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Aim: To discuss ethical issues related to a complex study (PROFID) involving the development of a new, partly artificial intelligence-based, prediction model to enable personalised decision-making about the implantation of an implantable cardioverter defibrillator (ICD) in postmyocardial infarction patients, and a parallel non-inferiority and superiority trial to test decision-making informed by that model., Method: The position expressed in this paper is based on an analysis of the PROFID trials using concepts from high-profile publications in the ethical literature., Results: We identify ethical issues related to the testing of the model in the treatment setting, and to both the superiority and the non-inferiority trial. We underline the need for ethical-empirical studies about these issues, also among patients, as a parallel to the actual trials. The number of ethics committees involved is an organisational, but also an ethical challenge., Conclusion: The PROFID trials, and probably other studies of similar scale and complexity, raise questions that deserve dedicated parallel ethics and social science research, but do not constitute a generic obstacle. A harmonisation procedure, comparable to the Voluntary Harmonization Procedure (VHP) for medication trials, could be needed for this type of trials., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Children with medical complexity is an increasing population whose parents and healthcare providers face multiple decisions. Shared decision-making is a process where patients, their families and healthcare providers collaborate to make decisions based on clinical evidence and informed preferences of the family. Shared decision-making has benefits for the child, family and healthcare providers, including improved parental understanding of the child's difficulties, increased participation, improved coping skills and more efficient healthcare use. It is, however, poorly implemented., Aims and Methods: A scoping review was conducted to explore shared decision-making for children with medical complexity in community health services, including how shared decision-making is defined in research, how it is implemented, including barriers and facilitators and recommendations for research. Six databases were systematically searched for papers published in English up to May 2022: Medline, CINAHL, EMBASE, PsycINFO, PubMed, Cochrane Database of Systematic Reviews and sources of grey literature. The review is reported according to the Preferred Reporting Items for Scoping Reviews., Results: Thirty sources met the inclusion criteria. Most factors can either be a facilitator or barrier to shared decision-making depending on the context. Two significant barriers to shared decision-making in this population include uncertainty about the child's diagnosis, prognosis, and treatment options and the presence of hierarchy and power imbalance during clinical encounters with healthcare providers. Further influencing factors include continuity of care, the availability of accurate, accessible, adequate, and balanced information and the interpersonal and communication skills of parents and healthcare providers., Conclusion: Uncertainty about diagnosis, prognosis and treatment outcomes for children with medical complexity are additional challenges to the known barriers and facilitators to shared decision-making in community health services. Effective implementation of shared decision-making requires advancement of the evidence base for children with medical complexity, reducing power imbalance in clinical encounters, improving continuity of care, and improving the availability and accessibility of information resources., Competing Interests: Competing interests: No, there are no competing interests., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Background Amid the calls for 'more public health evidencé, we also need simple understandable methods of determining when more research really is needed. This paper describes a simple decision aid to help policymakers, researchers and other decision makers assess the potential 'information value' of a new public health randomised controlled trial. Methods The authors developed a flow chart to help make explicit (1) the user's information needs, (2) the intended use of the new information that the study will produce, (3) the added value of the evidence to be derived from the new study and (4) the levels of precision, bias and generalisability required by the user Results The flow chart is briefly illustrated, first in generic form and then in a worked example, showing how it may be used in deciding whether a new study should be commissioned to evaluate the health impact of allowing motorcycles to use bus lanes in London Conclusions In this paper, the authors have presented a flow chart for enacting an informal 'Value-of- Information'-like approach to deciding when a new public health evaluation is needed. The authors do not suggest that the flow chart approach is technically the equivalent of Value-of-Information methods. Nonetheless, it represents a valuable perspective and process to adopt, and this structured approach will be more revealing than an unstructured thought experiment as the basis for decisions about a new study. To aid in its development as an effective tool, we invite users from a variety of perspectives and contexts to review it, to use it in practice and to send us their comments. INSETS: What is already known on this subject;What this study adds. [ABSTRACT FROM AUTHOR]

The Israeli law of abortions (1977) legally authorises hospital committees to decide upon women's requests for selective abortion. One of the law's clauses determines that abortions can be approved in cases of an embryopathy. However, the law does not provide any clear definitions of those fetal 'physical or mental defects' in terms of severity and/or likelihood, which remain open to interpretation by the committee members. This paper aimed to determine which ethical methodologies are used by committee members and advisors as they face the dilemma of abortion approval due to mild to moderate possible embryopathy. Twenty interviews demonstrated that they use mainly a combination of deontology and a contextual -- relational model. Their ethical considerations are both contextual such as the family's/woman's relational network and are influenced by the ethical principles of autonomy and in cases of late abortions the value of life. The findings reveal a paradoxical picture: on the one hand, committee members hold liberal perceptions and in practice abortion requests are very seldom rejected. On the other hand, the Israeli abortion law and practice of abortion committees is still problematical from liberal and feminist rights perspectives. This paradox is discussed further by reflecting upon the relevant theory as well as the Israeli context. The paper concludes by suggesting that within the specific Israeli sociopolitical climate the requirement for committee approval of what should be a private decision might be necessary in order to placate religious or other opposition to abortion. [ABSTRACT FROM AUTHOR]

