Australia II: A Case Study in Engineering Ethics.

Australia II became the first foreign yacht to win the America's Cup in 1983. The boat had a revolutionary wing keel and a better underwater hull form. In official documents, Ben Lexcen is credited with the design. He is also listed as the sole inventor of the wing keel in a patent application submitted on February 5, 1982. However, as reported in New York Times, Sydney Morning Herald, and Professional Boatbuilder, the wing keel was in fact designed by engineer Peter van Oossanen at the Netherlands Ship Model Basin in Wageningen, assisted by Dr. Joop Slooff at the National Aerospace Laboratory in Amsterdam. Based on telexes, letters, drawings, and other documents preserved in his personal archive, this paper presents van Oossanen's account of how the revolutionary wing keel was designed. This is followed by an ethical analysis by Martin Peterson, in which he applies the American NSPE and Dutch KIVI codes of ethics to the information provided by van Oossanen. The NSPE and KIVI codes give conflicting advice about the case, and it is not obvious which document is most relevant. This impasse is resolved by applying a method of applied ethics in which similarity-based reasoning is extended to cases that are not fully similar. The key idea, presented in Peterson's book The Ethics of Technology (Peterson, The ethics of technology: A geometric analysis of five moral principles, Oxford University Press, 2017), is to use moral paradigm cases as reference points for constructing a "moral map".

Clinical innovation ethics frameworks: A systematic narrative review.

BACKGROUND: It is common for doctors to engage in clinical innovation-i.e. to use novel interventions that differ from standard practice, and that have not yet been shown to be safe or effective according to the usual standards of evidence-based medicine-in the belief that this will benefit their patients. Clinical innovation is currently poorly defined and lacks cohesive oversight mechanisms. METHODS: A systematic narrative review, with the aim of identifying areas of similarity and divergence in innovation ethics frameworks developed across different medical specialties. RESULTS: 47 articles were included in the review. Few ethical issues raised by the ethics frameworks appear to be unique to distinct areas of practice. While variations exist in the oversight mechanisms suggested, these are again not specific to areas of practice, but rather reflect either cautious or more permissive attitudes towards clinical innovation. CONCLUSIONS: There is considerable overlap amongst ethics frameworks developed for use in diverse areas of practice. This reflects a tendency to treat innovative interventions in each area of practice as "exceptional" and a failure to develop "higher order" frameworks such as those that have been developed for research. Those involved in the oversight of clinical innovation need to aim for a balance between exceptionalism and harmonisation.

Guiding Ethical Principles in Engineering Biology Research.

Engineering biology is being applied toward solving or mitigating some of the greatest challenges facing society. As with many other rapidly advancing technologies, the development of these powerful tools must be considered in the context of ethical uses for personal, societal, and/or environmental advancement. Researchers have a responsibility to consider the diverse outcomes that may result from the knowledge and innovation they contribute to the field. Together, we developed a Statement of Ethics in Engineering Biology Research to guide researchers as they incorporate the consideration of long-term ethical implications of their work into every phase of the research lifecycle. Herein, we present and contextualize this Statement of Ethics and its six guiding principles. Our goal is to facilitate ongoing reflection and collaboration among technical researchers, social scientists, policy makers, and other stakeholders to support best outcomes in engineering biology innovation and development.

Moving innovation to practice: an Ethics Committee opinion.

The introduction of new strategies, tests, and procedures into clinical practice raises challenging ethical issues involving evaluation of evidence, balancing benefits and harms, supporting patient autonomy, avoiding conflict of interest, and promoting advances in health-care. The purpose of this document is to assist reproductive health practitioners as they introduce new interventions into the clinical care that they provide to patients. This document replaces the previously published document of the same name, last published in 2016.

The ethics of sensor technology use in clinical research.

