In the context of research, beneficence refers to the requirement that the researcher should maximise benefit to participants whilst minimizing harm. The broad rule of thumb is that the chance of benefit should always outweigh the chance of harm. This has given rise, amongst other things, to the situation where completely unproved treatments (of which there are many in medicine and healthcare) cannot be withheld from patients in the absence of very strong arguments to the contrary. The reason for this is somewhat obscure. After all, if some treatment has no evidence behind it, what possible objection could there to for withholding it? In fact, there are at least a couple. First, it is argued, quite rightly, that lack of evidence of effectiveness is not evidence of lack of effectiveness, and there is a fair case for saying that a treatment which has been in use for many years might confer some benefit, even if we have yet to amass the evidence for that benefit. Proponents of evidence-based practice are, paradoxically, often very keen to make this point in reporting the findings of systematic reviews. Balanced against this, however, we might take the commonsense view that (a) interventions often survive because of the vested interests of powerful people even if ineffective and unpopular, and (b) if a treatment that had been in use for many years was effective, one would have expected to find evidence of that effectiveness by now. We leave it to you to judge between these competing arguments. The second argument against the withholding of unproven treatments is, we feel, less contentious. If a patient knew that a treatment was being withheld, they might suffer psychological damage, on the basis that they were aware that it had been offered in the past and that some people, rightly or wrongly, believed it was effective or that they had received benefit from it. Moreover, because there are clear associations between psychological distress and recovery from illness, this distress might indeed affect their physical response and do them harm. Of course, offering unproven treatments is not in any obvious way a major act of beneficence, either in the research context or any other. Moreover, offering such a treatment infringes a person’s autonomy by compromising their ability to give informed consent, unless it is made completely clear to them that the treatment offered is of no proven value.

Whilst it is hard to say which of the four principles mentioned here is pre-eminent, non-maleficence (the avoidance of doing harm or the risk of doing harm), might be a good candidate (although at least one famous medical ethicist has argued otherwise (Gillon, 2003)). This is because we intuitively believe it is wrong to do harm to others. However, it is not always clear, in research settings, when disadvantages outweigh advantages: in other words, a minor harm may sometimes be offset by a greater good. However, in line with the Nuremberg Code, this argument only has force when it is applied to a single individual. It is unethical to do all but the most trivial harm (say, taking a small blood sample) to a research subject for the benefit of others alone. But what if that injection is associated with a test for an illness for which there is currently no known cure? This might be considered an unacceptable level of harm if there were further harmful consequences for the person (e.g. psychological distress; risk of exclusion from medical or life insurance) if the test proved positive. Of course, if the illness is curable, or if there is some other clear benefit to the person, then the harm is possibly offset by such a benefit to a considerable degree. Indeed, it might even be thought of as unjust to withhold such a test from someone.

Justice is essentially the requirement that a thing or activity be fairly distributed amongst people. As a result, researchers are required to ensure that all individuals have an equal chance of being included from a study or benefiting from its results. For example, it is obviously unjust to exclude people from a study on the basis of race, colour, gender, age and so on. It is also unjust to exclude people, however, on the basis of other personal characteristics. One issue which affects researchers is the issue of linguistic preference or ability. It is typical to see researchers attempting to exclude from studies people whose first language is not English, or who have difficulties with writing and understanding written English. This means that these individuals do not benefit from the opportunity to participate in such studies, and is, therefore unfair or unjust towards them. It also has a further unjust consequence in that the study will then be carried out, for example, exclusively on people whose first language is English, and that results of the study will then be applied to those whose first language is not. Because they may differ from the English speakers in terms of other personal characteristics, this generalisation may be inappropriate and, therefore, unjust. Once again, there are potential grey areas here, because there are many languages for which validated measures have not yet been developed. It would be unwise to stop doing all research which involved such measures until they had been developed in all relevant languages, and would probably do, on balance, more harm than continuing to conduct such studies. At the same time, the research community has a responsibility to ensure that, wherever possible, adequate provision is made for non-English speakers and people who have difficulty with the written language, as well as continuing to develop scales which will be accessible by all.

These four principles inform the appropriate conduct of many aspects of research activity. Because they are so broad, their application is a matter of interpretation and judgement. It is also often difficult for researchers (who are not necessarily experts in ethics) to see precisely how they apply to their own studies. As a consequence, RECs seek to apply these principles on a case-by-case basis, usually in line with detailed criteria derived from these general notions.