The value of conscience in healthcare ethics is widely debated. While some sources present it as an unquestionably positive attribute, others question both the veracity of its decisions and the effect of conscientious objection on patient access to health care. This paper argues that the right to object conscientiously should be broadened, subject to certain previsos, as there are many benefits to healthcare practice in the development of the consciences of practitioners. While effects such as the preservation of moral integrity are widely considered to benefit practitioners, this paper draws on the work of Hannah Arendt to offer several original arguments in defence of conscience that may more directly benefit patients, namely that a pang of conscience may be useful in rapidly unfolding situations in which there is no time to reflect satisfactorily upon activities and that, given the hierarchical nature of healthcare institutions, a right to defy authority on the basis of conscience may benefit junior staff who lack the institutional power to challenge the orders of superiors. [ABSTRACT FROM AUTHOR]

Theoretical and empirical research in bioethics frequently focuses on ethical dilemmas or problems. This paper draws on anthropological and phenomenological sources to develop an alternative framework for bioethical enquiry that allows examination of a broader range of how the moral is experienced in the everyday lives of individuals and groups. Our account of moral experience is subjective and hermeneutic. We define moral experience as "Encompassing a person's sense that values that he or she deem important are being realised or thwarted in everyday life. This includes a person's interpretations of a lived encounter, or a set of lived encounters, that fall on spectrums of right-wrong, good-bad or just-unjust". In our conceptualisation, moral experience is not limited to situations that are heavily freighted with ethically-troubling ramifications or are sources of debate and disagreement. Important aspects of moral experience are played out in mundane and everyday settings. Moral experience provides a research framework, the scope of which extends beyond the evaluation of ethical dilemmas, processes of moral justification and decision-making, and moral distress. This broad research focus is consistent with views expressed by commentators within and beyond bioethics who have called for deeper and more sustained attention in bioethics scholarship to a wider set of concerns, experiences and issues that better captures what is ethically at stake for individuals and communities. In this paper we present our conceptualisation of moral experience, articulate its epistemological and ontological foundations and discuss opportunities for empirical bioethics research using this framework. [ABSTRACT FROM AUTHOR]

Non-treatment decisions concerning demented patients are complex: in addition to issues concerning the health of patients, ethical and legal issues are involved. This paper describes a method for the development of a guideline that clarifies the steps to be taken in the decision making process whether to forgo curative treatment of pneumonia in psychogeriatric nursing home patients. The method of development consisted of seven steps. Step 1 was a literature study from which ethical, juridical and medical factors concerning the patient's health and prognosis were identified. In step 2, a questionnaire was sent to 26 nursing home physicians to determine the relative importance of these factors in clinical practice. In a meeting of nine experienced physicians (step 3), the factors identified in step 2 were confirmed by most of these professionals. To prevent the final guideline being too directive, a concept guideline that included ethical and legal aspects was designed in the form of a "checklist of considerations" (step 4). Experts in the fields of nursing home medicine, ethics and law reviewed and commented on the concept guideline (step 5). The accordingly adapted "checklist of considerations" was tested in a pilot study (step 6), after which all experts endorsed the checklist (step 7). The resulting "checklist of considerations" structures the decision making process according to three primary domains: medical aspects, patient's autonomy, and patient's best interest (see annex at end of paper). [ABSTRACT FROM AUTHOR]

Circumcision of a male child was recently ruled illegal by a court in Germany on the grounds that it violates the child's rights to bodily integrity and self-determination. This paper begins by challenging the applicability of these rights to the circumcision debate. It argues that, rather than a sweeping appeal to rights, a moral analysis of the practice of circumcision will require a careful examination of the interests of the child. I consider three of these interests in some detail. The first is the interest in avoiding a moderate decrease in expected future sexual pleasure. I argue that even if such a decrease were to occur, it is not wholly unreasonable to think that this might actually be a good thing for the child. Second, I consider the interest in self-determination. I argue that this interest is not as strong as it might appear because the adult's circumcision decision is subject to a variety of biases and a significant lack of information. Finally, I consider the child's interest in avoiding the future costs of adult circumcision. I argue that this interest becomes much stronger in the religious case because the child is quite likely to choose to become circumcised as an adult. The likelihood of the child choosing circumcision in the religious case also reduces the extent to which infant circumcision violates his interest in self-determination. I conclude that male infant circumcision falls within the prerogative of parental decision-making in the secular case and even more clearly so in the religious case. Finally, I distinguish male circumcision from female genital cutting in several important respects and argue that we can coherently hold that male circumcision is permissible without also endorsing all forms of female genital cutting. [ABSTRACT FROM AUTHOR]

