Christian Munthe

There is growing interest in contact tracing apps for pandemic management. It is crucial to consider ethical requirements before, while, and after implementing such apps. In this paper, we illustrate the complexity and multiplicity of the ethical considerations by presenting an ethical framework for a responsible design and implementation of CT apps. Using this framework as a starting point, we briefly highlight the interconnection of social and political contexts, available measures of pandemic management, and a multi-layer assessment of CT apps. We will discuss some trade-offs that arise from this perspective. We then suggest that public trust is of major importance for population uptake of contact tracing apps. Hasty, ill-prepared or badly communicated implementations of CT apps will likely undermine public trust, and as such, risk impeding general effectiveness.

Standard versions of the requirement of informed consent state that patients who are offered to enter a clinical trial of a medical procedure should be informed about risks and possible benefits of this procedure (compared to available alternatives) in order to facilitate a rational decision whether or not to participate. However, in many real cases where new medical procedures are to be clinically tested for the first time the information available for such communication to prospective patients is very scarce, vague and/or uncertain. This phenomenon is illustrated by the clinical introduction of new procedures in reproductive medicine, such as preimplantation genetic diagnosis (PGD). Regarding such procedures, it has ben argued that, in such cases, the quality of the available information may be too low for the obtaining of informed consent to be possible, even if it is successfully communicated. Others, instead, holds that informed consent may always be obtained regardless of the quality of the available information. Unfortunately, the standard litterature on informed consent give no clue as to which of these interpretations is correct. This issue is explored by connecting the concept of informed consent to ethical ideas of respect for autonomy and ideas of rational decision making. It is argued, first, that low quality of available information regarding the risks and possible benefits of a medical procedure may indeed make the obtaining of informed consent from patients to undergo this procedure impossible even in theory. However, it is also argued that whether or not this is the case must be relativized to the actual needs and deires of individual patients. Thus, regarding one and the same procedure, informed consent may be impossible to obtain from some patients due to the low quality of the available information regarding this procedure, but still be possible to obtain from other patients.

Public health is often distinguished from heaslth care in that it is said to serve more 'collective' goals, such as 'the common good' rather than the good of individual people. However, it is not clear what this good is supposed to be (although it is supposed to be 'common'). In regular health care we see in the West a gradual expansion of traditional goals exclusively in terms of length and quality of life to goals having to do more with autonomy - the ability of people to control and direct their own lives. This has lead to a number of questions regarding how such an ethical ideal of promotion of autonomy may be construed, whether or not it really is an ideal, what practical consequences it has etc.

In response to Koplin and Wilkinson, I argue, first, that the uncertain clinical prospects of human-pig chimera based transplantation makes the reason to spend resources for clarifying whether such practice might imply serious ethical breach due to enhanced cognitive capacities of the chimeras rather weak. T he benefits of further pursuing this avenue of research is so uncertain, so that taking even very unclear risks of serious ethical breach is not worth the price in terms of spent resources, and therefore only limited resources should be spent to clarify such risk before the project is abandoned due to unacceptable risks. Second, I argue that as there are some reason to pursue this avenue further, the analogy to the notion of halting all farming of larger animals for food does not hold up. The reason is that we do not need to probe any further any comparable risk to know that such farming practices should be halted. A fundamental underlying issue to the question discussed by Koplin and Wilkinson1 in this paper is formulated when they write: > We should therefore be confident that human-pig chimeras would lack morally relevant cognitive capacities before setting out to use them as a source of transplantable human organs. This leaves open the question of how confident …

The IOC and WADA have announced their ambition to develop control program in order to detect athletes' illegitimate use of genetic technology for enhancing performance. Although it is far from clear what such uses should be counted as illegitimate, as well as to what extent the idea of control programs for such things is a feasible idea, I will assume that such programs will concern so-called somatic genetic modifications that aims at altering the athlete's initial bodily biochemistry in a way that may enhance performance without the presence of any medical reason for undertaking such modifications. This means that the envisioned control-program will have to make use of the method of genetic testing in order to detect the possible presence (or non-presence) of various genetic variants within the athlete. As a consequence of this, several ethical issues familiar within the field of genetic testing for health purposes are suddenly actualised within the area of doping control. These issues concern primarily how to handle and communicate the information about the athlete that is uncovered by such testing. However, due to the ways in which gene doping may be performed, in the case of atheletic control programs, issues of medical safety and the question of what hardships it is reasonable to require of athletes to endure also become paramount. As a consequence, one may ask whether or not sporting ethics will have to consider applying the rule of informed consent in connection to testing programs of the kind here discussed.

