The online version of the original article can be found under doi:10.1007/s11948-007-9045-2.

I defend normative externalism from the objection that it cannot account for the wrongfulness of moral recklessness. The defence is fairly simple—there is no wrong of moral recklessness. There is an intuitive argument by analogy that there should be a wrong of moral recklessness, and the bulk of the paper consists of a response to this analogy. A central part of my response is that if people were motivated to avoid moral recklessness, they would have to have an unpleasant sort (...) of motivation, what Michael Smith calls “moral fetishism”. (shrink)

This essay examines the sanitary policies for the protection of overseas communities that Italian fascism employed during the empire. From 1935–1936, the vast scale of the Ethiopian campaign, as well as intensive colonisation programmes, gave new political visibility to the issue of safeguarding Italian settlers from the risks of the tropical climate. In this period, the problem of how Italians could adapt to overseas environments moved beyond the boundaries of scientific discussion to become a major concern of colonial rule. (...) Analysing both the medical literature and archival sources, this essay examines the concepts and practices that underpinned the fascist project for the “reclamation” of the empire: from the intensification of hygienic propaganda, to the redefinition of the medical-geographical boundaries of tropical risk, and to the expansion of social security benefits, which were extended to harms caused by tropical diseases. Finally, it investigates how the notion of acclimatisation was transformed within the context of the regime's imperial ideology, showing how the conception of the tropics as a pathogenic space remained widespread, fuelled by the regime's organicistic vision and its concerns for upholding the racial prestige of Italians in the colony. (shrink)

The question "When are research risks reasonable in relation to anticipated benefits?" is at the heart of disputes in the ethics of clinical research. Institutional review boards are often criticized for inconsistent decision-making, a problem that is compounded by a number of contemporary controversies, including the ethics of research involving placebo controls, developing countries, incapable adults and emergency rooms. If this pressing ethical question is to be addressed in a principled way, then a systematic approach to the ethics of (...) risk in research is required. Component analysis provides such a systematic approach. (shrink)

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies (...) by healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government. (shrink)

This article is devoted to the study of the nature of the influence of elections on the risks of revolutionary destabilization. The authors study different approaches to estimating the probability of revolutionary events in an election year. Different types of revolutionary events are distinguished within the framework of the level of political violence. The primary reasons for the activation of the politically active part of the population, both in autocracies and in transitional political regimes, are identified, including the factionalization (...) of elites, the activation of "sleeping" institutions, the growth of political competence among individuals, the consolidation of the prodemocratic opposition and its institutionalization, electoral fraud and other manifestations of unfair political competition, greater emotional involvement of the population in political processes, and so on. The findings support the conclusion that elections promote peaceful revolutionary episodes and reduce the likelihood of armed uprisings. The novelty of the study lies in the fact that the influence of elections on the risks of revolutionary destabilization is considered in the regime context. The authors explore how elections affect violent or non-violent revolutionary actions in certain political regimes, according to Jack A. Goldstone's typology (full autocracies, partial autocracies, factional democracies, partial democracies and full democracies). The authors conclude that holding elections reduces the risks of armed revolutionary destabilization in all types of regimes, except for factional democracies. On the other hand, unarmed revolutionary action is more likely in an election year - in all regime types except full democracies. At the same time, holding elections primarily increases the risks of unarmed revolutionary uprisings in intermediate regimes / anocracies. However, even among anocracies, factional democracies stand out, where in the election year the risks of unarmed (as well as armed) revolutionary episodes increase significantly more than in partial autocracies and in partial non-factional democracies. At the same time, for consolidated democracies, holding elections is a factor that inhibits rather than provokes revolutionary destabilization. In full autocracies, the risk of unarmed revolutionary action increases in an election year, but not as much as in intermediate regimes. (shrink)

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the (...) class='Hi'>risks to participants are reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated (...) in research are not greater than those encountered during the performance of routine physical or psychological examinations or tests”. (shrink)

