Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Technological revolutions are dissected into three stages: the introduction stage, the permeation stage, and the power stage. The information revolution is a primary example of this tripartite model. A hypothesis about ethics is proposed, namely, ethical problems increase as technological revolutions progress toward and into the power stage. Genetic technology, nanotechnology, and neurotechnology are good candidates for impending technological revolutions. Two reasons favoring their candidacy as revolutionary are their high degree of malleability and their convergence. Assuming the emerging technologies develop (...) into mutually enabling revolutionary technologies, we will need better ethical responses to cope with them. Some suggestions are offered about how our approach to ethics might be improved. (shrink)

Gene-editing technologies, such as CRISPR/Cas9, are internationally ethically fraught. In the United States, policy surrounding gene-editing has yet to be implemented, while the science continues to speed ahead. However, it is not enough that policy be implemented: in order for policy to establish limits for the technology such that benefits are possible while threats are kept at bay, such policy must be ethical. In turn, the ethics of gene-editing is a culturally determined field of inquiry. This piece presents a proposal (...) for a study whose goal is to arrive at ethical policy recommendations for policymakers. To achieve this goal, this study proposes, what needs to be done is, first, to understand the full history and foundation of gene-editing by conducting a thorough legal, bioethical, and policy review for precedent assisted reproductive technologies and genetic reproductive technologies. Following this effort, an empirical study must be conducted involving careful surveys of key stakeholder groups on their knowledge and opinions of gene-editing. Such stakeholder groups must include bioethicists, medical geneticists, and lay persons, including those in the disability community. (shrink)

The purpose of this article is to reflect on the changes that the implementation of artificial wombs would bring to society, the family, and the concept of motherhood and fatherhood through the lens of two recent books: Helen Sedgwick’s The Growing Season and Rebecca Ann Smith’s Baby X. Each of the two novels, set in a near future, follows the work of a scientist who develops artificial womb technology. Significantly, both women experience concerns about the technology and its long-term effects (...) that make both of them leave their laboratories and rethink the technology they invented, while considering its many ethical implications. Both novels can be seen as feminist revisionary rewritings of Aldous Huxley’s Brave New World, rejecting the vision of rows of mass-produced, anonymous babies in artificial wombs, stressing instead the closeness of the parents to their offspring. They nevertheless critically evaluate not only the many potential benefits for women of ectogenetic technology but also the possible disadvantages and pitfalls. (shrink)

The precautionary principle has often been described as an extreme principle that neglects science and stifles innovation. However, such an interpretation has no support in the official definitions of the principle that have been adopted by the European Union and by the signatories of international treaties on environmental protection. In these documents, the precautionary principle is a guideline specifying how to deal with certain types of scientific uncertainty. In this contribution, this approach to the precautionary principle is explicated with the (...) help of concepts from the philosophy of science and comparisons with general notions of practical rationality. Three major problems in its application are discussed, and it is concluded that to serve its purpose, the precautionary principle has to (1) be combined with other decision principles in cases with competing top priorities, (2) be based on the current state of science, which requires procedures for scientific updates, and (3) exclude potential dangers whose plausibility is too low to trigger meaningful precautionary action. (shrink)

Value Sensitive Design (VSD) is an established method for integrating values into technical design. It has been applied to different technologies and, more recently, to artificial intelligence (AI). We argue that AI poses a number of challenges specific to VSD that require a somewhat modified VSD approach. Machine learning (ML), in particular, poses two challenges. First, humans may not understand how an AI system learns certain things. This requires paying attention to values such as transparency, explicability, and accountability. Second, ML (...) may lead to AI systems adapting in ways that ‘disembody’ the values embedded in them. To address this, we propose a threefold modified VSD approach: 1) integrating a known set of VSD principles (AI4SG) as design norms from which more specific design requirements can be derived; 2) distinguishing between values that are promoted and respected by the design to ensure outcomes that not only do no harm but also contribute to good; and 3) extending the VSD process to encompass the whole life cycle of an AI technology in order to monitor unintended value consequences and redesign as needed. We illustrate our VSD for AI approach with an example use case of a SARS-CoV-2 contact tracing app. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Innovation in basic science is often a cause for won­der and excitement. Those associated with a new development are quick to point out the anticipated benefits: a cure for cancer or dementia, an end to unsafe water or hunger. These advocates are slower to draw at­tention to the possible costs, which may become known only much later. It is always hard to have an accurate overview, as it is almost impossible to predict the total effects of the widespread adoption of (...) any new technology and, especially, its longer‐term or cumulative effects, as as­bestos and CFCs demonstrate. For this reason, some policy‐makers or members of the public hope that we can apply “the precautionary principle” to innovation. Unfortunately, if one is looking for a principle that can guide action, then, strictly speaking, there is no pre­cautionary principle. One might better speak of a “pre­cautionary approach,” although even this needs to be unpacked. (shrink)

