Kidney Sales and the Burden of Proof

Janet Radcliffe Richards’ The Ethics of Transplants outlines a novel framework for moral inquiry in practical contexts and applies it to the topic of paid living kidney donation. In doing so, Radcliffe Richards makes two key claims: that opponents of organ markets bear the burden of proof, and that this burden has not yet been satisfied. This paper raises four related objections to Radcliffe Richards’ methodological framework, focusing largely on how Radcliffe Richards uses this framework in her discussion of kidney sales. We conclude that Radcliffe Richards’ method of inquiry hinders our ability to answer the very question that it ought to help us resolve: What is there best reason to do, all things considered

Universal Norms and Conflicting Values

While UNESCO's Universal Draft Declaration on Bioethics and Human Rights highlights appropriate ethical values, its principles are stated in absolute terms and conflict with one another. The Draft Declaration fails to sufficiently address the possibilit

On the Dual Uses of Science and Ethics Principles, Practices, and Prospects

Ethics, humanity, techonolog

Human Challenge Studies in Endemic Settings

This open access book provides an extensive review of ethical and regulatory issues related to human infection challenge studies, with a particular focus on the expansion of this type of research into endemic settings and/or low- and middle-income countries (LMICs). Human challenge studies (HCS) involve the intentional infection of research participants, and this type of research is rapidly increasing in frequency worldwide. HCS are widely considered to be an especially promising approach to vaccine development, including for pathogens endemic to LMICs. However, challenge studies are sometimes controversial and raise complex ethical issues, some of which are especially salient in endemic and/or LMIC settings. Informed by qualitative interviews with experts in infectious diseases and bioethics, this book highlights areas of ethical consensus and controversy concerning this kind of research. As the first volume to focus on ethical issues associated with human challenge studies, it sets the agenda for further work in this important area of global health research; contributes to current debates in research ethics; and aims to inform regulatory policy and research practice. Insofar as it focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided here is directly relevant to HCS involving pandemic diseases including COVID19

Human Challenge Studies in Endemic Settings

This open access book provides an extensive review of ethical and regulatory issues related to human infection challenge studies, with a particular focus on the expansion of this type of research into endemic settings and/or low- and middle-income countries (LMICs). Human challenge studies (HCS) involve the intentional infection of research participants, and this type of research is rapidly increasing in frequency worldwide. HCS are widely considered to be an especially promising approach to vaccine development, including for pathogens endemic to LMICs. However, challenge studies are sometimes controversial and raise complex ethical issues, some of which are especially salient in endemic and/or LMIC settings. Informed by qualitative interviews with experts in infectious diseases and bioethics, this book highlights areas of ethical consensus and controversy concerning this kind of research. As the first volume to focus on ethical issues associated with human challenge studies, it sets the agenda for further work in this important area of global health research; contributes to current debates in research ethics; and aims to inform regulatory policy and research practice. Insofar as it focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided here is directly relevant to HCS involving pandemic diseases including COVID19

Professionalization as a governance strategy for synthetic biology

This article considers professionalization as a governance strategy for synthetic biology, reporting on social science interviews done with scientists, science journal editors, members of science advisory boards and authors of nongovernmental policy reports on synthetic biology. After summarizing their observations about the potential advantages and disadvantages of the professionalization of synthetic biology, we analyze professionalization as a strategy that overcomes dichotomies found in the current debates about synthetic biology governance, specifically “top down” versus “bottom up” governance and scientific fact versus public values. Professionalization combines community and state, fact and value. Like all governance options, professionalization has limitations, particularly regarding war and peace. It is best conceptualized as potentially part of a wider range of governance mechanisms working in concert: a “web of prevention”

Impartiality and infectious disease: Prioritizing individuals versus the collective in antibiotic prescription

