The concept of community is increasingly the focus of political argument in Britain, the United States and elsewhere around the world. The sense people have of belonging to coummunities provides a powerful motivation which continues to affecct the political and social face of the world. Recently, debate about the relationship between individuals and their communities has become central to the making of both, American and European social policy. In the United Kingdom this is especially apparent in the area of health (...) care, where ideas of community have informed recent legislation concerning community care, community health trusts and the Children Act among others. This volume explores the focus of interest in community and the emerging theoretical oppostion between communitarianism and liberalism, as well as the practical, theoretical and ethical issues relating to community in the health care professions, including a discussion of the health service as Civil Association, an analysis of liberal and communitarian views on the allocaiton of health care resources, an exploration of the use of genetic information and an examination of health care decision making for incapacitated elderly patients. (shrink)

Der Selbstbestimmungdes Patienten kommt in der modernen Debatte über das Gesundheitswesen eine zentrale Bedeutung zu. Selbstbestimmung ist aber ein voraussetzungsvoller Begriff, der für Patientengruppen wie Demenzbetroffene, deren Entscheidungs- und Einwilligungsfähigkeit nachlässt oder nicht mehr gegeben ist, eine Reihe von Fragen aufwirft. Auf der Grundlage der jeweiligen Symptomentwicklung der Demenzerkrankung und eigener Erfahrungen im Umgang mit Demenzbetroffenen wirdde rEntwicklungdes Willens in den verschiedenen Stadien der Demenz nachgegangen. Dabei wird den Dimensionen der Differenziertheit der Denkinhalte, der Beurteilungsbasis und der Entscheidungskonstanz eine besondere (...) Bedeutung zugemessen und für eine Graduierung der Selbstbestimmungsmöglichkeiten im Umgang mit Demenzbetroffenen plädiert. Wegen der Schwererkennbarkeit der oft verschlüsselten Willensbekundungen Demenzbetroffener wird der Willenswahrnehmung und dem Training der genauen Beobachtung, Einfühlung und Sensibilität im Umgang mit den Betroffenen großes Gewicht beigemessen. Als Ziel wird die jeweils weitestgehende Selbstbestimmung, im Verlaufe der Erkrankung auch Teilselbstbestimmung und schließlich Mitwirkung bei der individuellen Wohlbestimmung im Sinne eines Grundrechtsschutzes vertreten. (shrink)

Die Arzneimittelzulassung und der Aufnahmeprozess zur Kostenerstattung sollen die Entwicklung und Vermarktung von pharmazeutischen Innovationen mit Patientennutzen nicht behindern, zugleich aber die Wirtschaftlichkeit der Arzneimittelversorgung für die Kostenträger nicht gefährden. Eine Anpassung der Verfahren an die Merkmale personalisierter Arzneimittel erscheint notwendig. Dabei ist allerdings zu fragen, ob eine ungerechtfertigte Privilegierung erfolgt. In den USA und in der EU werden die jeweiligen Zulassungsverfahren für Arzneimittel und Tests schrittweise angepasst und integriert. Zulassung und Erstattungsentscheidungen sollen koordiniert werden. Eine Privilegierung, wie bei Arzneimitteln (...) für seltene Indikationen (Orphan Drugs), findet jedoch für personalisierte Medizin nicht statt. Es bestehen keine unzumutbaren Hürden für die Hersteller. Zurückhaltung bei der Entwicklung innovativer Produkte wäre deshalb nicht gerechtfertigt. (shrink)

Population-level biomedical research has become crucial to the health system’s ability to improve the health of the population. This form of research raises a number of well-documented ethical concerns, perhaps the most significant of which is the inability of the researcher to obtain fully informed specific consent from participants. Two proposed technical solutions to this problem of consent in large-scale biomedical research that have become increasingly popular are meta-consent and dynamic consent. We critically examine the ethical and practical credentials of (...) these proposals and find them lacking. We suggest that the consent problem is not solved by adopting a technology driven approach grounded in a notion of ‘specific’ consent but by taking seriously the role of research governance in combination with broader conceptions of consent. In our view, these approaches misconstrue the rightful location of authority in the way in which population-level biomedical research activities are structured and organized. We conclude by showing how and why the authority for determining the nature and shape of choice making about participation ought not to lie with individual participants, but rather with the researchers and the research governance process, and that this necessarily leads to the endorsement of a fully articulated broad consent approach. (shrink)

