Protecting the wellbeing
Ethics of dementia research
Background information about the protection of wellbeing
Wellbeing is notoriously difficult to define. The World Health Organisation partly and indirectly defines wellbeing through its definition of mental health:
“Mental health is defined as a state of well-being in which every individual realizes his or her own potential, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to her or his community (WHO, 2011).”
This definition emphasises productivity and the ability to contribute to society. This is also reflected in several other definitions of wellbeing. Some, alternatively, define wellbeing as a state of being or feeling happy and healthy or as a good or satisfactory state of existence, sometimes linked to health and prosperity.
In this report, there are sections which address issues such as consent, involving people with dementia in research, considering risks and benefits and protecting their interests. Collectively, the points raised may contribute towards ensuring that it is possible for people with dementia, amongst others, to take part in research, without undue stress, exploitation or danger and in so doing both participate in and contribute to society. In this section of the report, we examine issues linked to the way that people with dementia participating in research are considered and treated. This is more directly linked to wellbeing in the sense of feeling good about oneself, in relation to others and with regard to society.
According to White (2008), wellbeing is also a dynamic process with material, relational and subjective elements which occur within a particular timeframe and geographical space. Please see figure 3 below.
Figure 3: Wellbeing as process (White, 2008)
People’s understanding and perception of wellbeing may change from one moment in time to another (e.g. as people age, linked to changes in health and on the basis of people’s experiences in life and on the people they encounter). Time in relation to the perception of wellbeing is not limited to the present time but also covers people’s reflections about the past and expectations for the future (which may be affected by the experience of dementia). Perceptions of wellbeing may also be affected by their geographical location (the space in which one lives and moves about) (White, 2008).
Perceptions of wellbeing are socially constructed within cultural contexts. The relational dimension of wellbeing is very important and repeatedly occurs in people’s definitions of wellbeing (White, 2008). However, there may also be cultural differences in the importance attributed to wellbeing. In a recent four-nation survey involving 431 adults from Canada, India, China and India, which explored factors which people consider “make for a good life”, wellbeing and contentment was fourth out of the thirty most prevalent indicators identified (Tafarodi et al., 2011). It was not amongst the top ten most prevalent indicators for the Canadian participants whereas it was the third most prevalent for Indian participants, being cited more often than wealth, success and close and enduring friendships. This may indicate different interpretations of the term wellbeing as well as different degrees of importance attributed to it.
Nevertheless, people who participate in research are voluntarily contributing to society and irrespective of the importance that they assign to their own wellbeing, it is the duty and responsibility of researchers to protect participants’ wellbeing and even to contribute towards it if possible. Participating in research can and should be a positive experience.
Dignity is an important ethical issue in research and is linked in some way to certain other ethical principles such as respect for privacy and confidentiality, the sanctity of life, respect for justice and inclusiveness, and respect for vulnerable research participants. It has been described as the cardinal principle of modern research ethics and as a principle which aspires to protect the multiple and interdependent interests of the person - from bodily to psychological to cultural integrity (Health Canada, 2007). Hellström et al. (2008) suggest that excluding people with dementia from research is an affront to their dignity whereas including them in research may enhance their dignity of personal identity.
Nordenfelt (2002) identified four types of dignity: Menschenwürde, the dignity of merit, the dignity of moral stature and the dignity of identity. Menschenwürde is the dignity that is inherent in being a human being. This German term reflects the undeniable value of human beings regardless of their social, mental or physical properties. Another term that is often used is “basic dignity”. People have the same degree of Menschenwürde throughout their whole lives and it is something that cannot be taken away from a person (Nordenfelt, 2002).
The dignity of merit applies to people who are considered as having achieved excellence or distinction such as a high rank (Nordenfelt, 2002). This may be formally bestowed on a person or informally achieved by artists, athletes or scientists but nevertheless acknowledged and respected. This kind of dignity can be acquired and lost. In the context of research, people with dementia can be officially recognised for their contribution to society, in some cases officially by means of public recognition, in other cases, on a more personal basis through the gratitude of those involved in or likely to benefit from the study. For many people who take part in research, their participation is anonymous and part of a global effort which is worthy of merit but unfortunately not always acknowledged.
Another type of dignity is that of moral stature which is linked to the respect that people have for themselves and to their own dignified conduct, as well as to respecting other people’s rights (Nordenfelt, 2002). As a person’s capacities in various areas of everyday life gradually decline as a result of having dementia, the social roles they have or could have may be adversely affected. The opportunities to reciprocate or to engage in activities which they considered worthwhile and beneficial to others may be reduced. Being able to benefit other people through participation in research may, for some people, contribute towards their sense of self-respect. However, some research methods may result in people’s deficiencies being highlighted or in attention being drawn to behaviour which might be considered by the participants or other people as undignified. This need not be the case even for studies involving measurement of various capacities, provided that the researchers are sensitive to the need to protect the person’s dignity.
