In March 2019, the World Health Organization (WHO) declared that humanity was entering a global pandemic phase. This unforeseen situation caught everyone unprepared and had a major impact on several professional categories that found themselves facing important ethical dilemmas. The article revolves around the category of biomedical and clinical engineers, which were among those most involved in dealing with and finding solutions to the pandemic. In hindsight, the major issues brought to the attention of biomedical engineers have raised (...) important ethical implications, such as the allocation of resources, the responsibilities of science and the inadequacy and non-universality of the norms and regulations on biomedical devices and personal protective equipment. These issues, analyzed one year after the first wave of the pandemic, come together in the appeal for responsibility for thought, action and, sometimes, even silence. This highlights the importance of interdisciplinarity and the definitive collapse of the Cartesian fragmentation of knowledge, calling for the creation of more fora, where this kind of discussions can be promoted. (shrink)

Due to the impact of biomedical technologies on human wellbeing, biomedical engineering presents discipline-specific ethical issues that can have global, economic, environmental, and societal consequences. Because ethics instruction is a component of accredited undergraduate engineering programs in the US, we developed an ethics assignment that provided biomedical engineering students with a framework for ethical decision-making and challenged them to critically reflect on ethical issues related to contemporary medical devices. Thematic analysis performed on student reflections (n = (...) 73) addressed two research questions: (i) what considerations do biomedical engineering undergraduates describe when asked to critically reflect on ethical issues related to contemporary medical devices; and (ii) how do students describe their participation in bioethical discussions? Students described design, economic factors, and empathy most frequently as considerations. Further, students reported confidence in their ability to engage in ethical discussion upon assignment completion. Overall, our analysis builds understanding of student attitudes and engagement to help inform future ethics curriculum development. (shrink)

Biomedical Science Law & Practice is a practical strategic guide to the management of legal risks in biomedical science transactions, and commercialization of innovation and technology through strategic intellectual property licensing. This book provides a concise introduction to strategic legal risk management issues and strategic value creation in the entire biomedical science value chain, including legal liability issues from R&D, clinical trials, production of devices and market roll-out, protection of innovation through intellectual property (patents, copyrights, trade (...) marks and trade secrets); and commercialization of biomedical science innovation through strategic licensing and technology transfer, including unique licensing arrangements relating to genome. Checklists, sample agreements and biomedical patents and real life and hypothetical case studies used in the book facilitate learning at the operational or technical level of execution. (shrink)

Today, advances in medicine and biotechnology occur at a rapid pace and have a profound impact on our lives. Mechanical devices can sustain an injured person's life indefinitely. Computed tomography (CT) and magnetic resonance imaging (MRI) scans of the body and brain can reveal disorders before symptoms appear. Genetic testing of embryos can predict whether people will have diseases earlier or later in life. It may even become possible to clone human beings. These and other developments raise difficult ethical (...) questions. Biomedical Ethics is an engaging philosophical introduction to the most important ethical positions and arguments in six areas of biomedicine: the patient-doctor relationship, medical research on humans, reproductive rights and technologies, genetics, medical decisions at the end of life, and the allocation of scarce medical resources. Concisely capturing the historical, contemporary, and future-oriented aspects of the field, author Walter Glannon discusses both perennial issues in medicine, such as doctors' duties to patients, and recent and emerging issues in scientific innovation, including gene therapy and cloning. Ideal for undergraduate courses in contemporary moral problems, introduction to ethics, and introduction to bioethics, Biomedical Ethics is accessible to students who have little or no background in ethical theory, medicine, or biotechnology. (shrink)

How can we register the participation of a range of elements, extending beyond the human subject, in the production of HIV events? In the context of proposals around biomedical prevention, there is a growing awareness of the need to find ways of responding to complexity, as everywhere new combinations of treatment, behavior, drugs, norms, meanings and devices are coming into encounter with one another, or are set to come into encounter with one another, with a range of unpredictable (...) effects. In this paper I consider the operation of various framing devices that attribute responsibility and causation with regard to HIV events. I propose that we need to sharpen our analytic focus on what these devices do, their performativity—that is, their full range of worldly implications and effects. My primary examples are the criminal law and the randomized control trial. I argue that these institutions operate as framing devices: They attribute responsibility for HIV events and externalize other elements and effects in the process. Drawing on recent work in science and technology studies as well as queer theory, I set out an analytic frame that marks out a new role for HIV social research. Attentiveness to the performative effects of these devices is crucial, I suggest, if we want better to address the global HIV epidemic. (shrink)