The just war tradition began life, primarily in the writings of Augustine and other Church Fathers, as a reaction to pacifism. In my view, contemporary just war adherents should also see pacifism as their main rival. The key question of the just war tradition is how to justify war, given that war involves intentionally attacking or killing innocent people. And this justificatory enterprise is not an easy one. Today some theorists argue that some, but not all, soldiers are liable to (...) be attacked, especially those who fight in an unjust war. In this view, some of those who fight and kill in unjust wars should not be excused for following orders or even for their ignorance. Yet, it is often hard to tell if one is fighting in an unjust war, or whether military orders are unjust. I will argue that, especially in light of new work by just war adherents, the moral risks of participating in war are so high that pacifism, at least in its contingent form, should be seen as a reasonable option. The new versions of the just war doctrine bring us much closer to pacifism than their adherents would admit. (shrink)

In this article it will be concluded that systematic menstrual tracking in women’s sport has the potential to cause harm to athletes. Since the ruling of Dobbs v. Jackson Women’s Health Organization (2022) in the United States, concerns regarding menstrual health tracking have arisen. Research suggests that the menstrual tracking of female athletes presents potential risks to “women’s autonomy, privacy, and safety in sport” (Casto 2022, 1725). At present, the repercussions of systematic menstrual tracking are particularly under-scrutinized, and this (...) paper seeks to combine novel research in the sport sciences with present ethical debates in the philosophy of sports. Utilizing Beauvoir’s feminist philosophy (2011), this paper argues that systematic menstrual tracking may contribute to the wider system of women’s oppression by exploiting female athletes, as well as enabling the internalization of submissive behaviour in cultures where athletes are expected to comply unquestioningly. Five policy recommendations are made concerning autonomy, informed consent, education, safeguarding and data access. The overall findings of this paper propose that a more in-depth understanding of the links between data, privacy, and the menstrual cycle are required by sports organizations and governing bodies if athletes are to be protected in a future where systematic menstrual tracking is inevitable. (shrink)

This article focuses on the association between the beliefs of small business owners and managers and their support for the community. Qualitative and quantitative data are utilized in an exploratory examination of two rationales for socially responsible behavior and of two kinds of support. Analyses show that the belief in strengthening the community as an important strategy for business success is positively associated with the provision of nonrisky and risky support. Risky support may threaten short-term business success. However, the belief (...) that a good public image is important for business success is negatively or not significantly associated with either risky or nonrisky support for the community. Findings uphold the position that there are significant variations in enlightened self-interest rationales that are differentially associated with business social performance among small business operators and demonstrate the usefulness of disaggregating social performance into risky and nonrisky variations. (shrink)

Context: The emergency situation caused by coronavirus disease 2019 (COVID-19) has affected different facets of society. Although much of the attention is focused on the health sector, other sectors such as education have also experienced profound transformations and impacts. This sector is usually highly affected by psychosocial risks, and this could be aggravated during the current health emergency. Psychosocial risks may cause health problems, lack of motivation, and a decrease of effectiveness at work, which in turn affect the (...) quality of teaching. Despite their importance, there are hardly any studies that analyze psychosocial risks of non-university teachers during a health emergency such as that caused by COVID-19. Objectives The aim of this study was to analyze the perception of COVID-19 and the psychosocial risks of non-university teachers comparing Spain and Mexico during the state of alarm caused by COVID-19. Methods Data were collected from 421 non-university teachers (80.2% women; 56.3% from Mexico, 43.7% from Spain) aged 24–60 ( M = 39.32, SD = 10.21) via a self-completed questionnaire during the pandemic from March to April 2020. Results Data analysis suggests that inequity is the most important risk, followed by work overload. Teachers appear to be moderately satisfied with the information on COVID-19 and the measures taken, while their satisfaction with the available resources is lower. When comparing the two countries, significant differences can be observed in every risk considered except for social support, with lower levels in Mexican teachers compared to Spanish ones. In the case of the perception of COVID-19 and its impact, the perception in general of levels of information, measures, and resources is better among Mexican teachers than among Spanish ones, who present higher scores of the impact of the health emergency. Conclusion The results underline the importance of the professional’s perception of resources during a health emergency, which could prevent to some extent burnout and possible alterations associated with it. The measures taken by the responsible entities and the provision of information do affect teachers not only directly but also indirectly by making them more vulnerable to psychosocial risks that could affect their health and professional performance, thus affecting students as well. (shrink)