Utilitarian arguments on bioethical issues regarding human reproduction typically start with the view that it is wrong, other things being equal, not to procreate when this would have resulted in an additional being with a life worth living. The paper takes this view for granted and examines the common utilitarian claim that overpopulation and destitution in the world mean that, in practice, this obligation to procreate, other things being equal, often turns into a (categorical) obligation not to procreate. A version of this argument is defended -- a version called the argument from transfer -- according to which, rather than having additional children and care for them in order to make them happy, many people in the West ought to abstain from procreation and take care of destitute children already existing. The reasoning leading up to this conclusion raises some philosophical questions, seldom discussed in connection with bioethics, which indicate that the argument from transfer, although supporting the claim above, cannot neutralise the obligation to create more happy people as easily as assumed by utilitarians. It is argued that the argument from transfer may place many people facing the choice of procreation in a peculiar moral dilemma

We consider the implications for the ethical evaluation of research programs of two fundamental changes in the revised research ethical guideline of the Council for International Organizations of Medical Sciences. The first is the extension of scope that follows from exchanging “biomedical” for “health‐related” research, and the second is the new evaluative basis of “social value,” which implies new ethical requirements of research. We use the example of antibiotic resistance interventions to explore the need to consider the instances of what we term the pragmatic risks of such interventions to evaluate the social value of certain kinds of health‐related research. These (pragmatic) risks severely threaten the social value of interventions in every area where human and social responses significantly impact on their effectiveness. Thus, the social value of health‐related research needed to demonstrate its effectiveness depends on the extent and successful management of such risks. Research designed to take into account the management of pragmatic risks also gives rise to similar types of risks, and the potential for social value in light of those risks needs to be considered in ethical reviews based on the new guidelines. We argue that, to handle this new expanded task, the international system of research ethical review addressed by the guidelines needs institutional development.

In recent years a principle for responsible risk-taking called "The Precautionarity Principle" (PP) has been put forward in several policy documents regarding risk-management of technological and environmental issues. PP involves two claims: 1. An ethical claim according to which it is irresponsible to, for example, use new technologies, regdless of how large benefits these are known to bring, unless it has been proven that they will not give rise to unacceptable long term risks. 2. An administrative/political claim according to which the burden of supplying the proof spoken of in claim 1 is to be laid on the supplier of the new technology. This paper deals only with claim 1, which is the real "precautionarity claim". PP has produced much enthusiasm in different political circles, where it is often held out as a landmark for a new thinking in risk-management. However, while claim 2 is clear enough, it is rather obscure how the precautionarity claim is to be understood. In particular, it is not clear to what extent (if any) this claim implies anything new for risk-analysis. This is so since the precautionarity claim does not say anything about what is to be counted as a proof, or what constitutes an unacceptable risk. The paper explores different conlicting interpretations of the precautionarity claim and demonstrates how the choice between these actualise hard ethical issues. In particular, the issue of how much damage we are allowed to cause in order to pursue safety and certainty is discussed. This issue is actualized when new technologies with known beneficiary effects cannot be proven to be "safe enough" according to some interpretations of the precautionarity claim unless investigated for a rather long period of time, during which the technology is not allowed to be used to produce the beneficiary effects it can produce. This problem is structurally similar to a well known issue in medical ethics regarding the rsponsibility of continuing a controlled clinical trial of a drug known to cure when this means that half of the patients suffers extra agony and earlier death because they get a placebo instead of the new drug..

