A common strategy in bioethics is to posit a prima facie case in favour of one policy, and to then claim that the burden of proof falls on those with opposing views. If the burden of proof is not met, it is claimed, then the policy in question should be accepted. This article illustrates, and critically evaluates, examples of this strategy in debates about the sale of organs by living donors, human enhancement, and the precautionary principle. We highlight general problems (...) with this style of argument, and particular problems with its use in specific cases. We conclude that the burden ultimately falls on decision-makers to choose the policy supported by the best reasons. (shrink)

Historically, scientists in training have learned the rules of ethical conduct by the example of their advisors and other senior scientists and by practice. This paper is intended to serve as a guide for the beginning scientist to some fundamental principles of scientific research ethics. The paper focuses less on issues of outright dishonesty or fraud, and more on the positive aspects of ethical scientific behavior; in other words, what a scientist should do to maintain a high level of ethical (...) conduct in research.There are a number of fairly specific rules, guidelines, or commonly accepted operating principles that have evolved for the ethical conduct of science. In order to discuss this code of ethics, this paper is divided into sections dealing with specific areas of scientific ethics. These areas are: data collection and storage, ownership of data, confidentiality, communication, authorship, collaboration, the peer review system, and rules of dealing with ethical complaints. Illustrative case histories are presented to provide examples of the type of ethical dispute or problem being discussed. If scientific trainees learn the accepted rules of behavior that govern the conduct of science, ethical problems that arise out of ignorance, misunderstanding, or poor communication can be avoided. (shrink)

The ability to reason independently from one's own goals or beliefs has long been recognised as a key characteristic of the development of formal operational thought. In this article we present the results of a study that examined the correlates of this ability in a group of 10-year-old children ( N = 61). Participants were presented with conditional and relational reasoning items, where the content was manipulated such that the conclusion to the arguments were either congruent, neutral, or incongruent with (...) beliefs, and either logically valid or logically invalid. Participants also received a measure of working memory capacity (the counting span task) and a measure of inhibitory control (the stop signal task). Indices of belief bias and logical reasoning on belief-based problems were predicted independently by both measures. In contrast logical reasoning on belief neutral problems was predicted by working memory alone. The findings suggest that executive functions play a key role in the development of children's ability to decontextualise their thinking. (shrink)

This article focuses mainly on (1) the policy of Delft University of Technology since 1992 as regards the university-wide introduction of a compulsory course on ethics and engineering, and (2) the ideal structure of such a course, including the educational goals of the course.

Ethics in science is integrated into an interdisciplinary science course called “Science, Technology and Society” (STS). This paper focuses on the section of the course called “Societal Impact on Science and Technology”, which includes the topics Misconduct in Science, Scientific Freedom and Responsibility, and the Use of Human Subjects in Research. Students in the course become aware not only of the science itself, but also of the process of science, some aspects of the history of science, the social responsibilities of (...) scientists, and the ethical issues in science. Teaching techniques include the instructor sharing experiences as a scientist with the students, sharing books and resources with students, utilizing current sources of information like the weekly “Science Times”, inviting guest speakers, and utilizing portfolios to assess student learning. (shrink)

Though the reputation of eugenics has been tarnished by history, eugenics per se is not necessarily a bad thing. Many advocate a liberal new eugenics—where individuals are free to choose whether or not to employ genetic technologies for reproductive purposes. Though genetic interventions aimed at the prevention of severe genetic disorders may be morally and socially acceptable, reproductive liberty in the context of enhancement may conflict with equality. Enhancement could also have adverse effects on utility. The enhancement debate requires a (...) shift in focus. What the equality and/or utility costs of enhancement will be is an empirical question. Rather than philosophical speculation, more social science research is needed to address it. Philosophers, meanwhile, should address head-on the question of how to strike a balance between liberty, equality, and utility in cases of conflict (in the context of genetics). (shrink)

Science is not taken for granted any longer. Society, politics and the media pose critical questions tending to censorship or at least control of science. How does science respond? It cannot exist and develop without freedom, but this does not mean freedom to amass knowledge and apply technological applications at any price and without restrictions. Science should be autonomous, but is not value-free. A distintion is made between external and internal social/ethical problems. The former refer to questions of the social/ethical (...) context and consequences of scientific research, and the latter to the rules of ‘good practice’ and scientific integrity. The role of academies of science, and of associations of such academies (e.g. All European Academies (ALLEA)) in developing codes of good scientific practice and fostering a proper sense of scientific values and standards is further discussed. (shrink)