Over the past decade, interest in human enhancement has waxed and waned. The initial surge of interest and funding, driven by the US Army’s desire for a ‘Future Force Warrior’ has partly given way to the challenges of meeting operational demands abroad. However the ethical opportunities provided by soldier enhancement demand that investigation of its possibilities continue. Benefits include enhanced decision-making, improved force capability, reduced force size and lower casualty rates. These benefits — and enhancement itself — carry concomitant (...) class='Hi'>risks, including morale issues due to tension between enhanced and unenhanced soldiers, the issues of enhanced veterans and ownership of enhanced bodies, challenges to the army’s core values and personal identity issues. A range of measures should be designed to highlight the opportunities offered by enhancement while also minimising the potential risks. This includes providing advice on which areas the army ought to demonstrate restraint in research for ethical reasons. (shrink)

The One Health approach to antimicrobial resistance (AMR) requires stakeholders to contribute to cross-sectoral efforts to improve antimicrobial stewardship (AMS). One Health AMR policy implementation is challenging in livestock farming because of the infrastructural role of antibiotics in production systems. Mitigating AMR may require the development of more stringent stewardship obligations and the future limitation of established entitlements. Drawing on Amatai Etzioni’s compliance theory, regulatory analyses and qualitative studies with stakeholder groups we examine the structural and socio-cultural dimension of antibiotic (...) use and AMS compliance in Australian beef and dairy production. We found a disconnect between how antibiotic use is conceptualised by farmers and the way in which AMS policies construe agricultural AMR risks. Under the umbrella of food safety standards and national-level prescribing restrictions, farmers and veterinarians interact around antibiotic use with different operating logics and compliance mechanisms. These parallel regimes service distinct and sometimes competing common goods of food security and antibiotic preservation. Further reforms to mitigate AMR need to account for the value orientations of different groups and the embeddedness of the constraints imposed by existing systems. Advocacy for greater AMR precaution in agriculture should acknowledge and compensate for erosions in competing common goods and the cost of proposed interventions. (shrink)

Lara Buchak defends a Weight-Ranked Utilitarianism (WRU) that she says avoids the critique of Rawls’s that is sometimes thought fatal: utilitarianism unjustifiably blurs the distinction between persons. Buchak’s defence depends upon (i) a version of Harsanyi’s assumption that parties to a social contract should reason as if they have an equal chance of being anyone and (ii) a hypothesis she explores in a recent article. I argue that her assumption and hypothesis are untenable. WRU fails of the generality to which (...) Buchak aspires because it fails for one of her most important cases: the distributive question posed by Rawls. (shrink)

How to avoid disease, how to breed successfully, and how to live to a reasonable age are questions that have perplexed humankind throughout history. This book explores our progress in understanding these challenges, and the risks and rewards of devising solutions. A broad range of topics are covered, including reproduction, the development of human progeny from conception to adulthood, staying healthy, ageing, cancer, infection and the burden of our genetic legacy.

A commentary on “Were There ‘Additional Foreseeable Risks’ in the SUPPORT Study?,” by Henry J. Silverman and Didier Dreyfuss; “SUPPORT: Risks, Harms, and Equipoise,” by Robert M. Nelson; “The Controversy over SUPPORT Continues and the Hyperbole Increases,” by Alan R. Fleischman; and “SUPPORT and Comparative Effectiveness Trials: What's at Stake?,” by Lois Shepherd, all in the January‐February 2015 issue.

A generation ago, we adopted a national system for the protection of human subjects in research. Today, that system is facing new challenges. Many argue that the system has failed to evolve in concert with dramatic changes in the research environment. Accordingly, efforts are underway to reform the existing process to make it both more efficient and more effective. At the same time, many are also reexamining the system in more fundamental ways — going well beyond considerations of policies and (...) compliance and raising questions that go to the very foundations of what constitutes an ethical conduct of human research.Experimentation involving human subjects is a necessary step in the process of translating scientific discovery and technological advancement into procedures and products that offer the prospect of better lives for all of us. It helps us to better understand why we do the things we do and believe what we believe. (shrink)

