This paper discusses the ethical and regulatory issues raised by ‘‘intragenics’’ – organisms that have been genetically modified using gene technologies, but that do not contain DNA from another species. Considering the rapid development of knowledge about gene regulation and genomics, we anticipate rapid advances in intragenic methods. Of regulatory systems developed to govern genetically modified organisms (GMOs) in North America, Europe, Australia, and New Zealand, the Australian system stands out in explicitly excluding intragenics from regulation. European systems are also (...) under pressure to exclude intragenics from regulation. We evaluate recent arguments that intragenics are safer and more morally acceptable than transgenic organisms, and more acceptable to the public, which might be thought to justify a lower standard of regulation. We argue that the exemption of intragenics from regulation is not justified, and that there may be significant environmental risks associated with them. We conclude that intragenics should be subject to the same standard of regulation as other GMOs. (shrink)

It is now widely acknowledged that play is central to our lives. As a phenomenon, play poses important questions of reality, subjectivity, competition, inclusion and exclusion. This international collection is the third in a series of books that aims to build paradigmatic bridges between scholars of philosophy and scholars of play. Divided into four sections, this book sheds new light on the significance of play for both children and adults in a variety of cultural settings. Its chapters encompass a range (...) of philosophical areas of enquiry such as metaphysics, aesthetics and ethics, and the spectrum of topics explored includes games, jokes, sport and our social relationship with the internet. With contributions from established and emerging scholars from around the world, The Philosophy of Play as Life is fascinating reading for all those with an interest in playwork, the ethics and philosophy of sport, childhood studies or the philosophy of education. (shrink)

This chapter contains sections titled: Two Killers in Montana Naming, Metaphor, and the Language of Serial Murder What's in a Name? The Wolf and the Widow Naming: Putting Practice into Theory Metaphor: Wolf in Sheep's Clothing Metaphor: White Wolf Revisited I Am Become Wolf: Anthropomorphism and Zoomorphism Strange Bedfellows For Further Contemplation.

The contributors to this issue focus on legal internationalism, including hybrid mixes with nationalist forms. They have provoked us as editors to think more about these sites and forms of engagement. Sankey shows how civic participation in the ECCC has played a key role in surfacing the gendered harms of separation and starvation. Turan highlights the problems with ICC exclusion of the experience of men and boys from sexual violence. Peroni expresses her hesitations over the Istanbul Convention given an association (...) between assumed vulnerability and migrant women, while admiring its uncoupling of violence and culture. Cruz’s interview with Wendy Brown contextualizes and expands on these themes as they consider, with other participants, the future of feminist theory in the context of neo-liberal capturing of rights and legal space. Thinking more about internationalism and commitment in this context also helps us hold a mirror up to ourselves as we reflect more critically on our own naming of FLS as an ‘international’ journal. Together these contributions, and the reviews of new work, play a role in fleshing out an editorial commitment to enacting the journal as a living thing that ‘hangs together somehow’ even as it is known differently in different places. (shrink)

The model of major transitions in evolution devised by Maynard Smith and Szathmáry has exerted tremendous influence over evolutionary theorists. Although MTE has been criticized for inconsistently combining different types of event, its ongoing appeal lies in depicting hierarchical increases in complexity by means of evolutionary transitions in individuality. In this paper, we consider the implications of major evolutionary events overlooked by MTE and its ETI-oriented successors, specifically the biological oxygenation of Earth, and the acquisitions of mitochondria and plastids. By (...) reflecting on these missed events, we reveal a central philosophical disagreement over the explanatory goals of major transitions theory that has yet to be made explicit in the literature. We go on to argue that this philosophical disagreement is only reinforced by Szathmáry’s recent revisions of MTE in the form of MTE 2.0. This finding motivates us to propose an alternative explanatory strategy: specifically, an interactionist metabolic perspective on major transitions. A metabolic framework not only avoids many of the criticisms that beset classic and revised MTE models, but also accommodates missing events and provides crucial explanatory components for standard major transitions. Although we do not provide a full-blown alternative theory and do not claim to achieve unity, we explain why foregrounding metabolism is crucial for any attempt to capture the major turning points in evolution, and why it does not lead to unmanageable pluralism. (shrink)

