We argue that some algorithms are value-laden, and that two or more persons who accept different value-judgments may have a rational reason to design such algorithms differently. We exemplify our claim by discussing a set of algorithms used in medical image analysis: In these algorithms it is often necessary to set certain thresholds for whether e.g. a cell should count as diseased or not, and the chosen threshold will partly depend on the software designer’s preference between avoiding false positives and (...) false negatives. This preference ultimately depends on a number of value-judgments. In the last section of the paper we discuss some general principles for dealing with ethical issues in algorithm-design. (shrink)

A majority opinion seems to have emerged in scholarly analysis of the assortment of technologies that have been given the label “synthetic biology.” According to this view, society should allow the technology to proceed and even provide it some financial support, while monitor­ing its progress and attempting to ensure that the development leads to good outcomes. The near‐consensus is captured by the U.S. Presidential Commission for the Study of Bioethical Issues in its report New Directions: The Ethics of Synthetic Biology (...) and Emerging Technologies, which arguably marked the end of a preliminary round of analysis about the ethical and policy questions raised by synthetic bi­ology. Like a number of other, earlier documents issued by various groups around the world, the re­port called attention to questions about how the technology will be used; whether it might be mis­used; what sorts of accidents might happen along the way; the economic, environmental, and social impacts of the eventual applications; whether the very idea of “synthetic biology” should be trou­bling; and how the debate over all of these ques­tions will be conducted. Also like most similar documents, however, while it called for careful monitoring and oversight of technology, it did not recommend any significant new constraints on its development and use. The commission's stance was that it would be “imprudent either to declare a moratorium on synthetic biology until all risks can be determined and mitigated, or to simply ‘let science rip,’ regardless of the likely risks.”In this report, we will take stock of the current consensus, comment on some of the major points of disagreement, and identify the next steps for the debate. In part I, we offer a brief overview of the research and applications commonly grouped together under the heading of synthetic biology, partly in order to set the stage for the rest of the discussion and partly because we want to highlight some conceptual problems that attend the very la­bel given this field. In parts II, III, and IV, we take up, respectively, three broad classes of concerns that arise in the context of synthetic biology: con­cerns about the intrinsic or inherent value of do­ing synthetic biology, concerns about the concrete harms and benefits of doing synthetic biology, and concerns about justice. Addressing these concerns requires a method for bringing the public's values to bear on policy‐making concerning emerging biotechnologies; in part V, we discuss the chal­lenges in developing such a method. (shrink)

Confronted with the possibility of severe environmental harms, such as catastrophic climate change, some researchers have suggested that we should abandon the principle at the heart of standard decision theory—the injunction to maximize expected utility—and embrace a different one: the Precautionary Principle. Arguably, the most sophisticated philosophical treatment of the Precautionary Principle is due to Steel. Steel interprets PP as a qualitative decision rule and appears to conclude that a quantitative decision-theoretic statement of PP is both impossible and unnecessary. In (...) this article, we propose a decision-theoretic formulation of PP in terms of lexical utilities. We show that this lexical model is largely faithful to Steel’s approach, but also that it corrects three problems with Steel’s account and clarifies the relationship between PP and standard decision theory. Using a range of examples, we illustrate how the lexical model can be used to explore a variety of issues related to precautionary reasoning. (shrink)

In the initial phase of the COVID-19 pandemic, Sweden’s response stood out as an exception. For example, Sweden did not introduce any lockdowns, while many other countries did. In this paper I take the Swedish Corona Commission’s critique of the initial Swedish response as a point of departure for a general analysis of precaution in relation to pandemics. The Commission points out that in contrast to many other countries Sweden did not follow ‘the precautionary principle’. Based on this critique, the (...) Commission proposes that the precautionary principle should be included among Sweden’s guiding principles for crisis management. However, as the debate on this principle during the last 30 years indicates, the principle is loaded with problems. I discuss one of these problems, namely its lack of clarity. I argue, however, that this problem is not unsurmountable. A principle is lacking clarity precisely by being a principle and not a rule with a well-defined meaning. As a principle it indicates a direction but does not prescribe a specific action. However, to be action-guiding its content needs to be specified by rational deliberation. With this in mind, I propose a framework for specification of the precautionary principle as applied to pandemics. The framework focuses on the principle’s four key elements: threat, uncertainty, action and responsibility. I also suggest certain general ethical restrictions on specification. (shrink)