This paper examines the concept of ‘openness with patients’ from the stand-point of the limitations of biomedical ethics. Initially we review contemporary critiques of bioethics and, in particular, of principlism; we relate how other; somewhat neglected, forms of medical ethics can yield useful information and provide moral guidance.The main section of the paper then shows how a bioethical approach to openness misses the social context in our example, the viewpoints of patients; we present some of the increasing wealth of research (...) evidence which points towards patients wanting more information and a greater degree of openness.Finally we put forward that a principlist’s objection to active encouragement of openness might be based on the risk of infringing upon the ‘right not to know’. We reject this by arguing how rights can be trumped. (shrink)

Realizing the benefits of translating psychiatric genomics research into mental health care is not straightforward. The translation process gives rise to ethical challenges that are distinctive from challenges posed within psychiatric genomics research itself, or that form part of the delivery of clinical psychiatric genetics services. This article outlines and considers three distinct ethical concerns posed by the process of translating genomic research into frontline psychiatric practice and policy making. First, the genetic essentialism that is commonly associated with the genomics (...) revolution in health care might inadvertently exacerbate stigma towards people with mental disorders. Secondly, the promises of genomic medicine advance a narrative of individual empowerment. This narrative could promote a fatalism towards patients' biology in ways that function in practice to undermine patients' agency and autonomy, or, alternatively, a heightened sense of subjective genetic responsibility could become embedded within mental health services that leads to psychosocial therapeutic approaches and the clinician-patient therapeutic alliance being undermined. Finally, adopting a genomics-focused approach to public mental health risks shifting attention away from the complex causal relationships between inequitable socio-economic, political, and cultural structures and negative mental health outcomes. The article concludes by outlining a number of potential pathways for future ethics research that emphasizes the importance of examining appropriate translation mechanisms, the complementarity between genetic and psychosocial models of mental disorder, the implications of genomic information for the clinician-patient relationship, and funding priorities and resource allocation decision making in mental health. (shrink)

In this paper we discuss ethical implications of the use of mobile phone apps in the control of the COVID-19 pandemic. Contact tracing is a well-established feature of public health practice during infectious disease outbreaks and epidemics. However, the high proportion of pre-symptomatic transmission in COVID-19 means that standard contact tracing methods are too slow to stop the progression of infection through the population. To address this problem, many countries around the world have deployed or are developing mobile phone apps (...) capable of supporting instantaneous contact tracing. Informed by the on-going mapping of ‘proximity events’ these apps are intended both to inform public health policy and to provide alerts to individuals who have been in contact with a person with the infection. The proposed use of mobile phone data for ‘intelligent physical distancing’ in such contexts raises a number of important ethical questions. In our paper, we outline some ethical considerations that need to be addressed in any deployment of this kind of approach as part of a multidimensional public health response. We also, briefly, explore the implications for its use in future infectious disease outbreaks. (shrink)

BackgroundCommunity engagement is increasingly promoted as a marker of good, ethical practice in the context of international collaborative research in low-income countries. There is, however, no widely agreed definition of community engagement or of approaches adopted. Justifications given for its use also vary. Community engagement is, for example, variously seen to be of value in: the development of more effective and appropriate consent processes; improved understanding of the aims and forms of research; higher recruitment rates; the identification of important ethical (...) issues; the building of better relationships between the community and researchers; the obtaining of community permission to approach potential research participants; and, the provision of better health care. Despite these diverse and potentially competing claims made for the importance of community engagement, there is very little published evidence on effective models of engagement or their evaluation.MethodsIn this paper, drawing upon interviews with the members of a Community Advisory Board on the Thai-Myanmar border, we describe and critically reflect upon an approach to community engagement which was developed in the context of international collaborative research in the border region.Results and conclusionsDrawing on our analysis, we identify a number of considerations relevant to the development of an approach to evaluating community engagement in this complex research setting. The paper also identifies a range of important ways in which the Community Advisory Board is in practice understood by its members to have morally significant roles and responsibilities beyond those usually associated with the successful and appropriate conduct of research. (shrink)