Empirical research into the ethics of emerging technologies, often involving foresight studies, technology assessment or application of the precautionary principle, raises significant epistemological challenges by failing to explain the relative epistemic status of contentious normative claims about future states. This weakness means that it is unclear why the conclusions reached by these approaches should be considered valid, for example in anticipatory ethical assessment or governance of emerging technologies. This paper explains and responds to this problem by proposing an account of (...) how the epistemic status of uncertain normative claims can be established in ethical and political discourses based on Jürgen Habermas’ discourse ethics. To better understand the nature of the problem, the relationship between norms, facts and the future is explored in light of potential meta-ethical fallacies faced in the field of empirical ethics. Weaknesses of current approaches to anticipatory ethical assessment and governance are then explored, including the Precautionary Principle and Technology Assessment. We argue that the epistemic status of uncertain normative claims can be understood within Habermas’ approach to political discourse, which requires ‘translation’ of uncertain claims to be comprehensible to other stakeholders in discourse. Translation thus provides a way to allow for uncertain normative claims to be considered alongside other types of validity claims in discourse. The paper contributes a conceptual account of the epistemic status of uncertain normative claims in discourse and begins to develop a ‘methodology of translation’ which can be further developed for approaches to research and ethical assessment supporting anticipatory evidence-based policy, governance and system design. (shrink)

Clustered regularly interspaced short palindromic repeats genome editing has already reinvented the direction of genetic and stem cell research. For more complex diseases it allows scientists to simultaneously create multiple genetic changes to a single cell. Technologies for correcting multiple mutations in an in vivo system are already in development. On the surface, the advent and use of gene editing technologies is a powerful tool to reduce human suffering by eradicating complex disease that has a genetic etiology. Gene drives are (...) CRISPR mediated alterations to genes that allow them to be passed on to subsequent populations at rates that approach one hundred per cent transmission. Therefore, from an anticipatory biomedical ethics perspective, it is possible to conceive gene drive being used with CRISPR to permanently ameliorate aberrant genes from wild-type populations containing mutations. However, there are also a number of possible side effects that could develop as the result of combining gene editing and gene drive technologies in an effort to eradicate complex diseases. In this paper, we critically analyse the hypothesis that the combination of CRISPR and gene drive will have a deleterious effect on human populations from an ethical perspective by developing an anticipatory ethical analysis of the implications for the use of CRISPR together with gene drive in humans. (shrink)

This discussion note offers a preliminary analysis of what recent developments in human germline gene editing tell us about the effectiveness of speculative and anticipatory modes of techno-ethics. It argues that the benefits of speculative discussions are difficult to detect thus far, and that pushing the focal point of ethical discourse well ahead of the current state of technology may prematurely undermine existing norms long before a broad consensus would justify moving beyond them.

During the last decades several tools have been developed to anticipate the future impact of new and emerging technologies. Many of these focus on ‘hard,’ quantifiable impacts, investigating how novel technologies may affect health, environment and safety. Much less attention is paid to what might be called ‘soft’ impacts: the way technology influences, for example, the distribution of social roles and responsibilities, moral norms and values, or identities. Several types of technology assessment and of scenario studies can be used to (...) anticipate such soft impacts. We argue, however, that these methods do not recognize the dynamic character of morality and its interaction with technology. As a result, they miss an important opportunity to broaden the scope of social and political deliberation on new and emerging technologies.In this paper we outline a framework for building scenarios that enhance the techno-moral imagination by anticipating how technology, morality and their interaction might evolve. To show what kind of product might result from this framework, a scenario is presented as an exemplar. This scenario focuses on developments in biomedical nanotechnology and the moral regime of experimenting with human beings. Finally, the merits and limitations of our framework and the resulting type of scenarios are discussed. (shrink)