CAPPE LPO Box 8260 ANU Canberra ACT 2601 Australia Tel: +61 (0)2 6125 4355, Fax: +61 (0)2 6125 6579; Email: michael.selgelid{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract This article reviews ethically relevant history of tuberculosis and recent developments regarding extensively drug resistant tuberculosis (XDR-TB). It argues that tuberculosis is one of the most important neglected topics in bioethics. With an emphasis on XDR-TB, it examines a range of the more challenging ethical issues associated with (...) tuberculosis: individual obligations to avoid infecting others, coercive social distancing measures, third-party notification, health workers' duty to treat contagious patients, and international justice. In each of these cases, key philosophical questions are highlighted and the need for empirical research/information is demonstrated. CiteULike Connotea Del.icio.us What's this? (shrink)

Whether or not MSF should provide unconditional treatment for lead poisoning in Nigeria partly depends on answers to empirical questions regarding what the overall consequences of such a practice are likely to be. Conditional provision of treatment may yield greater health benefits (especially if treatment resources are limited).

Although smallpox was declared eradicated in 1980, there are fears that stocks of the virus manufactured for military purposes by the Soviet Union may have fallen into the hands of “rogue nations” or terrorists. Worries about bioterrorism have thus sparked debate about whether or not the smallpox vaccine, which can be dangerous, should be offered to the general public. Meaningful public debate on this issue requires expert information about the likelihood that the virus will in fact be used as a (...) weapon. Informed voluntary individual decision making, about whether to get vaccinated if vaccine is made available to the public, would similarly require appreciation of the likelihood of attack. Public deliberation and private deliberation thus both require briefing by the intelligence community. (shrink)

Centre for Applied Philosophy and Public Ethics, The Australian National University, LPO Box 8260, ANU, Canberra ACT 2601, Australia. Email: michael.selgelid{at}anu.edu.au ' + u + '@ ' + d + ' '/ /- ->. Home page: http: //www.cappe.edu.au/staff/michael-selgelid.htmThis article advocates the development of a moderate pluralist theory of political philosophy that recognizes that utility, liberty and equality are legitimate, independent social values and that none should have absolute priority over the others. Inter alia, such a theory would provide (...) a principled means for striking a balance, or making trade-offs, between these values in cases of conflict. Recent developments in public health ethics have made progress in thinking about how to make trade-offs between liberty and utility in particular. While public health ethicists often claim that the least restrictive alternative should be used to achieve the public health goal in question, I argue that a plausible but under-recognized idea is that the least restrictive alternative might sometimes involve improvement of global health via redistributive taxation—i.e., rather than coercive social distancing measures. I conclude by demonstrating that the proportionality principle leaves open the question of when exactly utility outweighs liberty or vice versa—and I argue that, rather than speaking about the morality of liberty-infringing public health interventions in categorical/binary terms, it would be more fruitful and realistic to think and speak about the degree to which a liberty-infringing public health intervention is morally appropriate. CiteULike Connotea Del.icio.us What's this? (shrink)

This first part of this article critiques Sridhar Venkatapuram's conception of health as a capability. It argues that Venkatapuram relies on the problematic concept of dignity, implies that those who are unhealthy lack lives worthy of dignity, sets a low bar for health, appeals to metaphysically problematic thresholds, fails to draw clear connections between appealed-to capabilities and health, and downplays the importance/relevance of health functioning. It concludes by questioning whether justice entitlements should pertain to the capability for health versus health (...) achievements, challenging Venkatapuram's claims about the strength of health entitlements, and demonstrating that the capabilities approach is unnecessary to address social determinants of health. (shrink)