Confidentiality in genetic testing posesimportant ethical challenges to the currentprimacy of respect for autonomy and patientchoice in health care. It also presents achallenge to approaches to decision-makingemphasising the ethical importance of theconsequences of health care decisions. In thispaper a case is described in which respect forconfidentiality calls both for disclosure andnon-disclosure, and in which respect forpatient autonomy and the demand to avoidcausing harm each appear to call both fortesting without consent, and testing only withconsent. This creates problems not only forclinicians, (...) families and patients, but also forthose who propose clinical bioethics as a toolfor the resolution of such dilemmas.In this paper I propose some practical waysin which ethical issues in clinical geneticsand elsewhere, might be addressed. Inparticular I call for a closer relationshipbetween ethics and communication in health caredecision-making and describe an approach to theethics consultation that places particularemphasis on the value of interpersonaldeliberation in the search for moralunderstanding. I reach these conclusionsthrough an analysis of the concept of `moraldevelopment'' in which I argue that theachievement of moral understanding is anecessarily intersubjective project elaboratedby moral persons. (shrink)

The practice of medicine frequently involves the unconsented restriction of liberty. The reasons for unilateral liberty restrictions are typically that being confined, strapped down, or sedated are necessary to prevent the person from harming themselves or others. In this paper, we target the ethics of chemical restraints, which are medications that are used to intentionally restrict the mental states associated with the unwanted behaviors, and are typically not specifically indicated for the condition for which the patient is being treated. Specifically, (...) we aim to identify the conditions under which chemical restraints are ethically permissible. It is wrong to assume that what is morally true of physical restraints is also true of chemical restraints. Our aim is thus to identify the conditions under which chemical restraints are permissible while distinguishing these conditions from those of the application of physical restraints. (shrink)

This is a practical, versatile, case-based introduction to bioethics for anyone interested in the ethical issues raised by modern medicine. It is designed to be used for individual reference, as well as a set text in group teaching or open learning environments. The workbook is structured around a variety of guided activities designed to introduce and examine the major ethical questions. The activities are clustered around actual cases (provided by an international team of health care professionals), commentaries (from clinicians, ethicists, (...) and lawyers), and short papers. The range of problems covered includes ethical issues raised by new reproductive and genetic technologies, the rights of vulnerable groups, and allocation of scarce medical resources. This workbook will be invaluable to practitioners, medical and nursing students, and anyone who needs to develop skills in ethical analysis for clinical practice or research. (shrink)

Two potentially lifesaving protocols, emergency preservation and resuscitation and uncontrolled donation after circulatory determination of death, currently implemented in some U.S. emergency departments, have similar eligibility criteria and initial technical procedures, but critically different goals. Both follow unsuccessful cardiopulmonary resuscitation and induce hypothermia to “buy time”: one in trauma patients suffering cardiac arrest, to enable surgical repair, and the other in patients who unexpectedly die in the ED, to enable organ donation. This article argues that to fulfill patient-focused fiduciary obligations (...) and maintain community trust, institutions implementing both protocols should adopt and publicize policies to guide ED physicians to utilize either protocol for particular patients, in order to address the appearance of conflict of interest arising from the protocols' similarities. It concludes by analyzing ethical implications of incentives that may influence institutions to develop the expertise required for uDCDD but not EPR. (shrink)

Entscheidungen der Therapiebegrenzung und in der Betreuung am Lebensende sind häufig komplex und von ethischen Problemen begleitet. Im Mittelpunkt der Untersuchung steht die entscheidende Frage, wie hilfreich existierende „Ethik-Richtlinien“, die eine ethische Orientierung bei solchen Entscheidungen geben sollen, in der klinischen Praxis tatsächlich sind. Die Frage, welchen Nutzen „Ethik-Richtlinien“ bei der Entscheidungsfindung haben oder haben können, wird hier exemplarisch an einem klinischen Fallbeispiel aus einer Ethik-Kooperationsstudie in der Intensivmedizin analysiert. Vergleichend werden hierzu „Ethik-Richtlinien“ aus Deutschland, der Schweiz und aus Großbritannien (...) herangezogen, die Gegenstand eines internationalen Projekts zur Analyse von Richtlinien waren. Die Möglichkeiten und Grenzen einer ethischen Orientierung an „Ethik-Richtlinien“ bei Entscheidungsproblemen der Therapiebegrenzung und in der Betreuung am Lebensende werden anhand der Fallstudie diskutiert und illustriert. Abschließend werden Schlussfolgerungen für die Entwicklung ethischer Richtlinien für die klinische Praxis formuliert. (shrink)