Nanotechnology presents significant challenges in terms of developing a regulatory framework. This is due to a lack of scientific knowledge about the behaviour of the technology in its interactions with biological and ecological processes, the environment and other technologies. Crucially, there is a great deal of uncertainty surrounding the potential environmental and human health and safety impacts of NT. Consequently, the development of NT is a potential test case for framing new models of ‘soft law’ voluntary governance as a substitute (...) for traditional command and control type regulation. Driven by ‘new science governance,’ an approach based on a combination of ideas in anticipatory ethics, future-oriented responsibility, upstream public engagement and deliberation and theories of justice may offer a solution. The uniqueness of the approach can be found in the incorporation of anticipatory approaches via public participation and deliberation as the input into procedural justice approaches with distributional justice as the output. The overarching objective of this work is to contribute to the discussion in relation to the internalisation of responsibility and the building of intellectual and societal capacity to anticipate negative consequences before they arise in the hope that such an approach could be the antithesis of the retrospective imposition of responsibility and liability after the harm is done, which is the outcome of traditional regulatory and ethical approaches. Ultimately, the purpose is to contribute to the long-term sustainability of NT. (shrink)

DNA databases have significant commercial value. Direct-to-consumer genetic testing companies have built databanks using samples and information voluntarily provided by customers. As the price of genetic analysis falls, there is growing interest in building such databases by paying individuals for their DNA and personal data. This paper maps the ethical issues associated with private companies paying for DNA. We outline the benefits of building better genomic databases and describe possible concerns about crowding out, undue inducement, exploitation, and commodification. While certain (...) objections deserve more empirical and philosophical investigation, we argue that none currently provide decisive reasons against using financial incentives to secure DNA samples. (shrink)

Does national success with an emerging technology require ethical sacrifices? This question is considered through the simultaneous consideration of ethics, investment, and outcomes in the nine jurisdictions that are making the largest investments in nanotechnologies—an important emerging technology. It is found that while ethical environment has no notable effect on pure and applied research, a more positive ethical environment is associated with measures associated with invention and commercialization. In summary, a race-to-the-top supports invention and commercialization of emerging technologies. A critical (...) finding as it suggests that issues such as corruption and regulation could be critical in limiting the extraction of social and economic benefit from emerging technologies (like nanotechnologies). (shrink)

To analyze which ethically relevant biases have been identified by academic literature in artificial intelligence algorithms developed either for patient risk prediction and triage, or for contact tracing to deal with the COVID-19 pandemic. Additionally, to specifically investigate whether the role of social determinants of health have been considered in these AI developments or not. We conducted a scoping review of the literature, which covered publications from March 2020 to April 2021. ​Studies mentioning biases on AI algorithms developed for contact (...) tracing and medical triage or risk prediction regarding COVID-19 were included. From 1054 identified articles, 20 studies were finally included. We propose a typology of biases identified in the literature based on bias, limitations and other ethical issues in both areas of analysis. Results on health disparities and SDOH were classified into five categories: racial disparities, biased data, socio-economic disparities, unequal accessibility and workforce, and information communication. SDOH needs to be considered in the clinical context, where they still seem underestimated. Epidemiological conditions depend on geographic location, so the use of local data in studies to develop international solutions may increase some biases. Gender bias was not specifically addressed in the articles included. The main biases are related to data collection and management. Ethical problems related to privacy, consent, and lack of regulation have been identified in contact tracing while some bias-related health inequalities have been highlighted. There is a need for further research focusing on SDOH and these specific AI apps. (shrink)

In this article, we report on eight grand challenges for value sensitive design, which were developed at a one-week workshop, Value Sensitive Design: Charting the Next Decade, Lorentz Center, Leiden, The Netherlands, November 14–18, 2016. A grand challenge is a substantial problem, opportunity, or question that motives sustained research and design activity. The eight grand challenges are: Accounting for Power, Evaluating Value Sensitive Design, Framing and Prioritizing Values, Professional and Industry Appropriation, Tech policy, Values and Human Emotions, Value Sensitive Design (...) and Intelligent Algorithms, and Value Tensions. Each grand challenge consists of a discussion of its importance and a set of tractable key questions. (shrink)

