Measures should be adopted to attract researchers from ethnic minority and other racialised groups to dementia research.
  • Researchers should encourage carers to support people with dementia in their participation in research, provided that the latter are in agreement.
  • It should not be presumed that people with dementia participating in research want their carer to participate or be present.

Methods and tools

  • The development of tools to differentiate between different stages of dementia should be encouraged.
  • Researchers should take into account individual differences and use methods which are appropriate to the impairments of individual people with dementia.
  • Researchers should also attend to remaining capacities of individual people with dementia and consider methods which correspond to those capacities in order to facilitate the involvement of people with dementia in research.
  • Researchers should consider the use of data collection methods which do not automatically exclude certain groups of people with dementia.
  • Researchers should ensure that the tools they use are suited to particular groups (e.g. to illiterate people).
  • Researchers should consider the use of tools (such as the MMSE) which have been modified for people from different cultures and educational levels.
  • Researchers should be creative in developing approaches which facilitate the involvement of people with dementia with a wide range of characteristics.
  • Research ethics committees should encourage researchers in the development of appropriate and acceptable approaches to dementia research aimed at the inclusion of a wider group of people with dementia.

 

 
 

Last Updated: jeudi 29 mars 2012

 

 
  • Acknowledgements

    The above information was published in the 2011 Report "The ethics of dementia research" as part of Alzheimer Europe's 2011 Work Plan which received funding from the European Union in the framework of the Health Programme.
  • European Union
 
 

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