Ethics and patient and public involvement in research

There are compelling reasons why we should wish to involve patients and the public in having a say in what research is conducted and how it is conducted. These reasons spring from all four of the principles outlined above.

If people wish to be involved in research, it is an offence to their autonomy if we do not allow them to do so as broadly as they might wish.

It is also offering them something of value, and so is an act of beneficence. More importantly, perhaps, to refuse to allow patients and the public a say is indefensible because to do so is a clear act of harm – we are treating them merely as objects in the research, preventing them from making a contribution they might wish to make, and decreasing the likelihood that the research will be relevant to them. This last offence may lead to further very practical and severe harms if it leads patients and the public to ignore results of beneficial research.

Finally, exclusion is unjust because it is unfair to exclude a particular group from participation on the basis of some irrelevant characteristic. In this case, the characteristic researchers have most often used to exclude patients and the public is that of lack of expertise in the subject matter. However, this is inappropriate in two ways: it is based on an assumption that technical expertise is necessary for making a contribution to research (it isn’t – such expertise is only necessary for specific methodological issues); it is based on too narrow a definition of expertise – for example, patients and the public have plentiful expertise in many areas, such as their experience of illness, even if we exclude the fact that many have become expert in the more traditional academic sense.

User involvement does, however, give rise to ethical issues in itself, most often when patients are acting as members of the research team in a way which involves contact with patients. The argument has been advanced that this is problematic mainly because (a) patients who are researchers (often called user-researchers) might know other patients whom they then interact with as researchers, and that this would be an infringement of the privacy of this second ‘researched’ group and (b) user-researchers might be upset because of exposure to sensitive information during the course of their research role. The ethical offences in (a) and (b) are purported to be against autonomy and non-maleficence, respectively.

However, if taken as arguments against user involvement, both these arguments, in our view, lack any ethical force. This is because they are based on the view that users as researchers are in some relevant way different from any other researcher, and that this difference leads to different conclusions about the ethical consequences for research subjects who come into contact with them and for the user-researchers themselves. A moment’s reflection reveals the problem with such a view. In (a), any researcher might come into contact with a subject whom they knew. In such an instance, we should expect them to behave appropriately, and the research protocol might even specify what they should do in such a case, in order to protect both researcher and subject. Naturally, we should expect any researcher to be advised or trained about what to do in such a case, and to respect confidentiality. There is no reason why we should not have similar expectations of, or offer similar advice and training, to a user-researcher as any other researcher.Not to do so, incidentally, would be an offence against the principle of justice.

Equally, in (b) any researcher might become distressed by what they are researching and should be entitled to appropriate training, advice and support around such issues – user-researchers are not unique in this respect. Finally, this view neglects the fact that we are all patients or carers at some time in our lives. This in itself undermines the above argument that user-researchers are in some important way different from other researchers, unless we wish to suggest that no researcher who has had any health problem or cared for someone with such a problem can carry out health research.

Ethics committees and research governance

In essence, the broad principles of autonomy, beneficence and justice drive the work of RECs, which consider the ethical aspects of proposed research projects in healthcare. This work is co-ordinated under a central umbrella organisation: the National Research Ethics Service (NRES). NRES attempts to standardise the work of RECs, with the aim of ensuring that the level of ethical practice in research is similar across the UK¹. The purpose of this standardisation is, ultimately, the protection of the public, specifically those individuals who become participants in research projects, but also, by ensuring that research is of a high standard, those people who eventually become users of the research, either as clinicians or patients. REC approval is also for the protection of the researchers themselves, because it provides a mechanism through which researchers can claim, in the event of any adverse event, that their research has been found to have reached certain minimum standards of ethical and methodological appropriateness.

All research work must receive REC approval before any data collection can begin, if that data collection involves any of the following: patients, relatives, staff, human tissue of any kind, access to patient records, use of National Health Service (NHS) premises. Additionally, approval may well be required if the researcher gains access to research participants by virtue of their role as a member of the NHS. For example, if you wished to interview mothers about the ways in which they gave medication to sick children, you could stand outside a school and stop them as they collected their children and offer them the chance to complete a questionnaire on such matters without seeking REC consent (although you would probably be unwise to do so unless you had some other robust system for ensuring the ethicality of the research). However, if you did exactly the same thing, but also told the parent that you were a health visitor working for such-and-such a primary care trust, you would definitely need REC consent, because you would be gaining access to the participants by virtue of your status as a health professional working in the NHS. The brief of RECs is to monitor and approve all NHS research activity, and it would be argued that your activity fell within this realm if you represented yourself as an NHS employee.

