Antecedentes

4.2.1 Ethical considerations of involving vulnerable people in research

Appropriately, research, which involves people with dementia requires a full ethics application. Section 10 of the HREC application identifies people with cognitive impairment as having a distinct vulnerability. There seems a persuasive view that the focus of informed consent is about the duty of care to others, rather than the protection of the vulnerable. Proof of consent is often reconstructed into a compulsory, non-negotiable contract-like agreement (Carter 2009). For institutions, there can be a tendency to favour traditional proof of consent as perceived protection against future litigation by participants (Ashencaen Crabtree 2013; Carter 2009). By its very nature, the risk-averse, legally oriented informed consent process also tends to subvert and undermine the egalitarian, respectful, collaborative relationship that lies at the heart of the majority of qualitative research (Carter 2009). There are several complex and potentially ambiguous ethical matters when involving people with dementia in research. Issues include assessing and proving capacity to provide informed consent to participate, as well as balancing the need to protect vulnerable people and honouring the core values of ‘respect for persons, justice, and beneficence’ (National Health and Medical Research Council et al. 2007a, p. 1.5; 2007b, p. 9). Key issues debated in academic circles are that of minimising risk while giving the vulnerable a voice, the use of research proxies and respecting the principles and values of the National Statement of Ethical Conduct in Human Research, 2007, and Australian Code for Responsible Conduct in Research, 2007 (Ashencaen Crabtree 2013; Goodman et al. 2011).

Some ethics committees are uncomfortable or reluctant to provide approval to involve people with dementia directly in research (Beattie 2009; Carter 2009; Cubit 2010). Consequently, many

researchers intend to include people with dementia, but to overcome the issues of getting approval and meeting timeframes, cast aside their own values and default to the use of proxies such as the family or meaningful carers to provide consent or to act as research surrogates (Dewing 2002; Goodman et al. 2011). While this affords a view that may not otherwise be available, the reliance on surrogates is not without issues. Spousal proxies, in particular, may also be frail, cognitively impaired and elderly, and family proxies have frequently been reported as being stressed by burden and grief imposed by caring for their unwell relative (Mullin et al. 2013). Further, the data gathered is

secondary and potentially inaccurate (McKeown et al. 2010).

The use of proxies assumes intimate personal knowledge of the person and unencumbered dissemination to the researcher. This information may, however, be based on the surrogates’ knowledge of their relative’s past values and preferences rather than the present (McKeown et al. 2010; Sabat 2005). Families may be motivated to report positively as they are concerned negative feedback may impact on their relative’s quality of care (Mullin et al. 2013) and reporting ill-being may be psychologically incongruent with their own needs (Vohra et al. 2004). The views of family and staff have also been found to contradict those of residents3 _{(Komaromy 2000; Tan et al. 2013).}

3 _{To aid ease of reading, the word resident is used interchangeably with ‘people with dementia’ throughout the thesis. All} resident participants included in the study and text had a diagnosis of dementia.

Notwithstanding the difficulties of engaging people with dementia in research, the use of proxies and exclusion of people with dementia from research is incongruent with current discourse. By

positioning people with dementia as vulnerable, their rights may be undermined, rendered unable to make personal decisions about the own lives including involvement in research and the potential to discuss their life experiences (Ashencaen Crabtree 2013; Sabat 2005). Exclusion from research can also be considered harmful to the person, discriminatory and controvert widely espoused notions of valuing personhood (Dewing 2002, 2007).

As discussed in Chapter 3, person-centred-care (PCC) was a significant move from ‘pathology to people’, although the philosophy is not always translating into practice (Dewar & Nolan 2013; Nolan et al. 2006). Similarly, the goals of PCC to value personhood are often not applied in research and people with dementia are excluded from research.

We cannot assume that people, even with late stage dementia, do not have meaning-making ability, and their expression is a fundamental human right and can assist us in understanding their

experiences (Dewing 2007; Edvardsson 2008). While appreciating the sensitive nature of involving people with dementia in research, their participation is core to providing a comprehensive

understanding of their lived experiences and the influence of the built environment on their sense of well-being.

People with dementia remain one of the most excluded research groups in our community, and while they are the primary users of RACF environments, minimal qualitative research has been done from their perspective (Kitwood 1995; Mullin et al. 2013; Rigby et al. 2010). It is important to hear their opinions, as it is likely that they will have a view that is relevant to the research.

Reliance on traditional methods to demonstrate the capacity to provide informed consent may often exclude people with dementia, with the denial of an essential aspect of selfhood and focussing on a person’s losses rather than their remaining capacity (Ashencaen Crabtree 2013; Goodman et al. 2011). Hellström et al. (2007, p. 611) argue that current notions of informed consent are universalistic, exclusionary, and based on what she calls a ‘one size fits all’ model of deterring consent.

