8. Ethics and research
Key points
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• Research is not simply a process of gathering data; it also involves ethical issues in conducting the study.
• Ethics relate to the protection of the human rights of those involved in research, and the obligations and responsibilities of the researcher. The main human rights the researcher must illustrate are respect for the individual, the protection against harm, and justice (fair treatment).
• Informed consent relates to the extent to which an individual agrees to take part in a study on the basis of a clear understanding of the purpose of the research and the implications of agreeing to take part.
• The ‘harm versus benefits’ ratio is an attempt to weigh up the possible disadvantages for an individual taking part in a study against the possible positive effects either for them or others in the future.
• Justice relates to the fair treatment of all those who are potentially or actually involved in the research process.
• All health research should be approved by a local research ethics committee (LREC) whose role is to protect the public and health staff against harm and exploitation. There may also be a local research and development (R&D) unit that will examine the technical aspects of a study prior to it going to an ethics committee.
• Projects that can be classified as audit or service evaluation are not required to be assessed by an ethics committee, but those responsible should still be mindful of the way the information is collected and the use to which it is put.
Research is not simply about the process of data collection; it is also concerned with the conduct of the researcher and the manner in which a study is carried out. Under research governance, this has to conform to set standards in the relationship between the researcher and those participating in the research, and the ethical management of the whole project. As with clinical practice, ethics in research must illustrate respect and maintain the trust that people have in health professionals, health organisations and researchers.
Ethical issues are a particular concern where research involves vulnerable groups such as women in pregnancy and labour, and babies, who form an even more vulnerable group. Both need their human rights respected and their safety and privacy safeguarded. Midwives work under the midwifery rules (NMC 2004) and a professional code of conduct (NMC 2008), and it is right that midwives are accountable for the way in which they conduct themselves when carrying out research. In the UK they must conform to the guidelines laid down in the Research Governance Framework for Health and Social Care (DoH 2005).
This chapter will examine the ethical issues raised by research in maternity services. These relate to the protection of fundamental human rights, and the obligations and responsibilities of the researcher in carrying out research. The main issues covered include informed consent, confidentiality, justice, and an assessment of possible benefits of participation in research balanced against possible disadvantages or ‘harm’.
Ethics can be defined as a code of behaviour considered correct, or, as Houser (2008: 53) puts it, ‘the study of right and wrong’. Within a research context, the Economic and Social Research Council (ESRC) (2010: 40) give the following definition:
Research Ethics refers to the moral principles guiding research, from its inception through to completion and publication of results and beyond – for example, the curation [safekeeping] of data and physical samples after the research has been published.
Ethics control what is permissible within research, making it is impossible to plan research in health care without anticipating and solving the ethical issues it raises. The increasing complexity and sophistication of research means that ethical issues have become more central to discussions about research than ever before (Bryman 2008). This has been reinforced by one high-profile example of participants in research suffering organ failure and serious illness as a result of inclusion in a drug trial (Mayor, 2006 and Wood and Darbyshire, 2006) and researcher misconduct where fictitious studies have been report in journals (Smith 2006). These have justified the continual attempts to make the safety and human respect of those receiving care paramount. Ethics are now the part of the research process that the researcher has to get right; otherwise the study will not get approval to take place.
Ethics relate to two groups of people; those carrying out research, who should be aware of their obligations and responsibilities in the way in which they carry out their activities, and the ‘researched upon’, who have basic human rights that should be protected. As with ethics generally, those relating to research provide a basis for deciding whether certain behaviour can be regarded as acceptable according to agreed principles and values. There are a number of problems implicit in this, as different people may have conflicting views and values on what is acceptable. To overcome this dilemma, Local Research Ethics Committees (LRECs) operate to consider research projects at a planning stage to ensure that they conform to national ethical guidelines and standards.
As medical research has been carried out for far longer and is more frequently conducted than midwifery research, it is not surprising that ethical principles have been developed with medical research very much in mind. This means that ethics committees often use the experimental approach synonymous with the ‘scientific’ method as the ‘gold standard’ against which others are measured. Ethical issues are therefore considered very much in relation to the potentially more dangerous implications of clinical trials.
Is it important for all midwives to know about research ethics? The simple answer is ‘yes’. Firstly, in making practice research-based the ethical aspects of a study must also be judged. It is not morally safe to implement research if it does not conform to ethical principles, as it casts doubt on the researcher’s honesty and integrity concerning all aspects of the study. Secondly, knowledge of research ethics may also be crucial if the midwife has to act as advocate for an individual mother, baby and family. This may include situations where someone has been invited to take part in research that is not ethical. The RCN (2007) guidelines on research, which have been adopted by midwifery, also point out that nurses and midwives may be called upon to act as witnesses to ensure that free and informed consent has been given prior to involvement in research. Under these circumstances, the midwife must be satisfied that the person concerned has received relevant information to make an informed decision, and is not under any duress or coercion to participate. What actually constitutes coercion can be difficult to identify but Johnson and Long’s (2010) explanation is helpful in that they suggest it is the use of ‘undue pressure or leverage’, such as an existing relationship with someone that will influence them to take part in a study. So, a midwife approaching those for whom they have already given care and advice may be seen to be coercing them to take part as they may feel that an obligation already exists and so the freedom to say ‘no’ is reduced in such cases.
