Abstract In this essay, a new approach for the ethical study of emerging technology ethics will be presented, called anticipatory technology ethics (ATE). The ethics of emerging technology is the study of ethical issues at the R&D and introduction stage of technology development through anticipation of possible future devices, applications, and social consequences. I will argue that a major problem for its development is the problem of uncertainty, which can only be overcome through methodologically sound forecasting and futures studies. I (...) will then consider three contemporary approaches to the ethics of emerging technologies that use forecasting: ethical technology assessment, the techno-ethical scenarios approach and the ETICA approach, and I considered their strengths and weaknesses. Based on this critical study, I then present my own approach: ATE. ATE is a conceptually and methodologically rich approach for the ethical analysis of emerging technologies that incorporates a large variety of ethical principles, issues, objects and levels of analysis, and research aims. It is ready to be applied to contemporary and future emerging technologies. Content Type Journal Article Category Original Paper Pages 1-13 DOI 10.1007/s11569-012-0141-7 Authors Philip A. E. Brey, Department of Philosophy, School of Behavioral Sciences, University of Twente, P.O. Box 217, 7500 AE Enschede, The Netherlands Journal NanoEthics Online ISSN 1871-4765 Print ISSN 1871-4757. (shrink)

Ex-vivo tissue engineering is an emerging medical technology. Its aim is to regenerate tissues and organs and to restore them to full physiological activity. Some clinical trials with human tissue engineered products have been conducted and others will follow. These trials not only have to confirm the therapeutic value of the HTEP, they also have to provide insight in its regenerative activity, its safety and long-term effects. The development of these trials is aggravated by the complexity of the tissue engineering (...) process and product. This paper investigates how this complexity influences the ethical conduct of clinical trials with HTEPs. We focus on the value and validity of the trial, the risk-benefit ratio and the protection of the trial participant. We argue that trials with HTEPs need a robust methodology. The risk-benefit ratio of a new HTEP must be determined and compared with available efficacious therapies. This requires the identification and minimisation of risks associated with tissue engineering. Finally a process as complex as tissue engineering presents serious challenges for the informed consent process, and for the protection of the trial participant during and after the trial. (shrink)

What kind of stuff is the world made of? What is the nature or substance of things? These are ontological questions, and they are usually answered with respect to the objects of science. The objects of technoscience tell a different story that concerns the power, promise and potential of things - not what they are but what they can be. Seventeen scholars from history and philosophy of science, epistemology, social anthropology, cultural studies and ethics each explore a research object in (...) its technological setting, ranging from carbon to cardboard, from arctic ice cores to nuclear waste, from wetlands to GMO seeds, from fuel cells to the great Pacific garbage patch. Together they offer fascinating stories and novel analytic concepts, all the while opening up a space for reflecting on the specific character of technoscientific objects. With their promise of sustainable innovation and a technologically transformed future, these objects are highly charged with values and design expectations. By clarifying their mode of existence, we are learning to come to terms more generally with the furniture of the technoscientific world - where, for example, the 'dead matter' of classical physics is becoming the 'smart material' of emerging and converging technologies. (shrink)

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts carry (...) within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments. (shrink)

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts carry (...) within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments. (shrink)

In this paper I explore the various meanings of embodiment from a patient’s perspective. Resorting to phenomenology of health and medicine, I take the idea of ‘lived experience’ as starting point. On the basis of an analysis of phenomenology’s call for bracketing the natural attitude and its reduction to the transcendental, I will explain, however, that in medical phenomenological literature ‘lived experience’ is commonly one-sidedly interpreted. In my paper, I clarify in what way the idea of ‘lived experience’ should be (...) revisited and, subsequently, what this reconsideration means for phenomenological research on embodiment in health and medicine. The insight that the body is a condition of possibility for world-disclosing yet, at the same time, itself conditioned by this world forces us to not only zoom in on the body’s subject-side, but also on its object-side. I argue that in order to render account for this double body ontology, phenomenology should include empirical sociological analyses as well. I thus argue in favor of the idea of a socio-phenomenology. Drawing on material from my own research project on embodied self-experiences after breast surgery, I show how this approach can be fruitful in interpreting the impact of disfigurements on a person’s embodied agency, or a person’s ‘I can’. (shrink)