Informed consent is founded on a required minimum of cognitive competence that is assessed in a clinical and non-situational manner, rather than a competency-based approach (Dewing 2002; Sabat 2005). Measuring capacity to consent is often based on neurological tests such as the Mini-Mental State Examination (MMSE), which has little bearing on a person’s ability to consent to research (Sabat 2005). The MMSE does not indicate the ability to talk about life, feelings, and lived experiences.

Assessing and proving capacity to consent is not straightforward for people with dementia (Goodman et al. 2011). The demands for designing methods and gaining research approval are a complex consideration of legal and ethical requirements, assessing capacity for consent and participation, adequately proving consent, and demonstrating sensitive research design to protect people with dementia.

The National Statement of Ethical Conduct in Human Research, 2007, updated March 2014, allows for tailored and thoughtfully designed consent alternatives. Section 2, Chapter 2.25 of The Ethics Statement provides for non-traditional consent methods such as ‘oral expression’ and ‘conduct

While the ambiguity about notions of the RACF as ‘home’, sense of home was discussed in Chapters 2 and 3, I adopted the term ‘resident’ consistent with use by the families, staff, and organisation.

implying consent’ providing they are appropriate and can be evidenced (National Health and Medical Research Council et al. 2007b, p. 9).

A move from traditional methods to more inventive, person-centred approaches is potentially more appropriate, and increases the likelihood of success as well as alleviating the concerns of others (McKeown et al. 2010). Prominent researchers advocate varying forms of flexible consent that are particularistic, inclusive, context-situated, and building upon strengths (Dewing 2002, 2007; Nolan et al. 2002). Further, as the experience of dementia is unique to each individual, any approach must also consider a range of abilities, and be individually customised.

Several innovative methods for proving consent were identified in the literature. Dewing (2007) argues for progressive consent based on person-centred nursing practices and people’s everyday experiences. Ashencaen Crabtree (2013) recommends an unfolding or ongoing consent that minimises risk by building a relationship of trust between all research participants. Nolan et al. (2002) promote an exchange model of consent and participation that values the benefits and perspectives of all participants equally in the research process. These models are based on mutual trust and valuing capabilities, which address vital ethical components of respect, justice, and beneficence.

Consent as an ongoing process is a widely accepted concept. Relatively self-explanatory terms used to describe continuous consent methods include process consent (Dewing 2002, 2007) and

progressive engagement (Robinson et al. 2011). McCormack (2002) designed a narrative-based approach to consent, and Ashencaen Crabtree (2013) argues for a verbal consent process where the explanation becomes a conversation and the parameters negotiated between parties.

Consent involving all parties in the research relationship is becoming increasingly more widely accepted. A multi-faceted approach enhances protection during research, minimises risks and alleviates many of the concerns of the family, staff, and care organisation (Beattie 2009). Several scholars identified working collaboratively with the family and staff to both recruit and communicate with potential participants with late-stage dementia as a successful approach (Cubit 2010; Hubbard et al. 2003; Nolan et al. 2002). An additional safeguard adopted in this study was to seek non- traditional consent from the person with dementia as well as traditional proxy consent from one of their close family members.

Notwithstanding moral issues, Beattie (2009) points out that there is no ‘gold standard’ at this point for proving informed consent. Even when every care is taken, a person’s assent or dissent may not be sufficiently explicit to allow research involvement or to adequately demonstrate consent

(Ashencaen Crabtree 2013). Scholars conclude that there is no way of judging whether anyone, with or without dementia, is fully informed (Ashencaen Crabtree 2013; Hellström et al. 2007). Therefore, the goal was to ensure maximally informed consent, which assumes that people with dementia have sufficient competency to make decisions about participation (Hellström et al. 2007; Murphy et al. 2005). Hubbard et al. (2003) conclude that judging the capacity to consent should be on a case-by- case basis, dependent on what the participant is being asked to do.

Potential harm can be minimised with a careful and sensitive research design that considers their well-being above the research agenda. Accordingly, processes were developed for the study that honoured and protected the person and was congruent with current discourse about personhood. I carefully demonstrated methods that were sensitive and tailored to the needs of people with dementia to the Ethics Committee, and approval was granted on June 1, 2015.