Gain-of-function research involves experimentation that aims or is expected to increase the transmissibility and/or virulence of pathogens. Such research, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOF research can pose risks regarding biosecurity and biosafety. In 2014 the (...) administration of US President Barack Obama called for a “pause” on funding of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions—and the US National Science Advisory Board for Biosecurity was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide review and summary of ethical literature on GOFR, identification and analysis of existing ethical and decision-making frameworks relevant to the evaluation of risks and benefits of GOFR, decision-making about the conduct of GOF studies, and the development of US policy regarding GOFR, and development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFR risk-benefit assessment, and when crafting its final recommendations. The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse : research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum—where imaginable cases of GOFR might range from those that are most ethically acceptable, at one end of the spectrum, to those that are most ethically problematic or unacceptable, at the other. The aim should be that any GOFR pursued should be as far as possible towards the former end of the spectrum. (shrink)

Centre for Applied Philosophy and Public Ethics (CAPPE), Menzies Centre for Health Policy, The Australian National University, LPO Box 8260, ANU Canberra ACT 2601, Australia. Tel.: +61 (0)2 6125 4355; Mobile: +61 (0)431 124 286; Fax: +61 (0)2 6125 6579; Email: michael.selgelid{at}anu.edu.au ' + u + '@' + d + ' '//--> Abstract Thomas Pogge has proposed a supplement to the standard patent regime whereby innovating companies would be rewarded in proportion to the extent to which their innovations lead (...) to reduction of the global burden of disease (GBD). This paper argues that an expansion of this proposal—whereby provision of already existing medicines are incentivised in a similar way—would provide a more comprehensive solution to the healthcare situation in developing countries. It then considers the practical challenges that the implementation of such a proposal (expanded or otherwise) would entail. Though these include difficulties associated with disease burden metric, I argue that the most serious difficulties are associated with the problem of causal attribution. A basic idea underlying Pogge's proposal is that the disease burden reduction attributable to particular interventions can be determined. Theoretically speaking, in cases involving multiple interacting causal factors, there may be no fact of the matter regarding the extent to which disease burden reduction should be attributed to one intervention as opposed to another; and (even if workable practical solutions to this theoretical challenge can be met) the data requirements for implementation would be daunting. CiteULike Connotea Del.icio.us What's this? (shrink)

ABSTRACT This paper reviews the dynamics behind, and ethical issues associated with, the phenomenon of drug resistance. Drug resistance is an important ethical issue partly because of the severe consequences likely to result from the increase in drug resistant pathogens if more is not done to control them. Drug resistance is also an ethical issue because, rather than being a mere quirk of nature, the problem is largely a product of drug distribution. Drug resistance results from the over‐consumption of antibiotics (...) by the wealthy; and it, ironically, results from the under‐consumption of antibiotics, usually by the poor or otherwise marginalized. In both kinds of cases the phenomenon of drug resistance illustrates why health (care) – at least in the context of infectious disease – should be treated as a (global) public good. The point is that drug resistance involves ‘externalities’ affecting third parties. When one patient develops a resistant strain of disease because of her over‐ or under‐consumption of medication, this more dangerous malady poses increased risk to others. The propriety of free‐market distribution of goods subject to externalities is famously dubious – given that the ‘efficiency’ rationale behind markets assumes an absence of externalities. Market failure in the context of drug resistance is partly revealed by the fact that no new classes of antibiotics have been developed since 1970. I conclude by arguing that the case of drug resistance reveals additional reasons – to those traditionally appealed to by bioethicists – for treating health care as something special when making policy decisions about its distribution. (shrink)

This issue of Journal of Medical Ethics includes a pair of papers debating the implications of moral bioenhancement for human freedom–and, especially, the question of whether moral enhancement should potentially be compulsory. In earlier writings Ingmar Persson and Julian Savulescu argue that compulsory moral bioenhancement may be necessary to prevent against catastrophic harms that might result from immoral behaviour.1 In “Voluntary moral enhancement and the survival-at-any-cost bias” Vojin Rakic agrees with P&S that moral bioenhancement is important, but he argues that (...) bioenhancement interventions should be voluntary rather than compulsory .Both Rakic and P&S disagree with Harris, who denies that moral enhancement could involve interventions beyond cognitive enhancement. Moral enhancement would essentially involve cognitive enhancement, according to Harris, because moral behaviour requires ability to distinguish right from wrong–ie, awareness and rational capacity.2 While Harris admits that those who know what is right might not always do what is right, he argues that we could not altogether prevent people from doing what is wrong without destroying freedom essential to their moral agency.According to Rakic, however, the fact that people who know what is right might not always do what is right reveals that mere cognitive enhancement would be inadequate to prevent immoral behavior–because much immoral behaviour results from weakness of will. Because people could freely chose to undergo moral enhancement, furthermore, according to Rakic, “our freedom will not be curtailed by it”. Presumably Rakic here supposes that if a person freely choses to be in State A then State A is necessarily compatible with–and a reflection of–her human freedom. Forcing a person to be in State A, on the other hand, …. (shrink)

The qualitative research of Baum and colleagues (2009), among other things, reveals that people are worried about the financial consequences of social-distancing measures and that lack of trust in...