RECs are themselves now governed by a strict code of practice which is meant to ensure that their own conduct is ethical. The importance of this, from both an ethical and legal standpoint, has been the growth of a considerable bureaucracy around ethics committees in the UK and applications by researchers to them. This has resulted in occasional frustration by researchers with ethics committees, and a feeling that such committees were a barrier to the conduct of research. However, ethics committees take the view that the protection of the public is paramount. At the same time they recognise that harm would also be done if no research took place, and try extremely hard to balance these two issues in a way which is fair to both researchers and the public.

This bureaucracy has led to the development of a single national application form and procedure to be completed by all researchers who need REC approval, and this process is mediated via the internet. Although student research receives a slightly different from of scrutiny from RECs, students undergo the same application procedure as experienced researchers undertaking large funded research projects. The rationale for this is simple – although the work of students may not be far-reaching in its effects on the public, its potential for causing harm to individual participants is not necessarily less than the potential in a major research project. People requiring REC approval are advised to prepare the document in good time, and the approval process can take up to 60 days. If you are interested in finding out more about the role of RECs, particularly if you think will be undertaking a study which requires approval, full information can be found on the NRES website (see the end of this chapter for details).

A further step in the process of gaining approval for a study is the need to seek Research Governance approval. This is obtained from the research office of any NHS institution in which the research is to be carried out. Hospital Trusts each have their own research office, but Primary Care Trusts and smaller mental health Trusts often share research governance arrangements between several trusts. Strictly speaking, research offices do not consider ethical issues, but examine whether a study is feasible in their setting or has any potential financial impact on the host Trust. However, there are implicit ethical issues in many of the things to be considered in granting research governance approval. For example, if there is a financial impact, this may divert money away from patient care. Similarly, if the arrangements for research sponsorship are inadequate (research sponsors act as guarantors for the good ethical, financial and practical governance of research projects for which they are sponsors), there is potential for harm to participants. Whilst the general role of each research office in considering applications for research governance is similar, there is no centralised application system, and different Trusts have interpreted their responsibilities in ensuring the good governance of research activities in different ways, resulting in different documentation and different levels of scrutiny in different settings. Therefore, the seeking of research governance for a large, multicentre study can be extremely challenging, even for large teams of experienced researchers.

What can you do?

Given the above description of the complexities of REC and research governance approval, you might justifiably wonder how you could possibly have the time or resources to become involved in any research at all. There are a few things we would say in response to this. First, do not try and do it on your own. If you are intending to do a piece of your own research, you need supervision with this, and a competent supervisor will be familiar with REC and research governance issues.

Second, as a novice researcher, you should be starting small, and so issues about NHS ethics and research governance approval probably will not apply to you. If not, and you are a student, your university will almost certainly have its own ethics procedures. Although these differ widely in different universities, some form of procedure is essential, not just to protect subjects, but also to protect you as a researcher from possible risk of complaint or legal action if something goes wrong during the research. Most university procedures are considerably easier to negotiate than the NHS, which reflects the fact that the studies they are involved with are usually less risky and raise fewer ethical issues than those carried out with patients. One particular point you should note is that, at the time of writing this second edition, there is still no centralised agreed process for ethical scrutiny of studies which are carried out in non NHS hospital settings. You can seek advice from the setting where you propose to carry out the research, but should probably also make sure that your project has been seen by a university ethics committee. In social care settings, there is a single social care REC covering the country, but researchers are only required to apply to it if their research involves people who may lack capacity (although some funding bodies require applications to the social care REC for other groups of research participants). Otherwise, researchers are advised to apply to their university REC. If you are researching in a sensitive area (and, here again, as a novice researcher, you would be unwise to do so without the help of an experienced supervisor), it is worth seeking advice from an NHS REC, even when you are not required to do so. NHS RECs can offer advice and give an ethics opinion on any research, although the willingness to do so may vary from one local committee to another.

Finally, involvement in research goes far beyond the carrying out of pieces of research involving contact with patients, or even the collection of data from participants at all. There are many highly respected researchers who have confined their activities almost entirely to carrying out reviews of published source material. Moreover, activity in research, for most of us, is about critical understanding and dissemination and implementation. This is well within the scope of every HCP and is an extremely valuable contribution both to research itself and to patient care. The rest of this book will offer you an introduction to the skills needed to make a contribution in whatever way is most appropriate for you at the moment.

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