The Natural Law Reader features a selection of readings in metaphysics, jurisprudence, politics, and ethics that are all related to the classical Natural Law tradition in the modern world. Features a concise presentation of the natural law position that offers the reader a focal point for discussion of ancient and contemporary ideas in the natural law tradition Draws upon the metaphysical and ethical categories put forth and developed by Aristotle and Aquinas Points to the historical significance and contemporary relevance of (...) the Natural Law tradition Reflects on a revival of interest in the tradition of virtue ethics and human rights. (shrink)

_John Stuart Mill_ investigates the central elements of the 19th century philosopher’s most profound and influential works, from _On Liberty_ to _Utilitarianism_ and _The Subjection of Women_. Through close analysis of his primary works, it reveals the very heart of the thinker’s ideas, and examines them in the context of utilitarianism, liberalism and the British empiricism prevalent in Mill’s day. • Presents an analysis of the full range of Mill’s primary writings, getting to the core of the philosopher’s ideas. • (...) Examines the central elements of Mill’s writings in easily accessible prose • Places Mill’s work and thought within the larger cultural and social context of 19th century Britain • Illustrates the continued relevance of Mill’s philosophy to today’s reader. (shrink)

A recent article in this journal described practical and conceptual difficulties faced by public health researchers studying scabies outbreaks in British residential care facilities. Their study population was elderly, decisionally incapacitated residents, many of whom lacked a legally appropriate decision-maker for healthcare decisions. The researchers reported difficulties securing Research Ethics Committee approval. As practicing healthcare ethicists working in a large Canadian research hospital, we are familiar with this challenge and welcomed the authors’ invitation to join the discussion of the ‘outstanding (...) ambiguities and further questions’ that their experience uncovered. We propose a Power of Attorney for Research as one substantive solution to help address the problems they identified. Although we acknowledge the familiar shortcomings associated with Advance Directives in the clinical context, we believe that Powers of Attorney for Research Participation, accompanied by Advance Research Directives, may increase the likelihood of gaining deeper understandings of potential participant’s values and priorities and how they might apply to foreseeable research opportunities. (shrink)

Biological dysfunction is regarded, in many accounts, as necessary and perhaps sufficient for disease. But although disease is conceptualized as all-or-nothing, biological functions often differ by degree. A tension is created by attempting to use a continuous variable as the basis for a categorical definition, raising questions about how we are to pinpoint the boundary between health and disease. This is the line-drawing problem. In this paper, we show how the line-drawing problem arises within “dysfunction-requiring” accounts of disease, such as (...) those of Christopher Boorse and Jerome Wakefield. We then provide several detailed examples to establish that biological dysfunction cannot provide a boundary. We examine potential ways of resolving the line-drawing problem, either by dropping one of the claims that generates it, or by appealing to additional criteria. We argue that two of these options are plausible, and that each of these can be applied with regard to different diseases. (shrink)

Overdiagnosis refers to diagnosis that does not benefit patients because the diagnosed condition is not a harmful disease in those individuals. Overdiagnosis has been identified as a problem in cancer screening, diseases such as chronic kidney disease and diabetes, and a range of mental illnesses including depression and attention deficit hyperactivity disorder. In this paper, we describe overdiagnosis, investigate reasons why it occurs, and propose two different types. Misclassification overdiagnosis arises because the diagnostic threshold for the disease in question has (...) been set at a level where many people without harmful disease are nonetheless diagnosed. We illustrate misclassification overdiagnosis using the example of chronic kidney disease. Misclassification occurs in diseases diagnosed using biomarkers or based on patient reported phenomena. Maldetection overdiagnosis arises because, at the time the diagnosis is made and despite the presence of a 'gold standard' diagnostic test, it is not possible to discriminate between harmful and non-harmful cases of the index disease. We illustrate maldetection overdiagnosis using the example of thyroid cancer. While there is some overlap between misclassification and maldetection overdiagnosis, this conceptual analysis helps to clarify the phenomenon of overdiagnosis and is a necessary first step in developing strategies to address the problem. (shrink)