Societal decisions regarding the possible granting of permission for industrial and power plants, waste disposals, traffic routes and other facilities implementing modern science and technology (here simply called technology-decisions) often provoke debates regarding the risks involved. A main theme in these debates concerns the magnitudes of these risks and whether or not they are worth taking to reach some aim. This is also a main theme in traditional risk-analysis and critical discussions of risk-management. However, sometimes the fact that some people do not want to be exposed to the risks in question has been suggested as an independent argument, i.e. regardless of the magnitudes of these risks. A well known phenomenon in this respect on the local and national level is what has been labelled "not in my backyard" (NIMBY), but the argument also has been used on an international level. In accordance, the view that unwanted risks are less acceptable than wanted or indifferent ones (regardless of their magnitudes) has been proposed as being highly relevant for technology-decisions. The paper explores to what extent there are good reasons for accepting such a proposal. The main part of the paper is devoted to an examination of the extent to which the view that unwanted risks are less acceptable than wanted ones can be supported by, on the one hand, welfare-based ethical theories underlying standard models for risk-analysis, such as utilitarianism, and, on the other, a moral requirement to respect the autonomy of individual persons. Also, the very concept of an unwanted risk is explored and some peculiarities are noted. It is argued that no categorical impermissibility of exposing people to unwanted risks can be supported. However, there are still good reasons for policy-makers to consider the degree to which risks are unwanted as a factor in technology-decisions that is relevant independently of the welfare-gains at stake. In particular, policy-makers should avoid paternalism in risk-management, i.e..

Parker’s article is a welcome attempt to address the importance of environmental sustainability in the realm of clinical ethics.1 We support the recent movement to seriously consider the environmental impact of healthcare institutions in bioethics.2 3 Still, we find two partly linked weaknesses of Parker’s analysis and guideline suggestion. These relate to a need in ‘green’ bioethics to see beyond the normal healthcare ethical focus on health-related values related to individual patients, and to primarily adopt institutional ways of framing central decision problems. Traditional bioethics applies a restricted scope of values to assess clinical decisions: primarily health-related patient well-being (including life) and patient autonomy. If a decision improves (or, as in Parker’s inhaler case, maintains) a patient’s health-related well-being, this supports it. However, if a decision improves a patient’s non health-related well-being, say, winning a beauty contest or securing a job by having cosmetic surgery, it is not supported. And so on. This idea of healthcare as, in Michael Walzer’s classic terminology, a separate ‘sphere of justice’ has two interrelated limitations: it reflects a bias towards individual patients over other people, and it restricts the scope of values allowed to influence healthcare ethical judgements. These limitations appear once we see that the issue addressed by Parker can be framed either as prescription decisions taken by individual doctors against the background of …

The notion of the best interest of children figures prominently in family and reproductive policy discussions and there is a considerable body of empirical research attempting to connect the interests of children to how families and society interact. Most of this research regards the effects of societal responses to perceived problems in families, thus underlying policy on interventions such as adoption, foster care and temporary assumption of custodianship, but also support structures that help families cope with various challenges. However, reference to the best interest of children can also be applied to a more basic issue in family policy, namely that of what is to be considered a family in the first place. This issue does not raise any questions regarding the proper conditions for when society should intervene in or change the family context of a child. Rather, it is about what social configurations should be recognized as a potentially fitting context for children to enter into and (if all goes well) eventually develop into adulthood within /.../ such that society’s default institutional arrangements allow it to have (by sexual and artificial reproduction, adoption, and combinations of these), care for and/or guard children. [This] will frame any further discussion of /.../ policies having further implications for, for example, the practices of adoption and reproductive technology, as well as regulation of custody in the event of separation or parental disagreement.

Daniel Steel’s new book on the precautionary principle illustrates the need to work ahead to fuse perspectives of epistemology and philosophy of science with those of ethics to accomplish progress in the debate on the proper role of precaution in a broad selection of bioethical areas. Steel advances the territory greatly with regard to conceptual clarity and epistemology, but from a bioethics standpoint he is mistaken in discounting the need for ethical underpinnings of a sound theory of the precautionary principle.

This article addresses how health professionals should monitor and safeguard their patients’ ability to participate in making clinical decisions and making subsequent decisions regarding the implementation of their treatment plan. Patient participation in clinical decision-making is essential, e.g. in self-care, where patients are responsible for most ongoing care. We argue that one common, fact-oriented patient education strategy may in practice easily tend to take a destructive form that we call error trawling. Illustrating with empirical findings from a video study of consultations between clinicians and adolescent patients with diabetes, we argue on independent grounds that this strategy not only risks to overlook significant weaknesses in patient decision competence, but also to undermine patient capacity for decision-making and implementing care. In effect, this strategy for clinically monitoring and addressing the problem of fragile decision-making capacity brings hazards in need of address. We clo...