Two interpretations of the precautionary principle are considered. According to the normative interpretation, the precautionary principle should be characterised in terms of what it urges doctors and other decision makers to do. According to the epistemic interpretation, the precautionary principle should be characterised in terms of what it urges us to believe. This paper recommends against the use of the precautionary principle as a decision rule in medical decision making, based on an impossibility theorem presented in Peterson . However, the (...) main point of the paper is an argument to the effect that decision theoretical problems associated with the precautionary principle can be overcome by paying greater attention to its epistemic dimension. Three epistemic principles inherent in a precautionary approach to medical risk analysis are characterised and defended. (shrink)

In recent years, personalized medicine (PM) has become a highly regarded line of development in medicine. Yet, it is still a relatively new field. As a consequence, the discussion of its future developments, in particular of its ethical implications, in most cases can only be anticipative. Such anticipative discussions, however, pose several challenges. Nevertheless, they play a crucial role for shaping PM’s further developments. Therefore, it is vital to understand how the ethical discourse on PM is conducted, i.e. on what (...) – empirical and normative – assumptions ethical arguments are based regarding PM’s current and future developments. (shrink)

To tackle zoonotic disease threats, a One Health approach is currently commonplace and generally understood as an integrated effort of multiple disciplines to promote the health of humans, animals and the environment. To implement One Health strategies in zoonotic disease control, many countries set up early warning systems, in which human and veterinary health professionals cooperate. These systems, like the Dutch Zoonoses Structure, can be successful to detect emerging disease threats. However, these systems are not well equipped to handle moral (...) dilemmas that can arise in zoonotic disease control, like the culling of healthy animals. This research studies the role of normative presuppositions of professionals involved in zoonotic disease control policies in the Netherlands. We found that these professionals in general adhered to a holistic view of the One Health concept, however, in practice an anthropocentric approach was dominant. Public health was identified as the trumping moral value, which reveals an inherent field of tension with the core of One Health thinking. The lack of ethical expertise in control systems for zoonotic diseases can lead to misconception of ethical principles, like the precautionary principle which is frequently evoked to justify disease control measures. (shrink)

In order to receive controlled pain medications for chronic non-oncologic pain, patients often must sign a “narcotic contract” or “opioid treatment agreement” in which they promise not to give pills to others, use illegal drugs, or seek controlled medications from health care providers. In addition, they must agree to use the medication as prescribed and to come to the clinic for drug testing and pill counts. Patients acknowledge that if they violate the opioid treatment agreement, they may no longer receive (...) controlled medications. OTAs have been widely implemented since they were recommended by multiple national bodies to decrease misuse and diversion of narcotic medications. But critics argue that OTAs are ethically suspect, if not unethical, and should be used with extreme care if at all. We agree that OTAs pose real dangers and must be implemented carefully. But we also believe that the most serious criticisms stem from a mistaken understanding of OTAs’ purpose and ethical basis. (shrink)

How should liberal-democratic governments deal with emerging vaccination hesitancy when that leads to the resurgence of diseases that for decades were under control? This article argues that vaccination policies should be justified in terms of a proper weighing of the rights of children to be protected against vaccine-preventable diseases and the rights of parents to raise their children in ways that they see fit. The argument starts from the concept of the ‘best interests of the child involved’. The concept is (...) elaborated for this context into the dual regime structure in which parents have fiduciary authority over what they consider to be best for their child, and the state has fiduciary authority over a child’s basic interests. This argument leads to conditional mandatory vaccination programs that should be informed by a correct balancing of the two legal principles of proportionality and precaution. This results in contextual childhood vaccination policies of upscaling interference: a three-tiered approach of increased intrusion, from voluntary program when possible and mandatory or even compulsory programs when necessary to protect the child’s basic interests. (shrink)