The dignity of personal identity is described as the kind of dignity that people attach to themselves as integrated and autonomous people who have their own history, future and relationships with other people (Nordenfelt, 2002). This type of dignity is dependent on other people in that a person’s perceived value and worthiness that is reflected back in the context of interaction. It can therefore be considered as an attribute that can be subjectively felt but also something which can be denied, ignored, withheld and violated. Examples of failure to respect a person’s dignity of personal identity include not treating somebody with respect, belittling, ridiculing or humiliating them, ignoring or insufficiently acknowledging them, seeing them as a member of a group rather than as a unique individual, and/or physically or mentally transgressing their personal space (Holmerová et al., 2007; Jacobson, 2007; Mann quoted in Horton, 2004). Such acts could occur in a wide range of settings, including the research setting. For further issues of relevance to the dignity of personal identity, please see sub-section 5.2.4 on personhood.
Nordenfelt (2002) explains that the dignity of personal identity is also objective because it can be violated even in cases where a person is not aware of the violation or even no longer alive. This has implications for the respect of people with end-stage dementia who may have reduced self-awareness and also for the way that a person’s body is treated in the case of post mortem brain tissue donation and research. The respect of the individual dignity of people with dementia, in general and especially in such circumstances, is equally important for the wellbeing of their relatives and loved ones.
Integrity refers to a kind of wholeness. According to the Danish philosophers, Rendtorff and Kemp (2000) integrity has two moral dimensions. The first consists of a created and narrated coherence of life, in the form of a coherent and complete life story, which should not be violated. The second consists of a personal sphere for experience, creativity and personal self-determination (Ebbesen and Pedersen, 2008). Some people with dementia may have difficulty communicating their life story and protecting or promoting their personal sphere. It may be difficult for researchers to understand the integrity of each person with dementia they encounter but they can reflect on whether their treatment of the person might in some way fail to respect their integrity. On the other hand, researchers may also be instrumental in promoting or respecting the integrity of research participants through the use of certain research methods, such as narrative interviewing, participant observation and ethnographic research, which focus on the whole person and provide a means for experience, creativity and self-determination.
Respect can be reflected in both behaviour and attitudes towards other people. Respect might include having consideration for another person’s feelings, refraining from offending him/her, and being polite and courteous toward him/her. There may be certain cultural differences between different groups in society as to what is considered as respectful (e.g. depending on cultural background, age and education).
Nevertheless, acts of consideration and attitudes which reflect genuine interest in a participant’s wellbeing are likely to be appreciated such as offering the person a seat, not keeping him/her waiting for longer than needed, the tone of voice used, providing refreshments, asking how the person is feeling and even offering a little gift as a token of appreciation at the end of a study. Accepting gestures of hospitality (e.g. when interviewing in the participant’s home) may also be an important sign of respect. Treating participants with respect is important for the ethical conduct of research in that it is linked to personhood and dignity and may in addition have an effect on the quality of data collected.
The importance of relationships
Personhood is at the core of several ethical principles and, like dignity, has a fundamental inherent character as well as one that is socially constructed and maintained. There is a huge ethical debate on the topic of personhood, covering for example, the role of consciousness, rationality and psychological and biological continuity, with possible implications for the legal status of a person (e.g. relating to the validity of advance directives). A full discussion of these issues is beyond the scope of this report in which the emphasis is quite simply on the relational aspect of personhood, namely the way in which people are recognised and treated as unique human beings as opposed to animals or inanimate objects.
For some people, personhood may be linked to spiritual beliefs (e.g. that a person has a unique essence). This is perhaps more common in the Judeo-Christian tradition. In Hindu, Buddhist and Native American cultures, many people believe that a person is reincarnated as another person or animal after death or that a person embodies the spirit of ancestors or animals (Goodfellow et al, 2003). In such cases, personhood may be understood slightly differently.
Interdependence has been described as a necessary condition of being human. This emphasizes the importance of relationships (Kitwood and Bredin, 1992). Buber (1970) identified two different ways in which people relate to one another, which are also of relevance to the maintenance of personhood in people with dementia. The I-It mode of relating is one in which a person relates to the other in a cool, distanced, non-involved way which fails to fully acknowledge the individuality of the other as the other is objectified. The I-Thou  mode of relating involves meeting the other person in a genuine human exchange (i.e. an authentic and meaningful encounter or dialogue). People with dementia may eventually lose the capacity to create and encourage a genuine human exchange. If, in addition, they have become an object in the eyes of other people, their personhood may be jeopardized.
In the context of care, Kitwood (1990) drew attention to processes and interactions which depersonalize people (described as “malignant social psychology”). Examples include infantilizing, disempowering, intimidating, labeling, stigmatizing, outpacing (going too fast for a person with dementia), invalidating (failing to validate the subjectivity of the person with dementia), banishment (being physically or psychologically separated from contact with other people) and objectification. These ways of relating to people with dementia could all occur in the research setting. This is quite clear from the following examples of objectification and intimidation which were provided by Kitwood (but in relation to care):
“The dementia sufferer  is not treated as a person; that is, as one who is an autonomous centre of life. Instead he or she is treated in some respects like a lump of dead matter, to be measured, pushed around, manipulated, drained, filled, dumped etc.
