The Issue Of Consent In Qualitative Research Nursing Essay

In everyday life the labelling of someone as having dementia and the taken-for-granted assumption that they will lack insight has profound implications for their independence and autonomy (Bond, 2002.p.163).

It is vital to consider the ethical issues that may arise during the research process, or any ethical issues that had not been disclosed to the particular ethics committee, so that they can be evaluated against possible damage and dealt with truthfully and respectfully (Alzheimer Europe, 2008). In every research project the ethical issues can be numerous and researchers will need to take proper ethical decisions about them. This essay addresses this subject and highlights some of these issues and challenges. It looks at ways in which patients who are suffering from dementia need to be addressed when conducting qualitative research on them and will highlight important issues; informed consent and the capacity to make a decision to become involved in a research project as well as confidentiality and anonymity. Illustrative examples will be used from research studies that explore in-depth views about dementia patients and ethics.

Occupational therapy has played a major role in assisting researchers conduct their work in an ethical manner when dealing with dementia patients. Occupational therapy refers to the use of treatments to ease the condition of patients with physical, mental or developmental problems. These help with the development, recovery, or maintenance of the daily living and work skills of these patients (College Occupational Therapist, 2010). Occupational therapy has played a very important role in the treatment of patients suffering from dementia (Creek, 2002). Occupational therapy interventions have always placed the focus on helping these dementia patients adapt to their environment. Carers are taught the required skills and educated on how to make patients feel comfortable (Creek, 2002). This way, occupational therapy underpins the ethical manner in which the qualitative studies on dementia patients’ needs to be done.

Treating long-term dementia requires that researchers conducting studies need to make some ethical considerations when dealing with them. Individual sufferers from dementia have in most cases been treated by traditional biomedical research methods which place most of the focus on the pathophysiology, the diagnosis of the patients and management of these individuals’ behaviour (Penrod et al., 2007). These methods place very little consideration on how they affect dementia patients. As a result, there is very little known with regard to how these processes impact the lives of patients and the cognitive loss they may suffer in the course of their treatment (McKeown et al. 2010).

Because of this there has been a growth in interest in introducing qualitative studies when dealing with dementia patients. Qualitative studies have been identified as better capturing the personal perspective of the dementia patient (Downs, 1997). In spite of the interest in introducing qualitative research processes into this field, very few have been conducted (Gibson, 2004). This is primarily because of the lack of information about the challenges of conducting qualitative research in persons with dementia; only limited material has been published on this subject (Cotrell & Schultz, 1993).

Qualitative research allows people with dementia to feel they have a voice; that others can listen to their concerns and are interested in their opinions and experiences (Kitwood, 1997). Another important finding is that these patients can very easily narrate the various ways through which they are able to cope with the difficult experiences that normally accompany cognitive impairment. Researchers only need to ask these patients and they will get a response (Phinney et al. 2002). Through the use of qualitative research processes researchers have been able to learn of the meaningful experiences and life values of these patients (Moore and Hollet, 2003). This information is very important for development and testing of the various interventions which can be used to reduce the stress, anxiety and fear always experienced by dementia patients (Beuscher and Grando, 2009). This will, in the end, help in improving the mental well-being of these patients and, consequently, improve the quality of their lives.

Including people with dementia in qualitative research studies is very important. Inclusion helps to make them feel useful and productive in society (Matano, 2003; McKeown, 2010). By allowing these dementia patients to participate in the study and give their contributions, which in the end are used in drawing conclusions about the study, they are able to have a sense of purpose and usefulness (Matano, 2003). Including these patients in the research study will also ensure that their conversations are listened to (Heggestad et al., 2013) and give them a feeling that their value as a person is honoured by the researchers. It is through the involvement of these patients in the studies that the researcher will be able to learn about their feelings, desires, and preferences when being attended to, in spite of the fact that the disease might affect how they express these feelings (Bourgeois, 2002).

