Ethics is a branch of philosophy and refers to moral values and moral conduct (Singer 1993, Porter 2000). It is also a method, procedure or view for deciding how to act when analysing complex issues (Porter 2000, Parahoo 2006). Put simply, ethical behaviour refers to what is ‘in accordance with principles of conduct that are considered correct, especially those of a given profession or group’ (Collins Dictionary 1986: 289). In this chapter we are concerned with the principles of conduct relating to health research. The chapter also addresses some of the issues pertaining to ethics committees. The discussion of ethics in this chapter is given in the context of current healthcare research policy in the UK by exploring key components of research governance and research and development (R&D) approval. The chapter concludes by looking at points to bear in mind when critiquing the ethics of research studies.

But first, it is important to note that ethics and research have not always gone hand in hand and, in the past, some historical and current ethical transgressions have taken place in a number of notable studies, which have led to the establishment of a code of conduct to which all researchers must adhere. Before considering how you can ensure that your research is ethically sound, we shall look at some of these transgressions so you can see how far we have come in the last few years in terms of ethical research.

Ethical transgressions in research

The Nazi medical experiments 1933–45: Experiments were conducted on prisoners of war and people in concentration camps, without their consent, to investigate:

• endurance (e.g. exposure to high altitudes, freezing temperatures);
  
• untested drug tolerance, poisons;
  
• malaria;
  
• torture;
  
• typhus;
  
• surgical procedures, usually performed without anaesthesia (Belmont Report 1979).

An examination of the Nazis’ records shows that the research was poorly conceived and conducted, and yielded questionable benefits – as well as being often fatal to the victims of the research, with the vast majority dying during or just after the procedure (Belmont Report, 1979).

The second example of ethical violations in research concerns the Tuskegee syphilis study that took place between 1932 and 1972 in the United States. This Public Health Service-initiated study investigated 400 African-American men in Alabama in order to determine the natural course of syphilis. Medical treatment for the disease was withheld from the men for the purpose of the research study. Participants were not informed of the reason and procedures of the research and so could not give their consent, informed or otherwise (Belmont Report 1979).

Third is the Jewish Chronic Disease Hospital study of 1963. This study was conducted in order to look at patients’ rejection of live cancer cells. As with the Tuskegee syphilis study, patients were not informed that they were in a research study and so did not give their consent, nor were they told that they were being injected with live cancer cells. Crucially, the study did not have ethics approval, even though the researchers knew that it was required (Belmont Report 1979).

Not all the problems with unethical research are to be found in the past. More recently, inquiries have been conducted into the removal of organs and tissues from deceased patients without the consent of their relatives (Bristol Royal Infirmary Report 2001, Royal Liverpool Children’s Inquiry Report 2001). These inquiries called into question the conduct of some of the health professionals concerned.

These conflicts in research have given rise to a code of ethics or a guide/framework all healthcare professionals have to adhere to, and which helps researchers ensure that their research is ethical and is put in place in order to protect participants and researchers alike.

Code of ethics

The first internationally recognised code was the Nuremberg Code of 1949 which emanated from the Nuremberg Trials of Nazi war criminals which were held after the Second World War when the researchers involved in the Nazi experiments were brought to trial. The Code includes guidance regarding:

• the consent process;
  
• the protection of participants from harm;
  
• taking into account the balance of risks and benefits inherent in a study

(Fry & Johnstone 2008).

The Nuremberg Code laid the foundation for the Helsinki Declaration (1964, as revised and updated in the 1970s, 1980s, 1990s and most recently in 2008). Three of the key principles of the Helsinki Declaration suggest that:

• the researchers should have respect for the individual’s right to self-determination and to make informed decisions regarding participating in the research;
  
• the participants’ welfare should override the interests of science and society;
  
• special attention should be given to vulnerable individuals and groups

(World Medical Association 2008).

In addition to these international codes, most disciplines have their own code of ethics. For example, the UK’ s Nursing and Midwifery Council (2004) , the Royal College of Nursing (2007) and The Chartered Society of Physiotherapy (2001) have all published standards for performance for their professionals. Areas covered in these codes include:

• informed consent;
  
• confidentiality;
  
• data protection;
  
• the right to withdraw from the study;
  
• any potential benefits and harm;
  
• the maintenance of professional knowledge and competence.

These values are shared by all UK healthcare professionals (Nursing and Midwifery Council 2004) and have to be evident in your research proposal, and of course in the research study itself.

Thus, all research should be undertaken in accordance with widely agreed principles such as those laid down in the Helsinki Declaration.

Having discussed the background to why we have to include ethical dimensions in all our research, we can turn to what these ethical principles are and how we apply them.

Ethical principles

Ethical principles can be found in the web program, in particular Beau-champ & Childress’s (2001) four principles which we are going to discuss next. The four principles approach is an internationally used framework which aims to address ethical issues. The four principles are:

• respect for autonomy;
  
• beneficence;
  
• non-maleficence;
  
• justice.

Although we are concentrating on these four, it is important to acknowledge, as some authors do (e.g. Beauchamp & Childress 2001, Storch et al. 2004, Parahoo 2006), that there are three more principles to cover in our research proposal and research study, namely:

• fidelity;
  
• veracity;
  
• confidentiality.