“The dementia sufferer is made afraid by such processes as head scans or psychological assessments, these being carried out in a somewhat impersonal way, by professionals who are powerful and competent, Sometimes intimidation includes threats, or actual physical assault.” (Kitwood, 1990, 38-39).
Objectification and cognitive separation
According to Kitwood and Bredin (1992), objectification involves a clear division being made between us (members of the so-called normal population) and them (people with dementia), whereby they are considered as being “in a bad way for they are afflicted with a primary degenerative disease in the grey matter” whilst we are “basically sound, undamaged, competent, kind”. Link and Phelan (2001; 2006) used the term “cognitive separation” to refer to the process (which they also defined as a component of stigma) whereby people with a socially salient attribute come to be seen as fundamentally different. Some researchers have explored this concept in the form of dis-identification, which is the extent to which a certain group of people are considered as being different to oneself (Servais and Saunders, 2007). This process of cognitive separation from certain groups of people, which can in the extreme lead to objectification, may serve the psychological function of protecting people from existential anxiety and helping them to continue believing in a stable, orderly and just world in which they identify with the in-group and convince themselves that they are very different from the out-group (Lerner, 1980; Novak and Lerner, 1968; Solomon et al., 1991).
The relationship between researchers and participants
In most forms of research, there are at least two distinct groups, namely the researchers and the participants. This does not necessarily imply an “us” and “them” relationship involving processes of cognitive separation. It is merely the result of the agreed temporary relationship between the two parties. After the research, most participants will return to their everyday lives and will no longer be a separate group. However, some participants are already perceived by many people, including the researchers, as being an identifiably separate group (e.g. based on age, cultural identity or health conditions such as dementia). This may be important for the purposes of obtaining appropriate support but may also increase the likelihood of cognitive separation, objectification and loss of personhood.
In addition, the process of research may involve subjecting people to batteries of tests, observing them, measuring response times or reactions, taking samples and so on. This can be done with consideration and respect, thereby respecting the personhood and dignity of the participants. However, as highlighted by Kitwood such treatment may also lead to the objectification of the person. In his “involutionary spiral of the dementia process”, Kitwood (1990) described how various ways of relating to people with dementia may lead to a diminished sense of personhood as well as shame, low self-esteem, social withdrawal and depersonalisation.
Researchers have different motives for carrying out research. Some are working towards the award of an academic degree, some are carrying out research in the context of their work (practitioner-researchers) and for some, research is their actual profession. Researchers therefore have their own personal interests such as the need to make a living, to obtain research grants, to publish in peer reviewed journals, to be officially recognised and to advance in their professional careers in addition to their interest in the research topic itself. There is a need for researchers to be cognizant of both the needs and values of the research participants with whom they are engaged and to have regard “not only to the content of research, but also to the process” (Kitwood, 1995).
In qualitative studies involving interviewing (either face to face or by telephone), people reveal information about how they think, feel and act to the researcher carrying out the study or in some cases to people who have been trained to collect such data on behalf of the researcher. In most cases, participants will have been assured that their identities will not be revealed and that the information they provide will be anonymised. This means that in addition to the use of pseudonyms (i.e. using a special code or name instead of the person’s real name), any information which might make it possible for another person to identify a particular participant will be changed. This is important in cases where quotes are included in published articles which anyone might pick up and read.
In studies involving surveys or questionnaires, it may also be possible to provide anonymity with regard to the researcher. This means that people can send completed questionnaires to the researcher without revealing their identity. This may result in greater honesty but makes it difficult to protect the well-being of participants. The questions asked may be disturbing to some people but the researcher would not know this. Even if s/he detected this in the response to open-ended questions or spontaneous comments on the form, the researcher would not be able to contact the person.
Information about third parties
In the course of an interview a person may reveal information about another person (sometimes spontaneously). Although such information would also be anonymised, the researcher may know that person and then knows information that that person might not have wanted to disclose. Although the researcher would hopefully treat such information with the same degree of confidentiality, it nevertheless represents an infringement of the right to privacy of other people as they did not consent to such disclosure (Hadjistavropoulos and Smythe, 2001).
Focus groups consist of focused discussions amongst homogenous groups within a group setting, facilitated by a moderator. People tend to disclose more about themselves to people who resemble them in various ways than they do to people who differ from them (Jourard, 1964). Self-disclosure is also facilitated by the existence of a non-threatening environment and perhaps in some cases due to being amongst relative strangers rather than personal acquaintances (Krueger and Casey, 2009). This is ideal for researchers who are interested in obtaining rich, meaningful data for their study but the researchers cannot guarantee that all members of the focus groups will respect the principle of confidentiality. Sometimes people may find that they know other members of the focus group and this may hamper self-disclosure and at the same time make anonymity within the group impossible.