Antimicrobial resistance (AMR) is a global public health disaster driven largely by antibiotic use in human health care. Doctors considering whether to prescribe antibiotics face an ethical conflict between upholding individual patient health and advancing public health aims. Existing literature mainly examines whether patients awaiting consultations desire or expect to receive antibiotic prescriptions, but does not report views of the wider public regarding conditions under which doctors should prescribe antibiotics. It also does not explore the ethical significance of public views or their sensitivity to awareness of AMR risks or the standpoint (self-interested or impartial) taken by participants. Methods: An online survey was conducted with a sample of the U.S. public (n = 158). Participants were asked to indicate what relative priority should be given to individual patients and society-at-large from various standpoints and in various contexts, including antibiotic prescription. Results: Of the participants, 50.3% thought that doctors should generally prioritize individual patients over society, whereas 32.0% prioritized society over individual patients. When asked in the context of AMR, 39.2% prioritized individuals whereas 45.5% prioritized society. Participants were significantly less willing to prioritize society over individuals when they themselves were the patient, both in general (p = .001) and in relation to AMR specifically (p = .006). Conclusions: Participants’ attitudes were more oriented to society and sensitive to collective responsibility when informed about the social costs of antibiotic use and when considered from a third-person rather than first-person perspective. That is, as participants came closer to taking the perspective of an informed and impartial “ideal observer,” their support for prioritizing society increased. Our findings suggest that, insofar as antibiotic policies and practices should be informed by attitudes that are impartial and well-informed, there is significant support for prioritizing society

Reconciling Regulation with Scientific Autonomy in Dual-Use Research

In debates over the regulation of communication related to dual-use research, the risks that such communication creates must be weighed against against the value of scientific autonomy. The censorship of such communication seems justifiable in certain cases, given the potentially catastrophic applications of some dual-use research. This conclusion however, gives rise to another kind of danger: that regulators will use overly simplistic cost-benefit analysis to rationalize excessive regulation of scientific research. In response to this, we show how institutional design principles and normative frameworks from free speech theory can be used to help extend the argument for regulating dangerous dual-use research beyond overly simplistic cost-benefit reasoning, but without reverting to an implausibly absolutist view of scientific autonomy

Deliberations of the Strategic Advisory Group of Experts on Immunization on the use of CYD-TDV dengue vaccine.

The Strategic Advisory Group of Experts (SAGE) on Immunization advises WHO on global policies for vaccines. In April, 2016, SAGE issued recommendations on the use of the first licenced dengue vaccine, CYD-TDV. In November, 2017, a retrospective analysis of clinical trial data, stratifying participants according to their dengue serostatus before the first vaccine dose, showed that although in high seroprevalence settings the vaccine provides overall population benefit, there was an excess risk of severe dengue in seronegative vaccinees. SAGE's working group on dengue vaccines met to discuss the new data and mainly considered two vaccination strategies: vaccination of populations with dengue seroprevalence rates above 80% or screening of individuals before vaccination, and vaccinating only seropositive individuals. We report on the deliberations that informed the recommendation of the pre-vaccination screening strategy, in April, 2018. Important research and implementation questions remain for CYD-TDV, including the development of a highly sensitive and specific rapid diagnostic test to determine serostatus, simplified immunisation schedules, and assessment of the need for booster doses

Between Scylla and Charybdis: reconciling competing data management demands in the life sciences

Background: The widespread sharing of biological and biomedical data is recognised as a key element in facilitating translation of scientific discoveries into novel clinical applications and services. At the same time, twenty-first century states are increasingly concerned that this data could also be used for purposes of bioterrorism. There is thus a tension between the desire to promote the sharing of data, as encapsulated by the Open Data movement, and the desire to prevent this data from ‘falling into the wrong hands’ as represented by ‘dual use’ policies. Both frameworks posit a moral duty for life sciences researchers with respect to how they should make their data available. However, Open data and dual use concerns are rarely discussed in concert and their implementation can present scientists with potentially conflicting ethical requirements. Discussion: Both dual use and Open data policies frame scientific data and data dissemination in particular, though different, ways. As such they contain implicit models for how data is translated. Both approaches are limited by a focus on abstract conceptions of data and data sharing. This works to impede consensus-building between the two ethical frameworks. As an alternative, this paper proposes that an ethics of responsible management of scientific data should be based on a more nuanced understanding of the everyday data practices of life scientists. Responsibility for these ‘micromovements’ of data must consider the needs and duties of scientists as individuals and as collectively-organised groups. Summary: Researchers in the life sciences are faced with conflicting ethical responsibilities to share data as widely as possible, but prevent it being used for bioterrorist purposes. In order to reconcile the responsibilities posed by the Open Data and dual use frameworks, approaches should focus more on the everyday practices of laboratory scientists and less on abstract conceptions of data