Recent calls for retraction of a large body of Chinese transplant research and of Dr Jiankui He’s gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications fail when unethical practices (...) are ongoing—as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research displays a lack of respect and concern for the victims and undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of ‘non-use’ of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians. (shrink)

The question of whether activism should be overtly embraced as part of the bioethicist's role deserves serious consideration. Like others, we agree that bioethics is inescapably partisan; bioethical deliberation is based on trying to determine morally relevant features of situations and morally justifiable outcomes. Where disagreement arises is over the degree to which bioethicists should be activists. Meyers argues for a somewhat circumscribed role, limited to action on ethically concerning institutional matters, for those who are financially independent of the institutions. (...) We take a broader view, arguing that some issues are so morally egregious that there is a duty to take a stand against them, even if the prospects of success are dim. There is a need for further debate, sharing of experiences, and analysis of case studies, to support bioethicists who take a stand. (shrink)

Many health care systems include programs that allow patients in exceptional circumstances to access medical interventions of as yet unproven benefit. In this article we consider the ethical justifications for—and demands on—these special access programs (SAPs). SAPs have a compassionate basis: They give patients with limited options the opportunity to try interventions that are not yet approved by standard regulatory processes. But while they signal that health care systems can and will respond to individual suffering, SAPs have several disadvantages, including (...) the potential to undermine regulatory and knowledge-generation structures that constitute significant public goods. The “balance” between these considerations depends in part on how broadly SAPs are used, but also on whether SAPs can be made to contribute to the generation of knowledge about the effects of health interventions. We argue that patients should usually be required to contribute outcome data while using SAPs. (shrink)

Current practices of identifying and treating small indolent thyroid cancers constitute an important but in some ways unusual form of overdiagnosis. Overdiagnosis refers to diagnoses that generally harm rather than benefit patients, primarily because the diagnosed condition is not a harmful form of disease. Patients who are overdiagnosed with thyroid cancer are harmed by the psycho-social impact of a cancer diagnosis, as well as treatment interventions such partial or total thyroidectomy, lifelong thyroid replacement hormone, monitoring, surgical complications and other side (...) effects. These harms seem to outweigh any putative benefit of knowing about a cancer that would not have caused problems if left undiscovered. In addition to harms to patients, thyroid cancer overdiagnosis leads to significant opportunity costs at a societal level, due to costs of diagnosis and treatment. Unlike many other overdiagnosed cancers, accurate risk stratification is possible with thyroid cancer. At the individual patient level, use of this risk information might support informed choice and/or shared decision-making, as mandated by clinical ethics frameworks. And this approach might, to some extent, help to reduce rates of diagnosis and intervention. In practice, however, it is unlikely to stem the rising incidence and associated harms and costs of overdiagnosed thyroid cancer, especially in situations where health professionals have conflicts of interest. We argue in this article that thyroid cancer overdiagnosis may be usefully understood as a public health problem, and that some public health approaches will be readily justifiable and are more likely to be effective in minimising its harms. (shrink)

Biomedical innovation and translation are increasingly emphasizing research using “big data.” The hope is that big data methods will both speed up research and make its results more applicable to “real-world” patients and health services. While big data research has been embraced by scientists, politicians, industry, and the public, numerous ethical, organizational, and technical/methodological concerns have also been raised. With respect to technical and methodological concerns, there is a view that these will be resolved through sophisticated information technologies, predictive algorithms, (...) and data analysis techniques. While such advances will likely go some way towards resolving technical and methodological issues, we believe that the epistemological issues raised by big data research have important ethical implications and raise questions about the very possibility of big data research achieving its goals. (shrink)

