SERVICIO DE AUTENTICACION Y AUTORIZACION

5.9.1 Ethical approval

The research protocol was approved by the School of Healthcare Sciences, Research Review and Ethics Screening Committee, Cardiff University on the 4th

June 2014. The School of Healthcare Sciences, Research Ethics Committee, Cardiff University gave ethical approval for the study on the 6th _{October 2014 (see}

Appendix 2). The conduct of the study was guided by research ethical frameworks (DoH 2005a; Royal College of Nursing 2009; Cardiff University 2011; Economic and Social Research Council 2012).

Following phase one of the study, minor changes were made to the research protocol and approved by the School of Healthcare Sciences Research Ethics Committee on the 18th _{& 25}th _{June 2015 (see Appendix 2). One change was made}

135

recruiting students from placement databases or lists held by universities would contravene the Data Protection Act 1998 (The Stationery Office 1998). The

research protocol was amended to state that students would be recruited by placing an advertisement on the student website or virtual learning environment. One research and development office recommended further strategies that could be used to heighten awareness of the study in NHS Trusts. This included informing mentor links and senior sisters in NHS Trusts about the study through meetings, email or letter and the placement of posters in clinical areas.

A further amendment was instigated by me, as the researcher following selection of the phase two case-study sites. Due to the geographical location of one case-study site, phase two in-depth interviews were changed from face to face interviews to telephone interviews. After approval of these minor changes, the Heads of School of two universities selected as case-study sites were invited by email to participate in phase two of the study. Heads of School from these universities gave permission for students and HEI staff to be approached and recruited into the study. The integrated research application system (IRAS) was used to gain research and development approval from the seven NHS Trusts associated with the two universities selected as cases in the phase two case-study in order to recruit mentors and infection prevention and control nurses.

One Research and Development office requested that two additional statements were included in participant information sheets and consent forms. The first statement was that direct quotes from the interview may be used in the thesis, publications and conference presentations. The second statement was about what would happen if a serious patient safety issue or poor practice was identified during the interview. Further minor amendments were made and approved by the School of Healthcare Sciences, Research Ethics Committee, Cardiff University on the 28th

July 2015 (see Appendix 2). For consistency these were added to all participant information sheets and consent forms following approval for minor amendments and all research and development offices informed. All seven NHS Trusts finally gave approval.

5.9.2 Ethical issues

It was not anticipated that many ethical concerns would arise because of the line of enquiry.There was no patient involvement in the study.Investigating nursing students’ education, training and assessment in aseptic technique was not

136

perceived to be highly sensitive. Possible ethical concerns were that students might have perceived pressure to take part in the phase two case-study. This was

minimised by selecting and conducting the phase two case-study at universities where the researcher was not employed as a lecturer. The researcher was unknown to the students and therefore they were unlikely to feel compelled to take part. Students only provided their contact details if they were willing to take part in the study. There was no coercion by the researcher for students or any other participant to take part or to continue to take part if they no longer wished to. Some infection prevention and control nurses were known to the researcher in one infection prevention team at Case-Study Site 1. The infection prevention team administrator co-ordinated and arranged interviews for those who wished to take part in the study. There was no direct contact between the researcher and infection prevention nurses initially.

5.9.3 Informed Consent

Individuals approached to be recruited to the study were informed that their

participation in the study was voluntary. Participants were assured that their choice about whether to participate or not in the study would be respected. The decision made would not affect their role as health professionals or their studies as a student. The role of the researcher as a nurse lecturer was acknowledged and no students or health professionals known to the researcher were coerced to

participate in the study (ESRC 2012).

All participants were informed of the purpose of the study, what the study entailed and reassured that all responses in the survey and interviews were to be made anonymous. Informed consent was gained from participants prior to the survey and interviews, through the provision of written and verbal information about the study (RCN 2011). Participant information sheets (see Appendix 3 & 7) informed

participants of the potential benefits and risks of the study and about where to go for support before, during and after the study (ESRC 2012). Participants were reminded that any information provided would not affect their employment as health

professionals or studies as students. Participants were asked to sign a consent form (see Appendix 3 & 7) once they had agreed to take part in the study. Participants were informed that they could withdraw from the study at any time without providing an explanation (RCN 2011). Participants who were deemed not to have capacity under the Mental Capacity Act 2005, (The Stationery Office 2007) were excluded from the study for their protection.

137

5.9.4 Confidentiality and anonymity

The dignity, rights and well-being of participants were protected by all data being coded to ensure anonymity and confidentiality (ESRC 2012). There was no

identification of case-study sites, organisations or individuals. All data were kept in a locked cabinet or on a University password protected computer and is to be retained for fifteen years in accordance with the Research Framework for Cardiff University (Cardiff University 2011) and the Data Protection Act 1998 (The Stationery Office 1998). Interviews were conducted by telephone, limiting the risk to the researcher. The next chapter will present the phase one survey findings.

138