Innovations permeate healthcare settings on an ever-increasing scale. Health technology innovations impact our perceptions and experiences of health, care, disease, etc. Because of the fast pace these HTIs are being introduced in different healthcare settings, there is a growing societal consensus that these HTIs need to be governed by ethical reflection. This paper reports a systematic review of argument-based literature which focused on articles reporting on ethical frameworks to screen or evaluate HTIs. To do this a four step methodology was (...) followed: Literature search conducted in five electronic literature databases; Identification of relevant articles; Development of data-extraction tool to analyze the included articles; Analysis, synthesis of data and reporting of results. Fifty-seven articles were included, each reporting on a specific ethical framework. These ethical frameworks existed out of characteristics which were grouped into five common ones: Motivations for development and use of frameworks; Objectives of using frameworks; Specific characteristics of frameworks ; Ethical approaches and concepts used in the frameworks; Methods to use the frameworks. Although this multiplicity of ethical frameworks shows an increasing importance of ethically analyzing HTIs, it remains unclear what the specific role is of these analyses. An ethics of caution, on which ethical frameworks rely, guides HTIs in their design, development, implementation, without questioning their technological paradigm. An ethics of desirability questions this paradigm, without guiding HTIs. In the end, a place needs to be found in-between, to critically assess HTIs. (shrink)

In this contribution, we set out a framework for ethical research and innovation. Our framework draws upon recent scholarly work recommending the introduction of new models at the intersection of ethics, strategy, and science and technology studies to inform and explicate how the decisions of researchers can be considered ethical. Ethical research and innovation is construed in our framework as a dynamic process emerging from decisions of multiple stakeholders in innovation ecosystems prior to, during and after the execution of a (...) research and innovation project. The framework can be used by different types of research organizations to implement governance models of ethical research and innovation. (shrink)

The integration of ethics into the day-to-day work of research and innovation is an important but difficult challenge. However, with the Aachen method for identification, classification and risk analysis of innovation-based problems an approach from an engineering perspective is presented that enables the integration of ethical, legal and social implications into the day-to-day work of R&I practitioners. AMICAI appears in particular capable of providing a procedural guidance for R&I practitioners based on a method established in engineering science, breaking down the (...) object of consideration into partial aspects and prioritizing the innovation-based problems in dependence of potential risk. This enables the user to apply AMICAI continuously during all stages of the research and development process and to analyze and choose between certain sociotechnical alternatives. In this way, problems that affect ethical, legal, and social aspects can be understood, reflected and considered in the mostly technically focused R&D process. The paper gives a general guidance about AMICAI by describing principles and assumptions, providing the steps of analysis and application aids, giving an example application, explaining the necessary adjustments of AMICAI compared to the methodical basis of failure mode, effects, and criticality analysis and discussing the advantages and limits. AMICAI’s simple applications can stimulate interdisciplinary cooperation in the R&D process and be a starting point for the development of an “open RRI risk analysis platform” allowing society to evaluate innovation-based problems. (shrink)

The approach to innovations known as Responsible research and innovation aims to move the innovation system towards creating products that strive to realize social values along with economic benefits. This paper discusses the systematic assessment of assistive technologies in order for them to meet the aims expressed in RRI. A central issue in the discussion is how to facilitate an integration of insights from the discourse on RRI with more established assessment approaches such as Health Technology Assessment. Based on the (...) literature on existing socio-ethical assessment tools, I investigate how these tools can be combined with HTA and how they can add perspectives from RRI that might increase the socio-ethical value of assistive technologies. Through a discussion on how to understand RRI, HTA, assessment and integration, I suggest a list of four possible approaches that have the potential to be applied as assessment approaches that integrate insights from RRI and HTA. These are then evaluated on their ability to address issues that have emerged from a literature review on RRI and assistive technologies, on empirical studies in this technology field and on their product focus. In conclusion, I argue that the Ethical Impact Assessment, the Socratic approach, the Ethical Matrix, and the HTA Core Model seem to be the most promising methodologies, but that these need adjustments to cover substantive themes from RRI. _Keywords:_ energy scenarios, justice, future generations, capabilities approach. (shrink)

The abundance of literature on ethical concerns regarding artificial intelligence (AI) highlights the need to systematize, integrate, and categorize existing efforts through a systematic literature review. The article aims to investigate prevalent concerns, proposed solutions, and prominent ethical approaches within the field. Considering 309 articles from the beginning of the publications in this field up until December 2021, this systematic literature review clarifies what the ethical concerns regarding AI are, and it charts them into two groups: (i) ethical concerns that (...) arise from the design of AI and (ii) ethical concerns that arise from human–AI interactions. The analysis of the obtained sample highlights the most recurrent ethical concerns. Finally, it exposes the main proposals of the literature to handle the ethical concerns according to the main ethical approaches. It interprets the findings to lay the foundations for future research on the ethics of AI. (shrink)

