Ethical considerations

The importance of conducting research ‘ethically’ is recognised internationally as an essential component of all research (Fry & Johnstone 2008, Macfarlane 2009). This study conformed to the international ethical standards of the Nuremberg Code (1949), the Belmont Report (The National Commission for the Protection of Human Subjects of Biomedical & Behavioral Research 1979) and the Declaration of Helsinki (World Medical Association 2004). In addition, as this was a nursing-based study, the ethical research guidelines of the nursing regulatory body (An Bord Altranais 2007) were adhered to. Ethical approval to conduct this study was sought and obtained from the ethics committees at the five research sites (Appendix 8). The following section discusses how the ethical principles of Respect, Beneficence (including non-maleficence) and Justice were upheld throughout this study.

4.9.1 The principle of respect Autonomy and self-determination

The principle of respect for persons encompasses the right to autonomy, the right to self-determination and the right to full-disclosure, all of which are the fundamental building blocks on which informed consent is based (An Bord Altranais 2007, Polit & Beck 20010, Dooley & McCarthy 2011). Autonomy and self-determination refer to the recognition by the researcher that the person has the right to freely choose if they wish to participate in the study (Polit & Beck 2010). To uphold the right to autonomy, patients were initially approached and briefed about the study by a gatekeeper, who ascertained their interest in participating. It was explicitly stated that non-participation would have no impact on their nursing or medical care and that involvement in the study was not a component of their in-hospital care. In an effort to enhance their autonomy and

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self-determination, patients were made aware that the interventionist was not employed by the research site. This helped to address any ethical concerns with respect to coercion.

Informed consent

Full disclosure is a pre-requisite to autonomy, self-determination and obtaining informed consent. In order to be considered valid, informed consent must incorporate full disclosure (Holm & Madsen 2009, Scott 2013) and the participant must demonstrate comprehension of the information received (Burns & Grove 2011, Scott 2013). To facilitate full-disclosure, those who expressed an interest in the study were provided with clear, unambiguous, verbal and written information about the study (Appendix 9). When designing participant documentation such as the participant information sheet and consent form, consideration was given to the content, font, layout, length, and accuracy of each item. In addition, the documents were tested for readability against current Irish adult literacy guidelines and Flesch readability statistics. Amendments were made to each draft and on repeat testing the scores were deemed appropriate at 64.9 (Flesch Reading Ease score) and 8.5 (Flesch-Kincaid Grade level).

The provision of clear information enabled participants to make an informed and considered judgment about whether or not to participate in the study. The voluntary nature of participation was emphasised, as was the freedom to withdraw from the study at any time, without explanation or consequence. Informed consent (Appendix 10) was only obtained when it was clear that the information about the study was understood.

Consent should be viewed as a process as opposed to an outcome (Jadad & Enkin 2007), as was the case in this study. Participants’ receptiveness to the one month telephone call and the return of the 3 and 12 month questionnaires were taken as on-going consent. When participants failed to return a questionnaire, they were contacted by telephone and on-going consent was checked verbally. A maximum of two telephone messages were left for each

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participant with whom verbal contact could not be made and the questionnaires were resent on one occasion only.

4.9.2 The principles of beneficence and non-maleficence

The ethical principle of beneficence mandates that researchers have an obligation to do good for others, while preventing or minimising risk or harm (non-maleficence) (Fry & Johnstone 2008, Polit & Beck 2010, Purtilo & Doherty 2011, Scott 2013). There was an expectation that the educational intervention would improve knowledge, attitudes and beliefs among ACS patients in the intervention group. This had the potential to reduce their pre-hospital delay time and associated mortality and morbidity. However, this benefit was not guaranteed. If the intervention was unsuccessful, those in the intervention group were not going to be harmed in any way by the information they received, as participants from both groups received ‘usual’ in-hospital care. While the control group were not expected to benefit from participation, their involvement in the study posed no threat or harm to them.

In the study, any participant who appeared tired, stressed or upset was given the opportunity to postpone or cancel data collection. This was underpinned by the recommendation that from an ethical perspective, researchers should take cognisance of the psychological and physical comfort of patients and where necessary, reschedule data collection (Fitzsimons & Strachan 2012). Furthermore, care delivery and visitors were given priority over the needs of the study. This often meant returning to a participant a second or a third time to complete data collection. In some cases, it resulted in the patient not being included in the study, despite the fact that theoretically they fulfilled the study eligibility criteria. Non-maleficence was addressed using these measures.

4.9.3 The principle of justice

The principle of justice requires that participants are selected fairly, so that the burdens and benefits of the research are distributed fairly (Smith Iltis 2006, Macfarlane 2009). Much debate has ensued over the years with respect to the ethics of RCTs and how randomisation deprives half the study population of a potentially better treatment (Freedman et al. 1987). Consistent with ethical

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guidelines, randomisation in this study was computer generated, therefore all participants had an equal chance of being assigned to either group.

Equipoise is the ethical requirement that the researcher is genuinely uncertain as to whether one treatment is better than the other (Smith Iltis 2006, Gerrish & Lacey 2010, Scott 2013). Within this study there was an expectation that the intervention would improve knowledge, attitudes and beliefs and reduce pre- hospital delay time for participants in the intervention group. However, there was genuine uncertainty as to whether this would happen, as most previous interventions that aimed to reduce pre-hospital delay time were unsuccessful. Thus equipoise was established in this RCT. It has been suggested that where clinical equipoise exists, there is no ethical concern with respect to randomisation (Freedman et al. 1987, Lilford 2003).

For ethical reasons control groups are rarely used in nursing research (Burns & Grove 2013). This was not a concern in this study, as both groups received usual in-hospital care. The educational intervention provided additional information, delivered by an individual (interventionist) who was not employed by the hospital. The control group was therefore not deprived of any care that would normally be provided outside the study. Furthermore, all participants in the control group were informed that if, on completion of the study, they wished to avail of the intervention, they could do so.

Protection of privacy and confidentiality

Justice was also upheld through the protection of participant privacy and confidentiality. Meticulous attention was paid to the handling of paper and electronic records. Data were collected and stored in keeping with the Data Protection Act (Government of Ireland 2003). During data collection, all hardcopy data were stored in locked cabinets in a secure location. The study number allocated to each participant was recorded on the participant’s contact details form. This number was the only identifying link feature to their corresponding questionnaires. Participant contact details were stored with the consent and eligibility forms in a locked cabinet. Questionnaires, which were identified only by study number, were stored separately. Electronic data were

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password protected and only the relevant interventionist knew their own individual password.

Nursing and medical staff were aware of the research sites and those patients who participated in the study. This was obvious through the role of the gatekeeper and the process of data collection at the bedside. However, nursing and medical staff are bound by their code of professional practice, which includes confidentiality, and were therefore not at liberty to disclose the identities of participating patients. Group allocation was concealed from all staff members and specific details obtained during the course of data collection were never disclosed, which further maintained confidentiality. Confidentiality of the research sites was maintained through number coding. Publications have not and will not include any identifying data about individuals or the research sites.

On completion of the study, all hardcopy records were returned to and are currently kept in a locked filing cabinet in the School of Nursing & Midwifery, Trinity College Dublin. Five years following completion of the study (2015), all non-anonymised hardcopy data will be shredded.