Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct, and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed (...) consent, the role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants. (shrink)

Owing to unique features of their design, cluster randomized trials complicate the interpretation of standard ethics guidelines. The recently published Ottawa statement on the ethical design and conduct of cluster randomized trials provides researchers and research ethics committees with detailed guidance on the design, conduct and review of cluster trials. The Ottawa statement sets out 15 recommendations, including guidance on the justification of study design, the need for research ethics committee review, the identification of research participants, obtaining informed (...) consent, the role of gatekeepers in protecting cluster interests, the assessment of benefits and harms, and the protection of vulnerable participants. (shrink)

With a view to addressing the moral concerns about the use of donor siblings, the Policy Statement of the American Academy of Pediatrics - Children as Hematopoietic Stem Cell Donors (the Policy) has laid out the criteria upon which tissue harvest from a minor would be permissible.

Lawrence P. Ulrich; A Reaction to the Consensus Statement of the Working Group on Roman Catholic Approaches to Determining Appropriate Critical Care, Christian.

This study examines the discursive history and interactive aspects of the opening statement in Anglo-American courts. Informed by the concepts of stance and engagement, the study explicates the process of conceptual interaction which turns the jurors into co-constructors of the discourse, thereby making the opening statement fictively dialogic. Drawing upon 51 opening statements as recorded in Proceedings of the Old Bailey, between 1759 and 1789, the qualitative and quantitative analysis reveals that interactive devices are an integral part of (...) the genre, and that pronouns appear to occur most frequently, followed by the lawyers’ use of attitude markers, questions, and reported discourse, respectively. With these devices, the lawyers are likely to be able to prime the jury into viewing the events and participants in a given direction. (shrink)

Luke Gormally; Some Observations on the Consensus Statement of the Working Group on Roman Catholic Approaches to Determining Appropriate Critical Care, Christia.

Joseph Boyle; The Genesis of the Consensus Statement of the Working Group on Roman Catholic Approaches to Determining Appropriate Critical Care, Christian bioet.

Stanley Hauerwas; Response to the ‘Consensus Statement of the Working Group on Roman Catholic Approaches to Determining Appropriate Critical Care’, Christian bi.

David M. Zientek; Response to the Consensus Statement of the Working Group on Roman Catholic Approaches to Determining Appropriate Critical Care, Christian bioe.

In his foreword to the Philosophical papers by Hans Hahn, Karl Menger mentions a controversy about the possibility or impossibility to speak about language within the Vienna Circle in the early 1930’s. He then adds: “Waismann proclaimed that one could not speak about language. Hahn took strong exception to this view. Why should one not – if perhaps in a higher-level language – speak about language? To which Waismann replied essentially that this would not fit into the texture of Wittgenstein’s (...) latest ideas.”1 Thanks to the publication of the protocols of the Vienna Circle by Friedrich Stadler in his book The Vienna Circle – Studies in the origins, development and influence of logical empiricism, we have access to some discussions within the circle in the years 1930 and 1931, that allow us a partial reconstruction of the controversy. In these minutes we attend a very lively discussion on the topic of ‘talking about language’. We would like to make more explicit the tenets of this controversy, starting from the discussions within the circle. We will then focus on the evolution of the positions of different members of the Circle, that reflect different attitudes towards this problem, that are expounded in articles published until 1936. Although its members strived to stay the closest, they could to the landmarks laid down by the Tractatus logico-philosophicus, some of its members broke with them in many respects. The need to admit the possibility of talking theoretically about language became more pressing as the works of Tarski and Godel began to exert an influence on the researches of its members. Two options emerged: talking about a language in another language (Hahn) or in the same language (Carnap). Hahn’s positions, despite their originality, stand close to those of Carnap, who presents in 1931 his meta-logical project. Disagreements with Waismann occured frequently. Neurath remained skeptical about such a development that could, according to him, lead back to metaphysical considerations. The protocols by Rosa Rand give us precious insights on the premises of this debate, symptomatic of the diversity of the positions and of the fruitfulness of the exchanges within the Vienna Circle at that time. However, this debate takes place in a broader setting, namely the discussion of the status of philosophical statements once the rejection of metaphysics is accomplished. The answers provided reflect strong dissenting currents within the circle. For Neurath, to conceive of philosophy as providing elucidations is mistaken. Science shall take the form of an encyclopedia, that contains heterogeneous discourses – exact formulated sentences, as well as piece of ordinary language – and is taken in a dynamic process. No discourse outside science can be accepted. For Schlick and Waismann, there is still room for philosophy as providing elucidations about language. For Carnap, the aim is to attain a logically suitable language for science; discussions in a natural language have only a provisional role, in order to attain an adequate language, in which the logic of science can be formulated. (shrink)

The aim of the paper is to develop a proper mathematical formalism which can help to clarify the necessary conceptual plugins to the special principle of relativity and leads to a deeper understanding of the principle in its widest generality.