Background Increase in global health research undertaken in resource poor settings in the last decade though a positive development has raised ethical concerns relating to potential for exploitation. Some of the suggested strategies to address these concerns include calls for providing universal standards of care, reasonable availability of proven interventions and more recently, promoting the overall social value of research especially in clinical research. Promoting the social value of research has been closely associated with providing fair benefits to various stakeholders (...) involved in research. The debate over what constitutes fair benefits; whether those that addresses micro level issues of justice or those focusing on the key determinants of health at the macro level has continued. This debate has however not benefited from empirical work on what stakeholders consider fair benefits. This study explores practical experiences of stakeholders involved in global health research in Kenya, over what benefits are fair within a developing world context. Methods and results We conducted in-depth interviews with key informants drawn from within the broader health research system in Kenya including researchers from the mainstream health research institutions, networks and universities, teaching hospitals, policy makers, institutional review boards, civil society organisations and community representative groups. The range of benefits articulated by stakeholders addresses both micro and macro level concerns for justice by for instance, seeking to engage with interests of those facilitating research, and the broader systemic issues that make resource poor settings vulnerable to exploitation. We interpret these views to suggest a need for global health research to engage with current crises that face people in these settings as well as the broader systemic issues that produce them. Conclusion Global health research should provide benefits that address both the micro and macro level issues of justice in order to forestall exploitation. Embracing the two is however challenging in terms of how the various competing interests/needs should be balanced ethically, especially in the absence of structures to guide the process. This challenge should point to the need for greater dialogue to facilitate value clarification among stakeholders. (shrink)

A team of renowned philosophers and a new generation of thinkers come together to offer the first book-length examination of the relationship between philosophical anthropology and animal studies.

Despite the lack of evidence for their effectiveness, the use of physical restraints for patients is widespread. The best ethical justification for restraining patients is that it prevents them from harming themselves. We argue that even if the empirical evidence supported their effectiveness in achieving this aim, their use would nevertheless be unethical, so long as well known exceptions to informed consent fail to apply. Specifically, we argue that ethically justifiable restraint use demands certain necessary and sufficient conditions. These conditions (...) are that the physician obtain informed consent for their application, that their application be medically appropriate, and that restraints be the least liberty-restricting way of achieving the intended benefit. It is a further question whether their application is ever medically appropriate, given the dearth of evidence for their effectiveness. (shrink)

Default positions, predetermined starting points that aid in complex decision-making, are common in clinical medicine. In this article, we identify and critically examine common default positions in clinical ethics practice. Whether default positions ought to be held is an important normative question, but here we are primarily interested in the descriptive, rather than normative, properties of default positions. We argue that default positions in clinical ethics function to protect and promote important values in medicine—respect for persons, utility, and justice. Further, (...) default positions in clinical ethics may also guard against harm. Where default positions exist, there are epistemic burdens to overturn them. The person wishing to reject the default position, rather than the person endorsing it, bears this burden. The person who bears the burden of meeting the epistemic requirements must provide evidence proportional to the degree of harm the default position protects against. Default positions that protect against significant harm impose significant epistemic requirements to overturn. This asymmetry not only makes medical decision-making more economical but also serves to promote and protect certain values. The identification and analysis of common and recognizable default positions can help to identify other default positions and the conditions under which their associated epistemic requirements are met. The article concludes with considerations of potential problems with the use of default positions in clinical ethics. (shrink)

This book brings together scholars from a variety of epistemological perspectives to explore the multiple ways in which sexuality does indeed matter in the arena of public education.

BackgroundLiterature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries.MethodsFrom November 2021 to January 2022, we conducted a literature search using a PRISMA (...) tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC.ResultsOut of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants’ understanding of IC.ConclusionOur review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants’ perspectives and the researchers’ views, while examining contextual factors that impact the IC process. (shrink)

The aim of this study is to assess patients' recall of their previous research participation. Recall was established during interviews and compared with entries from clinical notes. Participants were 49 patients who had previously participated in different types of research. Of the 49 patients, 45 (92%) interviewees recalled 69 of 109 (63%) study participations. Level of recall varied according to the type of research, some participants clearly recalled the details of research aims, giving consent and research procedures. Others recalled procedures (...) (e.g. DNA testing) but were unclear about their purpose. There was no significant effect of time on recall. Some types of research participation (e.g. DNA testing) may be recalled as clinical care. We argue that such misunderstandings may have the potential to undermine participants' ongoing consent, particularly in ongoing/longitudinal studies. Valid consent may be best achieved by re-assessing the scope of consent and relating it to the nature of the interventions themselves rather than the reasons for undertaking them. (shrink)

We thank all the thoughtful authors for their insightful comments. In this response, we try to address some of themes that emerged from the commentaries. We leave aside some of those comments that...