Termination of pregnancy after a certain gestational age and following prenatal diagnosis, in many nations seem to be granted with a special status to the extent that they by law have to be discussed within a predominantly medical context and have physicians as third parties involved in the decision-making process ('indication-based' approach). The existing legal frameworks for indication-based approaches, however, do frequently fail to provide clear guidance for the involved physicians. Critics, therefore, asked for professional ethics and professional institutions in order to provide normative guidance for the physicians in termination of pregnancy on medical grounds. After outlining the clinical pathway in an indication-based approach and the involved types of (clinical) judgements, this paper draws upon different understandings of professional ethics in order to explore their potential to provide normative guidance in termination of pregnancy on medical grounds. The analysis reveals that professional ethics will not suffice -- neither as a set of established norms nor as internal morality -- in order to determine the normative framework of indication-based approaches on termination of pregnancy. In addition, there seem to be considerable inconsistencies regarding the target and outcome between prenatal testing on the one hand and following termination of pregnancy on the other hand. A source of morality external to medicine has to be the basis of evaluation if a consistent and workable normative framework for termination of pregnancy and prenatal testing should be established. [ABSTRACT FROM AUTHOR]

The requirements of the UK Equality Act 2010 and some high profile criticism for using a potentially ageist methodology have prompted the National Institute for Health and Clinical Excellence (NICE) to assess the processes and methodology it uses to make appraisal decisions. This paper argues that NICE has established rigorous systems to protect against ageist decisions, has no track record of ageism and is well placed to meet the requirements of new UK equality legislation. [ABSTRACT FROM AUTHOR]

From the perspective of investigators conducting research involving pregnant women and fetuses, a woman's decision about whether to have an abortion can sometimes be relevant to the suitability of the woman and fetus as research subjects. However, prominent ethicists disagree over whether it is permissible for a woman's decision about abortion to be an inclusion or exclusion criterion for participation in research. A widely held view is that fetuses to be aborted and fetuses to be carried to term should be treated equally as research subjects. Some hold that this principle implies that a woman's decision about whether to have an abortion should not be an inclusion or exclusion criterion. This paper identifies types of research in which investigators might want to have inclusion or exclusion criteria based on decisions about abortion. It examines the arguments for and against having the woman's decision about abortion included in such criteria. It is argued that there are types of research in which such criteria are ethically permissible. [ABSTRACT FROM AUTHOR]

Recent evaluation of the practice of euthanasia and related medical decisions at the end of life in the Netherlands has shown a slight decrease in the frequency of physician-assisted death since the enactment of the Euthanasia Law in 2002. This paper focuses on the absence of euthanasia cases concerning patients with dementia and a written advance euthanasia directive, despite the fact that the only real innovation of the Euthanasia Law consisted precisely in allowing physicians to act upon such directives. The author discusses two principal reasons for this absence. One relates to the uncertainty about whether patients with advanced dementia truly experience the suffering they formerly feared. There is reason to assume that they don't, as a consequence of psychological adaptation and progressive unawareness (anosognosia). The second, more fundamental reason touches upon the ethical relevance of shared understanding and reciprocity. The author argues that, next to autonomy and mercifulness, "reciprocity" is a condition sine qua non for euthanasia. The absence thereof in advanced dementia renders euthanasia morally inconceivable, even if there are signs of suffering and notwithstanding the presence of an advance euthanasia directive. This does not mean, however, that advance euthanasia directives of patients with dementia are worthless. They might very well have a role in the earlier stages of certain subtypes of the disease. To illustrate this point the author presents a case in which the advance directive helped to create a window of opportunity for reciprocity and shared decision-making. [ABSTRACT FROM AUTHOR]

Two interpretations of the precautionary principle are considered. According to the normative (action-guiding) interpretation, the precautionary principle should be characterised in terms of what it urges doctors and other decision makers to do. According to the epistemic (belief-guiding) interpretation, the precautionary principle should be characterised in terms of what it urges us to believe. This paper recommends against the use of the precautionary principle as a decision rule in medical decision making, based on an impossibility theorem presented in Peterson (2005). However, the main point of the paper is an argument to the effect that decision theoretical problems associated with the precautionary principle can be overcome by paying greater attention to its epistemic dimension. Three epistemic principles inherent in a precautionary approach to medical risk analysis are characterised and defended. [ABSTRACT FROM AUTHOR]

Public health decision makers, funders, practitioners, and the public are increasingly interested in the evidence that underpins public health decision making. Decisions in public health cover a vast range of activities. With the ever increasing global volume of primary research, knowledge and changes in thinking and approaches, quality systematic reviews of all the available research that is relevant to a particular practice or policy decision are an efficient way to synthesise and utilise research efforts. The Cochrane Collaboration includes an organised entity that aims to increase the quality and quantity of public health systematic reviews, through a range of activities. This paper aims to provide a glossary of the terms and activities related to public health and the Cochrane Collaboration. [ABSTRACT FROM AUTHOR]

