Research ethics approval

Having established the nature of the study to be carried out, and considered the methods and theoretical perspectives, approval was sought from the regional research ethics committee (REC) and the research and development (R&D) department of the NHS trust sponsoring the research. There have been many perceived barriers and ethical concerns about undertaking research on palliative care patients (Duke and Bennett, 2010). These ethical concerns have been summarised into five broad groups concerned with: patient vulnerability; the moral acceptability of carrying out research in this group of patients; gaining informed consent; barriers such as gate-keeping and finally; having a research structure in place to support research in this context (Duke and Bennett, 2010). Ethical issues and methodological concerns have been considered by

researchers to be inextricably linked (Seymour et al., 2005); it is important to emphasise at this stage that I share this view and as such ethical concerns are considered to be an integral part of this research methodology.

Major ethical consideration was given to two particular aspects of this research:

 consent process for patients

 access to patients who lacked capacity 3.3.1 Consent from patients

This study sought to use the methods of participant observation and qualitative interviewing to gain an account of sedation in palliative care. Participant observation involved predominately an observation of clinical staff as they performed their daily tasks in caring for patients. Crucial to this study was that I could gain access to patients, to include them in the observation through their interactions with clinical staff. In this way I could witness the discussions taking place with regard to sedation rather than receive a second hand account after the event. One perspective considered was that patients were not necessarily the focus of the observation: rather the clinical staff were and it was their intentions and interpretations which I sought to access. In this way I could have argued that consent was not required from patients at all. Indeed Julia Lawton, in her study of patients in a hospice, used an ‘opt out’ approach whereby patients were given information about the research by staff members and could opt out

72 if they wished (Lawton, 2000: 31). She acknowledges however, that this ‘opt out’ may not have included all patients as it may have been impossible in an emergency situation to ensure that this happened (Lawton, 2001). I decided, however, that I would take more of an overt stance to gain consent from patients. The environment of the hospice was important in this decision; with ten single rooms and three shared bays, many patients were in single rooms. The single room environment is different to that of a main bay: it becomes more of the patient’s domain and I considered it more of an intrusion to enter than it would be to walk into a bay. Even within the public space of a hospice, great care is taken to make the hospice environment more like a home

environment. Thus entering into a private space within this, I felt, should be considered differently; more of a negotiated act wherein expressed permission is sought. I decided to seek consent from patients prior to undertaking observations for the above reasons. In addition, concerns about not doing so were raised by the medical director at the time, in one of many pre-study meetings with staff members.

When approaching patients I wished to be explicit about the nature of the study, however recognised that patients may feel uneasy or anxious about being admitted to a hospice and did not want to heighten anxieties further by introducing a study about sedation in an insensitive manner. In addition, just prior to starting the fieldwork, the concerns of physicians working in palliative care about sedation came to the fore in the media. The headline ‘Sentenced to Death on the NHS’(Devlin, 2009) was particularly emotive and I was concerned about some of the associations between sedation and hastening death made explicit in the media.

I decided a staged approach to consent would be appropriate, with the first approach to patients coming from a member of staff involved in their care. Ideally, this would occur 24-48 hours after their admission but frequently it was later on in their stay, depending on the busyness of the unit. The staff member would ask if I could speak to them about a research study which was going on in the hospice. If they received a positive

response, I would then go to see the patient to explain the study and address any questions they had. The ethics committee accepted that patients may prefer to give consent sooner than is ‘standard’ for research studies, and accepted a negotiated

approach to the cooling off time. This was expressed in the following terms in the REC form:

73 The ‘agreed time’ referred to above would be agreed between the researcher and the patient. Patients admitted to a hospice rely on the flexibility of their clinical team and those around them to adjust to their energy levels and fatigue, pacing the day to suit their needs. The researcher would wish to be responsive to this and be flexible in timing, according to the patient's wish, her visits to provide information and gain consent. This may mean that a patient would wish the researcher to provide information about the study and come back the following day, as would normally be expected in a research study with 24 hours allowed as a ‘cooling off’ period. Patients in a hospice, however, may have a different sense of time and urgency. They may wish to participate in the study and yet be aware of a short prognosis or of continued deterioration and fatigue. We would want to accommodate these patients in the study to allow their participation in a dynamic and changing clinical situation. While a cooling off period of 24 hours is ideal, this study aims to adapt to the patient’s needs and this would be to allow the patient to have as much time as they individually required in making a decision. The researcher would be acutely aware of the issues involved in, and guidelines for, gaining informed consent and take every step to ensure this consent process is rigorous in adhering to these.

