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)

A self-fulfilling prophecy in neuroprognostication occurs when a patient in coma is predicted to have a poor outcome, and life-sustaining treatment is withdrawn on the basis of that prediction, thus directly bringing about a poor outcome for that patient. In contrast to the predominant emphasis in the bioethics literature, we look beyond the moral issues raised by the possibility that an erroneous prediction might lead to the death of a patient who otherwise would have lived. Instead, we focus on the (...) problematic epistemic consequences of neuroprognostic SFPs in settings where research and practice intersect. When this sort of SFP occurs, the problem is that physicians and researchers are never in a position to notice whether their original prognosis was correct or incorrect, since the patient dies anyway. Thus, SFPs keep us from discerning false positives from true positives, inhibiting proper assessment of novel prognostic tests. This epistemic problem of SFPs thus impedes learning, but ethical obligations of patient care make it difficult to avoid SFPs. We then show how the impediment to catching false positive indicators of poor outcome distorts research on novel techniques for neuroprognostication, allowing biases to persist in prognostic tests. We finally highlight a particular risk that a precautionary bias towards early withdrawal of life-sustaining treatment may be amplified. We conclude with guidelines about how researchers can mitigate the epistemic problems of SFPs, to achieve more responsible innovation of neuroprognostication for patients in coma. (shrink)

The label ‘Translational Research’ (TR) has become ever more popular in the biomedical domain in recent years. It is usually presented as an attempt to bridge a supposed gap between knowledge produced at the lab bench and its use at the clinical bedside. This is claimed to help society harvest the benefits of its investments in scientific research. The rhetorical as well as moral force of the label TR obscure, however, that it is actually used in very different ways. In (...) this paper, we analyse the scientific discourse on TR, with the aim to disentangle and critically evaluate the different meanings of the label. We start with a brief reconstruction of the history of the concept. Subsequently, we unravel how the label is actually used in a sample of scientific publications on TR and examine the presuppositions implied by different views of TR. We argue that it is useful to distinguish different views of TR on the basis of three dimensions, related to (1) the construction of the ‘translational gap’; (2) the model of the translational process; and (3) the cause of the perceived translational gap. We conclude that the motive to make society benefit from its investments in biomedical science may be laudable, but that it is doubtful whether the dominant views of TR will contribute to this end. (shrink)

While Gabriel Watts and Ainsley Newson argue that diagnostic laboratories do not have a general duty to routinely reinterpret genomic variant classifications, they do formulate several restricted duties to actively reinterpret specific types of classifications.1 They place these duties with laboratories, acknowledging that they are setting aside any responsibilities that might arise for clinicians. Here, we will discuss the implications of this obligation for clinicians and the moral tension it may confront them with. We focus in particular on the consequences (...) of the proposed moral obligation to actively reinterpret variant classifications that carry a higher risk of being false positives. Such reclassification is likely to result in ‘downgrades’: previously pathogenic variants (pathogenic/likely pathogenic, P/LP) reclassified to benign (likely benign/benign, LB/B) or uncertain variants (variant of uncertain significance, VUS). Any laboratory policy to actively reinterpret (specific sets of) classifications will confront the clinician with the question whether the person tested should be recontacted on a reinterpretation of previously reported results. As others have pointed out, recontacting in general comes with challenges, since patients may not want to be recontacted or have forgotten about their genetic test.2 3 Recontacting in case of a downgrade, however, is particularly impactful. Previous studies on the psychosocial impact of reclassification on patients …. (shrink)

In this article we briefly summarize how converging technologies challenge elements of the existing symbolic order, as shown in the contributions to this special issue. We then identify the vision of ‘life as a do it yourself kit’ as a common denominator in the various forms of convergence and proceed to show how this vision provokes unrest and debate about existing moral frameworks and taboos. We conclude that, just as the problems of the industrial revolution sparked off the now broadly (...) established ideal of sustainability the converging technologies should be governed by the ideal of ‘human sustainability’. The essence of this ideal is formed by the ongoing discussion about the extent to which we may, or should want to, ‘make’ our environment and ourselves, and when it is better to simply accept what is given and what happens to us. (shrink)