Information about illegal behaviour
Sometimes, especially if they have been assured anonymity, participants may reveal information about behaviour that is unlawful or unethical (such as cheating in exams, stealing or abusing a vulnerable person). There may be less likelihood of this occurring if people are warned in advance but in some cases, people may unwittingly reveal such information. The researcher is then faced with a dilemma. On one hand, s/he promised the participant anonymity and confidentiality and should respect this promise (i.e. be trustworthy and honest) and on the other hand, s/he is ethically bound to report serious cases of abuse or other significant crimes. He/she may also be bound by deontological rules. This touches on the researcher’s sense of integrity as a researcher and member of society.
Sometimes, in applications for ethical approval, researchers are asked to explain how they would handle such situations, should they occur. This forces researchers to consider the possibility of this occurring and to have the necessary measures in place.
Storage of data
Often auditory or video recordings are made of interviews and usually a written transcript is made of the whole interaction. Some researchers literally label and cut up statements before sorting them into categories. Nowadays, the whole process of qualitative analysis has become much more sophisticated and several computer packages exist which facilitate the management of data. Consequently, the transcript and even video recordings of the interaction are usually transferred onto computers. This raises questions about access to various stored records (on paper, on film, on auditory recorders, in word format and on computerised qualitative data analysis packages). The data gradually become dispersed and researchers must consider who should have access to each source of data and how to ensure that unauthorised people do not.
At the same time, there is a need to ensure that data are stored for a sufficiently long period. In order to serve as proof of the findings in case of dispute, the original data (e.g. the voice recording or samples) should be stored beyond the end of the study. Researchers might also want to save data for possible further research which this then raises the issue of consent for the further use of research data (which has been addressed elsewhere in this report).
What is privacy?
Privacy covers issues related to the control and management of personal information about somebody’s thoughts, body and experiences (Fawcett and Garity, 2009). In the context of the person’s body information could perhaps be understood as including somebody else seeing that person’s body. The control and management of privacy by the person concerned depends to some extent on the situation or context, as well as his/her personal values and experience. There may also be cultural differences linked to what is considered acceptable or appropriate.
Privacy in observational research
In some forms of research, such as ethnographic or field research, the researchers are interested in observing naturally occurring behaviour and conversations. Sometimes (e.g. in participant observational studies), the researchers interact directly with the participants, sometimes joining them in their daily activities, whereas in others they remain separate and observe or record behaviour from a distance.
Observing other people’s behaviour represents an intrusion into their privacy. This is perhaps not so much the case when they are in the public domain (e.g. sitting in a park, waiting for a train or shopping) but there is a difference between passively watching people go about their daily lives and systematically studying their observed behaviour. Researchers must obtain consent if they want to observe people for the purposes of a study, either in person or by means of recording equipment. However, for some studies the people who are to be observed lack the capacity to consent or even assent to being observed. Their relatives or legal advisors may have consented to an observational study. They might not necessarily have explained to the person concerned that s/he is being observed.
Some people may not mind being observed and even appreciate the attention. Others may object to being observed or consent to it but then feel very uncomfortable about it and have a feeling that their privacy is being invaded (Parrot, 2002).
Provided that people know that they are being observed (and also where and when) and have the opportunity to consent and withdraw from the study, there should not be an ethical problem. The problem arises, when they are not aware of this or did not consent to it.
Observational research raises issues of dignity and respect. To a greater or lesser extent, people generally like to have some control over the image that they present to other people. One’s image is a reflection of one’s identity and may affect the way that one is treated by others. According to Goffman (1959), people manage their appearance and behaviour (in a similar way to actors taking on various roles and performances) and people cooperate with each other in supporting each other’s social identities and performances. People with dementia may find it increasingly difficult to manage their performance. Video recording without their consent results in a record being made of a performance which they might have preferred not to share.
In group settings, some people may have consented to being observed or filmed for research purposes but others not. However, it may be difficult for the researchers not to film them too and may occasionally interact with them. This may make some people with dementia feel uneasy and perhaps distrustful of the researchers. After all, how can they be sure that they are not also being studied? Also, even if they are not, they have nevertheless been filmed without their consent and that film may be seen by other people. They have no control over the diffusion of images that have been taken of them.
Privacy in the context of qualitative interviewing
When people consent to being interviewed, they should normally already have some idea of the topic that will be discussed. However, there are different approaches to qualitative interviewing ranging from very structured, to semi-structured, to unstructured. Sometimes participants will just have an idea of the general topic, sometimes they may already know the precise questions that they will be asked. One of the features of qualitative interviewing is that it is flexible so researchers may spend more time on some issues and less on others, follow up hunches, test out their understanding of what the person means and focus on novel issues that a person raises which are relevant to the topic.