Human consumption of pharmaceuticals often leads to environmental release of residues via urine and faeces, creating environmental and public health risks. Policy responses must consider the normative question how responsibilities for managing such risks, and costs and burdens associated with that management, should be distributed between actors. Recently, the Polluter Pays Principle (PPP) has been advanced as rationale for such distribution. While recognizing some advantages of PPP, we highlight important ethical and practical limitations with applying it in this context: PPP gives ambiguous and arbitrary guidance due to difficulties in identifying the salient polluter. Moreover, when PPP does identify responsible actors, these may be unable to avoid or mitigate their contribution to the pollution, only able to avoid/mitigate it at excessive cost to themselves or others, or excusably ignorant of contributing. These limitations motivate a hybrid framework where PPP, which emphasizes holding those causing large-scale problems accountable, is balanced by the Ability to Pay Principle (APP), which emphasizes efficiently managing such problems. In this framework, improving wastewater treatment and distributing associated financial costs across water consumers or taxpayers stand out as promising responses to pharmaceutical pollution from human use. However, sound policy depends on empirical considerations requiring further study.

The Swedish solution to the legal handling of professional conscientious refusal in healthcare is described. No legal right to conscientious refusal for any profession or class of professional tasks exists in Sweden, regardless of the religious or moral background of the objection. The background of this can be found in strong convictions about the importance of public service provision and related civic duties, and ideals about rule of law, equality and non-discrimination. Employee's requests to change work tasks are handled on a case-by-case basis within the frames of labour law, ensuring full voluntariness, and also employer's privilege regarding the organisation and direction of work, and duties of public institutions to provide services. Two complicating aspects of this solution related to the inclusion of ‘alternative medical’ service providers in a national health service, and professional insistence on conscientious refusal rights to accept legalised assisted dying are discussed. The latter is found to undermine the pragmatic reasons behind recent attempts by prolife groups to challenge the Swedish solution related to legal abortion in courts.

Effectiveness is a key criterion in assessing the justification of antibiotic resistance interventions. Depending on an intervention’s effectiveness, burdens and costs will be more or less justified, which is especially important for large scale population-level interventions with high running costs and pronounced risks to individuals in terms of wellbeing, integrity and autonomy. In this paper, we assess the case of routine hospital screening for multi-drug-resistant Gram-negative bacteria (MDRGN) from this perspective. Utilizing a comparison to screening programs for Methicillin-Resistant Staphylococcus aureus (MRSA) we argue that current screening programmes for MDRGN in low endemic settings should be reconsidered, as its effectiveness is in doubt, while general downsides to screening programs remain. To accomplish justifiable antibiotic stewardship, MDRGN screening should not be viewed as a separate measure, but rather as part of a comprehensive approach. The program should be redesigned to focus on those at risk of developing symptomatic infections with MDRGN rather than merely detecting those colonised.

Antibiotic resistance, arising when bacteria develop defences against antibiotics, is creating a public health threat of massive proportions. This raises challenging questions for standard notions in bioethics when suitable policy is to be characterized and justified. We examine the particular proposal of expediting innovation of new antibiotics by cutting various forms of regulatory ‘red tape’ in the standard system for the clinical introduction of new drugs. We find strong principled reasons in favour of such a lowering of the ethical standards of research and the clinical introduction of new antibiotic formulas. However, this support is undermined by pragmatic challenges owing to expected responses from stakeholders, creating uncertainty about which policies could actually be effectively implemented. We describe an underlying dilemma on how to rationally justify compromises between ideal ethical justification and pragmatic risks that needs to be further addressed in this light. We suggest a solution to this dilemma related to proposals of expediting antibiotic drug innovation.

Antibiotic resistance is widely recognized as a major threat to public health and healthcare systems worldwide. Recent research suggests that pollution from antibiotics manufacturing is an important driver of resistance development. Using Sweden as an example, this article considers how industrial antibiotic pollution might be addressed by public actors who are in a position to influence the distribution and use of antibiotics in high-income countries with publicly funded health systems. We identify a number of opportunities for these actors to incentivize industry to increase sustainability in antibiotics production. However, we also show that each alternative would create tensions with other significant policy goals, necessitating trade-offs. Since justifiable trade-offs require ethical consideration, we identify and explore the main underlying normative issues, namely, the weighing of local versus global health interests, the weighing of present versus future health interests, and the role of individualistic constraints on the pursuit of collective goals. Based on this analysis, we conclude that the actors have weighty principled reasons for prioritizing the goal of addressing pollution, but that translating this stance into concrete policy requires accommodating significant pragmatic challenges.