Físicas 35

Ethical Approvals

Before the research started ethical approval was sought and obtained from Durham University School of Medicine, Pharmacy & Health Ethics Committee (see appendix 12), University Hospital of North Tees Research & Development Peer Review Committee (see appendix 13), and the NHS National Research Ethics Service (NRES) North East Committee (see appendix 14). One minor amendment was submitted after the study began, an alteration to the GP letter, which was approved (see appendices 15 & 16).

Ethical Issues

All data was stored confidentially and used anonymously. Questionnaire participants were assigned an anonymous code, and interviewees, as well as any individuals named in interviews, were given a pseudonym to protect anonymity (Rubin & Rubin 1995). All physical documents were stored securely in locked filing cabinets and all data stored electronically (transcripts, audio recordings and questionnaire responses ) were anonymised before being put onto a password protected computer, within the University secure server.

Some of the main ethical issues which were identified and addressed for this project were the identification of eligible participants, the time at which patients were being approached, the potential for distress as a result of invitation to participate, and the potential for distress in interviews.

It was originally intended that the research nurses would screen referrals and send packs to eligible patients, so that I was not privy to any patient details prior to their consent. However, the lack of funding to support the nurse activities meant that the Research and Development department requested that I undertook this part of the process instead. In order to allow me to view urgent referrals without patients’ consent I applied to, and was granted, Caldicott approval (see appendix 13). In order to minimise the extent to which data was accessed and used without patient consent, no record was kept of patients who had been invited to the study.

75 The time at which we approached patients to take part in this study was a concern, as most patients would be awaiting results of investigations and diagnoses and we did not want to cause any confusion or distress to patients. It was decided that packs would be sent to patients within the two weeks after their first appointment, as leaving it much later than this would also mean that their help-seeking was more distant and participants may struggle to recollect their experiences.

As the majority of patients would not have a diagnosis at this point it was decided that the word ‘cancer’ should not be introduced, as it would possibly cause distress to patients if they assumed that the invitation to participate was because they had an as yet undisclosed cancer diagnosis. Therefore, the word ‘cancer’ was never used on any of the study documentation.

There was the potential for interviewees to become distressed as a result of talking about their help-seeking experiences, social context, or diagnosis, and procedures were in place to deal with such situations, should they have occurred. In instances where a participant was distressed I was to stop the interview, allow them to decide whether or not they wished to continue, and, if appropriate, signpost them to specific organisations (such as Macmillan or The Patient Experience Team at UHNT) who would have been able to support and address their concerns. No participants became distressed during the interviews, however, some did become upset. For these people I offered to stop the interview, an option which was never chosen, and allowed them the time to address their feelings before continuing with the interview. I think it is important to be clear that someone being upset is not necessarily a bad thing, nor does it inevitably equate to ‘distress’ or ‘harm’. For some, participating in an interview, and the opportunity to tell their story to a stranger, can be cathartic (Richards & Emslie 2000). It is not the interview itself which is upsetting, it is the topic being discussed, and as researchers sometimes we need to allow this, responding as humans, as opposed to researchers (Barbour 2014).

A final ethical consideration was the risk posed to myself by undertaking this research. By interviewing strangers within their own homes there was the possibility that I may have entered a dangerous situation, in which I was alone, vulnerable and exposed to harm. In order to protect myself I left the details of the interview in a sealed envelope with a colleague, along with an expected completion time, and once the interview was over I called them to confirm I was safe, following my research team’s lone working policy.

76 The other issue was that of the emotional impact of the interviews on myself. I had a support network available to me, in the form of my supervisors, as well as my husband and mother, whom I could talk to about my reactions and feelings to the interview, whilst ensuring that the interviewee remained anonymous in my discussions.

Patient and Public Involvement

The study was supported by two patient representatives, Margaret Johnson and John Shepherd. They were involved from the beginning of the PhD, and offered comments and advice about the research design and study documentation, including the study summary sheet, which was sent to all participants who indicated that they wished to be informed of the study findings (see appendix 17).