BJCN 2016 Doing Research: Planning for Ethical and Institutional Approval

BJCN 2016 – Doing research: Planning for ethical and institutional approval

Dave Mercer and Maria Flynn

Title: Doing research: Planning for ethical and institutional approval

Author Details:

Dave Mercer RMN, BA (Hons), MA, PGCE, PhD

Lecturer, Directorate of Nursing, School of Health Sciences, University of Liverpool, L69 3GB

Maria Flynn RN, BSc, MSc, PGCE, PhD

Senior Lecturer and Head of Postgraduate Studies, School of Health Sciences, University of Liverpool, L69 3GB

Corresponding Author: Dave Mercer, Lecturer, Directorate of Nursing, School of Health Sciences, University of Liverpool, L69 3GB

E: T: 0151 794 4742

Key Words:Cardiac nursing, nursing research ethics, ethical principles, ethical codes, ethical approval, valid informed consent, confidentiality, data management, neoliberalism

• Nursing research is a specific type of nursing practice
• Ethical principles that inform nursing care need to be translated into the practice of nursing research
• Contemporary ethical codes are designed to protect individuals who consent to take part in research studies, and developed as a response to human rights abuses in the twentieth century
• Nursing research, like nursing practice, has ethical, professional and political dimensions
• Ethical awareness is central to the planning and conduct of nursing research
• Ethical and institutional approval is essential to turning a ‘good idea’ into a ‘rigorous research project’

Abstract

Ethical and institutional approvals are essential requirements if a research proposal is to become a research project. This article critically approaches the history of ethical codes, and principles, in the context of politics and practice. It notes how international regulatory mechanisms that govern the research process in medicine and nursing represented a response to state-sanctioned human rights abuses of the last century. It is argued that ethical thinking, and awareness, is central to all stages of the research process. Attention is given to pragmatic ways that cardiac nurses can protect the rights and freedoms of individuals who make an informed decision to participate in a research study, service evaluation, or clinical audit; and how this can be documented, and conveyed, to an ethical or institutional review body. Lastly, we return to the socio-cultural and economic context that frames all health and social research, calling for equivalent standards of integrity, vigilance, and respect in nursing inquiry as would be expected in nursing care.

Introduction

Ethical awareness, and sensitivity,is central to all aspects of nursing practice. This includes clinical decision-making, education and research. The focus of this paper is on the latter, and develops ideas articulated in a previous publication in this series (Flynn & Mercer 2016) relating to the contribution cardiac nurses can make in formulating research questions and generating evidence for practice - expressed in terms of turning ‘ideas’ into ‘research proposals’. Integral to this set of processes is the absolute necessity of securing ethical approval, without which no study can be enacted in the real world. The challenge, here, is in translating a ‘research proposal’ into a ‘pragmatic research project’. ‘Ethics’ is a key strand of nursing philosophy and science centred on ‘moral knowledge’, which McEwen and Wills (2002; 14) describe as being “based on obligation to service and respect for human life.” In research terms this translates as upholding and protecting the humanity, and rights, of people who take part in research studies. This is about acknowledging that there might be risks to participation, but balancing these with benefits for similar individuals and the wider society. Agreement to volunteer to be a research participant has to be gained in accordance with the principles of ‘informed consent’.

Typically, within the structure of a written research proposal the section dealing with ‘ethical issues’ is located toward the latter part of the document. This is a purely procedural protocol, and should in no way be interpreted as an item of secondary importance to the details of research design and methodology which comprise the largest part. Rather, ethical awareness, and thinking,is fundamental to the fidelity and integrity of the research process. Together, these inform the design and methodological execution of any proposed study. Most notably, ethical considerations frame the selection of potential participants; the interventions or interviews that represent techniques of data collection; and,the safe management, and eventual disposal, of research data. Alongside the procedural apparatus of ethical approval, it should be remembered that, internationally,nurses are bound by their respective professional codes. If research is viewed as a “form of specialist nursing practice” with specific skill sets, it shares a singular commitment to the ethical values of the nursing profession (Sellman 2016; 26).

Ethical decision-making, in research terms, is a driving factor in the evolution of a research proposal, and not something to be ‘sorted out’ when the intellectual labour is completed. The construction of an ethically grounded project is a non-linear, and iterative, undertaking. That is, it develops through debate, discussion and reflection where ‘ethics’ occupy a position of primacy. From a critical perspective, the aims of this paper are to:

• Consider how ethical theory informs healthcare inquiry, with particular emphasis on knowledge development in cardiac nursing
• Discuss the ethical principles that govern healthcare and social research
• Explore how ethical thinking, and sensitivity,are essential components of research design
• Identify specific strategies to ensure the well-being, and safeguarding, of those who volunteer to participate in a research study

Ethical guidelines: ‘ahistory of the present’

The writings of French philosopher and historian of ideas, Michel Foucault (1926-1984), have become influential in the development of nursing theory and critical scholarship (e.g. Foucault2000). From this perspective, research is a political activity enabling nurse scholars to engage with, challenge, and resist,dominant knowledge(s) and oppressive systems of power in the context of nursing practice, and healthcare settings. Here, social relationshave been described as: “...an exercise of control over the patient, as embedded in prejudice, as a conflictive practice or as a site for dispute with other professionals”(Gastaldo & Holmes 1999; 235). A ‘history of the present’ is a complex Foucauldian concept (Garland 2014, Foucault 1973) that can be expressed more simply as asking how things came to be as they are, and how they might otherwise have been. We posit that it offers a fitting theoretical ‘peg’ on which to hang our discussion of ethics in the domain of nursing research.