ABSTRACTEthical scandals involving journalists in English-speaking West African countries have been documented to include conflict of interest, freebies, intellectual theft, deception, carelessness, kowtowing to advertisers and politicians, use of dubious evidence, and outright bias. This study explores how pronounced and clear the rules relating to these breaches are in the codes of these countries and whether the similarities and dissimilarities in wording indicate the influence of individual actors involved in writing them. Relying on thematic and qualitative document analysis methods, the (...) study found that rules in the codes addressing the ethical breaches are pronounced and clear. Although largely similar in content, the codes also feature important differences that are strongly related to the composition of the groups that wrote them. This study discusses why ethical challenges in these countries persist in the midst well-written code of ethics. (shrink)

Should those who work on ethics welcome or resist moves to open access publishing? This paper analyses arguments in favour and against the increasing requirement for open access publishing and considers their implications for bioethics research. In the context of biomedical science, major funders are increasingly mandating open access as a condition of funding and such moves are also common in other disciplines. Whilst there has been some debate about the implications of open-access for the social sciences and humanities, there (...) has been little if any discussion about the implications of open access for ethics. This is surprising given both the central role of public reason and critique in ethics and the fact that many of the arguments made for and against open access have been couched in moral terms. In what follows I argue that those who work in ethics have a strong interest in supporting moves towards more open publishing approaches which have the potential both to inform and promote richer and more diverse forms of public deliberation and to be enriched by them. The importance of public deliberation in practical and applied ethics suggests that ethicists have a particular interest in the promotion of diverse and experimental forms of publication and debate and in supporting new, more creative and more participatory approaches to publication. (shrink)

As the federal government distributed remdesivir to some of the states COVID-19 hit hardest, policymakers scrambled to develop criteria to allocate the drug to their hospitals. Our state, Michigan, was among those states to receive an initial quantity of the drug from the U.S. government. The disparities in burden of disease in Michigan are striking. Detroit has a death rate more than three times the state average. Our recommendation to the state was that it should prioritize the communities that bear (...) a disproportionate burden of suffering in the allocation of the new potential treatment. This recommendation is justified not only for new drugs with uncertain effects, but also for drugs of certain benefit or vaccines. For states with significant health disparities, such as Michigan, this allocation priority may help to repair them. In fact, any other allocation strategy may make them worse. (shrink)

The UK Genethics Club was established in November 2001 in order to provide a national forum of ethics support for the profession of clinical genetics in the UK. The forum brings together health professionals, medical ethicists and lawyers and support is provided through detailed discussion of cases and sharing of good practice. Clinical genetics professionals had previously voiced concerns about making extremely difficult ethical decisions, with profound implications, in something of a vacuum. Professionals saw a lack of guidance in the (...) area and lack of time for discussion of difficult cases as reasons for this. This paper describes the origins of the group and gives (anonymized) examples of some of the types of issues discussed. (shrink)

Global health emergencies such as the COVID-19 pandemic are contexts in which it is critical to draw upon learning from prior research and to conduct novel research to inform real-time decision-making and pandemic responses. While research is vitally important, however, emergencies are radically non-ideal contexts for its conduct, due to exceptional uncertainty, urgency, disruption, health needs, and strain on existing health systems, amongst other challenges. This generates novel ethical challenges and a broader conception of research ethics is necessary to effectively (...) address the complexity of pandemic research contexts. Going beyond traditional approaches to research ethics centring on the design of specific studies, this broader conception requires consideration of fundamental questions relating to the exercise of power and influence throughout research pathways, and a broader attention to both salient ethical issues, and the ethical responsibilities of stakeholders. These include important questions about responsibilities to gather evidence and generate knowledge systematically during emergencies, to implement policy responses in ways that are amenable to evaluation, and even potential moral obligations to participate in research. In situations of heightened uncertainty, additional questions arise about what constitutes sufficient evidence to justify the development and implementation of policy responses, and the responsibilities of scientific and social science researchers involved in policy-making processes. The four cases in this chapter prompt reflection on evolving and at times competing values and responsibilities of policy-makers, regulators, health authorities and researchers during the design and conduct of research, and proposed early implementation of research findings. These cases highlight issues arising when conducting research of national importance in a pandemic, where researchers are required to liaise with authorities responsible for pandemic responses and address complex ethical issues, including protecting the interests of participants and publics when tensions arise between prioritising the completion of research and accelerating the rollout of novel health interventions. This chapter invites reflection on the practical ethical implications of commitments to undertake research during emergencies, including the nature and scope of the relevant responsibilities of a range of stakeholders. (shrink)