Consequently, participants do not always realize until the questioning starts how deep or probing the questions will be. Some may find the depth of probing disturbing but have difficulty expressing why or stopping the interview, particularly if the interview is taking place in their own home. Some people may only start to feel uneasy about the depth of disclosure after the interview.
It is quite common for people with dementia to be interviewed in the presence of their carer as the latter can help the person to understand the questions or communicate their thoughts to the researcher. The presence of a carer may also be helpful in detecting fatigue, stress or discomfort and help bring the interview to a premature end. The researcher should also be attentive to such factors but having less knowledge about the participant might fail to detect the relevant signs. In some cases, researchers might be equally interested in the views of the carer and that is the reason for the presence of the carer (although clearly the two could be interviewed separately in that case).
A drawback to having the carer present is that it could interfere with the right to privacy of the person with dementia. It cannot be presumed that all couples share all their thoughts and feelings with each other. Moreover, depending on the topic, the presence of the carer may result in certain information being withheld which would not be conducive to good research but is an issue which researchers need to take into account when designing their study and in particular how to collect data.
Vulnerable groups and what we mean by vulnerability
A wide range of vulnerable human research participants have been identified in several reports and international documents on ethics and research. Those which might be relevant to people with dementia include people incapable of giving consent, people in nursing homes, ethnic and racial minority groups, older people, people with limited capacity or freedom to consent or to decline consent, people who will not derive benefit from participation, people for whom research is mixed with clinical care, the very sick and the institutionalized (Hurst, 2008). Vulnerability may also be contextual and influenced by dynamic processes which are not permanent. For example, a person may be more vulnerable at certain times of the day, in certain environments, after a couple of hours’ discussion or after an operation. Researchers cannot be expected to know specific circumstances which might render individual people vulnerable. Consultation with carers would therefore be beneficial.
Hurst (2008) draws attention to issues of particular importance when considering the protection of vulnerable research participants such as those linked to consent, harm and fairness. These issues are in fact relevant to all research participants but in the case of vulnerable research participants, depending on the particular feature which leads to them being considered as vulnerable, additional efforts may be needed to protect them. Consequently, the protection of vulnerable research participants does not address additional ethical issues; it simply increases the efforts needed to ensure that general ethical issues are adequately addressed for certain groups of people in order to reduce the likelihood of those people incurring additional or greater wrong (Hurst, 2008).
In the case of dementia, the main issues which might result in people with dementia (as a group, not individually) being considered as vulnerable are age, cognitive impairment, being dependent on others for care and/or being a resident in a long-term care institution. Additional factors may co-exist based on being a member of an ethnic minority group, gender, physical disability, sexual orientation and living situation (e.g. being homeless, a prisoner or nomadic). Research participants who have end-stage dementia represent yet another sub-group (this is further discussed in section 8 on end-of-life research). The particular vulnerability of people with dementia might therefore be linked to factors such as them not understanding the risks involved, giving invalid consent, being coerced to consent, not being respected (due to ageism and the stigma generally associated with mental disorders), not being consulted at all, being in a less powerful position, being denied access to participation or alternatively being exploited. This will vary depending on the situation of each individual and the severity of his/her dementia. Also, some studies may just involve people with dementia from a particular sub-group (e.g. people with dementia in institutional care, over a specific age, just male or just female, from an ethnic group etc.).
People in the last stage of a terminal illness have been described as especially vulnerable as they are faced with many losses, confronted with overwhelming burdens, may be afraid and may be experiencing unpleasant symptoms. Whenever a person is dependent on another for his/her treatment, care and wellbeing, there is a risk of that person feeling under pressure to participate in a study. Raudonis (1992) describes participants in end-of-life research as “a captive audience” but this could equally apply to other kinds of research carried out in institutional settings. Participants may be afraid that failure to cooperate will result in the loss of their place in a palliative care unit. People dying with or from dementia may be dependent on others involved in the research for the appropriate and timely administration of pain relief or to take care of their basic needs (Addington-Hall, 2002). They may be afraid of the consequences of non-compliance with the researcher’s requests and feel that having agreed, they no longer have any choice. Such fears may also apply to carers who are asked to consent on behalf of a person with dementia, particularly when the person is receiving care and treatment in a hospital or hospice where they cannot be present all the time.
Risks linked to categorizing groups of people as vulnerable
Several arguments have been put forward against a group-based approach to vulnerability.
First, it detracts somewhat from the perception of the potential vulnerability of all human beings (as being capable of suffering) as well as of the increased vulnerability of individuals based on reasons which are not immediately evident.
Second, it focuses on the groups concerned and highlights a particular attribute (i.e. being vulnerable). This could be interpreted as those groups having or being “the problem”. Another way of looking at vulnerability would be in the context of relationships between people. Hurst (2008) describes vulnerability as a two-way street also involving researchers who have a duty to avoid identifiable wrongs.
Third, the reference to groups contributes towards overlooking similarities and differences between both groups and individuals. For example, many groups require the same type of protection, some people belong to more than one group and some members of a group may need additional protection with regard to certain issues but not others (DuBois, 2008).