What, then, comes under the heading of ethical issues in research? According to the RCN (2007: 3) the essential elements that must be observed by all researchers include:
• informed consent,
• confidentiality,
• data protection,
• right to withdraw,
• potential benefits and the potential harms.
These will be covered throughout this chapter. The next section summarises the more recent development of ethics within health care.
Historical development of ethical principles
The present guidelines on research ethics have been influenced by a number of internationally accepted codes on the conduct of research. These were developed following the revelation of a number of scientific experiments on humans that were clearly unethical. Following their revelation, it was agreed that society should be protected from anyone who might carry out research that leads to the death or injury of those taking part. Through a series of refinements, the codes outlined in Box 8.1 have influenced present-day research practice in all branches of health care.
BOX 8.1
Major international ethical codes
The Nuremberg code
This was developed in 1947 as a result of the human experimentation carried out by the Nazi regime during World War II. The code consists of 10 principles that have been influential in the conduct of research, particularly experimental research, throughout the world. The major principle relates to obtaining informed consent from those involved in research. Although the code relates to physical interventions, account is also taken of psychological and emotional harm. One criticism of the code is that it depends on self-regulation by the experimenter.
The declaration of Helsinki
These guidelines were developed by the World Medical Assembly (WMA) in Finland in 1964 and updated regularly since then, including October 2008 (available at http://www.wma.net/en/30publications/10policies/b3/index.html). In addition to re-emphasising the principles of the Nuremberg Code, it developed clauses to protect subjects’ human rights. An important distinction is made between therapeutic and non-therapeutic research. Therapeutic research relates to situations where the individual may potentially benefit physically from the research, whereas in non-therapeutic research subjects probably will not benefit physically, although others may benefit in the future.
The Belmont report
The Belmont Report of 1978 highlighted what has become the three basic ethical principles of research:
1. respect for persons,
2. beneficence,
3. justice.
One of the report’s aims was to develop guidelines on the selection of those included in the research. The report emphasises the need for written consent of subjects, and the obligation of the researcher to assess the possible risk and benefits related to participation in research.
Nursing and midwifery guidelines
Ethical guidelines for nursing research were developed much later than those in medicine. The American Nurses’ Association (ANA) developed their principles in 1968, and have updated them periodically. These cover not only the basic principles regarding the use of human subjects, but also the role of the nurse as researcher and practitioner. In Britain, guidelines were produced by the RCN in 1977 with an update in 2007 (RCN 2007). This reinforces the major ethical issues regarding health care research and provides guidance on research governance, as explained below. The guideline provides helpful links to all the sources of information needed to apply for ethical approval. No separate guidelines exist for midwifery.
Research governance
Since 2005, research governance has been a core standard for all organisations delivering NHS care (DoH 2005) and illustrates the importance on the management of research activity in the UK as well as the USA, Canada and Australia. Haig (2008: 125) offers the following definition of clinical governance:
Research governance is a framework through which institutions are accountable for ethical quality, scientific acceptability and management of participant safety in research that they sponsor or permit.
Its role is to make organisations accountable for high standards in the protection of those participating in research. The intension is to increase the quality of research and to ensure that it is ‘managed’ safely and effectively. The DoH (2005) clinical governance framework is summarised under the following headings, using some of the original wording:
1. Ethics
All research involving patients, service users, care professionals or volunteers, or their organs, tissue or data, must be reviewed independently to ensure it meets ethical standards. This is achieved through a local research ethics committee (LREC), or equivalent within higher education. The study design must illustrate the high priority given to safeguarding the dignity, rights, safety and well-being of participants in a study. Informed consent is at the heart of ethical research and relates to staff as well as those receiving health care. Data collected, particularly from patients, should be used appropriately and protected. Secure systems must protect confidential information. Relevant service users and carers or their representative groups should be involved wherever possible in the design, conduct, analysis and reporting of research. Those included in research studies should reflect the diversity of groups within society. Risks, pain or discomfort to the individual must be minimised, but where they do exist, any risks must be in proportion to the potential benefit to the participant.
2. Science
Any research proposal must demonstrate a thorough search of current sources of knowledge has taken place to ensure that answers sought do not already exist. This is to avoid needless duplication of effort. The methodological details of any study must be examined by experts to ensure that the study is sound. There are special procedures for assessing the standard of clinical trials involving the testing of medicines and studies using human embryos. Data collected must be kept for an appropriate time for further use and monitoring.
3. Information
There should be free public access to information on studies that are being conducted and on their results once complete, whether the outcomes were favourable or not. In particularly, those involved in a study should have access to the findings along with those who could benefit from them. Studies should be open to critical review through scientific and professional channels. Researchers are under an obligation at the planning stage to state how they will disseminate the results of their study. This is to ensure that potential benefits from new knowledge are not lost by not publishing the results, or not making them available to key people and organisations.
4. Health, safety and employment
Research involving potentially dangerous or harmful equipment, substances or organisms should give priority to the safety of participants and other staff at all times, and health and safety regulations must be strictly observed. This should include the provision of information, containment, shielding and monitoring as required. In midwifery, the personal safety of the researcher where research is undertaken in someone’s home must be protected and built into the method of data collection.
5. Finance and intellectual property
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