Background, definitions and scope
Ethics of dementia research
- What is research?
- Dementia and dementia research
- Ethical dementia research
- Researchers and the ethical conduct of research
Research is a general term which covers all kinds of studies designed to find responses to questions by means of a systematic and scientific approach. It generally involves the use of predefined methods or procedures which are clearly documented, thereby making it possible for other people to understand exactly what the researchers did to arrive at their conclusions. In this way, the results and conclusions can be assessed and analysed in terms of relevance and accuracy, bearing in mind any limitations or factors which the researchers may have highlighted.
Simply asking for somebody’s opinion about a particular issue or asking them to indicate their preferences is not research as it lacks the systematic and scientific approach described above. Also, as will described later in the report, people who participate in research must have been provided with detailed information about the study and, on the basis of that information, have consented to taking part (please see section 4 on informed consent).
Different types of research
There are numerous types of research but a distinction is often made between medical research and social science research (particularly psycho-social research). Examples of medical research might, for example, include animal experimentation, genetic research and clinical trials of new medicinal products. Such research tends to draw mainly on the “natural sciences” such as biochemistry, physics and biology. Figure 1 below provides an example of different types of medical research.
Figure 1: Different types of medical research (main source: Röhrig et al., 2009)
Social science research, on the other hand, covers studies which focus on some aspect of society. It generally involves exploring, verifying or conceptualizing a particular social phenomenon or aspect of human life or behaviour. It has its roots in several fields of scholarship outside of the natural sciences. Figure 2 shows some of the main social science disciplines.
Figure 2: The main social science disciplines
Whilst some studies are clearly medical or social science research, the distinctions are sometimes blurred as researchers increasingly recognise the benefits of multi-disciplinary research. For example, medical researchers may want to explore psychological responses to various treatments and therefore adopt methods more typically associated with social science research (more information about different methods can be found in sub-section 2.1.3). It is therefore important to realise that there are, broadly speaking, two types of research but that there may be some overlap. Also, as researchers come from very different scholarly fields, they may approach research from different angles and have different perspectives of research.
World views guiding research
Researchers have different world views or belief systems which guide them in their research, influencing the decisions they make about how to conduct their studies, what counts as valid knowledge, what is the right way to obtain that knowledge, how it should be analysed (e.g. using quantitative or qualitative-based methods), and what their own role is in the process (Ritchie and Lewis, 2003; Tashakkori and Teddlie, 1998).
The various approaches to research are sometimes called research paradigms. The most common are perhaps positivism and interpretivism, which are generally associated with quantitative or qualitative methods of data collection and analysis, respectively (Snape and Spencer, 2003). In the past, there was considerable debate about which approach was “right” and some people argued that the two approaches were incompatible. For many years, the positivist paradigm was dominant and there was a tendency to judge the quality of research on the basis of whether it respected criteria applicable to the positivist tradition such as the researcher not having any influence on the data collected and whether the findings could be reproduced if the exact same procedure was carried out.
Nowadays, it is generally accepted that both approaches are valid and have their advantages and disadvantages. Principles of scientific integrity and procedure apply to research guided by both paradigms and include issues such as honesty, transparency about the procedure and a systematic approach to data collection and analysis, as well as avoiding misconduct such as the falsification or misrepresentation of findings, plagiarism and undeclared possible conflicts of interests (Aita and Richer, 2005).
Consequently, there is a third paradigm, that of pragmatism, in which the method used is that which appears to be suited to the research problem without getting caught up in philosophical debates about which is the best approach (Patton, 1990). Pragmatic researchers grant themselves the freedom to use any of the methods, techniques and procedures typically associated with quantitative or qualitative research. They recognise that every method has its limitations and that the different approaches can be complementary. Other researchers may adhere rather rigidly to methods associated with a specific research paradigm.
Qualitative and quantitative research methods
Qualitative studies concentrate mainly on words and meanings and aim to capture the richness and complexity of human experience, whereas quantitative studies involve recording or converting information obtained from participants in numerical form so as to enable statistical analysis of the findings and the generalisation of those findings to the wider population.
In quantitative studies, particularly those involving the development of medication or the use of experiments or large-scale surveys, one of the aims is to be able to generalize the findings (i.e. to infer that the findings can, to a high degree of probability, be considered as applying to a much wider group of people than those involved in the actual study). In other words, conclusions may be drawn about preferences, attitudes or the effects of a particular drug on people with dementia based on the information obtained from the group of people who participated in the study. This might range from a couple of hundred to over a thousand people depending on the type of study. Hypotheses are formulated (i.e. precise, carefully worded questions, which state a predicted outcome as well as the possibility that the outcome might not occur). By means of statistical analysis of the findings, the researchers determine with what degree of certainty they can claim that the findings could not be due to chance. Such studies are often referred to as quantitative studies.