4.2.2 Recruiting and informed consent processes to give voice to people with dementia

The design of recruiting, consent, and research processes drew on several relevant and successful methods that included people with dementia. Similar to consent methods described above,

recruitment was in several stages using a progressive engagement and collaborative approach based on ordinary daily experiences (Dewing 2002, 2007; Goodman et al. 2011; McKeown et al. 2010). Some of the obstacles to researching people with dementia were overcome by collaboration with family and staff. Dewing (2007) and Nolan et al. (2002) describe research methods that understand knowledge and capacity are situational, and support by others in a familiar environment strengthens the ability of people with dementia. By working within the environment, developing trust and rapport with residents, I was able to create sensitive, tailored means of communicating collaboratively with staff and family for each resident participant. In a recent Australian study adopting a similar approach, potential participants were found to express curiosity about the

researcher’s presence, providing a natural opportunity to discuss the study in everyday conversations and to recruit in a gentle manner (Chin 2010).

Based on McKillop and Wilkinson’s (2004) advice, the invitations, information sheets, and consent to participate forms were buff coloured, with large print format, and short, single sentences. While I designed both a traditional and a simplified version of invitations, information, and consent forms for residents, only the simplified version was utilised once I understood the actual capacity of the

residents (see Appendix 3).

Given that people with dementia have a diminished capacity for verbal communication, reasonably clear non-verbal and behavioural cues are considered a suitable form of communication (Clare 2010). Signatures customarily gathered as ‘proof’ of consent can be either non-verbal or verbal (Dewing 2007; Hubbard et al. 2003). Assent, an important concept in dementia care (Dewing 2007; Hubbard et al. 2003) was adapted in the research, allowing expression of intent even when verbal skills were diminished. I presented the information verbally to the resident in the presence of a family or staff member. This often took place over two or three short sessions so as not to overwhelm the resident. I initialled and dated each point of the consent, which was then verified by a Registered Nurse. In processes outlined by Dewing (2002) and (Young & Manthorp 2009), a biography was sought from a family member or meaningful carer to identify and recognise individuals’ usual signs of consent and assent, communication methods, and signs of ill-being or fatigue. This individualised information aided my interpretations as well as protecting the resident so that research conversations were sensitively delayed or ceased at the first sign of discomfort.

Residents were not approached about the study until research conversations with their participating family member had occurred so that their biography was developed to inform recruitment and consent methods, which were then tailored to suit the needs of each resident.

Several scholars identify the potential for staff bias when assisting the selection of potential participants (Chin 2010; Mullin et al. 2013). A direct recruitment process was engaged to minimise this risk. Rather than guiding selection, staff assisted by identifying unwell residents and overly stressed families. Through my voluntary work in the research setting, described below, I also built rapport and established familiarity with a number of potential participants early in the fieldwork and collaborated with staff and family to determine residents’ relative cognitive capacity and well-being. An aspect of potential power relations identified in other studies was that participants might feel an obligation to participate from concern that care or their relationships with staff could be negatively

affected (Goodman et al. 2011; Hellström et al. 2007). There was also potential that my ongoing presence in the wing as doing voluntary work as described below might have a similar effect on residents, family, and staff sense of obligation to participate. All participants were assured that participation was voluntary and this was reinforced on all invitations, project information sheets, and consent to participate forms. Further, I did not pressure participants to consent and ensured that I maintained friendly social relationships with everybody in the wing, regardless of whether they participated.

People with dementia may be easily confused or distracted in a conversation or research situation (Young & Manthorp 2009). Considerable care was taken to minimise these risks. For example, I used a small notebook so that my interactions with residents were less likely to be confused with staff care documentation processes. I carefully planned every visit so that all materials were to hand, the recording device checked, and batteries charged before entering the research setting to minimise fussing, fumbling, and rummaging which could potentially impair the flow of the conversation or distract the participants.

To facilitate residents’ recognition of the researcher, multiple cues including wearing the same clothing and the same striking necklace were worn at every visit. My carefully selected everyday clothing was discrete, not overly bold, formal or with fussy details. A warm coloured, simple floral shirt with plain trousers, dissimilar to the staff uniform was chosen to reduce the possibility of being identified as an authority figure.

The opportunity to share personal stories in a familiar environment, supported by others has been shown to contribute to strengthening self-identity for residents with dementia (Hellström et al. 2007). A study by Hellstrom et al. (2007) which included people with dementia found that if research can be an enriching experience for all involved when conducted in a safe context. Several

participants from all groups observed that participating in this study allowed them to share thoughts, opinions, practical ideas, and to have their experiences validated contributed to their sense of worth and well-being.

Indirect therapeutic benefits may have included a sense of inclusion for people rarely given a ‘voice’ as well as a sense of contributing positively to research with the potential to improve the design of future care homes and the lives of others. The spirit of the research engagement was one of a collaborative approach that valued all involved as equal conversation partners working together for a common goal to make things better for others. The research platform provided all participants with ‘permission’ to speak freely and the opportunity to talk to an attentive, non-judgemental, and interested listener without time constraints.

4.3 A hermeneutic phenomenological philosophical approach to research design