Since its inception, bioethics' principled stance has been to argue against paternalism and elitism, and for an inclusive ethical perspective. But at least in North America, the growth of bioethics as a special area of applied ethics has created conflicts within the field itself. Those who, a generation earlier, argued against paternalism and for both professional and public accountability in medical decision making are now part of the decision making process. Too often, it is argued in this paper, their allegiance is to the employer, or to a view of medicine that is institutionally based. As a result, it is suggested by this review, medical ethicists have adopted the perspective that, in the early 1970s, they most criticised. The answer, it is argued here, is to revisit a lexicographical ordering of responsibility in bioethics, one that recognises professionals as individuals with responsibilities, as citizens with a public posture, and finally, as professionals involved in the process of medical decision making. [ABSTRACT FROM AUTHOR]

This paper discusses the role of consent in decision making generally and its role in end of life decisions in particular. It outlines a conception of autonomy which explains and justifies the role of consent in decision making and criticises some misapplications of the idea of consent, particular the role of fictitious or "proxy" consents. Where the inevitable outcome of a decision must be that a human individual will die and where that individual is a person who can consent, then that decision is ethical if and only if the individual consents. In very rare and extreme cases such a decision will be ethical in the absence of consent where it would be massively cruel not to end life in order to prevent suffering which is in no other way preventable. Where, however, the human individual is not a person, as is the case with abortion, the death of infants like Mary (one of the conjoined twins in a case discussed in the paper), or in the very rare and extreme cases of those who have ceased to be persons like Tony Bland, such decisions are governed by the ethics of ending the lives of non-persons. [ABSTRACT FROM AUTHOR]

This paper compares and contrasts three different substantive (as opposed to procedural) principles of justice for making health care priority-setting or "rationing" decisions: need principles, maximising principles and egalitarian principles. The principles are compared by tracing out their implications for a hypothetical rationing decision involving four identified patients. This decision has been the subject of an empirical study of public opinion based on small-group discussions, which found that the public seem to support a pluralistic combination of all three kinds of rationing principle. In conclusion, it is suggested that there is room for further work by philosophers and others on the development of a coherent and pluralistic theory of health care rationing which accords with public opinions. [ABSTRACT FROM AUTHOR]

Savulescu maintains that our paper, which encourages clinicians to honour requests for "inappropriate treatment" is prejudicial to his atheistic beliefs, and therefore wrong. In this paper we clarify and expand on our ideas, and respond to his assertion that medicine, ethics and atheism are objective, rational and true, while religion is irrational and false. [ABSTRACT FROM AUTHOR]

League tables are just one example of the growing importance of "institutional success" in the health service. What are the implications of attaching importance to institutional success, and what impact might this have on professional ethics? This paper considers these issues and argues that public policy processes which centre on institutional performance, and which co-opt professional loyalties to this end, shift the balance between person-centred and impersonal standpoints in health care (from the former and towards the latter). There is no attempt to make a global ethical appraisal of this putative shift but rather to raise a matter of concern for those committed to a person-centred conception of professional ethics. [ABSTRACT FROM AUTHOR]

There is usually great concern over the use of psychiatric patients for clinical research, as it raises the ethical and legal issues of human dignity and autonomy. In this paper the authors describe and evaluate a follow-up neurobiological study of patients who had been discharged from a psychiatric research ward at least ten months earlier. It is pointed out that such studies are rare and that the writers were provided with the unique opportunity to examine attitudinal and motivational dimensions involved in the patients' agreement to participate in the study. [ABSTRACT FROM PUBLISHER]

Background: In oncology clinical development, objective response rate, disease control rate and early tumor size changes are commonly used as efficacy metrics for early decision-making. However, for immunotherapy trials, it is unclear whether these early efficacy metrics are still predictive of long-term clinical benefit such as overall survival. The goal of this paper is to identify appropriate early efficacy metrics predictive of overall survival for immunotherapy trials. Methods: Based on several checkpoint blockade based immunotherapy studies in metastatic melanoma, we evaluated the predictive value of early tumor size changes and RECIST-based efficacy metrics at various time points on overall survival. The cut-off values for tumor size changes to predict survival were explored via tree based recursive partitioning and validated by external data. Sensitivity analyses were performed for the cut-offs. Results: The continuous tumor size change metric and RECIST-based trichotomized response metric at different landmark time points were found to be statistically significantly associated with overall survival. The predictive values were higher at Week 12 and 18 than those at Week 24. The percentage of tumor size changes appeared to have comparable or lower predictive values than the RECIST-based trichotomized metric, and a cut-off of approximately 10% tumor reduction appeared to be reasonable for predicting survival. Conclusions: An approximate 10% tumor reduction may be a reasonable cut-off for early decision-making while the RECIST-based efficacy metric remains the primary tool. Early landmark analysis is especially useful for decision making when accrual is fast. Composite response rate (utilizing different weights for PR/CR and SD) may be worth further investigation. [ABSTRACT FROM AUTHOR]