As with nursing research, the topic of ethics cannot be disentangled from the larger sphere of politics. This is not an intellectual abstraction, of something removed from the lived-world of those who provide dignified and compassionate care to the sick and the vulnerable. The history of ethical codes that frame our professional thoughts and actions may date to antiquity (Mountokalakis 2014), but their contemporary manifestations are marked out by unpardonable human cruelty and immeasurable human suffering (Mercer 2015).Chief amongst medical/nursing abuses and violations spanning the twentieth century, described as some of the “darkest events in history” (Doody & Noonan 2016; 803), were captured in evidence presented during the Nuremberg Trials (1945-1946) in Germany (Owen 2006). War crimes perpetrated under the despotic period of National Socialist (Nazi) government included barbaric experiments undertakenby doctors and nurses, working in the concentration camp system, on non-consenting prisoners(Foth 2013, Benedict & Georges 2006).

The Nuremberg Code which emerged from these hearings provided one of the first internationally recognised efforts to establish ethical standards (Polit & Beck 2012) though more recent cases of unethical research and human rights violations, in other Western countries and the United States, have drawn attention to the continued importance of ethical scrutiny and conduct. The findings of The Royal Liverpool Children’s Inquiry Report (Redfern et al 2001), for example, focused on the unethical removal, retention, and disposal of human tissue at Alder Hey Hospital in the UK.

This historical context has witnessed the formulation of global regulatory guidelines for nursing practice and research. In the UK, the Nursing and Midwifery Council’s Code (NMC 2015; 2 emphasis added) outlines standards of conduct for nurses “whether they are providing direct care to individuals, groups or communities or bringing their professional knowledge to bear on nursing and midwifery practice in other roles, such as leadership, education or research.These debatesare summarised by Doody and Noonan (2016) who note that ethical nursing research has to be: subject to scrutiny by an independent ethical review board; scientifically robust; undertaken by investigators with adequate experience; and, adhere to ethical principles for the duration of the study.

Central to all ethical codes for medicine and nursing are four core values thatdate back to the writings of the classical Greek philosopher, Hippocrates,enshrined in the Hippocratic Oath (Mountokalakis 2014). These are:

Beneficence: Is about ‘doing good’ and always acting in the best interests of the individual to prevent any harm. In research terms, this involves an analytic consideration of risks balanced against the benefits for individual participants and the larger population.It may be the case that respondents will not benefit directly from participation, but that their doing so will offer altruistic hope for others in the future.

Non-maleficence: Is about extending the principle of beneficence, or ‘doing good’, to a principle of ‘doing no harm’. For nurse researchers, this means safeguarding the participant from unrealistic, or excessive, demands as a consequence of volunteering to take part in a research study. For cardiac nurses thinking about undertaking a piece of research, this would entail consideration of the health status, vulnerability, and emotional well-being of those that they would like to recruit into the study.

Respect for autonomy: Is about having regard for individual freedom of choice and agency, where decision-making is based on honest and accurate information. In a research context, this requires the principal investigator [PI] to provide any potential participant withdetailed facts about what the study involves, and what will be expected from them. This will include, both, the costs and benefits of taking part.

Justice: is about equality, equity, and fairness in the way that individuals are treated. When designing a study, and applying for ethical approval, nurse researchers should ensure that there is no bias or discrimination in the treatment of those who are invited, or who agree, totake part.

These four principles represent the ethical framework of the UK NHS research ethics service in assessing the risks/benefits of proposed research projects. This requires permissions from an NHS research ethics committee (NREC) and NHS research governanceapproval coordinated through the National Institute for Health Research (NIHR); with set standards explicitly stated in the Research Governance Framework. Nursing and healthcare projects also have to secure institutional approvals from a local Trust research and development (R&D) office and, on occasion, a University Ethics Committee (Tod et al 2009).

It is worth noting in the field of cardiac practice, that the research question will be driven by either the health needs of people they look after, interests of colleagues they work alongside or thewell-being of carers and family members with whom they liaise. In other words, it will be discipline specific. In contrast, the ethical dynamics of any proposed investigation will be governed by exactly the same principles as any other nursing or medical research.In the context of cardiac nursing, these principles, and issues, have been previously addressed by Wright and colleagues (2010). As Oye and colleagues (2016) note, though, qualitative research ethics are relational, situational and emerging; a distinction between ethical issues identifiable ‘on the desktop’ and those arising ‘on the spot’ that cannot be predicted. In short, the researcher when completing an ethics application can conjecture about potential issues, but cannot predict exactly what might happen during the process of data collection.