Genetic engineering techniques (e.g., CRISPR-Cas) have led to an increase in biotechnological developments, possibly leading to uncertain risks. The European Union aims to anticipate these by embedding the Precautionary Principle in its regulation for risk management. This principle revolves around taking preventive action in the face of uncertainty and provides guidelines to take precautionary measures when dealing with important values such as health or environmental safety. However, when dealing with ‘new’ technologies, it can be hard for risk managers to estimate (...) the societal or environmental consequences of a biotechnology that might arise once introduced or embedded in society due to that these sometimes do not comply with the established norms within risk assessment. When there is insufficient knowledge, stakeholders active in early developmental stages (e.g., researchers) could provide necessary knowledge by conducting research specifically devoted to what these unknown risks could entail. In theory, the Safe-by-Design (SbD) approach could enable such a controlled learning environment to gradually identify what these uncertain risks are, to which we refer as responsible learning. In this paper, we argue that three conditions need to be present to enable such an environment: (1) regulatory flexibility, (2) co-responsibility between researchers and regulators, and (3) openness towards all stakeholders. If one of these conditions would not be present, the SbD approach cannot be implemented to its fullest potential, thereby limiting an environment for responsible learning and possibly leaving current policy behind to anticipate uncertain risks. (shrink)

Approximately a quarter of a billion people around the world suffer from malaria each year. Most cases are located in sub-Saharan Africa where Anopheles gambiae mosquitoes are the principal vectors of this public health problem. With the use of CRISPR-based gene drives, the population of mosquitoes can be modified, eventually causing their extinction. First, we discuss the moral status of the organism and argue that using genetically modified mosquitoes to combat malaria should not be abandoned based on some moral value (...) of A. gambiae. Secondly, we argue that environmental impact studies should be performed to obtain an accurate account of the possible effects of a potential eradication of the organism. However, the risks from the purposeful extinction of A. gambiae should not overtake the benefits of eradicating malaria and risk assessments should be used to determine acceptable risks. Thirdly, we argue that the eventual release of the genetically modified mosquitoes will depend on transparency, community involvement, and cooperation between different nations. (shrink)

Synthetic biology is a cutting-edge area of research that holds the promise of unprecedented health benefits. However, in tandem with these large prospective benefits, synthetic biology projects entail a risk of catastrophic consequences whose severity may exceed that of most ordinary human undertakings. This is due to the peculiar nature of synthetic biology as a ‘threshold technology’ which opens doors to opportunities and applications that are essentially unpredictable. Fears about these potentially unstoppable consequences have led to declarations from civil society (...) groups calling for the use of a precautionary principle to regulate the field. Moreover, the principle is prevalent in law and international agreements. Despite widespread political recognition of a need for caution, the precautionary principle has been extensively criticized as a guide for regulatory policy. We examine a central objection to the principle: that its application entails crippling inaction and incoherence, since whatever action one takes there is always a chance that some highly improbable cataclysm will occur. In response to this difficulty, which we call the ‘precautionary paradox,’ we outline a deliberative means for arriving at threshold of probability below which potential dangers can be disregarded. In addition, we describe a Bayesian mechanism with which to assign probabilities to harmful outcomes. We argue that these steps resolve the paradox. The rehabilitated PP can thus provide a viable policy option to confront the uncharted waters of synthetic biology research. (shrink)

Technological advance affects almost all areas of human life. Rapid digitization, increased mobility, new biotechnologies, and nanotechnology deeply influence, amongst others, industrial production, entertainment, work, military affairs, and individual life. Besides overwhelmingly positive effects on wealth, comfort, innovation, and development, this also raises questions of unintended effects, of tensions with democracy, of the role of citizens, and of its sustainability facing environmental issues. Tools and procedures are needed to cope with this challenging situation. Technology assessment has been developed more than (...) fifty years ago to enable science, the economy, and society to harvest the potential of new technology to the maximum extent possible and to deal responsibly with possible adverse effects. It was developed more than 50 years ago in the U.S. Congress and has diversified considerably in the meantime. Parliamentary TA in many European states and at the international level, participatory TA at the local and regional levels worldwide, and TA as part of engineering processes are the most relevant fields today. Technology assessment is a growing field of interdisciplinary research and scientific policy advice. This volume gives an overview of motivations of TA, its history and its current practices, develops a fresh theoretical perspective on TA rooted in social theory and philosophy, and draws conclusions from the theoretical perspective for the further development of TA's practices. It provides the first comprehensive view on the growing field of TA at the international level. (shrink)