When information on a coma patient’s expected outcome is uncertain, a moral dilemma arises in clinical practice: if life-sustaining treatment is continued, the patient may survive with unacceptably poor neurological prospects, but if withdrawn a patient who could have recovered may die. Continuous electroencephalogram-monitoring is expected to substantially improve neuroprognostication for patients in coma after cardiac arrest. This raises expectations that decisions whether or not to withdraw will become easier. This paper investigates that expectation, exploring cEEG’s impacts when it becomes (...) part of a socio-technical network in an Intensive Care Unit. Based on observations in two ICUs in the Netherlands and one in the USA that had cEEG implemented for research, we interviewed 25 family members, healthcare professionals, and surviving patients. The analysis focuses on the way patient outcomes are constructed, the kind of decision support these outcomes provide, and how cEEG affects communication between professionals and relatives. We argue that cEEG can take away or decrease the intensity of the dilemma in some cases, while increasing uncertainty for others. It also raises new concerns. Since its actual impacts furthermore hinge on how cEEG is designed and implemented, we end with recommendations for ensuring responsible development and implementation. (shrink)

The question we raise in this paper is, whether patient involvement might be a beneficial way to help determine and achieve the aims of translational research and, if so, how to proceed. TR is said to ensure a more effective movement of basic scientific findings to relevant and useful clinical applications. In view of the fact that patients are supposed to be the primary beneficiaries of such translation and also have relevant knowledge based on their experience, listening to their voice (...) early on in the innovation process might very well increase the effectiveness of the translation. After explaining how the concept of TR emerged and what it entails, this paper shows through a literature review which arguments have been put forward to promote patient involvement in health care research in a more general sense. We examine whether, and if so how, these arguments are relevant for the discourse on TR and we identify pitfalls and dilemmas. Ultimately, we conclude that it may be worthwhile to experiment with patient involvement in TR but that the design of such involvement requires careful consideration. (shrink)

Converging Technologies, Shifting Boundaries Content Type Journal Article Pages 213-216 DOI 10.1007/s11569-009-0075-x Authors Tsjalling Swierstra, University of Twente Enschede Netherlands Marianne Boenink, University of Twente Enschede Netherlands B. Walhout, Rathenau Institute The Hague Netherlands R. Van Est, Rathenau Institute The Hague Netherlands Journal NanoEthics Online ISSN 1871-4765 Print ISSN 1871-4757 Journal Volume Volume 3 Journal Issue Volume 3, Number 3.

Biomedical research policy in recent years has often tried to make such research more ‘translational’, aiming to facilitate the transfer of insights from research and development to health care for the benefit of future users. Involving patients in deliberations about and design of biomedical research may increase the quality of R&D and of resulting innovations and thus contribute to translation. However, patient involvement in biomedical research is not an easy feat. This paper discusses the development of a method for involving (...) patients in biomedical research aiming to address its main challenges.After reviewing the potential challenges of patient involvement, we formulate three requirements for any method to meaningfully involve patients in biomedical research. It should enable patients to put forward their experiential knowledge, to develop a rich view of what an envisioned innovation might look like and do, and to connect their experiential knowledge with the envisioned innovation. We then describe how we developed the card-based discussion method ‘Voice of patients’, and discuss to what extent the method, when used in four focus groups, satisfied these requirements. We conclude that the method is quite successful in mobilising patients’ experiential knowledge, in stimulating their imaginaries of the innovation under discussion and to some extent also in connecting these two. More work is needed to translate patients’ considerations into recommendations relevant to researchers’ activities. It also seems wise to broaden the audience for patients’ considerations to other actors working on a specific innovation. (shrink)

Biomedical research policy in recent years has often tried to make such research more ‘translational’, aiming to facilitate the transfer of insights from research and development to health care for the benefit of future users. Involving patients in deliberations about and design of biomedical research may increase the quality of R&D and of resulting innovations and thus contribute to translation. However, patient involvement in biomedical research is not an easy feat. This paper discusses the development of a method for involving (...) patients in biomedical research aiming to address its main challenges. (shrink)

Since its advent, predictive DNA testing has been perceived as a technology that may have considerable impact on the quality of people’s life. The decision whether or not to use this technology is up to the individual client. However, to enable well considered decision making both the negative as well as the positive freedom of the individual should be supported. In this paper, we argue that current professional and public discourse on predictive DNA-testing is lacking when it comes to supporting (...) positive freedom, because it is usually framed in terms of risk and risk management. We show how this ‘risk discourse’ steers thinking on the good life in a particular way. We go on to argue that empirical research into the actual deliberation and decision making processes of individuals and families may be used to enrich the environment of personal deliberation in three ways: (1) it points at a richer set of values that deliberators can take into account, (2) it acknowledges the shared nature of genes, and (3) it shows how one might frame decisions in a non-binary way. We argue that the public sharing and discussing of stories about personal deliberations offers valuable input for others who face similar choices: it fosters their positive freedom to shape their view of the good life in relation to DNA-diagnostics. We conclude by offering some suggestions as to how to realize such public sharing of personal stories. (shrink)

The question we raise in this paper is, whether patient involvement might be a beneficial way to help determine and achieve the aims of translational research and, if so, how to proceed. TR is said to ensure a more effective movement of basic scientific findings to relevant and useful clinical applications. In view of the fact that patients are supposed to be the primary beneficiaries of such translation and also have relevant knowledge based on their experience, listening to their voice (...) early on in the innovation process might very well increase the effectiveness of the translation. After explaining how the concept of TR emerged and what it entails, this paper shows through a literature review which arguments have been put forward to promote patient involvement in health care research in a more general sense. We examine whether, and if so how, these arguments are relevant for the discourse on TR and we identify pitfalls and dilemmas. Ultimately, we conclude that it may be worthwhile to experiment with patient involvement in TR but that the design of such involvement requires careful consideration. (shrink)

Aim: To elicit preferences for prognostic information, attitudes towards withdrawal of life-sustaining treatment (WLST) and perspectives on acceptable quality of life after post-anoxic coma within the adult general population of Germany, Italy, the Netherlands and the United States of America. Methods: A web-based survey, consisting of questions on respondent characteristics, perspectives on quality of life, communication of prognostic information, and withdrawal of life-sustaining treatment, was taken by adult respondents recruited from four countries. Statistical analysis included descriptive analysis and chi2-tests for (...) dierences between countries. Results: In total, 2012 respondents completed the survey. In each country, at least 84% indicated they would prefer to receive early prognostic information. If a poor outcome was predicted with some uncertainty, 37-54% of the respondents indicated that WLST was not to be allowed. A conscious state with severe physical and cognitive impairments was perceived as acceptable quality of life by 17–44% of the respondents. Clear differences between countries exist, including respondents from the U.S. being more likely to allow WLST than respondents from Germany (OR = 1.99, p < 0.001) or the Netherlands (OR = 1.74, p < 0.001) and preferring to stay alive in a conscious state with severe physical and cognitive impairments more than respondents from Italy (OR = 3.76, p < 0.001), Germany (OR = 2.21, p < 0.001), or the Netherlands (OR = 2.39, p < 0.001). Conclusions: Over one-third of the respondents considered WLST unacceptable when there is any remaining prognostic uncertainty. Respondents had a more positive perspective on acceptable quality of life after coma than what is currently considered acceptable in medical literature. This indicates a need for a closer look at the practice of WLST based on prognostic information, to ensure responsible use of novel prognostic tests. (shrink)

In recent years, several authors have argued that the desirability of novel technologies should be assessed early, when they are still emerging. Such an ethical assessment of emerging technologies is by definition focused on an elusive object. Usually promises, expectations, and visions of the technology are taken as a starting point. As Nordmann and Rip have pointed out in a recent article, however, ethicists should not take for granted the plausibility of such expectations and visions. In this paper, we explore (...) how the quality of expectations on emerging technologies might be assessed when engaging in a reflection on the desirability of emerging technologies. We propose that an assessment of expectations’ plausibility should focus on statements on technological feasibility, societal usability, and desirability of the expected technology. Whereas the feasibility statement and, to a lesser extent, the usability statements are frequently quite futuristic, the claims on desirability, by contrast, often display a conservative stance towards the future. Assessing the quality of expectations and visions on behalf of emerging technologies requires, then, a careful and well-directed use of both skepticism and imagination. We conclude with a brief overview of the tools and methods ethicists could use to assess claims made on behalf of emerging technologies and improve the ethical reflection on them. (shrink)

Although it is now generally acknowledged that new biomedical technologies often produce new definitions and sometimes even new concepts of disease, this observation is rarely used in research that anticipates potential ethical issues in emerging technologies. This article argues that it is useful to start with an analysis of implied concepts of disease when anticipating ethical issues of biomedical technologies. It shows, moreover, that it is possible to do so at an early stage, i.e. when a technology is only just (...) emerging. The specific case analysed here is that of ‘molecular medicine’. This group of emerging technologies combines a ‘cascade model’ of disease processes with a ‘personal pattern’ model of bodily functioning. Whereas the ethical implications of the first are partly familiar from earlier—albeit controversial—forms of preventive and predictive medicine, those of the second are quite novel and potentially far-reaching. (shrink)

The convergence of biomedical sciences with nanotechnology as well as ICT has created a new wave of biomedical technologies, resulting in visions of a ‘molecular medicine’. Since novel technologies tend to shift concepts of disease and health, this paper investigates how the emerging field of molecular medicine may shift the meaning of ‘disease’ as well as the boundary between health and disease. It gives a brief overview of the development towards and the often very speculative visions of molecular medicine. Subsequently (...) three views of disease often used in the philosophy of medicine are briefly discussed: the ontological or neo-ontological, the physiological and the normative/holistic concepts of disease. Against this background two tendencies in the field of molecular medicine are highlighted: (1) the use of a cascade model of disease and (2) the notion of disease as a deviation from an individual pattern of functioning. It becomes clear that molecular medicine pulls conceptualizations of disease and health in several, partly opposed directions. However, the resulting tensions may also offer opportunities to steer the future of medicine in more desirable directions. (shrink)

The label ‘Translational Research’ (TR) has become ever more popular in the biomedical domain in recent years. It is usually presented as an attempt to bridge a supposed gap between knowledge produced at the lab bench and its use at the clinical bedside. This is claimed to help society harvest the benefits of its investments in scientific research. The rhetorical as well as moral force of the label TR obscure, however, that it is actually used in very different ways. In (...) this paper, we analyse the scientific discourse on TR, with the aim to disentangle and critically evaluate the different meanings of the label. We start with a brief reconstruction of the history of the concept. Subsequently, we unravel how the label is actually used in a sample of scientific publications on TR and examine the presuppositions implied by different views of TR. We argue that it is useful to distinguish different views of TR on the basis of three dimensions, related to (1) the construction of the ‘translational gap’; (2) the model of the translational process; and (3) the cause of the perceived translational gap. We conclude that the motive to make society benefit from its investments in biomedical science may be laudable, but that it is doubtful whether the dominant views of TR will contribute to this end. (shrink)

Health technology assessment (HTA) was developed in the 1970s and 1980s to facilitate decision making on the desirability of new biomedical technologies. Since then, many of the standard tools and methods of HTA have been criticized for their implicit normativity. At the same time research into the character of technology in practice has motivated philosophers, sociologists and anthropologists to criticize the traditional view of technology as a neutral instrument designed to perform a specific function. Such research suggests that the tools (...) and methods of more traditional forms of HTA are often inspired by an ‘instrumentalist’ conception of technology that does not fit the way technology actually works. This paper explores this hypothesis for a specific case: the assessments and deliberations leading to the introduction of breast cancer screening in the Netherlands. After reconstructing this history of HTA ‘in the making’ the stepwise model of HTA that emerged during the process is discussed. This model was rooted indeed in an instrumentalist conception of technology. However, a more detailed reconstruction of several episodes from this history reveals how the actors already experienced the inadequacy of some of the instrumentalist presuppositions. The historical case thus shows how an instrumentalist conception of technology may result in implicit normative effects. The paper concludes that an instrumentalist view of technology is not a good starting point for HTA and briefly suggests how the fit between HTA methods and the actual character of technology in practice might be improved. (shrink)

Since its advent, predictive DNA testing has been perceived as a technology that may have considerable impact on the quality of people’s life. The decision whether or not to use this technology is up to the individual client. However, to enable well considered decision making both the negative as well as the positive freedom of the individual should be supported. In this paper, we argue that current professional and public discourse on predictive DNA-testing is lacking when it comes to supporting (...) positive freedom, because it is usually framed in terms of risk and risk management. We show how this ‘risk discourse’ steers thinking on the good life in a particular way. We go on to argue that empirical research into the actual deliberation and decision making processes of individuals and families may be used to enrich the environment of personal deliberation in three ways: (1) it points at a richer set of values that deliberators can take into account, (2) it acknowledges the shared nature of genes, and (3) it shows how one might frame decisions in a non-binary way. We argue that the public sharing and discussing of stories about personal deliberations offers valuable input for others who face similar choices: it fosters their positive freedom to shape their view of the good life in relation to DNA-diagnostics. We conclude by offering some suggestions as to how to realize such public sharing of personal stories. (shrink)