Armed with expanded federal funding for human embryonic stem cell research and new methods for deriving pluripotent stem cells, stem cell researchers in the U.S. are poised to proceed with unprecedented speed toward the development of new clinical therapies. Staring into the new dawn of regenerative medicine, many observers may assume that the only responsible route to the clinic, both scientifically and ethically, is through FDA-approved clinical trials processes. Conventional wisdom dictates that, like pharmaceutical drugs and the use of biological (...) therapeutics, stem cell-based therapies will have to pass through a series of controlled studies — initially to assess safety and toxicity, then efficacy and comparative efficacy — before they can be justifiably administered to patients outside a clinical trials context. (shrink)

Ex-vivo tissue engineering is a quickly developing medical technology aiming to regenerate tissue through the introduction of an ex-vivo created tissue construct instead of restoring the damaged tissue to some level of functionality. Tissue engineering is considered by some as a new medical paradigm. We analyse this claim and identify tissue engineering’s fundamental characteristics, focusing on the aim of the intervention and on the complexity and continuity of the process. We inquire how these features have an impact not only on (...) the scientific research itself but also on the ethical evaluation of this research. We suggest that viewing tissue engineering as a new medical paradigm allows us to develop a wider perspective for successful investigation instead of focusing on isolated steps of the tissue engineering process in an anecdotal way, which may lead to an inadequate ethical evaluation. We argue that the concept of tissue engineering as a paradigm may benefit the way we address the ethical challenges presented by tissue engineering. (shrink)

In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or “NEST-ethics”). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics (...) arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some “good life” arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second “level” arguments—those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called “hard impacts”—quantifiable risks and benefits of the technology. Its “soft impacts”—effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention. (shrink)

In his 1987 book "Controlling Life: Jacques Loeb and the Engineering Ideal in Biology", Philip Pauly presented his readers with the biologist Jacques Loeb and his role in developing an emphasis on control of life processes. Loeb's work on artificial parthenogenesis, for example, provided an example of bioengineering at work. This paper revisits Pauly's study of Loeb and explores the way current research in regenerative medicine reflects the same tradition. A history of regeneration research reveals patterns of thinking and research (...) methods that both echo Loeb's ideology and point the way to modern studies. Pauly's work revealed far more than we readers realized at the time of its publication. (shrink)

In a world surrounded by smart objects from sensors to automated medical devices, the ubiquity of ‘smart’ seems matched only by its lack of clarity. In this article, we use our discussions with expert stakeholders working in areas of implantable medical devices such as cochlear implants, implantable cardiac defibrillators, deep brain stimulators and in vivo biosensors to interrogate the difference facets of smart in ‘implantable smart technologies’, considering also whether regulation needs to respond to the autonomy that such artefacts carry (...) within them. We discover that when smart technology is deconstructed it is a slippery and multi-layered concept. A device’s ability to sense and transmit data and automate medicine can be associated with the ‘sting’ of autonomy being disassociated from human control as well as affecting individual, group, and social environments. (shrink)

This paper discusses exceptional circumstances under which patients outside of clinical trials are likely to receive innovative stem cell-based interventions. These circumstances involve: (1) stem cell interventions not initially amenable to a clinical trials approach; (2) expanded access to investigational stem cell products (“compassionate use”); and (3) off-label uses of FDA approved stem cell products. This paper proposes a new approach to regulating these exceptional cases.

