Ethical considerations

4.15.1 Informed consent

To manage the complexities risk in relation to informed consent, it was important to produce clear information for both patient and staff participants (Streubert and Carpenter 2011). The informed consent process included an invitation letter, consent form and a participant information sheet for both patients and staff (appendices 10 to 15). The invitation letter introduced me as the researcher, stated the study was part of a Professional Doctorate research programme and linked the study to the cardiac wards. The information sheets took the form of a question and answer sheet detailing more in depth information about the study including contact numbers for more information and an independent advocate. The consent form for observation and interview detailed nine statements about agreement and understanding of the study.

The invitation to patients to participate in the research process followed two clear pathways, one for elective admission patients and one for emergency or non-elective admission patients. Elective admission patients were invited to participate in the study prior to their elective admission to the wards at pre admission clinics for either cardiac surgery or invasive cardiology procedures, a pre admission clinic takes several hours. The information about the study was discussed at the beginning of the clinic attendance and then followed up towards the end of the clinic visit giving the patient and their family/carers an opportunity to ask questions before signing the consent form. Following their admission elective patients were reminded of the study and had a further opportunity to ask questions and accept or decline participation, a period of 24 hours was given before participating in the study. The majority of patients on the wards were elective admissions however a smaller number of patients were admitted as non-elective patients usually through the emergency patient pathway. The patient would not have had the opportunity to attend any pre admission service and therefore no information about the study was given to the patients prior to their admission to the ward. Therefore informed consent for the patients was obtained after their admission to the ward. For this group of patients it was important that the approach to obtain informed consent didn’t compromise their clinical care. This group of patients were not considered for the informal consent process until they had been

119

on the ward for 24 hours and their clinical condition was stable, as determined by their consultant. Following this time period the patients were given information about the study, a follow up visit was then made half a day or day later to answer questions and if the patient accepted sign the informal consent form.

In the event of a patient dying or becoming unwell and losing capacity in the period after they had participated in an interview it was decided that their data would still be used within the study as it was obtained when informed consent had been provided.

Informed consent was obtained from ward nursing staff prior to the period of observation and interview, taking the form of several information giving sessions, to staff about the study. Each member of the ward staff was individually asked if they wished to participate in the study and written consent was obtained from those who voluntarily came forward.

To assure patient and ward staff confidentiality and anonymity each participant was identified by a number/pseudonym throughout the process of data collection and throughout the data analysis and dissemination of findings. Written authorisation from the wards local management team was gained to undertake the study but the identity without changing any relevant characteristics of the research setting is disguised.

4.15.2 Observation of poor practice

The study used trained observers to collect observational and interview data, these nurses were also trained to ensure continuing patient and staff consent as well as being aware of complexities and risks of observational research. It was not anticipated at any time throughout the rounding study that participation or data collection should cause a risk or burden to the research participants as it is part of usual clinical practice on wards. However, it was identified that there were some potential risks if the observer/interviewers did not adhere to the research structure, such as:

 patient fatigue or disruption to clinical care if the interview process took over 15 minutes

120

 participant staff nervousness at being observed in practice if the staff member was unaware or not fully informed of the study

 a reduction in time available for clinical work and interruption of patient care if the staff member was taken away from practice area for an interview that was too long.

It was also important the observer nurses understood their role in intervention and advocacy for example in the event of observing poor practice the researcher would need to intervene as a patient advocate as data collection should not put patients in danger. A strategy was introduced that enabled the observers to feedback concerns to the ward matron immediately after observing the rounding, but this was not required during the study. As I was the principal investigator and a member of the divisional management team it was important to identify an independent advocate who staff could confide in if they had concerns about the study or did not wish to take part, again this was available but not used during the study.

4.15.3 Political consideration

Linked to the ethical implications of the study was the potential political connotation to performing research within the lead researcher’s work place and being supported by the employer to perform the study. The researcher’s reflexivity may compromise their independence, there is a potential vulnerability to the researcher position (Creswell 2007), particularly as the Trust in line with the national agenda was rolling out and supporting rounding as a positive aspect of nursing practice. As a senior manager in the Trust and the researcher I had to be cognizant of the messages the research study was emitting and from its early inception ensure a robust dialogue with my managers throughout the research process to feedback emerging messages and findings (Robson 2011).

4.15.4 Data handling and storage

A master list of patients and their identifying numbers was maintained on an electronic database, containing the patients name and age, to ensure an audit trail for the study. The database was password protected and the password only known to the lead researcher. The lead researcher collected all data (observational data and digitally recorded interviews) at the end of each day. The data from the recorded interviews was then immediately

121

uploaded onto a secure password protected personal computer of the lead researcher at the end of each day and removed from the digital recording machine. Written observational data was stored in a secure filing cabinet within a locked office and transferred to electronic copy as soon as possible, with the hard copy being destroyed after the study was completed.

Following completion of the study the data will be retained in a secure electronic database within the Trust’s Research and Innovation Division for five years in line with current practice for non-invasive studies. The study product is for use within professional nursing and not the wider public domain but if participants wanted to know the results of the study they were provided with an email address to contact the lead researcher.

4.15.5 Ethical and R&D approval

Prior to the study taking place ethical approval was gained from the University’s Research Governance and Ethics Sub-Committee, the study was also registered and approved with the Trust’s Research & Innovation Division (appendix 16 and 17). The study was generating new knowledge about a major change to nursing care delivery. The study was asking patients and staff about the concept of rounding and exploring how it meets their needs, the study was more than an audit or service evaluation thus approval was also sought from the National Research Ethics Services through the completion of an Integrated Research Application Submission (IRAS). This approval was granted in February 2014 (appendix 18).

The research design and later findings peer reviewed by two experienced educational supervisors, successfully withstood the scrutiny of two doctorate progression panels with oral viva and critically appraised in my employing organisation by the Deputy Director of Nursing.