Sensor-based technologies are used today in clinical practice, research, and for monitoring people's health in homes across the United States. Although the increasing growth and complexity of such technologies promises both direct and indirect benefits, significant ethical concerns are raised. We discuss several of these concerns, particularly those that arise in clinical research and outline ethical considerations that pertain to the concept of informed consent, participants' understanding of risks and benefits and the need for tailored and accessible information that will enable participants to fully understand research implications. Balancing the benefits with the potential risks of advanced information technology will require ethically astute researchers who can address the challenges that might arise while advancing knowledge with innovation that can improve the lives of patients and families.

Monitoring functional status using a wearable real-time locating technology.

Sensor technologies enable real-time, continuous, and objective monitoring of activity and functioning in later life. In long-term care, timely assessment of functional status is needed to prevent falls and other acute events. However, the electronic forms and paper and pencil tools currently used are time-consuming and conducted too infrequently (e.g., every 6 months) to provide the sensitivity and specificity required. Staff are also unable to detect subtle changes in functioning through observation alone. The purpose of this paper is to discuss the use of a wearable real-time locating system that utilizes ultra wideband radio technology to continuously and objectively measure activity and aspects of functional status. This paper discusses the associated conceptualization and development of the scoring algorithms, raw data transformation, use of traditional paper and pencil tools and electronic health record data to validate sensor data, and other tips for those interested in this type of wearable sensor technology.

Why Do Firms Implement Responsible Innovation? The Case of Emerging Technologies in South Korea.

With the rise of responsible innovation (RI) initiatives in firms that commercialize innovation in recent years, experts have argued that in order for RI to succeed, practical issues must be considered. Accordingly, this paper explores RI from the perspective of Korean emerging technology development firms. Although social benefits are expected from RI, which aims to reduce the side effects of innovations for society, the implementation of RI requires changing firms' existing rules and routines. Therefore, predicting benefits and costs from the firm's perspective can shed light on the likelihood that RI will succeed. In this study, through an expert survey, the relative weights of RI-related benefit criteria (technological level, economic performance, and public contribution) and cost criteria (anticipation, reflexivity, inclusion, and responsiveness) were analyzed. On this basis, trends in priorities for RI levels were evaluated from present and future perspectives. Unexpectedly, firms recognized that even if constraints such as RI impose greater costs, they will eventually bring greater benefits. This finding indicates that innovation induced by RI overcomes obstacles, offsets costs, and then finally increases firms' competitiveness, and that firms are willing to do good for society through RI. In the long term, a firm's ethical activities may eventually result in improved performance by its management. Therefore, it can be concluded that, even if RI is enforced in a compulsory manner, it is highly likely that it can be well established and promoted even in firms that consider profit first.

Intelligent, Autonomous Machines in Surgery.

Surgeons perform two primary tasks: operating and engaging patients and caregivers in shared decision-making. Human dexterity and decision-making are biologically limited. Intelligent, autonomous machines have the potential to augment or replace surgeons. Rather than regarding this possibility with denial, ire, or indifference, surgeons should understand and steer these technologies. Closer examination of surgical innovations and lessons learned from the automotive industry can inform this process. Innovations in minimally invasive surgery and surgical decision-making follow classic S-shaped curves with three phases: (1) introduction of a new technology, (2) achievement of a performance advantage relative to existing standards, and (3) arrival at a performance plateau, followed by replacement with an innovation featuring greater machine autonomy and less human influence. There is currently no level I evidence demonstrating improved patient outcomes using intelligent, autonomous machines for performing operations or surgical decision-making tasks. History suggests that if such evidence emerges and if the machines are cost effective, then they will augment or replace humans, initially for simple, common, rote tasks under close human supervision and later for complex tasks with minimal human supervision. This process poses ethical challenges in assigning liability for errors, matching decisions to patient values, and displacing human workers, but may allow surgeons to spend less time gathering and analyzing data and more time interacting with patients and tending to urgent, critical-and potentially more valuable-aspects of patient care. Surgeons should steer these technologies toward optimal patient care and net social benefit using the uniquely human traits of creativity, altruism, and moral deliberation.