This seminal collection on the ethical issues associated with infectious disease is the first book to correct bioethics’ glaring neglect of this subject. Timely in view of public concern about SARS, AIDS, avian flu, bioterrorism and antibiotic resistance. Brings together new and classic papers by prominent figures. Tackles the ethical issues associated with issues such as quarantine, vaccination policy, pandemic planning, biodefense, wildlife disease and health care in developing countries.

The American Medical Association's Council on Ethical and Judicial Affairs' new “Guidelines to Prevent the Malevolent Use of Biomedical Research” are both timely and appropriate. These guidelines are a product of the increasing realization of the “dual use” potential of life science discoveries. Although biomedical research usually aims at the development of new medicines, vaccines, diagnostics, and so on, the very same discoveries that could benefit humankind in these ways also often have implications for the development of biological weapons. The (...) CEJA Guidelines draw attention to this fact and hold that physician–researchers have responsibilities regarding the uses to which their discoveries are put. Medical researchers should assess the likely social benefits and harms of their work and avoid projects where the latter outweigh the former. Knowledge and the advancement of science should not be the only aims of scientists; “commitment to public welfare and safety” are also essential. Toward the aim of preventing the malevolent use of research discoveries, the CEJA states that “regulatory oversight” of research, increased ethics education of physician researchers, and sometimes perhaps even censorship of research findings, are warranted. (shrink)

Purposeful infection of healthy volunteers with a microbial pathogen seems at odds with acceptable ethical standards, but is an important contemporary research avenue used to study infectious diseases and their treatments. Generally termed ‘controlled human infection studies’, this research is particularly useful for fast tracking the development of candidate vaccines and may provide unique insight into disease pathogenesis otherwise unavailable. However, scarce bioethical literature is currently available to assist researchers and research ethics committees in negotiating the distinct issues raised by (...) research involving purposefully infecting healthy volunteers. In this article, we present two separate challenge studies and highlight the ethical issues of human challenge studies as seen through a well-constructed framework. Beyond the same stringent ethical standards seen in other areas of medical research, we conclude that human challenge studies should also include: independent expert reviews, including systematic reviews; a publicly available rationale for the research; implementation of measures to protect the public from spread of infection beyond the research setting; and a new system for compensation for harm. We hope these additions may encourage safer and more ethical research practice and help to safeguard public confidence in this vital research alternative in years to come. (shrink)

Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews (...) with scientists and ethicists. Among other areas of consensus, we found that there was widespread agreement that LMIC HCS can be ethically acceptable, provided that they have a sound scientific rationale, are accepted by local communities and meet usual research ethics requirements. Unresolved issues include those related to (i) acceptable approaches to trade-offs between the scientific aim to produce generalisable results and the protection of participants, (iii) the sharing of benefits with LMIC populations, (iii) the acceptable limits to risks and burdens for participants, (iv) the potential for third-party risk and whether the degree of acceptable third-party risk is different in endemic settings, (v) the conditions under which (if any) it would be appropriate to recruit children for disease-causing HCS, (v) appropriate levels of payment to participants and (vi) appropriate governance of (LMIC) HCS. This paper provides preliminary analyses of these ethical considerations in order to (i) inform scientists and policymakers involved in the planning, conduct and/or governance of LMIC HCS and (ii) highlight areas warranting future research. Insofar as this article focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided is relevant to HCS (in HICs or LMICs) involving pandemic diseases including COVID19. (shrink)

ABSTRACTThis module examines ethical debates about the level of care that should be provided to human research participants. Particular attention is placed on the question of what should be considered an ethically acceptable control arm. You will also learn what relevant international and domestic regulatory documents say about standards of care.