Qualitative studies, on the other hand, generally involve recording, analysing and attempting to uncover the deeper meaning and significance of human behaviour and experience, including contradictory beliefs, ambiguities, behaviours and emotions. Researchers carrying out such studies are interested in gaining an in-depth understanding of people’s experience and not in obtaining information which can be generalized to other larger groups. They usually clearly identify a problem or topic that they want to explore, may be guided by a theoretical lens (a kind of overarching theory which provides a framework for their investigation) and formulate research questions. The approach to data collection and analysis is methodical but allows for greater flexibility than in quantitative research. Data is collected in textual form on the basis of observation and interaction with the participants e.g. through participant observation, in-depth interviews and focus groups. It is not converted into numerical form and is not statistically analysed.
Dementia is an umbrella term used to describe conditions which cause brain cells to die and lead to the gradual and progressive deterioration of memory as well as to changes in mood and personality. The gradual and progressive deterioration of cognitive functions, which is characteristic of dementia, such as memory, reasoning and planning, affects people’s capacity to carry out various activities such as getting washed and dressed, finding their way around, preparing meals and handling money etc. (Graham and Warner, 2009; Alzheimer Europe, 2011). The most common type of dementia is Alzheimer’s but there are numerous other types. Vascular dementia and dementia with Lewy bodies, for example, are also quite common and some people may have a combination of different types of dementia.
It is important to note that a person who has been diagnosed with Alzheimer’s disease (AD) also has dementia (because AD is a type of dementia). On the other hand, a person who has been diagnosed with dementia does not necessarily have AD because they may have a different type of dementia. However, the whole issue of the medical labels applied to people with dementia is likely to change soon as there have been proposals to replace the term “dementia” with the term “major neurocognitive disorder” in the forthcoming DSM-V (the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association). It is further proposed to label different types of dementia as being conditions associated with neurocognitive disorder (e.g. major neurocognitive disorder associated with vascular disease or mild neurocognitive disorder associated with Alzheimer’s disease) (American Psychiatric Association 2010).
Not all difficulties experienced by people with dementia can be attributed to the death of brain cells. According to the disability model, many of the problems faced by people with disabilities (including people with dementia) are due to the rather rigid and inflexible way that society is organised, which creates “excess disability”. Excess disability is defined by Brody et al. (1971) as "The discrepancy which exists when the individual’s functional incapacity is greater than that warranted by the actual impairment. In short, it denotes a gap between actual function and judged potential function” (pp. 125-126, in Werezak). Similarly, Kitwood (1993), whilst not denying the medical aspects of dementia, drew attention to a range of factors which might affect the progression of dementia including psycho-social factors.
Dementia research could be defined as any kind of research aimed at increasing the understanding of the disease biology and of disease prevention or improving the treatment, care, well-being and quality of life of people with dementia either directly or indirectly. This might include research into the condition itself, into the experience of having dementia or into care and treatment. People participating in dementia research (hereafter referred to as “participants”) are usually people with dementia, informal carers or professional carers but in some cases could be people without dementia and other specific groups. For example, researchers might be interested in learning about the attitudes, knowledge or fears about dementia of the general public or student nurses.
Determining what is ethical
Research should have scientific validity in the sense that it should be methodologically rigorous. It should have value in that it should be expected to result in health or knowledge advancement and it should involve minimum risk and have been independently reviewed (Emanuel et al., 2000). These are ethical concerns which apply to the whole research process from the initial choice of a research topic right up to the publication of results and the provision of feedback to participants, and will be addressed in more detail in various sections of this report. Ethical research must be based on morally sound principles and not on expediency (i.e. what is best for the researcher, sponsors or the government). The main focus of this document is on ethical issues in dementia research. By this, we do not mean dementia research carried out by ethicists but rather all kinds of research into dementia (e.g. medical, psychosocial, the development of assistive technology etc.), which is carried out in an ethically acceptable manner.
Different ethical models
There are different ways of determining whether a particular act is ethical (i.e. if it is morally acceptable to do it). This involves reflection about which actions are morally “right” and “wrong”, bearing in mind that good motivations may lead to wrong actions and that bad motivations do not rule out actions which are considered right. Dilemmas may occur whereby it is necessary to decide on a particular course of action rather than another and in so doing to give greater weight to certain moral concerns at the expense of others.
Some approaches to ethics focus on the outcome. This might involve judging whether the consequences of the act are good or bad (Noble-Adams, 1999) or what the best outcome would be for the greatest number of people (Peach, 1995 in Aita and Richer, 2005). In the utilitarian approach, for example, which was formulated by Bentham and Mill in the 19 th century, actions are considered as right if they are likely to promote the greatest happiness for the greatest number of people. Actions likely to result in the opposite would be considered as “wrong”. Evaluations of the various outcomes tend to focus on pain and pleasure. However, as pointed out by Petrini (2011), this approach only considers the amount of good and not the way in which it is distributed.