Are there some newborn infants whose short- and long-term care costs are so great that treatment should not be provided and they should be allowed to die? Public discourse and academic debate about the ethics of newborn intensive care has often shied away from this question. There has been enough ink spilt over whether or when for the infant's sake it might be better not to provide life-saving treatment. The further question of not saving infants because of inadequate resources has seemed too difficult, too controversial, or perhaps too outrageous to even consider. However, Roman Catholic ethicist Charles Camosy has recently challenged this, arguing that costs should be a primary consideration in decision-making in neonatal intensive care. In the first part of this paper I will outline and critique Camosy's central argument, which he calls the 'social quality of life (sQOL)' model. Although there are some conceptual problems with the way the argument is presented, even those who do not share Camosy's Catholic background have good reason to accept his key point that resources should be considered in intensive care treatment decisions for all patients. In the second part of the paper, I explore the ways in which we might identify which infants are too expensive to treat. I argue that both traditional personal 'quality of life' and Camosy's 'sQOL' should factor into these decisions, and I outline two practical proposals.

In this paper we clarify some issues related to our previous article 'After-birth abortion: why should the baby live?'.

When writing about policy, do you think in green or white? If not, I recommend that you do. I suggest that writers and journal editors should explicitly label every policy ethics paper either 'green' or 'white'. A green paper is an unconstrained exploration of a policy question. The controversial 'After-birth abortion' paper is an example. Had it been labelled as 'green', readers could have understood what Giubilini and Minerva explained later: that it was a discussion of philosophical ideas, and not a policy proposal advocating infanticide. A serious policy proposal should be labelled by writer(s) and editor(s) as 'white'. Its purpose should be to influence policy. In order to influence policy, I suggest three essential, and two desirable, characteristics of any white paper. Most importantly, a white paper should be set in the context in which the policy is to be made and applied.

A deficit in the number of organs available for transplantation persists even with an increase in donation rates. One possible choice of donor for organs that appears under-referred and/or unaccepted is patients with primary brain tumours. In spite of advances in the treatment of high-grade primary central nervous system (CNS) tumours, the prognosis remains dire. A working group on organs from donors with primary CNS tumours showed that the risk of transmission is small and outweighs the benefits of waiting for a normal donor, in survival and organ life-years, with caveats. This paper explores the possibility that, if information on organ donation were made available to patients and their families with knowledge of their inevitable fate, perhaps some will choose to donate. It would be explained that to achieve this, elective ventilation would be performed in their final moments. This would obviate the consent question because of an advance statement. It is accepted that these are sensitive matters and there will be logistic issues. This will need discussion with the public and other professionals, but it could increase the number of donors and can be extrapolated to encompass other primary CNS tumours.

This is a response to Dr Charlotte Rosalind Blease's paper 'Electroconvulsive Therapy (ECT), the Placebo Effect and Informed Consent', written by Julie K. Hersh who has had ECT. Hersh argues that placebo effect is impossible to prove without endangering the lives of participants in the study. In addition, informing potential ECT patients of unproven placebo effect could discourage patients from using a procedure that from experience has proven highly effective.

Recruitment processes for clinical trials are governed by guidelines and regulatory systems intended to ensure participation is informed and voluntary. Although the guidelines and systems provide some protection to potential participants, current recruitment processes often result in limited understanding and experiences of inadequate decision support. Many trials also have high drop-out rates among participants, which are ethically troubling because they can be indicative of poor experiences and they limit the usefulness of the knowledge the trials were designed to generate. Drawing on recent social-psychological and philosophical-ethical research on trial recruitment and patient participation in treatment decision-making, this paper identifies possibilities for improving communicative support for both initial decisions and ongoing participation in clinical trials. It highlights the potential of a shift in thinking about 'voluntariness', underpinned by relational understandings of autonomy, to encourage more nuanced judgements about the ethics of communication between trial staff and (potential) participants. The paper suggests that the idea of responsively enabling people to consider invitations or requests to participate in particular trials could serve as a general guide to communication. This might help ensure decisions about trial participation are meaningfully informed and voluntary, and that relationships between trial staff and participants contribute to positive experiences of trial participation and ultimately to the generation of the robust knowledge.