So our discussion will cover all seven.

Respect for autonomy (see the web program)

Respect for autonomy obliges the researcher to respect the participant’s informed decision whether or not to participate in the research study. This means that the researcher must ensure that the participant has full information about what the study entails, including any risks and benefits, and is given sufficient time to reflect on the information and to ask any questions they may have about the research and their role in it. This ensures that they enter into the research study voluntarily and with all the information that they need to make an informed decision as to whether or not to take part. Another aspect of respect for autonomy that we, as researchers, have to ensure occurs is that no participants are coerced, however important the study may be. In addition, the participants should be told that they have the right to withdraw at any stage without adverse consequences to them.

Another essential responsibility for the researcher preparing a research proposal is that there are mechanisms in place for ensuring that the confidentiality of the participants is fully maintained. This is crucial in any research study, and ethics committees scrutinise this aspect of the research proposal very carefully (see below).

Gelling (1999) proposes three types of autonomy:

Thus you can see that the right to self-determination and to be fully informed are key elements on which informed consent is based (Polit & Beck 2004).

Now we come to be thorny part of ethics and research: some groups are deemed to have diminished levels of autonomy or self-determination (e.g. those with cognitive impairment, the terminally ill, young children) or situations that severely restrict their liberty (e.g. prisoners or people compulsorily detained under the Mental Health Act), and it is absolutely crucial that such individuals are given additional protection to ensure that the principle of respect for autonomy is upheld (this issue is discussed later in the chapter).

Beneficence (see the web program)

The principle of beneficence requires the researcher to act in the best interests of the participant, according to their professional assessment. It requires the researcher ‘to do good’ with his/her research, so this has to be planned into the research proposal and the research study itself, and then a system of monitoring has to be installed in the research protocol. Monitoring the research ensures that it is being undertaken as envisaged during the planning phase (and must be included in the research proposal). Silverman (2007) points out that monitoring involves the researcher (and anyone connected with the research) sticking rigidly to approved protocols, including the full documentation of any adverse events (particularly in clinical trials) and ensuring the integrity of the data collected.

Thus, beneficence can be seen to be the most important principle for nurses and other health professionals involved in clinical research to be aware of and to act on, because it concerns the protection of patients by ensuring that the central tenet of ‘do no harm’ remains at the forefront of the research study.

But how can we determine that our research really is beneficial – that is, how can we be certain that the principle of beneficence applies to our research study? This is something for you to think about. One of the ways in which you can try to ensure beneficence is by adhering to ethical principles as you write and think about your research proposal and your study. Obtaining help and guidance from more senior researchers will also help you to make sure that you have applied the principle of beneficence. Another suggestion is to try to put yourself in the place of the participants and ask yourself questions such as: Would I like that procedure to be done to me or would I like to be asked that question? Fortunately, there is enough guidance in current practice and from our earlier training to ensure that we do not stray too far from the principle of beneficence in our dealings with patients and clients. However, it is worthwhile pointing out that the principle of beneficence is not always as straightforward as it may appear to be. Generally, as healthcare professionals we are concerned with alleviating suffering and saving lives, but sometimes we can be faced with a dilemma. For example, Dubois (2005) argues that in palliative medicine stopping treatment, in an appropriate clinical context, may be viewed as an act of beneficence when the continuation of life is viewed by the patient as harmful. Examples like this are what make ethics such an interesting, but at times frustrating, subject.

However, much of the principle of beneficence is quite clear-cut-all you have to do is ask yourself: ‘Will this be of benefit to the patient/client?’

Examples of beneficence include:

• providing vaccinations for the general population;
  
• encouraging a patient to stop smoking;
  
• starting an exercise programme and encouraging healthy eating in particular groups.

Now let’s look at these examples in more detail. Are they always beneficent? That depends on your viewpoint and this is where bias in its broadest sense comes into play. If you believe in the efficacy of vaccinations in preventing ill-health, then you would certainly say that the first example is beneficial. However, the parents of a child who, after receiving the MMR vaccination, is found to be autistic may have a different view. Whether the MMR vaccination has actually caused the child’s autism is immaterial – it is the parents’ perception that matters to them in deciding whether the vaccination adheres to the principle of beneficence.

Turn now to the second example. Is stopping smoking always beneficial? Well, as healthcare professionals, we would say yes every time. It is certainly better for physical health, but what about psychological well-being? Suppose that you perceive that the only enjoyable thing in your life is smoking – would you agree that giving up smoking is beneficial to you? And what about someone who is dying and enjoys a cigarette – is the risk of their contracting cardiovascular disease or lung cancer still a worry? Again, it is the individual who is important here. The same argument applies to the third example.

What we hope that you have come to realise is that nothing is carved in stone – we have to look at individual cases (something we are taught to do as healthcare professionals), and we should take the same stance with potential participants and subjects in our proposed research studies. This is why we said that, as you are planning your research study and starting to write your research proposal, you should try to put yourself in the place of the potential participants and subjects of your study, and ask yourself: ‘What in this study is beneficial to me and what is not?’