Obtaining informed consent is a major part of conducting or planning a research project that needs participant autonomy (Houghton 2010). Consent is defined by Gillon (1986) p.113 as a "voluntary uncovered decision, made by a sufficiently competent or autonomous person on the basis of adequate information to accept or reject some proposed course of action that will affect him or her". There is an increasingly relevant debate about consent, particularly with dementia sufferers. Researchers can easily view dementia patients as objects in need of protection and not capable of explaining their perceptions, preferring to ask family and/or close friends. Many people with dementia are capable of expressing their desire to participate in research and engage in discussion (Tee and Lathlean, 2004). As the dementia progresses however, the person’s ability to understand and value the consequences of contributing to research deteriorates. Informed consent means gaining the agreement of a dementia patient to participate in the research process and ensuring he or she has sufficient information to be able to decide whether to participate or not (Hoghton et al. 2010). Ethics committees demand that the proposal for research projects should clearly explain in detail the main questions to be addressed, the advantages from participating in the research along with any problems and what tasks will be performed (Berghmans and Meulen, 1995). These writers give as one of their five principles for research in dementia that:

Researchers should be very sensitive to verbal and non-verbal signs and signals that might be interpreted as symptoms of distress resulting from participation in the project (p.651).

In this situation, the dementia patient may be aware of being distressed but not conscious of their right to withdraw from a research study at any time. It is also not always straightforward how to obtain a valid consent form. Obtaining informed consent is therefore one of the critical issues related to the conduct of qualitative studies with dementia sufferers. Their disease makes it unusually difficult when it comes to decision-making (Lai and Karlawich, 2007). As a result, these patients are often very vulnerable to the researchers’ behaviour. When conducting research on them it is thus very important that the researchers safeguard the patients’ rights. This is where the thorny issue of obtaining informed consent from the patient comes in. The capacity of such patients to give informed consent needs to be addressed very carefully by the researchers before engaging the patients in the research process (Hellstrom et al. 2007). The researchers need to ensure that the proposed participants understand in detail the nature of the research and are aware of the consequences that may accompany their participation in the studies (Lai and Karlawich, 2007).

As Hellstrom et al. (2007) point out in their studies, most of the time dementia is not accompanied by a lack of the capacity to give informed consent. But because the manner by which the capacity to give informed consent is assessed in relation to any patient is inherently inconsistent, Sherratt (2007) recommends that it is appropriate for those planning the research to come up with a way through which they can determine the capacity of the potential participants for the studies, and implement it. There needs to be a plan for addressing the assessment of the cognitive capacity of the patients before conducting the study. Using these methods, the researchers will be able to make a decision on the capacity of the patient to give consent (Gibson et al., 2004).

Heggestad et al. (2012) were concerned about the ethical issues relating to capability to give consent by sufferers from dementia and balances this by respecting the autonomy of choice about participating. Disempowering a person is not respecting that person’s autonomy. Therefore, Heggestad et al. suggest it is important the participants understand the research process and constantly renegotiate their consent. They also thought that giving these participants the chance to sign their own consent would ensure that autonomy and integrity were maintained.

In the event that a patient is seen not to have the capacity to consent to participate in a research study it is the responsibility of the researcher conducting the study to seek this consent elsewhere. This can be sought from a proxy decision-maker (Holt et al., 2008). Most of the time this will be a family caregiver. This is known as the double-informed consent method for research and is in line with the recommendation from Sherratt (2007). The method is important in making sure there is enough capacity of consent before proceeding with the studies, hence promoting the autonomy of these dementia patients participating in studies (Beck and Shue, 2003). Many researchers view proxy consent as inappropriate and to be avoided where necessary. Ethical review committees would without doubt need an explanation for the use of proxy consent (McKeown, 2010). As explained above, many researchers hold the view that it is commonly hard to explain the technical details of a study in ways that anyone can understand within the limits of their level of ‘competence’ (Cacchione, 2011). If this cannot be done, including such an individual in a study raises important ethical concerns and needs a strong reason. McKeown (2010) highlighted that the requirement for consent from a proxy, where the research subject lacks capacity means that the proxy must be immediately available in order to allow timely recruitment to the dementia research project. If the proxy has to be a family member or friend, then their timely presence is frequently not possible in practice and should mean excluding from dementia research those who lack the capacity to consent (Cubit, 2010). The Code of Ethics and Professional Conduct of the College of Occupational Therapists, 2010; Section 2.1, therefore states that:

Occupational therapists should negotiate and act on behalf of the patients in relation to upholding and promoting the autonomy of the individuals.