The precautionary principle is often invoked in relation to pregnant women and may be one of the underlying reasons for their continuous underrepresentation in clinical research. The principle is appealing, because potential fetal harm as a result of research participation is considered to be serious and irreversible. In our paper, we explore through conceptual analysis whether and if so how the precautionary principle should apply to pregnant women. We argue that the principle is a decision-making strategy underlying risk-benefit decisions in (...) clinical research, which can be applied to pregnant women. However, the current application is a strong one, leading to the promotion of absolute exclusion or, less often, absolute inclusion of pregnant women. In order to change this paralyzing situation, a shift toward weak precautionary thinking is necessary. Instead of automatic extreme precaution, a balance will be found between harms and potential benefits of including pregnant women in clinical research. (shrink)

November 2009’s announcement of the USPSTF’s recommendations for screening for breast cancer raised a firestorm of objections. Chief among them were that the panel had insufficiently valued patients’ lives or allowed cost considerations to influence recommendations. The publicity about the recommendations, however, often either simplified the actual content of the recommendations or bypassed significant methodological issues, which a philosophical examination of both the science behind screening recommendations and their import reveals. In this article, I discuss two of the leading ethical (...) considerations at issue in screening recommendations: respect for patient autonomy and beneficence and then turn to the most significant methodological issues raised by cancer screening: the potential biases that may infect a trial of screening effectiveness, the problem of base rates in communicating risk, and the trade-offs involved in a judgment of screening effectiveness. These issues reach more broadly, into the use of “evidence-based” medicine generally, and have important implications for informed consent. (shrink)

Obstetric ultrasound is the well-recognized prenatal test used to visualize and determine the condition of a pregnant woman and her fetus. Apart from the clinical application, some businesses have started promoting the use of fetal ultrasound machines for nonmedical reasons. Non-medical fetal ultrasound (also known as ‘keepsake’ ultrasound) is defined as using ultrasound to view, take a picture, or determine the sex of a fetus without a medical indication. Notwithstanding the guidelines and warnings regarding ultrasound safety issued by governments and (...) professional bodies, the absence of scientifically proven physical harm to fetuses from this procedure seems to provide these businesses with grounds for rapid expansion. However, this argument is too simplistic because current epidemiological evidence is not synchronous with advancing ultrasound technology. As non-medical fetal ultrasound has aroused very significant public attention, a thorough ethical analysis of this topic is essential. Using a multifaceted approach, we analyse the ethical perspective of non-medical fetal ultrasound in terms of the expectant mother, the fetus and health professionals. After applying four major theories of ethics and principles (the precautionary principle; theories of consequentialism and impartiality; duty-based theory; and rights-based theories), we conclude that obstetric ultrasound practice is ethically justifiable only if the indication for its use is based on medical evidence. Non-medical fetal ultrasound can be considered ethically unjustifiable. Nevertheless, the ethical analysis of this issue is time dependent owing to rapid advancements in ultrasound technology and the safety issue. The role of health professionals in ensuring that obstetric ultrasound is an ethically justifiable practice is also discussed. (shrink)

The COVID-19 pandemic has shown that zoonotic diseases are a great threat for humanity. During the course of such a pandemic, public health authorities often apply the precautionary principle to justify disease control measures. However, evoking this principle is not without ethical implications. Especially within a One Health strategy, that requires us to balance public health benefits against the health interests of animals and the environment, unrestricted use of the precautionary principle can lead to moral dilemmas. In this article, we (...) analyze the ethical dimensions of the use of the precautionary principle in zoonotic disease control and formulate criteria to protect animals and the environment against one-sided interpretations. Furthermore, we distinguish two possible conceptions of the precautionary principle. First, we notice that because of the unpredictable nature of zoonotic diseases, public health authorities in general focus on the idea of precaution as preparedness. This reactive response often leads to difficult trade-offs between human and animal health. We therefore argue that this policy should always be accompanied by a second policy, that we refer to as precaution as prevention. Although zoonotic diseases are part of our natural world, we have to acknowledge that their origin and global impact are often a consequence of our disturbed relation with animals and the environment. (shrink)