Fourth, there is a risk of stereotyping vulnerable research participants. This might involve attaching additional attributes (such as weak, needy, powerless etc.) which devalue those groups of people and may lead to unfair treatment or discrimination. Stereotypes are inaccurate generalizations which exaggerate and distort similarities and ignore the differences between people from various identifiable groups. Linking vulnerability to particular groups may also reinforce existing stereotypes associated with those groups (e.g. that people with dementia are totally incapacitated).
Finally, there is a risk that categorizing people as vulnerable might result in their over-protection. This would prevent them from exercising their autonomy and having an equal right to take part in research. It could also interfere with the advancement of science and at the same time prevent people with dementia from benefiting from the results of research into their condition, care and treatment (Hurst, 2008).
Types of vulnerability and a non-group-based approach to vulnerability
An alternative non-group based approach to vulnerability involves assessing people for specific vulnerabilities and heightened risks. A specific condition or diagnosis (e.g. dementia) would alert researchers and justify them in assessing people with that condition for different types of vulnerability insofar as they relate to their study (DuBois, 2008). Six types of vulnerability have been identified by the National Bioethics Advisory Commission (2001). These are: cognitive or communicative vulnerability, institutional vulnerability, deferential vulnerability, medical vulnerability, economic vulnerability and social vulnerability.
Transparency and official recognition of researchers and studies
Researchers are not always recognisable as such. They do not tend to have official cards proving their status as a researcher, although most principal researchers would have documents proving that they had been granted ethical approval, governance approval or funding. This should be stated in the participant information sheet which all potential participants should receive as part of the informed consent process. However, very few people would ask to see copies of such authorisation.
Some researchers have academic posts, student identification or proof that they are a member of a recognised organisation (e.g. a pharmaceutical company, government body or advocacy group) which is carrying out research. When the researcher is a medical professional (e.g. a doctor or nurse), it may be unclear that s/he isalsoa researcher.
In observational/ethnographic research, the role of the researcher may be somewhat ambiguous in that it may be unclear who is a researcher and who is not. The researcher might, for example, participate in the research in the guise of a member of staff (e.g. observing people with dementia or even other members of staff). In some studies, researchers may actually be members of staff (e.g. in day care centres or nursing homes) who use data routinely collected during their daily work or during specific periods of observation. Ethical issues linked to transparency, but also to dignity, privacy and autonomy, therefore need to be addressed when carrying out research of this kind.
Sometimes, people with dementia and carers are asked for their opinions or advice (e.g. about services, care, support or other relevant issues). This may involve filling out a questionnaire, being interviewed or perhaps taking part in a focus group. It may represent a worthwhile attempt to improve some aspect of the lives of people with dementia or their carers (e.g. to develop useful assistive technology or improve services) but not fulfil the strict criteria for it to be classed as research. Such attempts to involve service users in the creation, development or improvement of services should be seen in a positive light provided that the nature of the questioning or involvement is clear to all involved.
A distinction can perhaps be made between scientific or academic research and what is sometimes called “market research” (which is an organised event to gather information about markets or customers). The involvement of people with dementia and carers in such studies is questionable when the purpose is solely for the commercial gain or personal interest of a company or individual and when this is not made clear or when the person with dementia lacks the necessary capacity to understand this. However, if information about the nature of the proposed involvement is provided and understood by the person with dementia or any other person who is asked to participate, they can make an informed decision about participation and may have reasons for wanting to be involved.
As has already been mentioned in sub-section 4.3, it is essential that people with dementia (or their legal representative if one has been appointed) understand the fundamental difference between research and treatment and that they are aware that they are consenting to research when this is the case. In some cases, researchers are not clear about this distinction either.
Research ethics committees often encourage researchers to involve patients and carers in the various stages of research such as the conceptualization and design of the study, and the dissemination of the results. Consulting people with dementia and carers in the initial development of the study and when drafting the protocol would take place before ethical approval was sought. As such, their involvement could be better described as co-researcher or advisor than as participant or subject. This has implications for the protection of their well-being. Although they would be involved in research, they would not have received a participant information sheet or signed a consent form, would not necessarily know in advance what to expect and would not benefit from the results of the reflection on ethical issues which is part of the process of seeking ethical approval for a study.
What is deception?
Deception was used fairly extensively in social psychology studies in the 1970s and 1980s (DuBois, 2008) but is not used as much nowadays (Hertwig and Ortmann, 2008). When used, it often involves lying (providing information that is untrue) and concealment (not revealing the purpose of the study or the identities of various people involved in the study) but there are other forms of deception such as exaggerating, making understatements and making indirect, ambiguous or misleading statements (Buller and Burgoon, 1996). Day et al. (2011), who carried out qualitative interviews with people with dementia about the use of lies and deception in dementia care, report that some people with dementia made a distinction between blatant lies and little white lies, the latter being associated with deceptive acts which are more subtle in nature.