Sexual self-determination is considered a fundamental human right by most of us living in Western societies. While we must abide by laws regarding consent and coercion, in general we expect to be able to engage in sexual behaviour whenever, and with whomever, we choose. For older people with dementia living in residential aged care facilities (RACFs), however, the issue becomes more complex. Staff often struggle to balance residents' rights with their duty of care, and negative attitudes towards older people's sexuality can lead to residents' sexual expression being overlooked, ignored, or even discouraged. In particular, questions as to whether residents with dementia are able to consent to sexual activity or physically intimate relationships pose a challenge to RACF staff, and current legislation does little to assist them. This paper will address these issues, and will argue that, while every effort should be made to ensure that no resident comes to harm, RACFs must respect the rights of residents with dementia to make decisions about their sexuality, intimacy and physical relationships.

Until recently, moral case deliberation (MCD) sessions have mostly been facilitated by external experts, mainly professional ethicists. We have developed a train the facilitator programme for healthcare professionals aimed at providing them with the competences needed for being an MCD facilitator. In this paper, we present the first results of a study in which we evaluated the programme. We used a mixed methods design. One hundred and twenty trained healthcare professionals and five trainers from 16 training groups working in different healthcare organisations throughout the Netherlands were included. After completion of the programme, participants feel sufficiently confident and equipped to facilitate an MCD session. Feeling competent does not mean that participants have no doubts or questions left. Rather, they are aware of their limitations and see the need for continuous learning. According to the respondents, the actual exercise of facilitating MCD during and in between the training sessions contributed most to the development of competences necessary for being an MCD facilitator. Respondents without prior experience of participating in MCD sessions felt less competent after the training than those who had participated in MCD sessions before. Self-attributed competence varied between participants with different professional backgrounds.

Recent scientific advances mean the widespread introduction of non-invasive prenatal diagnosis (NIPD) for chromosomal aneuploidies may be close at hand, raising the question of how NIPD should be introduced as part of antenatal care pathways for pregnant women. In this paper, the authors examine the ethical implications of three hypothetical models for using NIPD for aneuploidy in state-funded healthcare systems and assess which model is ethically preferable. In comparing the models, the authors consider their respective timings; how each model would fit with current screening and diagnostic tests offered to pregnant women; the implications of offering NIPD at different stages of pregnancy; and the potential for each model to support reproductive autonomy and informed decision-making. The authors conclude by favouring a model that would be offered at 11-13 weeks gestation, alongside existing combined screening, provided that this is accompanied by measures to maximise informed decision-making, for example, provision of adequate pretest and post-test counselling.

Medical ethical analysis remains dominated by the principlist account first proposed by Beauchamp and Childress. This paper argues that the principlist model is unreflective of how ethical decisions are taken in clinical practice. Two kinds of medical ethical decisions are distinguished: biosocial ethics and clinical ethics. It is argued that principlism is an inappropriate model for clinical ethics as it is neither sufficiently action-guiding nor does it emphasise the professional integrity of the clinician. An alternative model is proposed for decision making in the realm of clinical ethics.

The Israeli law of abortions (1977) legally authorises hospital committees to decide upon women's requests for selective abortion. One of the law's clauses determines that abortions can be approved in cases of an embryopathy. However, the law does not provide any clear definitions of those fetal 'physical or mental defects' in terms of severity and/or likelihood, which remain open to interpretation by the committee members. This paper aimed to determine which ethical methodologies are used by committee members and advisors as they face the dilemma of abortion approval due to mild to moderate possible embryopathy. Twenty interviews demonstrated that they use mainly a combination of deontology and a contextual-relational model. Their ethical considerations are both contextual such as the family's/woman's relational network and are influenced by the ethical principles of autonomy and in cases of late abortions the value of life. The findings reveal a paradoxical picture: on the one hand, committee members hold liberal perceptions and in practice abortion requests are very seldom rejected. On the other hand, the Israeli abortion law and practice of abortion committees is still problematical from liberal and feminist rights perspectives. This paradox is discussed further by reflecting upon the relevant theory as well as the Israeli context. The paper concludes by suggesting that within the specific Israeli sociopolitical climate the requirement for committee approval of what should be a private decision might be necessary in order to placate religious or other opposition to abortion.

In this paper, I respond to criticisms by John Harris, contained in a commentary on my article "Harris, harmed states, and sexed bodies", which appeared in the Journal of Medical Ethics, volume 37, number 5. I argue that Harris's response to my criticisms exposes the strong eugenic tendencies in his own thought, when he suggests that the reproductive obligations of parents should be determined with reference to a claim about what would enhance 'society' or 'the species'.

In New Zealand an advance directive can be either an oral statement or a written document. Such directives give individuals the opportunity to make choices about future medical treatment in the event they are cognitively impaired or otherwise unable to make their preferences known. All consumers of health care have the right to make an advance directive in accordance with the common law. When we consider New Zealand's rapidly ageing population, the fact that more people now live with and die of chronic rather than acute conditions, the importance given to respecting autonomous decision-making, increasing numbers of individuals who require long-term residential care, and financial pressures in the allocation of medical resources, there would seem to be a number of compelling reasons to encourage individuals to write or verbalize an advance directive. Indeed the promotion of advance directives is encouraged. However, caution should be exercised in promoting advance directives to older people, especially in light of several factors: ageist attitudes and stereotypes towards them, challenges in the primary healthcare setting, and the way in which advance directives are currently focused and formulated. This paper considers some of the specific challenges that need to be addressed if the promotion of advance directives are to improve outcomes of patient treatment and care near the end of life.