Furthermore, there may be more than one issue at stake and it would be difficult to measure maximum happiness. Maximising happiness may even conflict with other values such as justice, fairness, solidarity and honesty. In addition, there are a lot of different actors  directly or indirectly involved in or affected by research such as health and social care providers, pharmaceutical companies, shareholders, people in search of a cure or better treatment, researchers and academics, insurance companies and future generations. This means that there a lot of different interpretations as to the value of different outcomes as well as different motivations driving action and different opinions about the importance of particular ethical principles.
Other theorists consider whether the nature of an act is right or wrong irrespective of the consequences because something is believed to be good if it is consistent with moral rules and principles. This is often described as a deontological theory and a classic example is Kant’s theory. He stated that as man  is a moral agent, he is responsible for his actions. They are intrinsically right or wrong. Critics argue that the consequences of actions should not be ignored (Petrini, 2011).
Some people believe that ethical principles are universal (ethical universalism) whereas others take the view that such principles are related to a specific culture or individual choice (ethical relativism) and hence not generalizable to people with different cultural beliefs (Pojman, 2002). The latter has also been referred to as communitarian ethics which maintains that moral thinking has its origins in the historical traditions of particular communities and that consequently, it is a cultural rather than abstract concept in that communities share values, customs, institutions and interests (Petrini, 2011). Aita and Richer (2005) suggest that this approach is particularly important in the case of multi-site studies and healthcare research involving multidisciplinary collaboration. However, even research at a single site may involve people from different cultural backgrounds and both researchers and participants with diverse ethical perspectives. On the other hand, an over-emphasis on communitarian ethics might result in a “tyranny of the majority” in which the majority defines what is beneficial, morally right or “a good life”, which may result in an unfair outcome for some groups of people (Petrini, 2011).
Contrary to approaches which focus on the majority or the community, “personalism” strives to achieve common good by promoting and enhancing the good of the individual guided by values such as respect for life, sociality and solidarity, and responsibility (Petrini, 2011).
Applying various ethical models to specific issues
In our previous work on the ethical issues linked to the use of assistive technology (AT) by and for people with dementia, Alzheimer Europe decided against developing a hierarchy of ethical principles or basing decisions solely on outcomes or motives. We opted for an approach to making decisions about the ethical use of AT based on a careful consideration of specific aspects of each decision needing to be made (set in a particular moment in time and place, involving a range of actors and relationships, and people with different needs, wishes and interests) but with an emphasis on the well-being of the person with dementia. This inevitably involves a consideration of principles, motives and outcomes and ensuring that we do not lose sight of individuals with dementia.
In the case of the ethics of research, there are different issues at stake. There is a need to reflect simultaneously on the well-being and happiness of the individual research participant as well as on that of the wider social group and future generations who stand to benefit from the research. The fact that many people participate in research with the aim of helping others does not lessen the need to protect their wellbeing and promote their happiness.
Some of the ethical models mentioned above might seem fairly contradictory and one might wonder how a working group made up of people from different professional and personal backgrounds and with different perspectives about dementia, research and ethics could come to any kind of consensus. However, a pragmatic approach to the topic of dementia research and a common concern about the wellbeing of participants in such research makes this possible.
According to Petrini (2011), pragmatic and utilitarian approaches are quite common nowadays. However, when faced with practical problems, it is possible to adopt a case-by-case approach, find common ground and reach a consensus. The core value is the individual and personalism (described in the previous sub-section) is the best approach to face ethical problems.
 Definition of actor = one who does something or who takes part in any affair.
 “man” should be understood as meaning human beings (i.e. men and women). The term is used here simply to reflect the language usage at the time the statement was made.
In the case of research, we also need to consider the researchers themselves. Researchers come from a wide range of backgrounds and despite their common interest in research have a wide range of personalities and characters. They are not ethical or unethicalper sebut may conduct research ethically or unethically. Certain personality traits, such as integrity, trustworthiness and honesty, may increase the likelihood of researchers conducting ethical research but sometimes unethical conduct may be linked to lack of knowledge or awareness.
Beauchamp and Childress (2001) considered the relevance and desirability of five virtues for health professionals. These included compassion, discernment, trustworthiness, integrity and conscientiousness. They also considered the ethics of care which focuses on relationships involving care, responsibility, trust, fidelity and sensitivity with particular reference to the doctor-patient relationship. In some forms of research, researchers strive to maintain a certain distance from participants in order to minimise the possibility of influencing the kind of data collected whereas others approach data collection more from the perspective of a collaborative act involving the social (re)construction of meaning. Either way and even in the absence of a relationship based on the provision of care, researchers have responsibilities towards participants and should be trustworthy and sensitive to their needs.
Last Updated: jeudi 29 mars 2012