Assessing social risks has proven difficult for IRBs. We undertook a novel effort to empirically investigate social risks before an HIV prevention trial among drug users in Thailand and China. The assessment investigated whether law, policies and enforcement strategies would place research subjects at significantly elevated risk of arrest, incarceration, physical harm, breach of confidentiality, or loss of access to health care relative to drug users not participating in the research. The study validated the investigator's concern that drug (...) users were subject to serious social risks in the site localities, but also suggested that participation in research posed little or no marginal increase in risk and might even have a protective effect. Our experience shows that it is feasible to inform IRB deliberations with actual data on social risks, but also raises the question of whether and when such research is an appropriate use of scare research resources. (shrink)

Many instances of scientific research impose risks, not just on participants and scientists but also on third parties. This class of social risks unifies a range of problems previously treated as distinct phenomena, including so-called bystander risks, biosafety concerns arising from gain-of-function research, the misuse of the results of dual-use research, and the harm caused by inductive risks. The standard approach to these problems has been to extend two familiar principles from human subjects research regulations—a favorable (...) risk-benefit ratio and informed consent. We argue, however, that these moral principles will be difficult to satisfy in the context of widely distributed social risks about which affected parties may reasonably disagree. We propose that framing these risks as political rather than moral problems may offer another way. By borrowing lessons from political philosophy, we propose a framework that unifies our discussion of social risks and the possible solutions to them. (shrink)

Martin Luther King, Jr., quoting the 19th-century clergyman Theodore Parker, claimed that the arc of the moral universe “bends toward justice.” One hopes he is right, perhaps especially at times when history appears to have taken something of a detour. The 40th anniversary of the Belmont Report offers the opportunity to evaluate the arc of research ethics, to assess where it is going and whether it too is bending toward justice.The Belmont Report is the work of the National Commission, which (...) was charged with identifying “the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects.” The Commission first considered the possibility of deriving these... (shrink)

Some ethicists argue that patient confidentiality is absolute and thus should never be broken. I examine these arguments that when critically scrutinised, become porous. I will explore the concept of patient confidentiality and argue that although, this is a very important medical and bioethical issue, this needs to be wisely delivered to reduce third party harm or even detriment to the patient. The argument for absolute confidentiality is particularly weak when it comes to genetic information and inherited disease.

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies (...) by healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government. (shrink)

In order to illuminate the potential harms of MRI research, we present data obtained by examining MRI research proposal files that had been submitted for review to several Canadian Research Ethics Boards. The data reveal that REB review of the studies contained omissions, considerable variability, and sometimes confusion regarding MRI research risks and risk classification. If our findings reflect the general state of REB review of MRI research in Canada and elsewhere, there is a pressing need for REBs to (...) be educated about MRI risks in order to responsibly facilitate the disclosure of these research risks in consent forms and during the consent process. Developing a standard template consent form that discloses MRI research risks might be a way to ensure attention to and disclosure of risks. (shrink)

In medical research, it is not unusual that risks are ruled out without any specification the exact risk that was ruled out. This makes it difficult to balance expected health benefits and risk of harm when choosing between alternative treatment options. International guidelines for reporting medical research results are sufficiently specific when it comes to establishing health benefits. However, there is a lack of standards for reporting on ruling out risks. We argue that transparency is needed, as in (...) the case of non-inferiority trials. The Consolidated Standards of Reporting Trials and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements should be revised accordingly. (shrink)

Composed of scientific and technical experts and lay members, thousands of research ethics committees—Institutional Review Boards in the United States—must identify and assess the potential risks to human research subjects, and balance those risks against the potential benefits of the research. IRBs handle risk and its uncertainty by adopting a version of the precautionary principle. To assess scientific merit, IRBs use a tacit ``sanguinity principle,'' which treats uncertainty as inevitable, even desirable, in scientific progress. In balancing human subjects (...) risks and scientific benefits, IRBs use uncertainty as a boundary-ordering device that allows the mediation of the science and ethics aspects of their decisions. One effect is the entangling of methodological and ethical review. Some have suggested these should be more clearly separated, but decisions by research ethics committees depend in part on the negotiating space created by incommensurable approaches to uncertainty. (shrink)

