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. (shrink)

The purpose of this article is to develop a conception of death with dignity and to examine whether it is vulnerable to the sort of criticisms that have been made of other conceptions. In this conception “death” is taken to apply to the process of dying; “dignity” is taken to be something that attaches to people because of their personal qualities. In particular, someone lives with dignity if they live well (in accordance with reason, as Aristotle would see it). It (...) follows that health care professionals cannot confer on patients either dignity or death with dignity. They can, however, attempt to ensure that the patient dies without indignity. Indignities are affronts to human dignity, and include such things as serious pain and the exclusion of patients from involvement in decisions about their lives and deaths. This fairly modest conception of death with dignity avoids the traps of being overly subjective or of viewing the sick and helpless as “undignified”. (shrink)

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. (shrink)

Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguements 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. (shrink)

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. (Journal of Medical Ethics 2001;27:110–113) Keywords: Neonates; randomised controlled trials; best interest; ethics. (shrink)

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. (shrink)

My original paper suggested that an ethics of care which failed to specify how, and about what, to care would be devoid of normative and descriptive content. Bradshaw's approach provides such a specification and is, therefore, not devoid of such content. However, as all ethical approaches suggest something about the 'what' and 'how' of care, they are all 'ethics of care' in this broader sense. This reinforces rather than undermines my original conclusion. Furthermore, Bradshaw's 'ethics of care' has philosophical and (...) historical problems which I outline. (shrink)

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. (shrink)

“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: empirical beliefs about the nature of illness and 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. (shrink)

People with severe learning disability are particularly difficult to include in the research process. As a result, researchers may be tempted to focus on those with learning disability who can be included. The problem is exacerbated in this field as the political agenda of inclusion and involvement is driven by those people with learning disability who are the higher functioning. To overcome this we should first detach the notion of consent from ideas about autonomy and think instead of it as (...) a way to avoid wronging others; this fits the original historical use of consent in research. This allows us to think in terms of including participants to the best of their abilities rather than in terms of a threshold of autonomy. Researchers could then use imaginative ways to include the least able and to ensure they are not wronged in research or by exclusion from it. (shrink)

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. (shrink)