The approach to the study was always centred on being as unobtrusive as possible and carrying out this research with as little interruption to patients and their family as possible, while giving the opportunity to participate to all.

All patients admitted to the hospice who were aged 18 years or over were considered to be eligible for the study, with the exception of those admitted for a short planned admission (SPA). Those admitted for a SPA would be in the hospice for only a short period of time and going through the process of consent for a matter of two or three days was felt to be overly burdensome for these patients, with little perceived benefit or contribution to the study. The rationale for including all patients, while being interested primarily in those receiving sedation, was to incorporate the changing nature of patients admitted to a hospice. Limiting the scope of the study to just those receiving sedation may have captured the views of some of the patients, their significant others and healthcare professionals, but would not have been able to capture the decision-making

74 processes from its origin. Through the inclusion of all patients, I kept open the potential to see decision-making as it happened, rather than simply the outcome of this process. In addition, this method potentially allowed more patients to make a decision for themselves about their participation in research: those sedated to the point of losing capacity required a decision to be made by a ‘consultee’ (Mental Capacity Act, 2005).

3.3.2 Patient lacking capacity

Inclusion of patients who lacked capacity was a further area which required negotiation. The Mental Capacity Act (2005) required that certain criteria were met prior to the inclusion of patients lacking capacity in research. These were assessed by the REC. The inclusion of those who lacked capacity was considered as crucial in a study which was investigating sedation. While patients may be sedated to varying levels, it was inevitable that some would be sedated to the point they lacked capacity to consent to research. Their inclusion was vital in seeking to understand not only the processes of decision-making about starting sedation, but ongoing reviews and attitudes of those around a sedated patient. Thus two patient groups were considered: those who lost capacity during the course of observation (for which they had given consent) and those who lacked capacity from the onset. The former were asked to indicate their

preferences in the situation where they lost capacity: to allow the observations to continue or to cease, and for the information previously gathered (when they had capacity) to be used or destroyed. All patients were given a pseudonym so removing this data from the data set would have been possible. All patients involved in the observations consented both for the observations to continue should they lose capacity and for data previously gathered (when they had capacity) to continue to be used in the research study. Clearly there are concerns about accepting what a patient states at one point in time and assuming it holds for the future when they are in an incapacitated state. Lawton shared this concern:

just because patients had given me their consent to be included in my research on their admission to the hospice, such consent could not necessarily be taken for granted in my later encounters with them (Lawton, 2000: 32)

The process of gaining consent for observation of a patient who once had and subsequently lost capacity, took into account their statement about future wishes. In

75 addition I considered any expression which may have indicated that they did not want me to continue with the observation in the present. I also took into account the wishes of their significant others and the advice of the medical team; if they felt it inappropriate for me to observe an encounter I respected this, while acknowledging that this may have limited some of my exposure. This process of gaining consent may be regarded as a form of ‘process consent’ (Usher and Arthur, 1998). The research process may be regarded as a two way process, under constant negotiation. Thus a patient’s role in the research was considered at each point of encounter in that they were asked each time if it they were happy for me to stay and observe. In this interaction there was a reminder that I was a researcher and this was my role in the interaction; this was how I was

introduced on ward rounds or when observing staff with patients. It is clear that my role as a researcher was explicit on a day to day basis. This may not be the ideal position when conducting ethnography, however when conducting research in this field, I felt the ongoing disclosure of my role was worth the ‘risk’ of influencing behaviours taking place in front of me (Hammersley and Atkinson, 2007: 87-89). I do not consider these disclosures to have undermined my research, however through a reflexive process am highly aware of their influences on what I was able to observe. Clearly I chose a

position which may well have changed the nature of what was observed but in doing so, maintained trust and integrity in the research process.

The process of gaining consent from patients who lacked capacity from the start of the observation was managed differently. Relatives or significant others of patients who lacked capacity were asked by a member of staff if I could speak to them about the study. I would introduce the study to this person and ask if he or she felt it might be something which the patient, when they had capacity, would have wanted to participate in. If they felt the patient would have wished to participate, I asked if they would be willing to act as a ‘personal consultee’ and provided further written information about this. I explained that a significant other would have to agree to become a personal consultee and then agree that they felt participating in the study would be in keeping with the patient’s wishes. They were given a cooling off period to digest this

information; the duration of which was negotiated between myself and the potential consultee. For those without anyone able to act as a personal consultee the process of obtaining a nominated consultee was considered but not required in the data collection period.

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