In the 1940s and 1950s thousands of lobotomies were performed on people with mental disorders. These operations were known to be dangerous, but thought to offer great hope. Nowadays, the lobotomies of the 1940s and 1950s are widely condemned. The consensus is that the practitioners who employed them were, at best, misguided enthusiasts, or, at worst, evil. In this paper I employ standard decision theory to understand and assess shifts in the evaluation of lobotomy. Textbooks of medical decision making generally (...) recommend that decisions under risk are made so as to maximise expected utility (MEU) I show that using this procedure suggests that the 1940s and 1950s practice of psychosurgery was justifiable. In making sense of this finding we have a choice: Either we can accept that psychosurgery was justified, in which case condemnation of the lobotomists is misplaced. Or, we can conclude that the use of formal decision procedures, such as MEU, is problematic. (shrink)

The COVID-19 pandemic has shown that zoonotic diseases are a great threat for humanity. During the course of such a pandemic, public health authorities often apply the precautionary principle to justify disease control measures. However, evoking this principle is not without ethical implications. Especially within a One Health strategy, that requires us to balance public health benefits against the health interests of animals and the environment, unrestricted use of the precautionary principle can lead to moral dilemmas. In this article, we (...) analyze the ethical dimensions of the use of the precautionary principle in zoonotic disease control and formulate criteria to protect animals and the environment against one-sided interpretations. Furthermore, we distinguish two possible conceptions of the precautionary principle. First, we notice that because of the unpredictable nature of zoonotic diseases, public health authorities in general focus on the idea of precaution as preparedness. This reactive response often leads to difficult trade-offs between human and animal health. We therefore argue that this policy should always be accompanied by a second policy, that we refer to as precaution as prevention. Although zoonotic diseases are part of our natural world, we have to acknowledge that their origin and global impact are often a consequence of our disturbed relation with animals and the environment. (shrink)

Introduction The bioethics literature reflects significant interest in and concern with the use of genetic and genomic information in various settings. Because psychiatric treatment and research raises unique ethical, legal, and social issues, we conducted a scoping review of the biomedical, bioethics, and psychology literature regarding the application of genetic and genomic tools to psychiatric disorders (as listed in the DSM-5) and two associated behaviors or symptoms to provide a more detailed overview of the state of the field. Objectives The (...) primary objective was to examine the available bioethics, biomedical, and psychology literature on applying genetic and genomic tools to psychiatric disorders (other than neurodevelopmental disorders) and two behaviors or symptoms sometimes associated with them (aggression or violence and suicidality) to identify the disorders to which these tools have been applied, the contexts in or purposes for which they have been applied, the ethical, legal, or social concerns associated with those uses, and proposed recommendations for mitigating those concerns. Methods We used Arksey and O’Malley’s scoping review framework: (1) identify the research question; (2) identify relevant studies; (3) select studies; (4) chart the data; and (5) collate, summarize, and report results (2005). We relied on Levac et al. to inform our application of the framework (2010). The PRISMA extension for scoping reviews checklist informed our reporting (2018). We searched three electronic databases MEDLINE (PubMed), Embase, and PsycInfo (EbscoHost) for peer-reviewed journal articles in English to identify relevant literature. One author screened the initial results and additional screening was done in consultation with other authors. A data extraction form using DSM-5 diagnostic categories (excluding neurodevelopmental disorders) was developed and two authors independently each reviewed approximately half of the articles. Inter-rater reliability was ensured by double-coding approximately 10% of the papers. An additional author independently coded 10% of the articles to audit the data. Results In 365 coded publications, we identified 15 DSM-5 diagnostic categories in addition to the two pre-selected behaviors or symptoms (aggression or violence and suicidality) to which genetic or genomic tools have been applied. We identified 11 settings in or purposes for which these tools were applied. Twenty-two types of ethical, legal, or social concerns associated with the application of genetic or genomic tools to these disorders or behaviors/symptoms were identified along with 13 practices or policies that could mitigate these concerns. Conclusion Genetic and genomic tools have been applied to a wide range of psychiatric disorders. These raise a range of ethical, legal, and social concerns. Additional research is warranted to better understand the concerns and effective ways to address them. Advancing the literature to identify relevant ethical, legal, or social concerns and solutions to those problems likely requires greater attention to specific applications of genetic or genomic tools to particular psychiatric disorders and associated behaviors/symptoms as well as broad stakeholder engagement. (shrink)