This article describes a qualitative investigation of environmental ethics as construed by environmental activists. Twenty-nine participants responded in writing to open-ended questions on their definitions of an environmental ethic, how they expressed and experienced this moral orientation in their lives, and what sustained it. Four major themes emerged. First, ethical consideration of the natural environment pervaded morality, values, and private and public life. Second, emotional or spiritual experiences, or personal fulfillment, were important for many. Third, there was disagreement on the (...) relationships among environmental principles, intentions, and behaviors, as well as the necessity of prescribing specific behaviors. Finally, there were diverse views on the role of humanitarian concerns in an environmental ethic. These themes are discussed in terms of parallels to religious experience, motivations for an environmental ethic, and implications for nonenvironmental realms of ethics and justice. (shrink)

Breast cancer screening aims to help women by early identification and treatment of cancers that might otherwise be life-threatening. However, breast cancer screening also leads to the detection of some cancers that, if left undetected and untreated, would not have damaged the health of the women concerned. At the time of diagnosis, harmless cancers cannot be identified as non-threatening, therefore women are offered invasive breast cancer treatment. This phenomenon of identifying non-harmful cancers is called overdiagnosis. Overdiagnosis is morally problematic as (...) it leads to overall patient harm rather than benefit. Further, breast cancer screening is offered in a context that exaggerates cancer risk and screening benefit, minimises risk of harm and impedes informed choice. These factors combine to create pathogenic vulnerability. That is, breast cancer screening exacerbates rather than reduces women’s vulnerability and undermines women’s agency. This paper provides an original way of conceptualising agency-supporting responses to the harms of breast cancer overdiagnosis through application of the concept of pathogenic vulnerability. (shrink)

Bioethics, Volume 35, Issue 7, Page 623-633, September 2021.

Many healthcare practices expose people to risks of harmful outcomes. However, the major theories of moral philosophy struggle to assess whether, when and why it is ethically justifiable to expose individuals to risks, as opposed to actually harming them. Sven Ove Hansson has proposed an approach to the ethical assessment of risk imposition that encourages attention to factors including questions of justice in the distribution of advantage and risk, people’s acceptance or otherwise of risks, and the scope individuals have to (...) influence the practices that generate risk. This paper investigates the ethical justifiability of preventive healthcare practices that expose people to risks including overdiagnosis. We applied Hansson’s framework to three such practices: an ‘ideal’ breast screening service, a commercial personal genome testing service, and a guideline that lowers the diagnostic threshold for hypertension. The framework was challenging to apply, not least because healthcare has unclear boundaries and involves highly complex practices. Nonetheless, the framework encouraged attention to issues that would be widely recognised as morally pertinent. Our assessment supports the view that at least some preventive healthcare practices that impose risks including that of overdiagnosis are not ethically justifiable. Further work is however needed to develop and/or test refined assessment criteria and guidance for applying them. (shrink)