Non-maleficence (see the web program)

The third of our ethical principles – non-maleficence – complements beneficence and assumes that intentional harm to participants is prevented. In current clinical care, many beneficial therapies also have associated risks – think of the potential adverse reactions listed in the information that accompanies medicines and you will see the truth in this statement.

Consequently, we have to accept that there is the potential for harm in even the ethically best designed research study, So, when preparing our research proposal, we have to accept this and try to minimise any risks (and also have some means of countering any adverse reactions, whether these are physical, emotional or psychosocial) that may occur during our research study. We also have to look at the key ethical consideration in all research, namely, do the benefits outweigh the risks?

Research should benefit the participant by contributing to their welfare and/or that of society as a whole (Parahoo 2006).This is discussed at length in the context of palliative care in the web program (see under ethics there).

Thus the concepts of weighing the potential benefit to the patient against the potential harm, along with the patient’s stated views, are employed in healthcare decision-making. Consider again a dying patient (an area of great controversy in healthcare) and continuing aggressive, life-prolonging treatment can be seen as a violation of non-maleficence (Dubois 2005). Similarly, euthanasia, along with the premature, unrequested or uninformed withdrawal of treatment, may also be viewed as violations of non-maleficence (Dubois 2005).

Justice (see the web program)

The fourth ethical principle – justice – requires the researcher to be fair to participants by acting impartially. Of great importance in the use of this principle is that the needs of the participants should come before the objectives of the study; similarly, vulnerable groups should not be used merely for the researcher’ s convenience (Parahoo 2006). Polit & Beck (2004) explain that fair treatment means that:

• The selection of participants must be based on research requirements and not on the vulnerability or compromised position of the individual.
  
• Participants have the right to fair and equitable treatment before, during and after participating in the study.
  
• The researcher is obliged to honour all promises and commitments made in the research proposal.
  
• Courtesy and tact are expected at all times.
  
• Participants have the right to non-prejudicial treatment if they decide to withdraw from the study.
  
• Participants should have access to feedback to clarify issues raised in the study.
  
• Participants should have access to professional help in the event of physical and/or psychological damage as a result of the study.
  
• Researchers should show respect for different cultural beliefs.

In essence, the principle of justice is seen in the research process by there being a fair and equitable distribution of benefits and burdens, as well as fairness in the selection of research subjects (Khan et al. 1998, Aita & Richer 2005).

Having looked briefly at the four basic ethical principles, we now turn our attention to the other three principles as identified by Beau-champ & Childress (2001), Parahoo (2006) and Storch et al. (2004), namely fidelity, veracity and confidentiality.

Fidelity

Fidelity refers to the building of trust between the participant/subject and the researcher (ICN 2006). Research participants entrust themselves to the researcher, who has an obligation to safeguard their welfare. They should be told of the risks of the study when the researcher is seeking their consent. This is very closely linked to beneficence and non-maleficence, and is just as important because the researcher and the participant/subject in effect make a contract, which is formalised by the signing and witnessing of the consent form.

Veracity

This principle is linked to the basic principles of respect for autonomy, beneficence and non-maleficence and it obliges the researcher to be truthful about the study, even if in so doing potential participants are deterred from entering the study (Polit & Beck 2008). Although linked to these three basic principles, veracity is more closely linked to the principle of autonomy (Gillon 1994). Patients’ autonomy is infringed if information that may contribute to their informed decision-making is withheld from them. Consequently, if their autonomy is infringed or not heeded, they are not able to make a fully informed decision.

Confidentiality

The issue of confidentiality is discussed in the web program under ethics. Ensuring the confidentiality and privacy of research data is a key principle in the research process and is very closely scrutinised by the research ethics committee. In order to reduce the risk of identifying the participants from their comments or other data, many researchers use identification numbers or pseudonyms so that only the researchers and the participants can make the connection between comments and other data and their identity. Protecting identity and confidentiality extends to the dissemination of findings (see chapter 10 and the web program). Another important consideration, particularly when writing up and disseminating your findings, is that you should make sure that the research site(s) as well as the participants cannot be identified, because it may be possible to identify the participants (patients/clients or other healthcare professionals) if the research site(s) are known.

Summary

This has been a brief look at the principles that underlie any ethical research study; it is important to be aware of them and to be comfortable with them because they are the principles that guide our ethical and professional conduct when we are involved in any research. We acknowledge that although we have given you information on, and have stressed the importance of, these principles, the fact remains that they cannot cover all eventualities that you may come across as a researcher. Therefore, we have to stress, as indeed all responsible organisations do, that as registered professionals we must take responsibility for all our actions no matter the situation or environment in which we work, whether we are acting as clinical practitioners or as researchers.

You will find more on this subject in the accompanying web program.

Research ethics committees

Now we turn to research ethics committees. Unfortunately, the words ‘research ethics committee’ produce an anxious state in some researchers. This is often the result of having previously submitted a research proposal that was rejected. This is unfortunate because our experience has been overwhelmingly positive, and we have found them to be generally very helpful, caring, insightful and, above all, friendly.