A classification of the global catastrophic risks of AI is presented, along with a comprehensive list of previously identified risks. This classification allows the identification of several new risks. We show that at each level of AI’s intelligence power, separate types of possible catastrophes dominate. Our classification demonstrates that the field of AI risks is diverse, and includes many scenarios beyond the commonly discussed cases of a paperclip maximizer or robot-caused unemployment. Global catastrophic failure could happen (...) at various levels of AI development, namely, before it starts self-improvement, during its takeoff, when it uses various instruments to escape its initial confinement, or after it successfully takes over the world and starts to implement its goal system, which could be plainly unaligned, or feature-flawed friendliness. AI could also halt at later stages of its development either due to technical glitches or ontological problems. Overall, we identified around several dozen scenarios of AI-driven global catastrophe. The extent of this list illustrates that there is no one simple solution to the problem of AI safety, and that AI safety theory is complex and must be customized for each AI development level. (shrink)

Objectives: There are indications that institutional review board members do not find it easy to assess the risks and benefits in medical experiments, although this is their principal duty. This study examined how IRB members assessed the risk/benefit ratio of a specific phase II breast cancer clinical trial.Participants and methods: The trial was evaluated by means of a questionnaire administered to 43 members of IRBs at six academic hospitals and specialised cancer centres in the Netherlands. The questionnaire addressed: identification (...) and estimation of inconvenience, toxicity, psychosocial distress, and benefits of trial participation to patients; identification and estimation of benefits to future patients and medical science; assessment of the trial’s RBR; and assessment of its ethical acceptability.Results: Most IRB members expected trial participation to involve fairly or very serious inconvenience, fairly severe to sometimes life-threatening toxicity, and serious psychological and social consequences. Conversely, the perceived likelihood of benefits to patients was modest. Most regarded the study as important, and the balance between risks and benefits to be favourable, and believed that the protocol should be approved. The IRB members’ final judgement on the trial’s ethical acceptability was significantly correlated with their RBR assessment of the protocol.Conclusions: Because most patients who participate in clinical trials hope this will prolong their lives, it is suggested that patient information should better describe the anticipated benefits—for example, the likelihood of prolonging life. This would allow patients to make decisions regarding participation based on realistic expectations. (shrink)

SUPPORT, a study involving approximately 1,300 premature infants who were randomly assigned to treatment protocols that differed in whether they offered higher or lower levels of oxygen saturation, was purportedly an example of comparative effectiveness research performed in the intensive care unit. However, SUPPORT became highly controversial. One source of controversy involved the proper determination of “reasonably foreseeable risks.” Commentators debated whether randomization to contrasting restrictive strategies that are within existing standard‐of‐care treatments imposed additional “reasonably foreseeable risks” greater (...) than what study participants would have received outside of the research. A second controversial issue had to do with disclosures in informed consent documents. This article explores these issues.We argue that randomization to contrasting restrictive interventions lying at the outer ends of “standard‐of‐care” practices differs in important ways from unrestricted “standard‐of‐care” practices available outside of a proposed study; that research involving such randomization might pose additional “reasonably foreseeable risks” from what occurs in “standard‐of‐care” practices; and that for trials whose study designs are similar to the SUPPORT study, respect for persons requires the disclosure of information about the nature of the experimental procedures and their risks. (shrink)

Volume 25, Issue 2, February 2025, Page 61-64.

The American Journal of Bioethics, Volume 12, Issue 10, Page 12-14, October 2012.

Biesta states at the beginning of his intervention that he will speak “as an educationalist” outside not only of “philosophical work with children” but “outside of philosophy”. What are the implications of these assumptions in terms of “what is philosophy?” and “what is education?” Can we really speak about “philosophical work with children” outside philosophy? What are the consequences of taking this position? From this initial questioning, in this response some other questions are offered to Biesta’s presentation: is philosophical work (...) with children about asking better questions or asking questions better as he states in his presentation? Finally, pfc risks as presented by Biesta are examined: a) being reduce to critical thinking, i.e., “to keep a clear head”; b) even being extended to creative and caring thinking, it could “stay in the head” and “not touch the soul”; c) that through the building of communities of inquiry in the classroom, we establish a kind of artificial setting where “we end up living in an idea about the world rather than the world”. The response ends with a last reference to Biesta’s approach of education in terms of “growing” and existence in terms of a “grown-up way” of being in the world. (shrink)