RationaleSurrogates of critically ill patients often have inaccurate expectations about prognosis. Yet there is little research on how intensive care unit clinicians should discuss prognosis, and existing expert opinion-based recommendations give only general guidance that has not been validated with surrogate decision makers.ObjectiveTo determine the perspectives of key stakeholders regarding how prognostic information should be conveyed in critical illness.MethodsThis was a multicenter study at three academic medical centers in California, Pennsylvania, and Washington. One hundred eighteen key stakeholders completed in-depth semistructured (...) interviews. Participants included 47 surrogates of adult patients with acute respiratory distress syndrome; 45 clinicians working in study ICUs, including physicians, nurses, social workers, and spiritual care providers; and 26 experts in health communication, decision science, ethics, family-centered care, geriatrics, healthcare disparities, palliative care, psychology, psychiatry, and critical care.Measurements and main resultsThere was broad support among surrogates for existing expert recommendations, including truthful prognostic disclosure, emotional support, tailoring the disclosure strategy to each family's needs, and checking for understanding. In addition, stakeholders offered suggestions that add specificity to existing recommendations, including: In addition to conveying prognostic estimates, clinicians should help families "see the prognosis for themselves" by showing families radiographic images and explaining the clinical significance of physical manifestations of severe disease at the bedside. Many physicians did not support using numeric estimates to convey prognosis to families, whereas many surrogates, clinicians from other disciplines, and experts believed numbers could be helpful. Clinicians should conceptualize prognostic communication as an iterative process that begins with a preliminary mention of the possibility of death early in the ICU stay and becomes more detailed as the clinical situation develops. Although prognostic information should be initially disclosed by physicians, other members of the multidisciplinary team-nurses, social workers, and spiritual care providers-should be given explicit role responsibilities to reinforce physicians' prognostications and help families process a poor prognosis emotionally.ConclusionsFamily members, clinicians, and experts identified specific communication behaviors that clinicians should use to discuss prognosis in the critical care setting. These findings extend existing opinion-based recommendations and should guide interventions to improve communication about prognosis in ICUs. (shrink)

Twenty-nine environmental activists (mean age, 49.8) responded in writing to questions on influences that gave rise to environmental ethics in their own lives. Answers represented all phases of the lifespan. Through a qualitative analysis, six principle themes emerged: (a) deep environmental concern and an affiliation with nature often began in early childhood; (b) a combination of intellectual or academic and direct experiences with nature contributed to the development of environmental ethics; (c) familial and extra familial models were influential; (d) for (...) some, environmental ethics was tied to spiritual, cultural, or religious feeling; (e) the development of environmental ethics was linked with identity and generativity issues; and (f) historical events interacted with individual development in the formation of an environmental ethics. These themes are discussed in terms of continuities and discontinuities in lifespan development, the role of the family and of history, and the relation between reason and emotion in the development of an environmental ethics. (shrink)

The interaction between evidence-based medicineand doctors' duty of care to patients iscomplex. One the one hand, there is surely anobligation to take account of the bestavailable evidence when offering health care topatients. On the other hand, it is equallyimportant to be aware of important shortcomingsin the processes and practices ofevidence-based medicine. There are tensionsbetween the population focus of evidence-basedmedicine and the duties that doctors have toindividual patients. Implementingevidence-based medicine may have unpredictableconsequences upon the overall quality of healthcare. Patients may have (...) a range of reasons forpreferring one form of treatment over another,not all of which are captured by currentformulations of evidence. This paper examinesthese issues, using relevant examples fromevidence-based medicine. (shrink)

Medicine seeks to overcome one of the most fundamental fragilities of being human, the fragility of good health. No matter how robust our current state of health, we are inevitably susceptible to future illness and disease, while current disease serves to remind us of various frailties inherent in the human condition. This article examines the relationship between fragility and uncertainty with regard to health, and argues that there are reasons to accept rather than deny at least some forms of uncertainty. (...) In situations of current ill health, both patients and doctors seek to manage this fragility through diagnoses that explain suffering and provide some certainty about prognosis as well as treatment. However, both diagnosis and prognosis are inevitably uncertain to some degree, leading to questions about how much uncertainty health professionals should disclose, and how to manage when diagnosis is elusive, leaving patients in uncertainty. We argue that patients can benefit when they are able to acknowledge, and appropriately accept, some uncertainty. Healthy people may seek to protect the fragility of their good health by undertaking preventative measures including various tests and screenings. However, these attempts to secure oneself against the onset of biological fragility can cause harm by creating rather than eliminating uncertainty. Finally, we argue that there are good reasons for accepting the fragility of health, along with the associated uncertainties. (shrink)