End of life care pathways: ethical and legal principles.

Myths have developed surrounding the law and ethical principles in end of life care, which can make care provision at the end of life complex and fraught with potential dilemmas. This article examines three of the most common myths related to the provision of palliative care and highlights their inadequacy when set against the ethical and legal principles on which end of life care pathways are based.

Should desperate volunteers be included in randomised controlled trials?

Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.

OBJECTIVE: To assess whether continuous consent, a process in which information is given to research participants at different stages in a trial, and clinician training in that process were effective when used by clinicians while gaining consent to the Total Body Hypothermia (TOBY) trial. The TOBY trial is a randomised controlled trial (RCT) investigating the use of whole-body cooling for neonates with evidence of perinatal asphyxia. Obtaining valid informed consent for the TOBY trial is difficult, but is a good test of the effectiveness of continuous consent. METHODS: Semistructured interviews were conducted with 30 sets of parents who consented to the TOBY trial and with 10 clinicians who sought it by the continuous consent process. Analysis was focused on the validity of parental consent based on the consent components of competence, information, understanding and voluntariness. RESULTS: No marked problems with consent validity at the point of signature were observed in 19 of 27 (70%) couples. Problems were found mainly to lie with the competence and understanding of the parents: mothers, particularly, had problems with competence in the early stages of consent. Problems in understanding were primarily to do with side effects. Problems in both competence and understanding were observed to reduce markedly, particularly for mothers, in the post-signature phase, when further discussion took place. Randomisation was generally understood but unpopular. Information was not always given by clinicians in stages during the short period available before parents gave consent. Most clinicians, however, were able to give follow-up information. DISCUSSION: Consent validity was found to compare favourably with similar trials examined in the Euricon study. CONCLUSION: Adopting the elements of the continuous consent process and clinician training in RCTs should be considered by researchers, particularly when they have concerns about the quality of consent they are likely to obtain by using a conventional process.

How should public health professionals engage with lay epidemiology?

"Lay epidemiology" is a term used to describe the processes through which health risks are understood and interpreted by laypeople. It is seen as a barrier to public health when the public disbelieves or fails to act on public health messages. Two elements to lay epidemiology are proposed: (a) empirical beliefs about the nature of illness and (b) values about the place of health and risks to health in a good life. Both elements have to be dealt with by effective public health schemes or programmes, which would attempt to change the public's empirical beliefs and values. This is of concern, particularly in a context in which the lay voice is increasingly respected. Empirically, the scientific voice of standard epidemiology should be deferred to by the lay voice, provided a clear distinction exists between the measurement of risk, which is empirical, and its weighting, which is based on values. Turning to engagement with values, health is viewed to be an important value and is discussed and reflected on by most people. Public health professionals are therefore entitled and advised to participate in that process. This view is defended against some potential criticisms.

Choosing Health and the inner citadel.

It is argued in this paper that the latest UK government white paper on public health, Choosing Health, is vulnerable to a charge of paternalism. For some years libertarians have levelled this charge at public health policies. The white paper tries to avoid it by constant reference to informed choice and choice related terms. The implication is that the government aims only to inform the public of health issues; how they respond is up to them. It is argued here, however, that underlying the notion of informed choice is a Kantian, "inner citadel" view of autonomy. According to this view, each of us acts autonomously only when we act in accord with reason. On such a view it is possible to justify coercing, cajoling, and conning people on the basis that their current behaviour is not autonomous because it is subject to forces that cause irrational choice, such as addiction. "Informed choice" in this sense is compatible with paternalism. This paternalism can be seen in public health policies such as deceptive advertising and the treatment of "bad habits" as addictions. Libertarians are bound to object to this. In the concluding section, however, it is suggested that public health can, nonetheless, find ethical succour from alternative approaches.

Should research samples reflect the diversity of the population?

Recent research governance documents say that the body of research evidence must reflect population diversity. The response to this needs to be more sophisticated than simply ensuring minorities are present in samples. For quantitative research looking primarily at treatment effects of drugs and devices four suggestions are made. First, identify where the representation of minorities in samples matters-for example, where ethnicity may cause different treatment effects. Second, where the representation of a particular group matters then subgroup analysis of the results will usually be necessary. Third, ensuring representation and subgroup analysis will have costs; deciding on whether such representation is worthwhile will involve cost benefit analysis. Fourth, the representation of minorities should not be seen as mainly a locality issue. For qualitative research it is argued that the representation of diversity is often important. Given the small samples of many qualitative projects, however, the best way to ensure representation occurs is to allow a proliferation of such research, not to stipulate such representation in samples.