Introducing a Future-Oriented Approach to Health-Care Technologies and Welfare Policies: An Innovative Ethics Project in Sweden.

This article is a description of a 2-year program (May 2017-April 2019) intended to introduce new approaches to addressing ethical issues resulting from the introduction of new health-care technologies and welfare policies. In contrast to the traditional retrospective approach in addressing ethical issues after they occur, this program intended to address ethical issues proactively, before they occurred. This future-focused approach is one way to better keep up with the acceleration of change that society confronts. This project introduced innovative approaches in dealing with unintended consequences and ethical issues resulting from the implementation of new health-care technologies and welfare policies in the Halland region of Sweden.

The ethics of innovation for Alzheimer's disease: the risk of overstating evidence for metabolic enhancement protocols.

Medical practice is ideally based on robust, relevant research. However, the lack of disease-modifying treatments for Alzheimer's disease has motivated "innovative practice" to improve patients' well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients (clinical ethics); second, about the way in which data from new non-validated practice are communicated via the scientific and lay press (scientific communication ethics); and third, about the prospect of making new non-validated interventions widely available before more definitive testing (public health ethics). We argue that the authors of metabolic enhancement protocols for Alzheimer's disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer's disease.

The Belmont Report and Innovative Practice.

One of the Belmont Report's most important contributions was the clear and serviceable distinction it drew between standard medical practice and biomedical research. A less well-known achievement of the Report was its conceptualization of innovative practice, a type of medical practice that is often mistaken for research because it is new, untested, or experimental. Although the discussion of innovative practice in Belmont is brief and somewhat cryptic, this does not reflect the significant progress its authors made in understanding innovative practice and the distinctive ethical issues it raises. This article explores the history and broader context of Belmont's conception of innovative practice, its strengths and weaknesses, and its contemporary relevance for scholars working in bioethics and health policy. While this conception of innovative practice deserves our attention, it is inherently limited in some important ways.

Knowledge development, technology and questions of nursing ethics.

This article explores emerging ethical questions that result from knowledge development in a complex, technological age. Nursing practice is at a critical ideological and ethical precipice where decision-making is enhanced and burdened by new ways of knowing that include artificial intelligence, algorithms, Big Data, genetics and genomics, neuroscience, and technological innovation. On the positive side is the new understanding provided by large data sets; the quick and efficient reduction of data into useable pieces; the replacement of redundant human tasks by machines, error reduction, pattern recognition, and so forth. However, these innovations require skepticism and critique from a profession whose mission is to care for and protect patients. The promise of technology and the new biological sciences to radically and positively transform healthcare may seem compelling when couched in terms of safety, efficiency, and effectiveness but their role in the provision of ethical nursing care remains uncertain. Given the profound moral and clinical implications of how today's knowledge is developed and utilized, it is time to reconsider the relationship between ethics and knowledge development in this new uncharted area.

Industrial Biotechnology: To What Extent Is Responsible Innovation on the Agenda?

The UK Industrial Biotechnology (IB) Strategy presents a consistent plan to develop the IB sector but fails to endorse an innovation process that allows for input from multiple publics. This could be disadvantageous for the bioeconomy: there are notable cases where negligence to address societal dimensions has caused innovation failure.

The Ethics of Socially Assistive Robots in Aged Care. A Focus Group Study With Older Adults in Flanders, Belgium.