The bioethics literature has paid little attention to matters of informed reproductive decision-making among women of childbearing age who have chronic kidney disease (CKD), including women who are on dialysis or women who have had a kidney transplant. Women with CKD receive inconsistent and, sometimes, inadequate reproductive counseling, particularly with respect to information about pursuing pregnancy. We identify four factors that might contribute to inadequate and inconsistent reproductive counseling. We argue that women with CKD should receive comprehensive reproductive counseling, including (...) information about the possibility of pursuing pregnancy, and that more rigorous research on pregnancy in women with CKD, including women on dialysis or who have received a kidney transplant, is warranted to improve informed reproductive decision making in this population. (shrink)

Obstetric ultrasound is the well-recognized prenatal test used to visualize and determine the condition of a pregnant woman and her fetus. Apart from the clinical application, some businesses have started promoting the use of fetal ultrasound machines for nonmedical reasons. Non-medical fetal ultrasound (also known as ‘keepsake’ ultrasound) is defined as using ultrasound to view, take a picture, or determine the sex of a fetus without a medical indication. Notwithstanding the guidelines and warnings regarding ultrasound safety issued by governments and (...) professional bodies, the absence of scientifically proven physical harm to fetuses from this procedure seems to provide these businesses with grounds for rapid expansion. However, this argument is too simplistic because current epidemiological evidence is not synchronous with advancing ultrasound technology. As non-medical fetal ultrasound has aroused very significant public attention, a thorough ethical analysis of this topic is essential. Using a multifaceted approach, we analyse the ethical perspective of non-medical fetal ultrasound in terms of the expectant mother, the fetus and health professionals. After applying four major theories of ethics and principles (the precautionary principle; theories of consequentialism and impartiality; duty-based theory; and rights-based theories), we conclude that obstetric ultrasound practice is ethically justifiable only if the indication for its use is based on medical evidence. Non-medical fetal ultrasound can be considered ethically unjustifiable. Nevertheless, the ethical analysis of this issue is time dependent owing to rapid advancements in ultrasound technology and the safety issue. The role of health professionals in ensuring that obstetric ultrasound is an ethically justifiable practice is also discussed. (shrink)

