Ethical issues

4.9.1 Sensitive topic /potential risk to participants

Research in health care commonly involves sensitive topics and is often associated with potential social and psychological harm (Boulton, 2009). It is important to acknowledge that drinking alcohol in pregnancy may be a sensitive issue. However, in this study I was interested in speaking to women about their views and perceptions of issues about alcohol consumption in pregnancy rather than providing women with potential

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causing information. I adopted a non-judgemental and neutral approach to ensure that participants were relaxed, comfortable and above all, spoke freely. It was initially decided that, if a participant became distressed and decided to discontinue participation in the interview or focus group, any information already obtained from such a participant would be removed from the study and destroyed. Fortunately, there was no such experience. Yet, “interviews are interventions because they affect people” (Patton 2002: 405). Therefore, an information sheet containing contact details of a midwife and local alcohol support services (West Lothian Drug and Alcohol Services, and West Lothian Alcohol and Drug Action Team) were available for participants who may have exhibited signs of distress or who wanted further information. However, only one pregnant woman requested such advice from me. She was asked to speak to the contact midwife who was available in a nearby office at the end of the interview, and was given an information sheet for further support. She however, declined to speak to the midwife and jokingly said, ‘I will look it up on the internet’. I followed her up with a phone call the next day but she reassured me that everything was all right; therefore, no further action was taken.

In order to safeguard against any potential risk to participants or to me (as a male researcher), all interviews with women were conducted in a designated room within NHS premises.

4.9.2 Informed consent

Written informed consent was sought from all participants before commencing each interview or focus group (see Appendix 18 for an example of the consent form used).

4.9.3 Confidentiality and anonymity

In order to comply with the Data Protection Act 1998 (The National Archives, 1998), confidentiality was maintained at all times throughout the study. However, in relation to

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data from policy implementers, the information sheet indicated that their organisations would be mentioned in the report but their names would not (see Appendix 8 for information sheet). This was because it was recognised that there was a possibility that their colleagues could identify them, as they constituted a small pool of experts in the area.

At the beginning of the interview or focus group, participants were reassured that their contribution would remain confidential. Audio−recordings of each participant were assigned a unique identification number in the interview transcript. Moreover, I did all the transcribing and no third party had access to the data other than my supervisors.

Data generated within the study was stored securely. Participants’ names as provided on the consent forms and demographic data were stored securely in a locked cabinet within an office in the University of Stirling. All information, including memos and field notes, was entered into a database on a computer in the University of Stirling. After the study, data will be securely stored and kept in accordance with the University of Stirling regulation – which is that data is kept for 10 years then securely destroyed.

4.9.4 Ethical constraints

I encountered a number of ethical challenges, which impacted on the research process.

Firstly, the original application to NHS research ethics committee on 27^th November 2009, outlined that the study would utilize focus groups and individual interviews as a means of data collection for midwives and pregnant women. However, the ethics committee refused to grant me approval and insisted that only focus groups should be used. Subsequently, a second application was made incorporating the changes they requested. This was approved. However, within a month of delivering 240 information packs to midwives which they were requested to pass to pregnant women to inform

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them of the study, no responses were received. Upon further discussions with midwives, they explained that some of the pregnant women who were informed about the study expressed considerable interest in taking part but raised doubt about being involved in discussing the issue in a group context, whilst others were concerned about the time commitment involved in taking part in a focus group.

From the 100 information packs distributed to midwives, five midwives expressed interest of taking part but it proved impossible to convene a date for a focus group that was suitable for more than any two of them. This was understandable because by their nature of work, community midwives are geographically dispersed and their work patterns differ.

Consequently, on the 4^th May 2010, I used these reasons as a basis to apply for a protocol amendment and requested that the ethics committee grant me the permission to conduct individual interviews with both midwives and pregnant women. This application was granted.

It is important to highlight that NHS ethics committees usually have set dates for meetings to discuss applications, which are usually some weeks apart. This means that several weeks elapse between the time an application is made and the time that an outcome is received. Considering the time constraint associated with full-time doctoral study, the events above had a substantial toll on my data collection period.

Another issue that possibly interfered with recruitment was the venue for conducting the interviews. In the original ethics application, I indicated that interviews would take place at a venue convenient to participants. However, the ethics committee insisted that all interviews should be conducted in a designated room within an NHS premises in

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order to safeguard against any potential risk to participants or to me as a researcher. The basis of this request was not made clear but I felt it was possibly on gender lines, namely a male researcher interviewing pregnant women. However, as a result the very limited choice of venues available probably contributed to the low response rate this study experienced.

Finally, regarding the recruitment of pregnant women who had received ABI, I planned to recruit these women retrospectively by requesting a list of all women who have received ABI in NHS Lothian and inviting a sample of them to take part. This decision was made following discussions with relevant staff who indicated that it was possible to generate this list. This strategy received ethics approval but unfortunately NHS Lothian maternity services management did not approve the strategy and they insisted that women should be recruited prospectively through their midwives. However, the prospective recruitment strategy they required proved extremely difficult as none of the pregnant women in this category expressed an interest in participating. An alternative would have been to try and recruit from other health boards but there was no guarantee that this would have been more successful. Moreover, establishing new clinical contacts and recruiting from other health boards would have meant investing more time and resources, which were deemed not viable within the constraint of this doctoral study.

Finally, for ethical reasons, this study required midwives to make the initial approach to pregnant women about the study. This prevented a direct contact between study participants and me. This was considered appropriate as midwives gave the information packs to only the women who satisfied the inclusion criteria. However, it was impossible to know whether midwives distributed all the packs or not. Nevertheless, anecdotal feedback indicated that they proactively distributed them.

141 4.9.5 Ethical approval

The study received ethical approval from the School of Nursing, Midwifery & Health (University of Stirling) Ethics Committee. All research within the school is required to receive approval from the School Ethics Committee. Participants involved in this study (with the exception of the pilot) were Scottish Government staff and NHS staff or patients. Therefore, approvals were also sought from the NHS Research Ethics Committee and NHS Lothian Research and Development office. All NHS research governance approvals for the study were granted between January 2010 and June 2010 (see Appendices 19, 20, 21 and 22).