Researchers commonly are not able to approach potential participants directly but have to negotiate the approach through gatekeepers (Cubit, 2010; Hellstrom et al., 2007; Sherratt, 2007). Gatekeepers are professional organisations where people are looked after, in addition to service providers, caregivers, parents or relatives. These gatekeepers have no legal rights in respect of the person’s decision to participate in research but generally control the places where they may be accessed and they may, in addition, have legal responsibility for an individual’s well-being in that setting (Health et al., 2004). For that reason, they have the power to refuse consent for a researcher to recruit participants in a particular setting. Moreover, where agreement is given, they have the power to determine the ways in which potential participants are informed about a study and the process of consent, which may influence potential participants’ willingness to participate. (Cubit, 2010 and Sherratt, 2007) have identified issues in relation to gatekeepers and the consent of participants to research study participation. The first concerns an over-protective attitude by gatekeepers which may result in people being denied the chance to participate in research (Health, 2004). The second concerns a failure of gatekeepers to provide opportunities for potential participants to exercise their choice to participate in research (Sherratt, 2007). In relation to the first of these, some gatekeepers may prevent contact by researchers for a variety of reasons, one of which may be an assumed lack of competence on the part of the potential research participant (Health et al., 2004). Even where access is agreed the gatekeeper may seek consent from relatives as well as the consent of the individual concerned (Holt et al., 2008). Even though a person wants to participate, their wishes therefore may be trumped by rejection from a relative (Holt et al., Sherratt, 2007). In most cases researchers are not in a position to challenge an institution’s judgment to refuse access or to seek further consent from relatives. A variety of ways to manage the issue of ‘presumed’ consent have been recognised in ways that do not reveal to gatekeepers that individuals are actually taking part in the research. These include respecting the rights of participants to remain silent in discussion groups, letting participants discourse what they need to in interviews and allowing them not to complete questionnaires (Sherratt, 2007).

The last challenge to the issue of consent in qualitative research on dementia patients is from whom to request consent to obtaining observational data in the clinical setting and whether written or verbal consent is necessary. For dementia patients, the most appropriate is to obtain verbal consent when collecting observational data in the clinical setting (Houghton, 2010). Moore and Savage (2002) and Griffiths, (2008) report that there is no need to seek any consent. Griffiths (2008) made the judgment not to seek any consent because she believed that the patients were acutely ill and should not be ‘bothered’ with the detail of research projects and the process of consent. Similarly, Moore and Savage (2002) stated that patients became anxious when told of the need for consent. In the Occupational Therapy code of ethics and professional conduct, section: 2.3 (2010) it is stated that informed consent is a continuing requirement which needs adequate explanation. An occupational therapist must therefore ensure the patients continue to understand the information they receive and any changes to that information, thereby continuing to consent to the research projects in which they are participating. The research studies the author uses to illustrate the issues of informed consent depend on building up a relationship of trust with the participant in order to obtained consent. It is further suggested that a process consent method is a necessary requirement for person-centered research. The advantage of informed consent is that results are likely to be more accurate because the participants are aware of the purpose of the research and know they can opt out from the project at any time (Dewing, 2002).

In conclusion it is clear that researchers, when conducting research projects using qualitative studies on patients with dementia, need to give serious consideration to ethical issues. It is important for these researchers to develop an attitude with which dementia sufferers will not have a problem when contributing their knowledge with regards to several issues. As emphasized by Kitwood (1997), dementia sufferers also need to be given a voice in the conduct of qualitative studies. This would make these individuals feel acknowledged in the wider community since the researchers will have shown they respect their values just as they do those of any other individuals. Much as the aim of this whole process is to provide these people with a voice in the community it is also vital that the researcher considers the feasibility of interviewing these patients. Among the important issues that researchers need to consider are the ethical issues of assent and consent. It is the researchers’ responsibility to be careful of and protect the participants’ dignity (Moore & Hollet, 2003). This is especially important for patients suffering from dementia. Getting the consent of the patient and backing it up with approval from a close family member is vital. In the event that the participant does not meet the criteria for capacity to consent it is important that the researcher refrains from using information provided by this participant in the compilation of the research data. We have observed that ethical issues which surface are not always simple to resolve, but it is essential to spot potential ethical problems so that ways can be found to address them. Whether or not a piece of research must be first submitted to an ethics committee, raising ethical queries during the planning period helps to ensure the security of both participants, particularly dementia patients, and researchers – eventually leading to improved, as well as reasonable research.