While an ethical obligation to report findings of clinical research to trial participants is increasingly recognised, the academic debate is often vague about what kinds of data should be fed back and how such a process should be organised. In this article, we present a classification of different actors, processes and data involved in the feedback of research results pertaining to an individual. In a second step, we reflect on circumstances requiring further ethical consideration. In regard to a concrete research setting--the one of clinico-genomic research--we discuss what kinds of difficulties have to be faced when returning individual research results to trial participants. In a last step, we elaborate on a stepwise model to trigger the individual feedback process. Hence, this paper gives guidance on how to feedback individual research results in a specific research setting and responds at the same time to new challenges in the debate on the duty to return individual research findings.

In a number of papers, including the one published in this journal, Robert Sparrow has mounted attacks on consequentialism using principally what he takes to be an important fact, which he believes constitutes a reductio ad absurdum of consequentialism in its many forms and of this author's approach to enhancement and disability in particular (see page 276). This fact is the current longer life expectancy of women when compared with men. Here the author argues that Sparrow's arguments and entire approach utterly fail. In doing so the author hopes to shed further light on the role of normalcy, normal species functioning and species-typical functioning in debates about enhancement and disability.

This paper criticises John Harris's attempts to defend an account of a 'harmed condition' that can stand independently of intuitions about what is 'normal'. I argue that because Homo sapiens is a sexually dimorphic species, determining whether a particular individual is in a harmed condition or not will sometimes require making reference to the normal capacities of their sex. Consequently, Harris's account is unable to play the role he intends for it in debates about the ethics of human enhancement.

Background: In the Netherlands, using drugs to deliberately end the life of a severely defective newborn baby who is in extreme suffering can be permissible under very precise circumstances. This does not mean that all Dutch neonatologists are willing to engage in such behaviour. This paper discusses the use of neuromuscular blockers (NMBs) in connection with abstention decisions in neonatology and the boundaries between 'deliberate ending of life' and other end-of-life decisions. These boundaries are of paramount importance because, of all end-of-life decisions, only 'deliberate ending of life' must be reported by the responsible doctor and exposes him to the risk of being prosecuted., Methods: 14 Dutch neonatologists were presented with a hypothetical case of a severely asphyxiated baby who faces a long dying process after withdrawal of 'medically futile' (zinloos) life-sustaining ventilation. Doctors were asked whether it is acceptable to administer NMBs in this situation and whether such behaviour should be reported., Results and Conclusions: Doctors' responses were heterogeneous, showing that the acceptability of using NMBs in certain situations and the boundaries between end-of-life decisions are currently a subject of discussion among Dutch neonatologists. Many respondents reported feeling threatened by the potential involvement of the criminal law authorities in the system of control over 'deliberate ending of life'.

Since their introduction as 'no code' in the 1980s and their later formalization to 'do not resuscitate' orders, such directions to withhold potentially life-extending treatments have been accompanied by multiple ethical issues. The arguments for when and why to instigate such orders are explored, including a consideration of the concept of futility, allocation of healthcare resources, and reaching a balance between quality of life and quality of death. The merits and perils of discussing such decisions with patients and/or their relatives are reviewed and the unintended implications of 'do not attempt resuscitation' orders are examined. Finally, the paper explores some alternative methods to approaching the resuscitation decision, and calls for empirical evaluation of such methods that may reduce the ethical dilemmas physicians currently face.

Most contributions to the current debate about the consideration and application of empirical information in ethics scholarship deal with epistemological issues such as the role and the meaning of empirical research in ethical reasoning. Despite the increased publication of empirical data in ethics literature we still lack systematic analyses and conceptual frameworks that would help us to understand the rarely discussed methodological and practical problems in appraising empirical research. This paper demonstrates the need for critical appraisal and its crucial methodological role in the application of empirical information in ethical reasoning. Furthermore, it systematically examines the criteria and the appropriate appraisal of empirical research and the associated challenges by highlighting current problems in empirical ethics literature. These problems reveal the following challenges for a critical and responsible consideration of empirical information in ethical reasoning: (i) training in the basic skills of locating and communicating empirical data from the relevant studies; (ii) training in basic knowledge of how to critically appraise empirical (qualitative and quantitative) research and its results; (iii) determination of quality standards for empirical ethics research; (iv) adequate reporting of the methodology and results of empirical ethics research in scientific journals.