Some researchers use deception but opt for controlled transparency in which participants are not deceived or tricked but the information provided just covers the essential details that participants need to know in order to make an informed decision.
Deception may also occur where people agree to take part in a study because they believe that it will be beneficial to them. This is called the therapeutic misconception. This may be due to their failure to understand the difference between treatment or care and research and not involve any kind of deliberate deception. However, it is the duty of researchers to ensure that potential participants have understood this distinction.
Arguments in favour of the use of deception
Deception about the purpose of the study has been justified on the grounds of social desirability. This means that there is a risk that if participants know everything about the study, they may give responses or try to behave in a way that that they think will be perceived as socially desirable or acceptable by the researcher. However, irrespective of whether deception is used, other reactions are possible. According to Tashakkori and Teddlie (1998),
- some participants will try to be helpful by behaving in accordance with what they think the researcher wants,
- some participants will be negativistic or suspicious and deliberately do the opposite of what they think the researcher wants, and
- some will try to act and answer authentically.
The use of deception in research is still accepted by the American Psychological Association (APA) provided that 1) the study is of significant value, 2) that non-deceptive procedures are not feasible, 3) that deception would not cause pain or severe emotional distress and 4) that participants are informed of the deception at the latest at the conclusion of the data collection, so that they can withdraw their data if they so wish (DuBois, 2008).
Benham (2008) argues in favour of deception in social-behavioural research based on a presumed “enrichment benefit”. He describes this as a unique opportunity to gain insight into oneself or others based on conditions or methods to which people do not normally have access. This is, of course, based on researchers revealing the deception and the results of the study to the participants afterwards, which is probably not always the case.
It is possible that for people with limited capacity or whose capacity deteriorates during the course of the study or before the results are made available, the concept of deception may not be fully understood or its revelation may come too late. Also, some might be unable to gain insight into themselves or others due to cognitive impairments. Depending on the duration of the study and the speed of cognitive decline of participants with dementia, debriefing may be impossible for some participants.
Nevertheless, it is possible that the total prohibition of all forms of deception in research would prevent researchers from carrying out many important studies which would have been beneficial for society (Kimmel, 1998) and such prohibition could therefore be considered as immoral (Christensen, 1988).
Arguments against the use of deception in research
Baumrind (1976) argues that the benefits to society are often over-estimated and the costs to the individual and society underestimated. In line with a personalist approach to ethics, which places greater value on the life and integrity of the person than on any function that the person might be called upon to serve, and as ethical theories do not tend to condone deception as a principle of action, Baumrind concludes that deception is unacceptable within research and that researchers who use deception are taking advantage of people’s implicit trust (Baumrind, 1964 and 1976). She further states:
“Only by acting in accord with agreed-upon rules, keeping promises, and avoiding deceit can human beings construct for themselves a coherent, consistent environment in which purposive behavior becomes possible. Thus, the long-range good that truth-telling promotes facilitates self-determination or authority over one's own person.” (Baumrind, 1976, 23-11)
This seems to be particularly relevant in the case of dementia research in which some participants may be struggling to make sense of their everyday lives, as well as venturing into the unfamiliar domain of research.
Other criticisms of the use of deception are that it fails to respect participants, may result in loss of trust, may harm participants and may foster insincerity amongst participants which would be counterproductive to researchers and that other approaches should be found (Baumrind, 1964; Sieber, 1982 in DuBois, 2008). It has also been suggested that deception in research may wrong people (NHS, 2009). This has connotations of injustice, violation and being discredited.
With regard to psychological wellbeing, deception may result in feelings of incongruence, perhaps resulting in people feeling that they have acted in a way which is not in keeping with their values. Guidelines (e.g. from the American Psychological Association) suggest that deception should not be used if it would be likely to cause severe emotional distress. There must be some measure of severe emotional distress which is meaningful to people with dementia and which takes into account the difficulties they may experience communicating their distress. Feeling tricked or deceived may be particularly worrying for people who are dependent on others for their wellbeing and care as is the case for many people with dementia. Moreover, if the distress occurs after the study, there may be no measures in place to help the participant deal with it.
Clare (2003) draws attention to emotion-based coping strategies which are often used by people with dementia (such as denial or normalization of the illness or symptoms) and how the discovery of a lie may inhibit such strategies by forcing people to face their illness.
The study by Day et al. (2011) into the attitudes of people with dementia regarding lies and deception in dementia care suggests that the impact of lies and deception may differ according to who is using such practices, the stage of dementia of the person on the receiving end, whether s/he is aware of the lie and whether it is in his/her best interests. The participants felt that lying elicited distress or anger due to the impact on relationships or self-concept, and that they found it patronising or demeaning, implying that they were perceived as a person with dementia rather than a “normal” person. Whilst this study was small scale, it suggests that the use of lies and deception may be perceived differently by people who have dementia than by people who do not.
