Ethical considerations

Attention was focused on the central ethical issues of respect for the research participant. These included respect for autonomy, the provision for informed consent, anonymity and confidentiality, and protection from harm. These principles ensured the study process and outputs reflected the codes of both professional practice and the research governance framework (Department of Health, 2005), and met the requirements of the relevant Multi-Centre Ethics Committee as directed by the Central Office of Research Ethic Committees11_.

4.2.4.1 Informed Consent

The provision of informed consent is central to the ethical conduct of all research and respects participant autonomy to make informed decisions whether to take part, whether to withhold or whether to later withdraw consent from participation within a

10 _{NVivo 7 training via The University of Liverpool Deanery & Departmental Postgraduate training}

providing the opportunity for regular updates (23-24th Nov 2006; 29-30th Nov 2007; 9-10th June 2008).

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study. Study documentation packs12_{, including participant/clinician information sheets,}

letters of invitation to participate and consent forms were developed conforming to the recommendations within the COREC Guidelines for Researcher’s Version 2.0 November 2005 (Davies, 2005).

The approach of potential recruits was by invitation letter from their treating clinician. A returned reply slip was taken as implying agreement for contact to be made. Informed consent was supported by encouraging women read the study documentation in their own time. Stamp-addressed reply envelopes were provided with each study documentation pack and women could both indicate interest and provide consent during clinic attendance or by returning the reply slip on the invitation letter/consent form. The approved research protocol placed responsibility on the recruiting clinicians to identify and approach patients who met the inclusion criteria; this restricted my direct contact with potential recruits. Study documentation was distributed by clinical staff to female patients who met the eligibility criteria. The exact number of study documentation packs distributed was not known, preventing writing to women who had not replied to the first invitation. This potential limitation was balanced by the duration of recruitment (September 2006 – July 2009) allowing potential recruits to be approached on several different clinic visits, therefore providing an opportunity to revise their initial decision concerning participation. Contact was maintained with all women who returned a reply slip/signed consent form.

All women were required to provide consent prior to their involvement in the study, and consent was reaffirmed prior to commencing digital recording. Consent for clinic observation, both participants and the clinicians were made aware of each other’s consent. Consent was re-confirmed as arrangements were made for the follow-up interview, and again prior to beginning the interview.

4.2.4.2 Confidentiality and anonymity

Anonymity is defined as the means of securing the identity of those taking part in the study from anyone outside of the research team13 _{(Lewis, 2003). While clinicians were}

12 _{See Appendix 1 Study Documentation.}

13 _{The research team refers to myself (Janine Winterbottom) and my two academic supervisors}

aware of women they had selected as meeting the inclusion criteria (and those observed in consultation), it was only the research team who knew the final study population. It was acknowledged within the study documentation that absolute anonymity could not be offered or guaranteed.

Confidentiality in the context of qualitative research means the avoidance of attributing individual participant comments within any report, presentation, publication or the final submitted thesis. This includes both direct attribution, such as comments linked to a name or role, or place of residence, and indirect attribution such as by reference to a collection of characteristics that might reveal the identity of the participant (Lewis, 2003). These issues were managed at the point of transcription, with all names removed and replaced by descriptors, such as [location]. Participants were assigned an alphanumeric reference. The ID code was recorded and only accessed by the study author, or academic supervisors if required, following ethical codes of practice. Digitally recorded audio files and transcripts were stored electronically and access to all computerised stored and generated data was password protected. Data collection, storage and disposal conformed to the Ethics and Clinical Governance approval warranted, and conformed to the Data Protection Act.

Issues of confidentiality and the potential for indirect attribution were acknowledged as harder to guarantee and, therefore, the study documentation drew attention to this risk. Attempts to minimise the potential indirect breach of confidentiality was managed through the scrutiny of all reports and documentation (either verbal presentation, or in written form) by proof reading by the research team. The use of textual quotes when reporting the results reflects the need to sufficiently represent the links between the data and analysis, and the ability to portray meaning and understanding (Langdridge, 2007; White et al., 2003).

4.2.4.3 Protecting participants from harm

The potential for harm fell into three main areas: sensitivity of topic; confusion surrounding the clinician-researcher role; and, managing disclosures which might indicate the participant’s risk of harm (Lewis, 2003).

1. Sensitivity of topic – The potential for causing distress, either by the probing nature of interview/focus-group questions, or by the intrusion of the researcher

observing the participant’s clinic appointment, were addressed by the careful construction and revision of the topic guide (see Appendix 2), and by the explicit provision of support from a clinical psychologist being made available. Patient educational literature and details of the local patient voluntary services were also provided at the close of participant contact.

2. Confusion surrounding the clinician-researcher role – My professional and employment background was made explicit within the study documentation to protect against the risk of exploitation through any confusion concerning the researcher role (Arthur and Nazroo, 2003). The non-interventional basis of the research was emphasised, with participants informed that the study was not therapeutic.

3. Managing disclosures – Study documentation (see Appendix 1) defined the circumstances when interventions to manage disclosures would be justified. Consent to disclose information felt to be in the best interests of the participant was required; initially encouraging the participant to take action, and if necessary agreeing the content of any communication with their epilepsy clinician or General Practitioner. Duty to adhere to the guidelines for disclosure of suspicion of abuse was maintained by my substantive and honorary NHS contracts. Disclosures within the focus groups represented an additional challenge and was managed during focus group introductions, covering topics of disclosure and maintaining the privacy of fellow focus group participants as a form of respect (MW Smith, 1995).