The Mental Capacity Act (2005) is an impressive piece of legislation that deserves serious ethical attention, but much of the commentary on the Act has focussed on its legal and practical implications rather than the underlying ethical concepts. This paper examines the approach that the Act takes to best interests. The Act does not provide an account of the underlying concept of best interests. Instead it lists factors that must be considered in determining best interests, and the Code of Practice to the Act states that this list is incomplete. This paper argues that this general approach is correct, contrary to some accounts of best interests. The checklist includes items that are unhelpful. Furthermore, neither the Act nor its Code of Practice provides sufficient guidance to carers faced with difficult decisions concerning best interests. This paper suggests ways in which the checklist can be developed and discusses cases that could be used in an updated Code of Practice.

In 2006, a paper in the journal Archives of Pediatric and Adolescent Medicine described a novel case of growth attenuation therapy and other treatments carried out on Ashley, a severely cognitively, neurologically and physically disabled 6-year-old girl. Some of the moral arguments that have sprung up in respect of the so-called "Ashley treatment" are considered, and it is suggested that they all miss something-that the proper treatment of Ashley may have as much to do with doctors' duties to themselves as with their duties to her. It is suggested that the Ashley treatment may have been in violation of doctors' self-regarding duties and that this possibility is worthy of further investigation.

This paper uses the case of solo doctors to explore whether working in relative isolation from one's peers may be detrimental to ethical decision-making. Drawing upon the relevance of communication and interaction for ethical decision-making in the ethical theories of Habermas, Mead and Gadamer, it is argued that doctors benefit from ethical discussion with their peers and that solo practice may make this more difficult. The paper identifies a paucity of empirical research related to solo practice and ethics but draws upon more general medical ethics research and a study that identified ethical isolation among community pharmacists to support the theoretical claims made. The paper concludes by using the literary analogy of Soderberg's Doctor Glas to illustrate the issues raised and how ethical decision-making in relative isolation may be problematical.

The notions of "expert" and "expertise" imply that some people have more credibility than others on certain matters. While expert authority is often taken for granted, there are questions as to whether expert power in some cases can be a form of epistemic oppression. Informed by bedside disagreements between family and clinicians as well as feminist discussions of epistemic oppression, this paper argues for a commitment to epistemic humility and the adoption of a two-way collaborative approach between clinicians and families that can help to enhance professionals' own understanding of their theoretical framework and also promote responsive patient care.

What are the criteria for reasonable clinical judgements? The reasonableness of macro-level decision-making has been much discussed, but little attention has been paid to the reasonableness of applying guidelines generated at a macro-level to individual cases. This paper considers a framework for reasonable clinical decision-making that will capture cases where relevant guidelines cannot reasonably be followed. There are three main sections. (1) Individual claims on healthcare from the point of view of concerns about equity are analysed. (2) The demands of responsibility and equity on professional clinical performance are discussed, and how the combination of these demands emerges into seven requirements that constitute the framework is explored. Since this framework is developed to assist in reasonable clinical decision-making, practical implications of all these requirements are also suggested. (3) Challenges concerning the framework are discussed. First, a crucial presumption that the framework relies upon is considered-namely, clinicians' willingness to justify their decisions as requested. Then how public deliberation may influence clinical decision-making is discussed. Next is a consideration of how clinicians' need to have confidence in their own judgements in order to perform in a manner worthy of trust would be compatible with adherence to the framework supported by public deliberation. It is concluded that fair distribution in the interplay between macro- and micro-level considerations can be secured by legitimising procedures on each level, by ensuring well-organised and continuing public debate and by basing individual clinical judgements upon well-justified and principled normative bases.

Based on extensive questionnaire data, this paper focuses on parents' views about children's right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings.

A recurrent issue in the vast amount of literature on reasoning models in ethics is the role and nature of moral intuitions. In this paper, we start from the view that people who work and live in a certain moral practice usually possess specific moral wisdom. If we manage to incorporate their moral intuitions in ethical reasoning, we can arrive at judgements and (modest) theories that grasp a moral experience that generally cannot be found outside the practice. Reflective equilibrium (RE) provides a framework for balancing moral intuitions, ethical principles and general theories. Nevertheless, persisting problems associated with the use of intuitions need to be addressed. One is the objection that moral intuitions lack the credibility necessary to guide moral reasoning. Ethicists have tried to solve this problem by formulating criteria to separate the "bad" intuitions from the "good" ones at the beginning of the reasoning process. We call this the credible input-justified outcome strategy. An example is the appeal to the common morality by Beauchamp and Childress. We think this approach is unsuccessful. As an alternative, we outline the good reasoning-justified outcome strategy. It connects to a variant of RE in which intuitions from different sources are incorporated. We argue that the elements of RE have different levels of justificatory power at the start of reasoning. In our strategy, each element can gain or lose justificatory power when it is tested in a reasoning process that meets several criteria.