OBJECTIVES: Socially assistive robots (SARs) need to be studied from older adults' perspective, given their predicted future ubiquity in aged-care settings. Current ethical discourses on SARs in aged care are uninformed by primary stakeholders' ethical perceptions. This study reports on what community-dwelling older adults in Flanders, Belgium, perceive as ethical issues of SARs in aged care. METHODS: Constructivist grounded theory guided the study of 9 focus groups of 59 community-dwelling older adults (70+ years) in Flanders, Belgium. An open-ended topic guide and a modified Alice Cares documentary focused discussions. The Qualitative Analysis Guide of Leuven (QUAGOL) guided data analysis. RESULTS: Data revealed older adults' multidimensional perceptions on the ethics of SARs which were structured along three sections: (a) SARs as components of a techno-societal evolution, (b) SARs' embeddedness in aged-care dynamics, (c) SARs as embodiments of ethical considerations. DISCUSSION: Perceptions sociohistorically contextualize the ethics of SAR use by older adults' views on societal, organizational, and relational contexts in which aged care takes place. These contexts need to inform the ethical criteria for the design, development, and use of SARs. Focusing on older adults' ethical perceptions creates "normativity in place," viewing participants as moral subjects.

The American Democratic Deficit in Assisted Reproductive Technology Innovation.

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely those who work within the U.S. Food and Drug Administration, the public is unable to participate in the decision-making process. This lack of a public discourse undermines the goals of the administrative state, which include democratic participation, transparency, and accountability. The United Kingdom, on the other hand, has had a markedly divergent experience with assisted reproductive technology innovation. Instead of ignoring the various ethical, social, and legal issues surrounding assisted reproductive technology innovation, the United Kingdom engaged in a five-strand public consultation on the topic of mitochondrial transfer, a form of assisted reproductive technology that uses genetic modification in order to prevent disease transmission. This article argues that after a multi-decade standstill in terms of the public discourse related to ethical issues associated with assisted reproductive technology and germline modification, it is time for the United States to institute a more democratic inquiry into the scientific, ethical, and social implications of new forms of assisted reproductive technology and ultimately, forthcoming medical innovations that involve genetic modification.

[Genetic edition and theological ethics]. / Reflexiones ético-teológicas ante la edición genética.

This paper tries to look forward to the incoming ethical challenges related with genetic editing. It begins with contextualizing genetic edition within the specific nature of modern technology. Afterwards it presents the contrast between natural beings and artifacts that sheds light for answering the question about the real possibility of replacing natural beings, as they are, with technologically projected living beings. In the third place, after acknowledging the scarce attention given by contemporary theology to technology, it shows the convergence of the Christian concept of creation with the respect for balance in nature, as most part of the contemporaty ecological sensibility upholds. Building on this common ground it shows that the Christian attitude towards technology is not technofobical but the integration of technology -a central element of contemporary culture- with nature, accepting the limitation of any natural being including mankind. In this way, vulnerability, as a visible consequence of this finitude, is the very attribute of human beings that makes ourselves equal and requieres recongnition of our common dignity, way over the idea of acquiring an ideal perfection through technology, even if it was accesible to all.

Building the case for actionable ethics in digital health research supported by artificial intelligence.

The digital revolution is disrupting the ways in which health research is conducted, and subsequently, changing healthcare. Direct-to-consumer wellness products and mobile apps, pervasive sensor technologies and access to social network data offer exciting opportunities for researchers to passively observe and/or track patients 'in the wild' and 24/7. The volume of granular personal health data gathered using these technologies is unprecedented, and is increasingly leveraged to inform personalized health promotion and disease treatment interventions. The use of artificial intelligence in the health sector is also increasing. Although rich with potential, the digital health ecosystem presents new ethical challenges for those making decisions about the selection, testing, implementation and evaluation of technologies for use in healthcare. As the 'Wild West' of digital health research unfolds, it is important to recognize who is involved, and identify how each party can and should take responsibility to advance the ethical practices of this work. While not a comprehensive review, we describe the landscape, identify gaps to be addressed, and offer recommendations as to how stakeholders can and should take responsibility to advance socially responsible digital health research.

Owning Ethical Innovation: Claims about Commercial Wearable Brain Technologies.

The wearable neurotechnology market targets consumers with promises of cognitive benefit and personal wellness. Scientific evidence is essential to substantiate claims about utility, safety, and efficacy and for informed choice and public trust.