Ethical review of health service research in the UK: implications for nursing.

BACKGROUND: This paper examines the current systems and structures for ethical review of health services research in the United Kingdom (UK). Past criticisms and the adequacy of recent governance arrangements for Ethics Committees in addressing these are discussed. The implications for nurses are then considered. RATIONALE: This examination of the situation is prompted by the demand for more innovative research designs in health care evaluation, new regulations and guidance, and a climate of public anxiety regarding research conduct in the UK. FINDINGS: The evolution of Research Ethics Committees (RECs) has been slow and resulted in a lack in consistency. Criticisms made of RECs can be categorized into four main areas. New governance arrangements for RECs have emerged as potential solutions to these criticisms. This review identifies the limitations of the new governance arrangements in addressing past criticisms because of two factors. The first is insufficient funding. The second is confusion about the confidentiality and consent requirements of clinicians working in areas where research is conducted and on whom recruitment processes often rely. The current situation regarding health research ethical review has implications for nurses, whether they are working as researchers, members of Ethics Committees or clinicians where research is conducted. CONCLUSION: The new governance arrangements may go some way to addressing past problems. However, investment in RECs is required. It is also important to realize that maintaining ethical probity in health service research is a tripartite concern. It is reliant as it is on the actions of Ethics Committees and clinical research partners as well as those of the researchers themselves.

Is it in a neonate's best interest to enter a randomised controlled trial?

Clinicians are required to act in the best interest of neonates. However, it is not obvious that entry into a randomised controlled trial (RCT) is in a neonate's best interest because such trials often involve additional onerous procedures (such as intramuscular injections) in return for which the neonate receives unproven treatment or a placebo. On the other hand, neonatology needs to develop its evidence base, and RCTs are central to this task. The solution posited here is based on two points. First, "best interest" is not equivalent to "the best possible interest" only to "best interest within a certain realm". The realm of deliberation when asking the title question is the neonate's health. Deliberating in this realm may involve the exclusion from consideration of some factors that might be thought relevant (such as parental wealth). Furthermore, circumstances may dictate the need to deliberate on other factors that might be thought irrelevant (such as health care resources). Second, deciding on a neonate's best interest does not involve "putting oneself in its shoes". Rather, it involves asking in what it has an interest, or stake. These will include some things in which we all, as human beings, have a stake, such as medical progress. Putting these two points together, in the realm of health the answer to whether RCT entry is in a neonate's best interest is usually very finely balanced. Where this is the case, it is reasonable to invoke a broader notion of best interest and include a broader range of elements in which the neonate has a stake, including medical progress. In this way RCT entry can, usually, be said to be in a neonate's best interest.

Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study.

BACKGROUND: Questions have been asked about whether the process of obtaining informed consent from parents to clinical trials on neonates leads to valid consent. We undertook a study in nine European countries to assess this issue and to seek any practical improvements. METHODS: Semi-structured interviews were conducted with parents of 200 babies who had been asked for consent to neonatal trials and 107 neonatologists seeking consent. Analysis assessed the validity of the consent process against four components: parental competence; information given; parental understanding; and voluntariness of consent. FINDINGS: 59 of the 200 parents had given valid consent or refusal but the remainder had problems in one or more of the component areas (42 for competence, 43 for information, 44 for understanding, and 21 for voluntariness). The proportions with impaired consent were greatest for research in an emergency situation and for that associated with risk or discomfort greater than standard treatment. Information sheets were little used by parents in deciding whether to consent. Parents highly valued their involvement in the informed consent process, and clinicians generally agreed on the value of the process. INTERPRETATION: Current standards of informed consent to neonatal research projects could be improved. Research personnel should receive guidance on legal and ethical constraints governing the process. Oral and written information should be given at the same time. Parents could be made aware that research projects have been examined by research ethics committees. Little support was found for the argument that informed consent should be relinquished for the parents' own good. Further study is needed to identify which elements of the process are valued by parents and clinicians in a process that has some unavoidable limitations.

Should Zelen pre-randomised consent designs be used in some neonatal trials?

My aim is to suggest that there is a case for using a randomised consent design in some neonatal trials. As an example I use the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. In some trials the process of obtaining consent has the potential to harm the subject, for example, by disappointing those who end in the control group and by creating additional anxiety at times of acute illness. An example of such were the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. Pre-randomised consent could avoid or lessen these harms. However, a number of ethical objections are made to these research designs. They involve denial of information, using people, denial of choice, and "overselling" of allocated treatment. Furthermore, they are the wrong response; better communication might be the answer, for example. I argue that these objections are not completely persuasive. However, they are enough to suggest caution in the use of such designs.