The General Medical Council’s Outcome for Graduates, published in 2018,1 is the latest guidance for medical schools on the GMC’s expectations of the undergraduate medical curriculum. One of its three top level outcomes—Professional Values and Behaviours—refers to medical ethics and law, professionalism and patient safety competencies. Furthermore, the recent proliferation of patient safety inquiries in the UK2–4 has elevated the emphasis on ethical medical practice5 and critical medical ethics and law competencies for future doctors. In response to these developments and (...) to ensure an up to date offering, the Institute of Medical Ethics Education Committee has updated the consensus statement on the core curriculum for medical ethics and law for doctors of tomorrow.6 This refined curriculum is the result of a national consultation process. We asked for the views of all lead teachers of medical ethics and law in all UK medical schools, the UK’s chief medical officers, the GMC, and delegates at our annual education conference in 2017 who …. (shrink)

The 6th Consensus Statement on Concussion in Sport is authored by the Concussion in Sport Group (CiSG) and intends to provide evidence-based recommendations on concussion management for the welfare of sports participants. However, the authors of the Consensus Statement have declared many competing links to third-party groups. While the declaration of an author’s competing interests is now a widely accepted practice within academic publishing aimed at greater transparency and research integrity, it is not a measure to remove the (...) potential influence of third-party links. In the case of the Consensus Statement, this leaves uncertainty about how the potential sources of third-party bias declared by individual members of the CiSG may have influenced the CiSG’s interpretation of the existing state of evidence on concussion management and impacted the content of the recommendations contained with the Consensus Statement. Openly declaring third-party links falls short of securing trustworthiness in the Consensus Statement recommendations since it leaves end-users of the Consensus Statement with the task of interpreting the impact(s) of these competing interests with little information to guide them. This is because the authors themselves offer neither explanation nor guidance concerning potential bias arising from the competing interests that they have declared, which impinges upon the ability of readers to evaluate the trustworthiness of the content. The status quo could be improved by excluding researchers who have conflicts of interest. Nevertheless, if authors with competing interests are permitted to be part of the CiSG (as is the status quo), then I propose a novel option for increasing transparency that would require authors of the Consensus Statements to provide a reflexive explanation, not simply a declaration, of their competing interests. (shrink)

This paper discusses the issue of overriding the right of individual consent to participation in cluster randomised trials (CRTs). We focus on CRTs testing the efficacy of non-pharmaceutical interventions. As an example, we consider school closures during the COVID-19 pandemic. In Norway, a CRT was promoted as necessary for providing the best evidence to inform pandemic management policy. However, the proposal was rejected by the Norwegian Research Ethics Committee since it would violate the requirement for individual informed consent. This sparked (...) debate about whether ethics stand in the way of evidence-based health policy, since the Norwegian Research Ethics law’s strict requirements for individual consent make it practically impossible to carry out CRTs of public health interventions. We argue that, in the case of the school closure trial, the suggested CRT would not have eliminated an epistemic gap and thus would not have justified the violation of consent rights. First, we focus on the methodological challenges to estimating quantifiable effects of school closures in the specific case of an airborne infectious disease. Second, in line with Evidential Pluralism, we highlight the value of alternative lines of evidence for informing school closure policy in a pandemic. In general, we propose that a trial requiring the waiver of participants’ consent rights must be highly likely to eliminate an epistemic gap. We elaborate on the practical aspects of this criterion and discuss the potential advantages of adding it to the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. (shrink)

The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is to analyse a prototypical cluster (...) trial conducted in a low-resource setting with the Ottawa Statement; to identify ethical issues in the design or conduct of the trial not captured adequately and to make recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement. Our analysis identified six ethical aspects of cluster randomised trials in low-resource settings that require further guidance. The forthcoming revision of the Ottawa Statement should provide additional guidance on these issues: streamlining research ethics committee review for collaborating investigators who are affiliated with other institutions; the classification of lay health workers who deliver study interventions as health providers or research participants; the dilemma experienced by investigators when national standards seem to prohibit waivers of consent; the timing of gatekeeper engagement, particularly when researchers face funding constraints; providing ancillary care in health services or implementation trials when a routine care control arm is known to fall below national standards and defining vulnerable participants needing protection in low-resource settings. (shrink)

This essay explores how evidence-based policy can be developed for sport-related concussion (SRC), focusing particularly on the role and influence of the Consensus Statements of the Concussion in Sport Group (CiSG). Three credible policy purposes are suggested: (i) to mitigate acute health impacts of concussion events in sport; (ii) to reduce or eliminate the identified causes of SRC (direct blows to the head, neck, or body); and (iii) to improve long-term brain health outcomes for athletes. Eight of ten systematic reviews (...) commissioned for the most recent Consensus Statement, and ten of its thirteen headings, address the first purpose. The primary influence of the CiSG Consensus Statements has been to improve SRC acute response practice and protocols in professional/elite sport, which has always been their primary policy purpose, although evidence of improvement is more limited in child/adolescent and recreational sport. But a primary focus on mitigating acute health impacts has crowded out other credible policy purposes of concern to stakeholder groups with whom evidence-based policy for SRC must be co-produced. No recommendations are made to improve long-term brain outcomes for athletes because concerns about imperfections in evidence are cited to question the link between such outcomes and SRC. Modifications to reduce or eliminate purposive blows to the head, neck, or body that are permitted as a structural part of the way some sports are played are given very limited attention, even when discussing prevention, where they are just one approach considered alongside protective equipment, neuromuscular strengthening, and concussion management strategies. The essay concludes that the CiSG should shift the primary policy purpose of its Consensus Statements to address the identified causes of SRC: purposive blows to the head, neck, or body. Reducing or removing causes of SRC both better safeguards children/adolescents and renders debates about the link between SRC and long-term brain health outcomes superfluous. (shrink)

The author comments on the Consensus Statement from the point of view of an ethics consultant in Germany. Since many hospitals in Germany are under considerable competitive pressure, mission statements are becoming more and more important in order to draw a distinction between the different hospital types and to convey the meaning of the corporate identity both internally and externally. The Consensus Statement, which provides basic orientation without going into too much detail, can be a helpful initial document. (...) However, it does not deal with two specific problem areas which are examined more closely in the commentary: the application of risk-of-death algorithms in ICUs and the question of church membership of the caregivers to enable a proper preparation for death. The commentary also reveals certain differences in the discussions taking place in Anglo-Saxon countries and Continental Europe. (shrink)

This paper uses the Australian Council of Trade Unions (ACTU) statement of union values as its point of departure to explore the purpose and role of trade union values. Specifically, the paper questions whether the role of values is purely symbolic, serving as a guide to unions, or whether values have a broader role. Furthermore, the paper questions the scope of the ACTU statement, which is currently based on the public work of unions. In conducting this analysis, union (...) values are compared to the broader human values; moreover, the scope of the document is assessed against the historic activity and behaviour of unions as represented in extant union theory. Subsequently, the paper uses the emerging role of union values to critique the ACTU statement, concluding that while this statement makes a valuable contribution to union practice and debate, it can be extended to encompass other, more private areas of union activity. (shrink)

Gerald P. Mckenny; Critical Care Medicine and the Catholic Tradition: Reflections on the Consensus Statement, Christian bioethics: Non-Ecumenical Studies in Med.

(2011). ACCE, Pharmacogenomics, and Stopping Clinical Trials: Time to Extend the CONSORT Statement? The American Journal of Bioethics: Vol. 11, No. 3, pp. 11-13.

Acts of violence arising from hatred, racism, and bigotry have no place in a world of civility. The brutal attacks on Muslim worshippers at two mosques in Christchurch, New Zealand, leaving 51 dead and 49 injured, can never be justified. Through adopting Van Dijk's ideological square of 'Us. vs. Them' [3], the present study uncovers the impact statements of the attacks' survivors and victims' families, denouncing the severity of the event and expressing the shattering effects of the attacks on self, (...) society, and humanity at large. Over a period of three days, about 90 people delivered their statements in the High Court in Christchurch. The data were compiled through YouTube videos and news articles that reported the testimonies. The findings showed that the overall discursive strategy used in the impact statements is that of positive self-presentation and negative other-presentation. Such presentations are realized by focusing on the positive aspects of the ingroup members represented by the attacks' survivors, victims' families, and people of New Zealand on the one hand, and the negative characteristics of the out-group members represented by the terrorist, on the other. As the paper sends a strong message for accepting 'otherness' and rejecting antagonism, it is of significance to readers and researchers in inter-faith dialogue, human rights, equality, freedom, and justice. (shrink)

The prospect of using genome technologies to modify the human germline has raised profound moral disagreement but also emphasizes the need for wide-ranging discussion and a well-informed policy response. The Hinxton Group brought together scientists, ethicists, policymakers, and journal editors for an international, interdisciplinary meeting on this subject. This consensus statement formulated by the group calls for support of genome editing research and the development of a scientific roadmap for safety and efficacy; recognizes the ethical challenges involved in clinical (...) reproductive applications of genome editing but, importantly, rejects the idea that human reproductive germline modification is necessarily morally unacceptable; and highlights the importance of meaningful engagement in discussions of genome editing and the development of regulation and oversight mechanisms to govern future uses of such technologies. (shrink)

Background: Patients today interact with physicians, physician groups, and health plans, each of which may follow distinct ethical guidelines.Method: We systematically compared physician codes of ethics with ethics policies at physician group practices and health plans, using the 1998–99 policies of 38 organisations—18 medical associations , nine physician group practices , and 12 health plans —selected using random and stratified purposive sampling. A clinician and a social scientist independently abstracted each document, using a 397-item health care ethics taxonomy; a reconciled (...) abstraction form was used for analysis. This study focuses on ethics policies regarding professional obligation towards patients, resource allocation, and care for the vulnerable in society.Results: A majority in all three groups mention “fiduciary obligations” of one sort or another, but associations generally address physician/patient relations but not health plan obligations, while plans rarely endorse physicians’ obligations of advocacy, beneficence, and non-maleficence. Except for occasional mentions of cost effectiveness or efficiency, ethical considerations in resource allocation rarely arise in the ethics policies of all three organisational types. Very few associations, groups, or plans specifically endorse obligations to vulnerable populations.Conclusions: With some important exceptions, we found that the ethics policies of associations, groups, and plans are narrowly focused and often ignore important ethical concerns for society, such as resource allocation and care for vulnerable populations. More collaborative work is needed to build integrated sets of ethical standards that address the aims and responsibilities of the major stakeholders in health care delivery. (shrink)

The authorship policies of scientific journals often assume that in order to be able to properly place credit and responsibility for the content of a collaborative paper we should be able to distinguish the contributions of the various individuals involved. Hence, many journals have introduced a requirement for author contribution statements aimed at making it easier to place credit and responsibility on individual scientists. We argue that from a purely descriptive point of view the practices of collaborating scientists are at (...) odds with the requirement for author contribution statements. We also argue that from a normative point of view the authorship policies may be unnecessary. Our arguments draw on an examination of 35 years of retraction notices in the journal Science. (shrink)

The authorship policies of scientific journals often assume that in order to be able to properly place credit and responsibility for the content of a collaborative paper we should be able to distinguish the contributions of the various individuals involved. Hence, many journals have introduced a requirement for author contribution statements aimed at making it easier to place credit and responsibility on individual scientists. We argue that from a purely descriptive point of view the practices of collaborating scientists are at (...) odds with the requirement for author contribution statements. We also argue that from a normative point of view the authorship policies may be unnecessary. Our arguments draw on an examination of 35 years of retraction notices in the journal Science. (shrink)

Within-category induction is the projection of a generic property from a class to a subtype of that class. The modifier effect refers to the discovery reported by Connolly et al., that the subtype statement tends to be judged less likely to be true than the original unmodified sentence. The effect was replicated and shown to be moderated by the typicality of the modifier. Likelihood judgements were also found to correlate between modified and unmodified versions of sentences. Experiment 2 elicited (...) justifications, which suggested three types of reason for the effect-pragmatics, knowledge-based reasoning, and uncertainty about attribute inheritance. It is argued that the results provide clear evidence for the default inheritance of prototypical attributes in modified concepts, although a full account of the effect remains to be given. (shrink)

This study adapts the theory of reasoned action (Ajzen and Fishbein, 1980) to the behavior of fraudulent reporting on financial statements so as to examine the effects of moral reasoning and self-monitoring on intention to report fraudulently, using structural equation modeling. The paper seeks to investigate two of the red flags for financial statement fraud identified in Loebbecke et al.'s (1989) paper: client management displays a significant lack of moral fiber and client personnel exhibit strong personality anomalies. As expected, (...) high moral reasoners are more influenced than low moral reasoners by their own attitude towards the behavior. Contrary to prior research, low self-monitors are found to be more influenced than high self-monitors by subjective norms. Future research is recommended to investigate the counter-intuitive results for self-monitors, to consider the implications of group decision making as regards the promulgation of fraudulent financial statements, and to examine additional red flags for financial statement fraud. (shrink)

Business Ethics, the Environment & Responsibility, EarlyView.

On September 30–October 2, 2005, a group of individuals drawn from civil society organizations, governments, international agencies, and academic institutions came together in Montréal, Québec, Canada, for an international workshop entitled “Human Rights and Access to Essential Medicines: The Way Forward.” At the conclusion of the workshop, we drafted the “Montréal Statement on the Human Right to Essential Medicines.” This “Statement” is reprinted at the end of this comment, which offers some background on the problem addressed at the (...) workshop. (shrink)

A paper by Andorno and colleagues, recently published in Trends in Biotechnology, condemns support for heritable human genome editing (HHGE) that is claimed to be premature and to have occurred without sufficient public consultation. The general message of the paper is welcome in its emphasis on the importance of gaining broader perspectives on the uses and regulation of HHGE before calls for clinical use are made. However, some problematic arguments for their position lead them to seemingly condemn not only current (...) premature calls for clinical use of HHGE but also any analysis of the ways in which it might be appropriately regulated in the future. (shrink)