Carers may also feel misled, disappointed and distressed if they find out that the person with dementia will not benefit from the study which s/he is already taking part in. The subsequent lack of trust in researchers by people with dementia and their carers may damage the reputation of individual researchers or research organisations and even the research profession in general with possible consequences for the recruitment of participants for other studies (Epley and Huff, 1998; Ortmann and Hertwig, 1998).
The whole issue of possible harm caused by deception is unclear. Some researchers argue that research participants do not perceive deception as being harmful and that some even enjoy the experience of such studies and their educational benefits more than studies not involving deception (Christensen, 1988). They nevertheless suggest that the use of deception is more likely to be perceived as unethical in studies investigating private behaviours. Hertwig and Ortmann (2008) suggest that there are many factors influencing possible distress caused by deception such as how well a person tolerates loss of control and being fooled, his/her expectations about honesty within research and the extent and nature of the deception. Theyconclude that further research is needed to clarify the impact of deception on research participants.
 The word “thou” is another word for “you” (i.e. the second person singular pronoun). It is generally considered as being archaic but is still sometimes used in religious contexts and this is in keeping with Buber’s work.
 This is a reflection of the terminology used at the time Kitwood was writing. The term “sufferer” is not generally used nowadays to refer to people with dementia.
Protection against harm
- Researchers should have at least a basic understanding of dementia.
- Lay people (including carers of people with dementia) should be encouraged to sit on research ethics committees and to be actively involved in the assessment of dementia research.
- Lay people and professionals who sit on research ethics committees should be provided with any necessary training (e.g. linked to ethics, research or dementia).
- Researchers should envisage the possibility of participants experiencing emotional or psychological harm and ensure that any person who is exposed to their research materials or data collection processes knows whom to contact for support. This could be a member of the research team with the appropriate training and skills or perhaps a counsellor or relevant association.
- Participants should have the full contact details of a person whom they can contact in case of dissatisfaction with any aspect of the study. The contact person should be somebody who is not directly involved in the data collection and analysis but is knowledgeable about the study and has the means to deal with possible problematic situations.
Dignity, ignity, integrity and respect
- Respecting the dignity of people with dementia and carers (and other research participants) should include polite, respectful behaviour (e.g. being considerate, attentive and well-mannered), and respecting individuality and cultural traditions.
- Researchers should use appropriate language when speaking to or referring to people with dementia. Terms such as “demented” and “suffering from dementia” should be avoided.
- Researchers should, through their own behaviour and attitudes, strive to promote and protect the dignity of people with dementia even in cases where it seems that the latter are not concerned or lack awareness or insight.
- The protection of the dignity of research participants should extend to the body of the deceased person in the case of post-mortem research.
- Measures to promote the wellbeing of research participants should focus on what is positive and desirable, rather than concentrating solely on what is lacking and negative.
- As wellbeing is encompassing and holistic, as well as a subjective experience, attempts should be made during and after the research to assess how people feel or felt about the experience.
- The use of standard feedback forms and quantitative measures, which can be completed anonymously, should be considered. This may be particularly helpful in eliciting criticism and discontent.
- Qualitative methods and approaches involving direct, meaningful interaction with participants should also be considered for the purposes of obtaining feedback about participants’ wellbeing but also as a means to actively contribute to their wellbeing and communicate to them that they are valued.
- Researchers should try to meet people with dementia in a genuine human exchange, even in the absence of verbal communication.
- This may require familiarization with verbal and non-verbal communication techniques in order to facilitate interaction.
- Researchers should be aware of and if necessary challenge processes and interactions in the context of research which risk depersonalizing people with dementia.
Privacy and confidentiality
- Strategies to ensure privacy and confidentiality should be included in the research protocol.
- Participants should be informed in advance that if they participate in the study, whilst confidentiality would be assured, the researcher would have to consider taking appropriate action if informed of criminal acts.
- People with dementia should not be labelled in a blanket fashion as vulnerable.
- The diagnostic label of dementia should justify the assessment of people with dementia for specific vulnerabilities in relation to a specific study as they may be more vulnerable than others.
- Principal researchers should have some means of proving their status as researcher and of identifying their research assistants or co-researchers.
- A system should be developed by independent or academic research ethics committees to provide researchers having obtained ethical approval with a means of identification, which participants can verify.
- Measures should be taken to ensure that participants understand whether they are being asked to participate in research or in other activities such as service user-involvement, consultation or “market research.”
The use of deception, particularly with participants who have dementia, should be avoided and only used in exceptional circumstances.
Even in exceptional circumstances, the use of deception should only be considered if:
- an alternative design which would not involve deception is not possible;
- the study does not entail more than minimal risk;
- there is a sound scientific justification for the use of deception;
- participants will be debriefed after the study;
- other people or representatives from the target group of participants have been consulted in the design of the project.
If deception is used in a study, participants should have the right, once debriefed, to request that any data collected from them be excluded from the study.
Last Updated: jeudi 29 mars 2012