Is caring a virtue?

The significance of the question 'Is caring a virtue?' lies in the fact that both the ethics of virtue and the ethics of care have been proposed as alternatives to what may be termed 'bioethics'. The ethics of care has been of particular interest to nursing theorists, especially those who want to say that there is a body of distinctively nursing ethical theory which is different from bioethics. In answering the main question there are three supplementary aims: first, to explore the relationship between virtue ethics and the ethics of care, it is suggested that caring is not a virtue, but that the virtues involve caring correctly; second, to give a broad outline of what is meant by an ethics of virtue, including what it means to care correctly; and third, to examine implications of the theory for nursing.

Smoking and health: is discrimination fair?

The practice of discriminating against smokers for certain treatments is widespread. Discrimination is not wrong in itself; what is crucial is the criterion used. Discrimination against smokers appears to invoke criteria of benefit and desert. These criteria are not, and perhaps cannot be, applied consistently.

Uncertainties in the teaching of ethics to students of nursing.

Whilst ethics is now commonplace on nursing curricula in the United Kingdom there remains doubt as to how and what to teach. This doubt has its origins in interlinked uncertainties within nursing, ethics and education. In nursing there are uncertainties about whether we are teaching ethics to professionalize or because we are a profession, and about whether there is something which is uniquely 'nursing ethics'. In ethics there are competing paradigms of ethical theory and competing theories of moral development. In education there are competing epistemologies, theories of learning and models of curriculum planning. These uncertainties are interlinked and an understanding of them will help clarify the debate as to what to teach and how to teach it.

A classical view of the theory-practice gap in nursing.

The perceived problem of the theory-practice gap is built upon the assumption that theory can and must be directly applied to nursing practice, otherwise it is irrelevant. Whilst the spirit in which this claim is made is healthy, the assumption is false. An examination of the Greek origins of theory and practice show that the ancient Greeks had different terms for the different types of knowledge contained within theory and within practice. The type of knowledge associated with practice could not be taught through theory, nor well represented in theoretical terms. The knowledge of the bicycle rider and the piano player illustrate this well. If this is correct then simplistic notions of 'applied theory' are nonsensical. The knowledge of the practitioner is not theory, but something else. However, there is a proper relationship between theory and practice, and there are clear examples of this in the way science informs nursing practice. The problem is that much of this is obscured by the false claim of theorists that nursing theory (such as normative models) is also science. In fact, what it represents is inadequate attempts by theory to represent knowledge which cannot be represented in that form. Nursing is practice, not theory. If so, then the term 'nursing theory' seems to be oxymoronic.

Can there be an ethics of care?

There is a growing body of writing, for instance from the nursing profession, espousing an approach to ethics based on care. I suggest that this approach is hopelessly vague and that the vagueness is due to an inadequate analysis of the concept of care. An analysis of 'care' and related terms suggests that care is morally neutral. Caring is not good in itself, but only when it is for the right things and expressed in the right way. 'Caring' ethics assumes wrongly that caring is good, thus it can tell us neither what constitutes those right things, nor what constitutes the right way.

HIV and the boundaries of confidentiality.

Confidentiality is an acknowledged duty of the nurse. It has foundations in ethics and has some legal force. There is also a more disingenuous reason for citing it as a duty: that it helps a group attain professional status. This may cause an over-zealous attitude towards confidentiality in some professionals. There are legal and ethical limits to confidentiality which can be seen clearly in cases which arise out of human immunodeficiency virus (HIV). Whilst these make it clear that there are limits, neither the law nor ethics can state precisely what those limits are. Broad guidelines may be possible but in the end much will depend on the discretion and wisdom of the individual nurse. This can be informed by discussion of cases and of the ethical underpinnings of confidentiality.

An argument against the use of the concept of 'persons' in health care ethics.

This paper discusses the use of the concept of 'persons', and its related principle 'respect for persons', in health care ethics. It is suggested that the main use of the concept is in attempts to answer the questions: 'Who owes moral respect?' and 'To whom is it owed?'. An examination of different writers and their use of the concept of 'persons' show it to be unsuccessful in answering the first question, and dangerous and unacceptable in answering the second. Therefore, it is suggested the concept should not be used at all in health care ethics. An alternative idea is suggested, based on the work of Hursthouse (1992).