The COVID-19 pandemic once again confirmed that zoonotic diseases are a serious threat to humanity. These infectious diseases, transmitted from animals to humans, have the power to cause a global health crisis. Over time the risk on these outbreaks has increased. Some of the main drivers are global population growth, urbanization, worldwide transport, increased demand for animal protein, unsustainable agriculture, and climate change. This development has fueled a renewed interest in the relation between human, animal and environmental health. This was (...) framed in the concept of One Health: the integrative effort of multiple disciplines working locally, nationally, and globally to attain optimal health for people, animals, and the environment. At present, One Health is the worldwide standard to combat zoonotic diseases. In an ideal world such a strategy should lead to a better health for humans, animals and our environment. However, in practice it is not self-evident that a One Health approach in zoonotic disease control is actually in the interest of animals or the environment. From a holistic One Health perspective it can be difficult to accept the culling of healthy animals to protect public health. The same goes for long term confinement of free-range poultry, whose housing systems are often not suitable for this purpose, to prevent avian influenza outbreaks. Or antimicrobial reduction policies that lead to higher disease incidence and mortality in animals. These ethical considerations formed the start of this thesis. The aim of my research is to clarify the ethical assumptions of a One Health approach in zoonotic disease control, to explore how these can be coherently understood and justified and to indicate what this implies for policymaking. The outcome of my research contributes to the development of an ethic of One Health and will hopefully lead to a more socially acceptable zoonotic disease control. This project is related to the interdisciplinary Wageningen UR strategic research theme ‘Global One Health’. From my conceptual analysis, it follows that there is no universal interpretation of the One Health concept nor of a One Health approach in zoonotic disease control. Nevertheless, One Health has produced several successes in zoonotic disease control, surveillance and research. Due to its ambiguity, the One Health concept functions as a boundary object: by leaving room for interpretation to fit different purposes it facilitates cooperation. In many cases this results in the promotion of health of humans, animals and the environment. However, there are also situations in which this mutual benefit of a One Health approach is not that evident. For instance, when healthy animals are culled to protect public health. To address these moral dilemmas, it is important to develop an ethical framework. Such an ethic of One Health starts with acknowledging the moral status of animals and the indirect moral obligations we have towards ecosystems. Furthermore, it is necessary that we find an appropriate definition of health, which encompasses all three components of One Health. In chapter 3, I present the results of an empirical study on normative presuppositions of health professionals involved in zoonotic disease control policies in the Netherlands. This study reveals that in theory these professionals adhere to a holistic view of the One Health concept. However, in practice an anthropocentric approach was dominant. The study identified public health as a trumping moral value, which reveals an inherent field of tension with the core of One Health thinking. Furthermore, a lack of ethical expertise in control systems for zoonotic diseases can lead to misconception of ethical principles, like the precautionary principle. In chapter 4, I discuss that within a One Health strategy, that requires us to balance public health benefits against the health interests of animals and the environment, unrestricted use of the precautionary principle can lead to moral dilemmas. It must at least be clear that there is a harm and some scientific evidence for a cause and effect relation. Furthermore, precautionary measures should be effective, consistent, proportional and not counterproductive. An assessment of their effect should be integrated in the standard decision-models of public health authorities. Moreover, to ensure societal support these considerations should be transparent and open for dialogue. I present two possible conceptions of the precautionary principle. First, it is noticeable that because of the unpredictable nature of zoonotic diseases, public health authorities focus on the idea of ‘precaution as preparedness’. This reactive response leads to difficult trade-offs between human and animal health. I therefore argue that this policy should always be accompanied by a second policy: ‘precaution as prevention’. Addressing the underlying drivers of zoonotic diseases is a necessary condition to justify disease control measures that harm animals and ecosystems on the basis of the precautionary principle. In chapter 5, I elaborate the responsibilities of veterinarians within the One Health framework. Veterinarians are professionally responsible for the health and welfare of the animals under their care. Moreover, society expects veterinarians to safeguard food safety and public health. These societal expectations are sometimes overdemanding. A holistic perspective on One Health offers veterinarians a way out of the dichotomy between public and animal health, that is at the basis of many moral dilemmas in zoonotic disease control. This is explained with the ‘encapsulated health’ argument: the best way to safeguard human health is to promote the health of animals and the environment. In chapter 6, I conclude that before we decide to implement certain disease control measures, an ethic of One Health requires that we choose those interventions that have the least impact on the health of animals and ecosystems, while still effective enough to stop the disease. My research indicates that the contemporary conception of One Health is necessary but insufficient to address moral dilemmas related to emerging zoonotic diseases. A holistic interpretation of the One Health concept confronts us with underlying value conflicts but will ultimately promote human health more than the current anthropocentric conception. (shrink)