In this article, we investigate how to explain the difference between traditional design, engineering, and technology—which have exploited nature and put increasing pressure on Earth’s carrying capacity since the industrial revolution—and biomimetic design—which claims to explore nature’s sustainable solutions and promises to be regenerative by design. We reflect on the concept of mimesis. Mimesis assumes a continuity between the natural environment as a regenerative model and measure for sustainable design that is imitated and reproduced in biomimetic design, engineering, and technology. (...) We conceptualize mimesis in terms of two interdependent boundary conditions: differentiation and participation. We subsequently develop four characteristics of biomimicry as regenerative design, engineering, and technology: technological mimesis is 1) a participative differentiation of nature; 2) supplemental to natural mimesis in biomimetic design; 3) the participative differentiation of technological mimesis is constitutive of nature; 4) the participative differentiation of technological mimesis is always limited. (shrink)

Technologies for enhancement of the human body historically have taken the form of an apparatus: a technological device inserted in, or appended to, the human body. The margins of these devices were clearly discernible and materially circumscribed, allowing the distinction between the corporeality of the human body and the “machine” to remain both ontologically and materially secure. This dualism has performed some important work for human rights theorists, regulators, and policy makers, enabling each to imagine they can establish where the (...) human ends and the other begins. New regenerative products such as Infuse™ and Amplify™ subsist, as animal-derived scaffolds seeded with growth hormone implanted within a prosthetic device. They are much more materially complex, and their identities thus remain open to contestation. Following Lochlann Jain’s 2006 work, I thus attend closely to their social lives, particularly the stories that are told about them and how these are employed to construct understandings of what kind of a phenomenon they are: systemic drug, biologic, or combinatorial medical device. The significance of this classificatory project is revealed in the final section of this paper, which explores how these stories shape understandings of “product failure,” liability, and causation when such products overflow their material and ontological categorization and their recipients become disturbingly “more than human.”. (shrink)

In their 2007 paper, Swierstra and Rip identify characteristic tropes and patterns of moral argumentation in the debate about the ethics of new and emerging science and technologies (or “NEST-ethics”). Taking their NEST-ethics structure as a starting point, we considered the debate about tissue engineering (TE), and argue what aspects we think ought to be a part of a rich and high-quality debate of TE. The debate surrounding TE seems to be predominantly a debate among experts. When considering the NEST-ethics (...) arguments that deal directly with technology, we can generally conclude that consequentialist arguments are by far the most prominently featured in discussions of TE. In addition, many papers discuss principles, rights and duties relevant to aspects of TE, both in a positive and in a critical sense. Justice arguments are only sporadically made, some “good life” arguments are used, others less so (such as the explicit articulation of perceived limits, or the technology as a technological fix for a social problem). Missing topics in the discussion, at least from the perspective of NEST-ethics, are second “level” arguments—those referring to techno-moral change connected to tissue engineering. Currently, the discussion about tissue engineering mostly focuses on its so-called “hard impacts”—quantifiable risks and benefits of the technology. Its “soft impacts”—effects that cannot easily be quantified, such as changes to experience, habits and perceptions, should receive more attention. (shrink)

Seen as contributing to human enhancement, implanted technologies have recently been receiving a lot of attention. However, reflections on these technologies have taken the shape of rather speculative ethical judgments on “hyped” technological devices. On the other hand, while science and technology studies and philosophy of technology have a long tradition of analyzing how technological artifacts and tools transform and configure our lives, they tend to focus on use configurations rather than the intimate relations brought about by implanted technologies. Even (...) the cyborg has lost some of its hermeneutic power as it has been detached from its material grounds, becoming a discursive entity. In this article, I reclaim the importance of materiality and explore how people live with spinal cord stimulation, which is a type of neuromodulation technology. Implanted in bodies and seemingly out of sight, this technology does not cease to matter. Embodiment and incorporation are crucial for people to live well with SCS. Embodying the neuromodulation technology entails groping processes in which gestures are central and an increased intimacy with one’s bodily materiality. Incorporating it is highly relational and entangled with the bodies of loved and distant ones, humans and nonhumans. (shrink)

Examining a variety of bio-objects in contexts beyond the laboratory, Bio-Objects: Life in the 21st Century explores new ways of thinking about how novel bio-objects enter contemporary life, analysing the manner in which the boundaries between human and animal, organic and non-organic, and being 'alive' and the suspension of living, are questioned, destabilised and in some cases re-established.