Scholars, policymakers and organizations in the EU, especially at the level of the European Commission, have turned their attention to the ethics of (trustworthy and human-centric) Artificial Intelligence (AI). However, there has been little reflexivity on (1) the history of the ethics of AI as an institutionalized phenomenon and (2) the comparison to similar episodes of “ethification” in other fields, to highlight common (unresolved) challenges.Contrary to some mainstream narratives, which stress how the increasing attention to ethical aspects of AI is (...) due to the fast pace and increasing risks of technological developments, Science and Technology Studies(STS)-informed perspectives highlight that the rise of institutionalized assessment methods indicates a need for governments to gain more control of scientific research and to bring EU institutions closer to the public on controversies related to emerging technologies.This article analyzes how different approaches of the recent past (i.e. bioethics, technology assessment (TA) and ethical, legal and social (ELS) research, Responsible Research and Innovation (RRI)) followed one another, often “in the name of ethics”, to address previous criticisms and/or to legitimate certain scientific and technological research programs. The focus is on how a brief history of the institutionalization of these approaches can provide insights into present challenges to the ethics of AI related to methodological issues, mobilization of expertise and public participation. (shrink)

BackgroundCRISPR-Cas9, a technology enabling modification of the human genome, is developing rapidly. There have been calls for public debate to discuss its ethics, societal implications, and governance. So far, however, little is known about public attitudes on CRISPR-Cas9. This study contributes to a better understanding of public perspectives by exploring the various holistic perspectives Dutch citizens have on CRISPR-Cas9.MethodsThis study used Q methodology to identify different perspectives of Dutch citizens (N = 30) on the use of CRISPR-Cas9. The Q-sort method (...) aims at segmenting audiences based on the structural characteristics of their perspectives. Participants individually ranked 32 statements about CRISPR-Cas9 and discussed their rankings in small groups. By-person factor analysis was performed using PQMethod. Participants’ contributions to the discussions were used to further make sense of the audience segments identified.ResultsFive perspectives on CRISPR-Cas9 were identified: (1) pragmatic optimism (2) concerned scepticism; (3) normative optimism; (4) enthusiastic support; and (5) benevolent generalism. Each perspective represents a unique position motivated by different ranking rationales. Sorting rationales included improving health, preventing negative impacts on society, and fear of a slippery slope. Overall, there is broad, but not universal support for medical uses of CRISPR-Cas9.ConclusionsResearch on CRISPR-Cas9 should prioritise the broadly supported applications of the technology. Research and public debates on CRISPR-Cas9, its uses, its broader implications, and the governance of CRISPR-Cas9 are recommended. A discourse that includes all perspectives can contribute to the embedding of future uses of CRISPR-Cas9 in society. This study shows that Q methodology followed by group discussions enables citizens to contribute meaningfully to discourses about research. (shrink)

This paper presents results of a systematic literature review of RRI practices which aimed to gather insights to further both the theoretical and practical development of RRI. Analysing practices of RRI and mapping out main approaches as well as the values, dimensions or characteristics pursued with those practices, can add to understanding of the more conceptual discussions of RRI and enhance the academic debate. The results, based on a corpus of 52 articles, show that practices already reflect the rich variety (...) of values, dimensions and characteristics provided in the main definitions in use, although not all are addressed yet. In fact, articles dealing with uptake of RRI practices may be improved by including more methodological information. RRI practices may further the conceptual debate by including more reflection, and these may foster mutual responsiveness between theory and practice by early anticipating impacts. (shrink)

This paper presents results of a systematic literature review of RRI practices which aimed to gather insights to further both the theoretical and practical development of RRI. Analysing practices of RRI and mapping out main approaches as well as the values, dimensions or characteristics pursued with those practices, can add to understanding of the more conceptual discussions of RRI and enhance the academic debate. The results, based on a corpus of 52 articles, show that practices already reflect the rich variety (...) of values, dimensions and characteristics provided in the main definitions in use, although not all are addressed yet. In fact, articles dealing with uptake of RRI practices may be improved by including more methodological information. RRI practices may further the conceptual debate by including more reflection, and these may foster mutual responsiveness between theory and practice by early anticipating impacts. (shrink)

Ethical, legal and social implications are widely regarded as important considerations with respect to technological developments. Agile Worth-Oriented Systems Engineering is an innovative approach to incorporating ethically relevant criteria during agile development processes through a flexibly applicable methodology. First, a predefined model for the ethical evaluation of socio-technical systems is used to assess ethical issues according to different dimensions. The second part of AWOSE ensures that ethical issues are not only identified, but also systematically considered during the design of systems (...) based on information and communication technology. For this purpose, the findings from the first step are integrated with approaches from worth-centered development into a process model that, unlike previous approaches to ethical system development, is thoroughly compatible with agile methodologies like Scrum or Extreme Programming. Artifacts of worth-centered development called Worth Maps have been improved to guide the prioritization of development tasks as well as choices among design alternatives with respect to ethical implications. Furthermore, the improved Worth Maps facilitate the identification of suitable criteria for system evaluations in association to ethical concerns and desired positive outcomes of system usage. The potential of the AWOSE methodology has been demonstrated in the context of a technical system that supports elderly and people with particular handicaps. (shrink)

Purpose Cybersecurity in healthcare has become an urgent matter in recent years due to various malicious attacks on hospitals and other parts of the healthcare infrastructure. The purpose of this paper is to provide an outline of how core values of the health systems, such as the principles of biomedical ethics, are in a supportive or conflicting relation to cybersecurity. Design/methodology/approach This paper claims that it is possible to map the desiderata relevant to cybersecurity onto the four principles of medical (...) ethics, i.e. beneficence, non-maleficence, autonomy and justice, and explore value conflicts in that way. Findings With respect to the question of how these principles should be balanced, there are reasons to think that the priority of autonomy relative to beneficence and non-maleficence in contemporary medical ethics could be extended to value conflicts in health-related cybersecurity. Research limitations/implications However, the tension between autonomy and justice, which relates to the desideratum of usability of information and communication technology systems, cannot be ignored even if one assumes that respect for autonomy should take priority over other moral concerns. Originality/value In terms of value conflicts, most discussions in healthcare deal with the conflict of balancing efficiency and privacy given the sensible nature of health information. In this paper, the authors provide a broader and more detailed outline. (shrink)

PurposeThe purpose of this paper is to develop a critique of value sensitive design (VSD) and to propose an alternative approach that does not depart from a heuristic of value(s), but from virtue ethics, called virtuous practice design (VPD).Design/methodology/approachThis paper develops a philosophical argument, draws from a philosophical method (i.e. virtue ethics) and applies this method to a particular case study that draws from a narrative interview.FindingsIn this paper, authors show how an approach that takes virtue instead of value as (...) the central notion for aiming at a design that is sensitive to ethical concerns can be fruitful both in theory and in practice.Originality/valueThis paper presents the first attempt to ground an approach aimed at ethical technology design on the tradition of virtue ethics. As such, it presents VPD as a potentially fruitful alternative to VSD. (shrink)

To put frameworks of Responsible Innovation and Responsible Research and Innovation (R(R)I) into practice, engagement methods have been developed to study and enhance technoscientific experts’ capacities to reflexively address value considerations in their work. These methods commonly rely on engagement between technoscientific experts and social scholars, which makes them vulnerable to structural barriers to interdisciplinary collaboration. To circumvent these barriers, we adapt Socio-Technical Integration Research (STIR) for broader use within technoscientific communities. We call this adaptation: reflexive practitioner dialogues. While the (...) primary aim of this article is to introduce and explain the methodological adaptation, we also analyze results from a pilot study with participants who are involved in research on contemplative practices such as mindfulness meditation. The analysis is guided by research questions that sought to assess whether and under what conditions the practitioner dialogues support reflexive and practical engagement with value considerations in participants’ work. The results indicate that reflexive practitioner dialogues can stimulate reflexive awareness of value conflicts and help re-direct decision-making responsively. We characterize the conditions facilitating such responsiveness as “value exnovators,” highlighting the oft-unacknowledged interpersonal relational practices that support collaborative engagement with value considerations. We suggest that “exnovation”—exposing the strengths of given practices for their improvement—can support R(R)I practices by directing analytical attention to their micro-level carriers. (shrink)

BackgroundOur human societies and certainly also (bio) medicine are more and more permeated with technology. There seems to be an increasing awareness among bioethicists that an effective and comprehensive approach to ethically guide these emerging biomedical innovations into society is needed. Such an approach has not been spelled out yet for bioethics, while there are frequent calls for ethical guidance of biomedical innovation, also by biomedical researchers themselves. New and emerging biotechnologies require anticipation of possible effects and implications, meaning the (...) scope is not evaluative after a technology has been fully developed or about hypothetical technologies, but real-time for a real biotechnology.Main textIn this paper we aim to substantiate and discuss six ingredients that we increasingly see adopted by ethicists and that together constitute “ethics parallel research”. This approach allows to fulfil two aims: guiding the development process of technologies in biomedicine and providing input for the normative evaluation of such technologies. The six ingredients of ethics parallel research are: (1) disentangling wicked problems, (2) upstream or midstream ethical analysis, (3) ethics from within, (4) inclusion of empirical research, (5) public participation and (6) mapping societal impacts, including hard and soft impacts. We will draw on gene editing, organoid technology and artificial intelligence as examples to illustrate these six ingredients.ConclusionEthics parallel research brings together these ingredients to ethically analyse and proactively or parallel guide technological development. It widens the roles and judgements from the ethicist to a more anticipatory and constructively guiding role. Ethics parallel research is characterised by a constructive, rather than a purely critical perspective, it focusses on developing best-practices rather than outlining worst practice, and draws on insights from social sciences and philosophy of technology. (shrink)

BackgroundThis manuscript presents a framework to guide the identification and assessment of ethical opportunities and challenges associated with electronic patient records (EPR). The framework is intended to support designers, software engineers, health service managers, and end-users to realise a responsible, robust and reliable EPR-enabled healthcare system that delivers safe, quality assured, value conscious care.MethodsDevelopment of the EPR applied ethics framework was preceded by a scoping review which mapped the literature related to the ethics of EPR technology. The underlying assumption behind (...) the framework presented in this manuscript is that ethical values can inform all stages of the EPR-lifecycle from design, through development, implementation, and practical application.ResultsThe framework is divided into two parts: context and core functions. The first part ‘context’ entails clarifying: the purpose(s) within which the EPR exists or will exist; the interested parties and their relationships; and the regulatory, codes of professional conduct and organisational policy frame of reference. Understanding the context is required before addressing the second part of the framework which focuses on EPR ‘core functions’ of data collection, data access, and digitally-enabled healthcare.ConclusionsThe primary objective of the EPR Applied Ethics Framework is to help identify and create value and benefits rather than to merely prevent risks. It should therefore be used to steer an EPR project to success rather than be seen as a set of inhibitory rules. The framework is adaptable to a wide range of EPR categories and can cater for new and evolving EPR-enabled healthcare priorities. It is therefore an iterative tool that should be revisited as new EPR-related state-of-affairs, capabilities or activities emerge. (shrink)

This article raises the question of whether bioethics qualifies as a discipline. According to a standard definition of discipline as “a field of study following specific and well-established methodological rules” bioethics is not a specific discipline as there are no explicit “well-established methodological rules.” The article investigates whether the methodological rules can be implicit, and whether bioethics can follow specific methodological rules within subdisciplines or for specific tasks. As this does not appear to be the case, the article examines whether (...) bioethics’ adherence to specific quality criteria (instead of methodological rules) or pursuing of a common goal can make it qualify as a discipline. Unfortunately, the result is negative. Then, the article scrutinizes whether referring to bioethics institutions and professional qualifications can ascertain bioethics as a discipline. However, this makes the definition of bioethics circular. The article ends by admitting that bioethics can qualify as a discipline according to broader definitions of discipline, for example, as an “area of knowledge, research and education.” However, this would reduce bioethics’ potential for demarcation and identity-building. Thus, to consolidate the discipline of bioethics and increase its impact, we should explicate and elaborate on its methodology. (shrink)

La formulación de las políticas de investigación y desarrollo está siendo transformada de manera novedosa en los documentos más recientes que se elaboran en Europa. Una de las peculiaridades es que los patrones de investigación transitan hacia prácticas científico-tecnológicas más interactivas entre los distintos actores de la sociedad. Así, como respuesta a la naturaleza compleja de la investigación las primeras medidas se revelan en aquellas estrategias para la promoción de actitudes emprendedoras y colaborativas entre los actores académico-empresariales de la investigación (...) y el desarrollo. A estas iniciativas se superponen otros planteamientos que trascienden el objetivo primariamente economicista de la colaboración e integran los aspectos sociales y éticos en la investigación y el desarrollo. Sin embargo, estas transformaciones también están sujetas a diversas tensiones de base y a objetivos concurrentes. El artículo dilucida estas dinámicas de apertura-y-cierre y manifiesta que algunas de las relaciones y demandas se muestran más resistentes al cambio. (shrink)

In this paper we reflect on the looming question of what constitutes expertise in ethics. Based on an empirical program that involved qualitative and quantitative as well as participatory research...