Ethical and institutional approval: ‘getting ethics’

This section of the paper explores in greater depth the way that broad and guiding ethical principles, discussed above, are translated into the domain of cardiac nursing research. This will vary in accordance with the relationship that any individual nurse has to the process and practice of undertaking research. It is likely that, for many practice nurses, their first exposure to, or experience of, research will be linked to some form of post-graduate study or professional development. Or, they might have taken up a post as a research nurse, and be involved in gaining consent, and collecting data,on behalf of a larger team. The distinction between the roles of ‘nurse researcher’ and ‘research nurse’ is discussed by Bowrey and Thompson (2014) and Watmough and colleagues (2010). Possibly, it may be that a staff nurse working on a cardiac unit is asked by the ward manager to undertake an evaluation of one aspect of service-delivery. The features which differentiate the ethical requirements of empirical research, audit, and service evaluationare illustrated in Table 1.

Insert Table 1 here:Ethical cardiac nursing research, audit and service evaluation

Whatever the level, or experience, of the nurse researcher the process of gaining ethical and institutional approval can prove to be daunting, frustrating, and time consuming. This point is well made by Sellman (2016) who suggests that the character of the researcher plays a key part in mediating the process of ethical application, colloquially referred to as ‘getting ethics’. That is, nurses are, typically, ‘other regarding’ and focused on the needs of those they care for. If, though, they take on a research nurse role for mainly ‘self-regarding’ reasons it is conjectured that they are acting in a manner inconsistent with the core excellence(s) of nursing.

Box 1 briefly outlines an evaluative study commissioned by the British Heart Foundation (BHF),which was jointly undertaken by social/health and nurse researchers. The aim was to assess the impact of the paediatric cardiac liaison nurse (PCLN) role on services received by children and their families. The research design included the child, their family members, and PCLN perspectives.Further discussion about the process of applying for ethical approval will draw on this case study to explore the kind of challenges facing any research team.Attention is also given to factors that would require ethical consideration in relation to the sampling frame, recruitment of young people and family members who could be seen as emotionally vulnerable, in the context of a serious health issue. In addition, the researcher(s)need to demonstrate informed consent, confidentiality, and the safe/secure management of data.

Insert Box 1 here: Case study: An evaluation of paediatric cardiac liaison nursing (PCLN)

Valid informed consent: Obtaining informed consent is essential to the integrity of any research project and, if this is not the case, the work would be deemed unethical. In real terms it means that potential respondents must: be fully informed about the proposed study, and capable of understanding this; have the capacity to make a decision to participate, voluntarily, as an informed choice; be made aware of what will be expected of them; be guaranteed that all data collected will be treated in confidence; be made aware of what will happen to data when the study ends; and, be told that subjects/respondents are free to withdraw at any time without any impact on their rights/care (Hardicre 2014).

Informed consent is achieved by using a participant Information sheet, and documented on a participant consent form. The information sheet typically, poses a series of questions, each followed by a succinct answer, and is written in a straightforward wayfree of technical language or jargon. The usual items focus on:

• What are the qualifications of the researcher(s)?
• How is the research funded?
• What is the purpose of the research?
• Why the person has been asked to take part?
• What are the exact procedures that will be involved?
• How will the findingsof the research be used?
• What will happen if an individual decidesto take part in the research?
• What will happen if an individual decidesnot to take part in the research?
• How ethical approval was granted?
• How confidentiality will be maintained?
• What will happen to the research findings when the study is completed?

Information sheetsare given to potential respondents during the recruitment stage of the research, but with a period of time between this and actually inviting them to give consent to take part.This means that the person can take it away from the initial meeting with the researcher, have plenty of time to read it, ask advice of friends or colleagues, and think about any questions they would like to ask, orareas where further clarification might be needed. The respondent information sheet needs to be printed on headed stationery (e.g. the NHS Trust or university where the study is registered), be dated, and carry a version number. The nameand contact details of the PI are also included.

When the individual has had adequate time to read the participant information sheet and opportunity to discuss any concerns, they are asked to complete and sign a participant consent form. These present standard statements and tick-box responses [yes/no], with minor variations relating to the specific research study. Three essential items focus on ascertaining that the volunteer participant has:

• Read and understood the information sheet, and been afforded time to ask questions
• Understands that participation is voluntary and that they are able to withdraw at any time without adverse consequences
• Agreed to take part in the study

The participant and researcher both date and sign two copies of this document, retaining one each. Formatting and presentation of this form follows the same conventions as the information sheet discussed above.

Confidentiality and data management:

The ethical application process requires the PI to submit detailed information regarding the secure management, and storage, of data during the life of a research project. Respecting the confidentiality of participants, and data, is a key component of this. The following strategies are routinely used to achieve confidentiality: