Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

Background Since 2010 the People’s Republic of China has been engaged in an effort to reform its system of organ transplantation by developing a voluntary organ donation and allocation infrastructure. This has required a shift in the procurement of organs sourced from China’s prison and security apparatus to hospital-based voluntary donors declared dead by neurological and/or circulatory criteria. Chinese officials announced that from January 1, 2015, hospital-based donors would be the sole source of organs. This paper examines the availability, transparency, (...) integrity, and consistency of China’s official transplant data. Methods Forensic statistical methods were used to examine key deceased organ donation datasets from 2010 to 2018. Two central-level datasets — published by the China Organ Transplant Response System and the Red Cross Society of China — are tested for evidence of manipulation, including conformance to simple mathematical formulae, arbitrary internal ratios, the presence of anomalous data artefacts, and cross-consistency. Provincial-level data in five regions are tested for coherence, consistency, and plausibility, and individual hospital data in those provinces are examined for consistency with provincial-level data. Results COTRS data conforms almost precisely to a mathematical formula while Central Red Cross data mirrors it, albeit imperfectly. The analysis of both datasets suggests human-directed data manufacture and manipulation. Contradictory, implausible, or anomalous data artefacts were found in five provincial datasets, suggesting that these data may have been manipulated to enforce conformity with central quotas. A number of the distinctive features of China’s current organ procurement and allocation system are discussed, including apparent misclassification of nonvoluntary donors as voluntary. Conclusion A variety of evidence points to what the authors believe can only be plausibly explained by systematic falsification and manipulation of official organ transplant datasets in China. Some apparently nonvoluntary donors also appear to be misclassified as voluntary. This takes place alongside genuine voluntary organ transplant activity, which is often incentivized by large cash payments. These findings are relevant for international interactions with China’s organ transplantation system. (shrink)

In the context of divisive disagreements about how the British left should orient itself towards the current Labour Party, this intervention uses the Gorzian category of non-reformist reforms to critically evaluate the 2017–19 policy programme developed by the Corbyn-led Labour Party and draw out the implications for current strategic debates. It argues that the radical core of the Corbynite economic programme lay in its proposals for widening ownership and extending economic democracy, but that there was a tension between commodified and (...) decommodifying visions of these proposals. Exploring the different conceptions of political transformation implicit within each vision, the paper argues that only the latter had the potential to be non-reformist in the Gorzian sense. However, Gorz was concerned not merely with a reform’s content but also with how it was formulated and pursued. The paper ends by arguing that the transformative potential of the economic programme was not reflected in its political strategy and that this has important lessons for strategy today. (shrink)

Locked inpatient units are an increasing phenomenon, introduced in response to unforseen abscondences and suicides of patients. This paper identifies some value issues concerning the practice of locked psychiatric inpatient units. Broad strategies, practicalities and ethical matters that must be considered in inpatient mental health services are also explored. The authors draw on the published research and commentary to derive relevant information to provide to patients and staff regarding the aims and rationales of locked units. Further debate is warranted in (...) relation to best practice. Inpatient staff need to be aware of their practice values, be able to access education and supervision and negotiate apparent contradictions. Further patient/clinician focused enquiry is necessary to mitigate the negative and stigmatising effects of locked mental health units. (shrink)

In Ox. Pap. xxxii i ff., no. 2617, Mr. Lobel published fragments which he shows reason to believe are from Stesichorus’ Geryoneis. Further work has been done on them by Professor D. L. Page and Mr. W. S. Barrett, and the more substantial fragments are included in an Appendix to Page's Lyrica Graeca Selecta . Fr. 4, the most considerable piece, describes how, in Lobel's words: ‘a person, who I do not think there is much room to doubt is Heracles, (...) delivers a secret attack on somebody which consists in shooting him through the head. Though only one “forehead”, one “crown”, and one “neck” are mentioned and the Geryones of Stesichorus had six hands and six feet and therefore presumably three heads, as elsewhere , the possibility that Geryones is here in question does not seem to be ruled out.’. (shrink)

This article responds directly to an article published in Research Ethics in 2011 where Schrag argued against ethics review for social science and humanities research. He argued that review committees offer solutions in search of a problem, impose silly restrictions and apply inappropriate principles. He suggests that review committees typically lack appropriate expertise and argued that the process harms the innocent. This article refutes these claims and offers a case study of the ethical review process at Queen Mary University of (...) London (QMUL) to offer counter claims. The discussion highlights the way in which the QMUL process is sensitized to the challenges posed by social science and humanities research and is a process that, rather than focusing upon avoiding harm, emphasizes notions of care to both participants and researchers. (shrink)

When clinical services aspire to quality improvement, creative and innovative approaches to old problems are needed to drive such change. Whilst new ef orts should be applauded, information on this topic can be somewhat grey from an ethical and research point of view. Within the mental health profession there is currently an expectation to routinely evaluate care and disseminate i ndings. The notion of service enhancements under the guise of routine practice is an interesting and untested ethical issue. Should clinical (...) innovation continue to enjoy such impunity as patient autonomy is often compromised as they are often compelled to accept treatment under the coercion of mental health legislation? We believe that it should not. All involvement in any form of research is voluntary, thus patients should also have the right to decline participation in quality projects if they wish to do so. (shrink)

Justifying involuntary psychiatric treatment on the basis of a judgment that a person lacks capacity is usually expressed in terms of a person’s ability to make a decision about his or her health and treatment. Typically, this relates to the ability to refuse treatment. Exactly what “capacity” means, however, and how one determines when another individual lacks capacity, or lacks sufficient capacity, in this context is particularly controversial, with the United Nations Committee on the Rights of Persons with Disabilities insisting (...) that involuntary treatment be abandoned altogether and capacity tests avoided.Capacity is a concept that has multiple meanings and applications across different disciplines and... (shrink)

This second paper reports on a small ethnographic study of Argentine psychiatrists. A carefully selected group of six psychiatrists currently practicing in Buenos Aires participated in an in-depth semi-structured interview. The transcripts of the interviews were coded and a thematic analysis method was applied to construct a local theory of the professional values constructed by Argentine psychiatrists, and the circumstances in which such values were constructed. Our analysis indicated that Argentine psychiatrists constructed a number of values, frequently perceived as obligations (...) to their professional group and the needs of their patients. The two main strategies employed by Argentine psychiatrists were the diagnostic act and advocacy. We also identify that these values emerge in the context of recent broad historical and cultural inl uences upon the profession of psychiatry in Argentina, and the Argentine population in general. (shrink)

“[T]he current state of professional ethics instruction leaves much to be desired. In most law schools, it is relegated to a single required course that ranks low on the academic pecking order. Many of these courses, which focus primarily (and uncritically) on bar disciplinary rules, constitute the functional equivalent of ‘legal ethics without the ethics', and leave future practitioners without the foundations for reflective judgment. Although ethical issues arise in every subject, that would not be apparent from the core curriculum (...) …”1. (shrink)

Methods of ethical reasoning in psychiatry -- Psychiatric professional ethics and the social -- Communitarian ethics and the social -- Moral agency in psychiatry -- Involuntary psychiatric treatment -- Psychiatry across cultures -- Neoliberalism -- Psychiatry and popular culture -- Psychiatric ethics in the light of neuroscience -- Reappraisals -- Power and knowledge in psychiatry.

In lieu of an abstract, here is a brief excerpt of the content:Ethics CommentaryMichael Robertson, Senior Research FellowThe French philosopher Michel Foucault once recounted the story of the English King, George III, being restrained by his guards at the direction of his physician Dr. Willis. King George, presumably deranged by a psychotic mania consequent upon porphyria, was incapable of self-rule and his power was usurped by the medical profession in an act of coercion tantamount to treason. This for Foucault was (...) a profound metaphor of psychiatric power.1The plight of Mdm. W yokes the two most emotive issues in psychiatry — involuntary treatment and the administration of ECT. Whilst only utilised at an extremity of clinical practice, both of these are the most misunderstood of actions performed by the psychiatric profession. Yet, in many circumstances, they are life-saving.In essence, we are confronted with a profoundly depressed woman, whose illness is seemingly resistant to first line treatment and poses a serious, credible risk of harm. Most psychiatrists would regard this as somewhat of a psychiatric emergency. We are informed that Mdm. W’s family has transcended any cultural taboos about mental illness and is engaged in her care, has an extensive lived experience of her severe mood disorder and accepts, indeed welcomes, the use of ECT to terminate a severe episode of depression. In the course of a psychotic depression, Mdm. W is suffering profound distress and presents a risk of either suicide or serious medical complications if the episode persists. Despite the minimal discomfort during the actual administration of ECT, Mdm. W’s distress will be compounded by the further restraint needed to prevent from her eating and drinking prior to anaesthesia.It is difficult to know what Mdm. W’s experience of this situation would [End Page 230] be. Through the prism of her disturbed mental state, with its derangements in thinking, cognitive functioning and apprehension of reality, she would likely experience the situation as one of fear or terror; she would likely interpret ECT and the enforced restriction of oral intake prior to the procedure as punitive — further evidence of her “sins”, reinforcing her delusional guilt and nihilism. Yet to speak to Mdm. W in circumstances of euthymia or normal mood, where such derangements no longer occur, might reveal an utterly different perspective on the situation. Like many people with episodic mental illnesses, Mdm. W might, when such a scenario was put to her, consent to future treatment with ECT without equivocation. Indeed, many patients with bipolar disorder formulate advance directives in regard to the specific management of their possible future episodes of illness.If the clinical and legal aspects of this situation are so clear, why is there a sense of a dilemma in the realm of clinical ethics? Beyond the emotive nature of the situation, we see a deeply distressed woman being provided potentially life-saving treatment, which is being denied to her by the profound impairments of insight and judgement consequent upon her illness.In Singapore, such detention and enforced treatment under the Mental Capacity Act (2010) applies to a person with a mental illness or disorder who lacks capacity to make decisions in their own best interests based upon impairment of mind or brain. This would be considered a “capacity” based mental health law. In other jurisdictions, the legal test and evidentiary justification for such care may be predicated upon risk of harm to self or others. In either setting, Mdm. W’s clinical situation provides adequate legal justification for such enforced care.The moral justification of such laws falls into two general categories — the “risk” argument and the “capacity” argument. In mental health legislation, the “harm principle”, as first elaborated in John Stuart Mill’s On Liberty,2 is usually defined in terms of the construct of “risk”. Risk is a term that has multiple meanings in different disciplinary contexts, although all approaches to “risk” attempt to apply knowledge to an area of uncertainty.3 The notion of “risk assessment” is usually considered as the process of categorising individuals by their perceived likelihood of causing serious harm to themselves or harm to others. In the insurance industry, actuarial assessment is a mathematical discipline aimed at computing a probability of adversity... (shrink)

It is generally assumed, without argument, that legal theory, legal philosophy, philosophy of law, and jurisprudence all mean the same thing. This paper rejects that assumption, and in particular the assumption that jurisprudence is the same thing as legal philosophy. This assumption has recently been challenged by Roger Cotterrell in his article “Why Jurisprudence Is Not Legal Philosophy,” and I seek to build on his arguments by adding insights found in the work of Stanley Fish.

This paper draws on 'views and visions' responses collected at the time of the Land Use-UK project in 1996. Surveyors were groups of school children with contributions in more remote locations from adults. As well as mapping the landscape participants were asked about their hopes and visions for the grid squares surveyed. One kilometre squares were identified by stratified random sampling techniques from the Ordnance Survey National Grid. The responses indicated varying levels of optimism and pessimism. The sample of responses (...) in this paper relates to rural key squares ( N = 424) and urban key squares ( N = 413). Young surveyors appeared to be the most pessimistic and there was some correlation of increasing pessimism with increasing land use intensity. (shrink)

This paper draws on 'views and visions' responses collected at the time of the Land Use-UK project in 1996. Surveyors were groups of school children with contributions in more remote locations from adults. As well as mapping the landscape participants were asked about their hopes and visions for the grid squares surveyed. One kilometre squares were identified by stratified random sampling techniques from the Ordnance Survey National Grid. The responses indicated varying levels of optimism and pessimism. The sample of responses (...) in this paper relates to rural key squares ( N = 424) and urban key squares ( N = 413). Young surveyors appeared to be the most pessimistic and there was some correlation of increasing pessimism with increasing land use intensity. (shrink)

This second paper explores psychiatrists’ ethical obligations in the face of the failure of the social contract – inherent failures in distributive justice, the failure of the sovereign and the reconstitution of the social contract in post-conflict societies. Such situations present many sources of ethical tension between the professional ethical obligations of psychiatrists to their individual patients and to their society.

These two papers consider the concept of social justice and the ethical obligations psychiatrists may have in its regard. In this first paper, the concept of social justice is defined in terms of the successful function of the social contract. Basic conceptions of justice are then considered.

This chapter introduces the subject of personhood and its significance to Indic traditions and academic discourses. The category of 'person' is distinguished from the categories of 'self' and 'body' by virtue of its relational, permeable, and "extensional" or "expansive" character. The scholarly tendency to frame persons as "microcosms"-bodies that contain within the replication of the cosmos-at-large-is problematized. Indic persons are most often conceived as outward-facing, phenomenalistic, world-wide entities. Chapters of the work are summarized. Significance of Indic theories of personhood to (...) modern debates on environmental personhood and legal personhood is discussed. (shrink)

Murray Robertson tells how in an initially small Baptist Church in Christchurch, New Zealand, charismatic renewal brought about local outreach and expansion and the formation of community help centres and a kingdom bank, followed by mission to Asia as well as within the local neighbourhood. He describes the progress as a journey in three stages of seven years each, but looks forward to the challenge yet to come.

Fish's writings on philosophy, politics and law comprise numerous books and articles produced over many decades. This book connects those dots in order to reveal the overall structure of his argument and to demonstrate how his work in politics and law flows logically from his philosophical stands on the nature of the self, epistemology and the role of theory. Michael Robertson considers Fish's political critiques of liberalism, critical theory, postmodernism and pragmatism before turning to his observations on political substance and (...) political practice. The detailed analysis of Fish's jurisprudence explores his relationships to legal positivism, legal formalism, legal realism and critical legal studies, as well as his debate with Ronald Dworkin. Gaps and inconsistencies in Fish's arguments are fully explored, and the author provides a description of Fish's own positive account of law and deals with the charge that Fish is an indeterminacy theorist who undermines the rule of law. (shrink)

This is the definitive study of the history and accomplishments of the Frankfurt School. It offers elegantly written portraits of the major figures in the school's history as well as overviews of the various positions and directions they developed from the founding years just after World War I until the death of Theodor Adorno in 1969.The book is based on documentary and biographical materials that have only recently become available. As the narrative follows the Institute for Social Research from Frankfurt (...) am Main to Geneva, New York, and Los Angeles, and then back to Frankfurt, Wiggershaus continually ties the evolution of the school to the changing intellectual and political contexts in which it operated. He also interweaves these accounts with incisive summaries of substantive works by Horkheimer, Adorno, Benjamin, Fromm, Kirchheimer, Lowenthal, Marcuse, Neumann, Pollock, and Habermas.The book is self-contained and can serve as a general introduction to critical theory, but it also has a wealth of new material to offer those who are familiar with this tradition but would like to learn more about its history and context.Studies in Contemporary German Social Thought. (shrink)

This paper examines the puruṣa concept in the Caraka Saṃhitā, an early text of Ayurveda, and its relation to Indic thinking about phenomenal worldhood. It argues that, contrary to the usual interpretation, early Ayurveda does not consider the person to be a microcosmic replication of the macrocosmos. Instead, early Ayurveda asserts that personhood is worldhood, and thus the person is non-different from the phenomenal totality of his existence. This is confirmed by the CS’s several definitions of puruṣa, which are alternately (...) posed in terms familiar to Vaiśeṣika, early Sāṃkhya, early Buddhism, and Upaniṣadic monism. It is likewise confirmed by the Ayurvedic logic of sāmānya, which governs the meaning of the list of person-to-world correspondences in CS 4.5 and its often misinterpreted claim, puruṣo’yam lokasaṃmitaḥ. Finally it is confirmed in the program of Ayurvedic therapeutics, which aims at establishing various kinds of “appropriateness” for the sake of effecting samayoga—the “harmonious joining” of person and world. (shrink)