Socially assistive devices such as care robots or companions have been advocated as a promising tool in elderly care in Western healthcare systems. Ethical debates indicate various challenges. An important part of the ethical evaluation is to understand how users interact with these devices and how interaction influences users’ perceptions and their ability to express themselves. In this review, we report and critically appraise findings of non-comparative empirical studies with regard to these effects from an ethical perspective.Electronic databases (...) and other sources were queried using a comprehensive search strategy generating 9851 records. Studies were screened independently by two authors. Methodological quality of studies was assessed. For 22 reports on 21 datasets using a non-comparative design a narrative synthesis was performed.Data shows positive findings in regard to attitudes and emotional reactions of users. Varying perception of a social relation and social presence are the most commonly observed traits of interaction. Users struggle with understanding technical complexities while functionality of the devices is limited. This leads to a behavioral alignment of users towards the requirements of the devices to be able to make use of them.This evidence adds to three important ethical debates on the use of socially assistive devices in healthcare in regard to (1) reliability of existing empirical evidence to inform normative judgements, (2) ethical significance of the social presence of devices and (3) user autonomy in regard to behavioral alignment. (shrink)

Wearable devices are increasingly present in the health context, as tools for biomedical research and clinical care. In this context, wearables are considered key tools for a more digital, personalised, preventive medicine. At the same time, wearables have also been associated with issues and risks, such as those connected to privacy and data sharing. Yet, discussions in the literature have mostly focused on either technical or ethical considerations, framing these as largely separate areas of discussion, and the contribution (...) of wearables to the collection, development, application of biomedical knowledge has only partially been discussed. To fill in these gaps, in this article we provide an epistemic (knowledgerelated) overview of the main functions of wearable technology for health: monitoring, screening, detection, and prediction. On this basis, we identify 4 areas of concern in the application of wearables for these functions: data quality, balanced estimations, health equity, and fairness. To move the field forward in an effective and beneficial direction, we present recommendations for the 4 areas: local standards of quality, interoperability, access, and representativity. (shrink)

Wandering is a symptom of dementia that can have devastating consequences on the lives of persons living with dementia and their families and caregivers. Increasingly, caregivers are turning towards electronic tracking devices to help manage wandering. Ethical questions have been raised regarding these location-based technologies and although qualitative research has been conducted to gain better insight into various stakeholders' views on the topic, developers of these technologies have been largely excluded. No qualitative research has focused on developers’ perceptions of (...) ethics related to electronic tracking devices. To address this, we performed a qualitative semi-structured interview study based on grounded theory. We interviewed 15 developers of electronic tracking devices to better understand how they perceive ethical issues surrounding the design, development, and use of these devices within dementia care. Our results reveal that developers are strongly motivated by moral considerations and believe that including stakeholders throughout the development process is critical for success. Developers felt a strong sense of moral obligation towards topics within their control and a weaker sense of moral obligation towards topics outside their control. This leads to a perceived moral boundary between development and use, where some moral responsibility is shifted to end-users. (shrink)

The ways in which other animal species can be informative about human biology are not exhausted by the traditional picture of the animal model. In this paper, I propose to distinguish two roles which laboratory organisms can have in biomedical research. In the more traditional case, organisms act as surrogates for human beings, and as such are expected to be more manageable replicas of humans. However, animal models can inform us about human biology in a much less straightforward way, (...) by being used as measuring devices—what I call their instrumental role. I first characterize this role and provide criteria for it, before illustrating it with some examples from biomedical research, especially cancer research. In such an instrumental role, phenotypes are not expected to phenocopy human phenomena, but instead have the purely instrumental value of detecting or measuring differences. I argue that the instrumental role is more prevalent than might first be suspected, and that some characteristics of contemporary biomedical research are increasingly shifting the use of laboratory organisms to the instrumental role. Finally, in light of the distinction proposed, I discuss the meaning of the expression “animal model”. (shrink)

Advancements in technology are shifting the ways that biomedical data are collected, managed, and used. The pervasiveness of connected devices is expanding the types of information that are defined as ‘health data.’ Additionally, cloud-based mechanisms for data collection and distribution are shifting biomedical research away from traditional infrastructure towards a more distributed and interconnected ecosystem. This shift provides an opportunity for us to reimagine the roles of scientists and participants in health research, with the potential to more (...) meaningfully engage in partnership across the research process. At the same time, these emerging practices present a potential to expose research participants to unanticipated and unintended consequences. Social norms and policy can help to mitigate these risks, but their development is often slow relative to the pace of technological advances and, as such, they can become reactive rather than prospective. As an alternative, the integrated development of data governance structures within technological advancements, supports their effective implementation, evaluation and evolution in a manner that can balance the benefits and risks of biomedical researcher in a decentralized ecosystem. (shrink)

We survey the meta-ethical tools and institutional processes that traditional Islamic ethicists apply when deliberating on bioethical issues. We present a typology of these methodological elements, giving particular attention to the meta-ethical techniques and devices that traditional Islamic ethicists employ in the absence of decisive or univocal authoritative texts or in the absence of established transmitted cases. In describing how traditional Islamic ethicists work, we demonstrate that these experts possess a variety of discursive tools. We find that the ethical (...) responsa—i.e., the products of the application of the tools that we describe—are generally characterized by internal consistency. We also conclude that Islamic ethical reasoning on bioethical issues, while clearly scripture-based, is also characterized by strong consequentialist elements and possesses clear principles-based characteristics. The paper contributes to the study of bioethics by familiarizing non-specialists in Islamic ethics with the role, scope, and applicability of key Islamic ethical concepts, such as “aims” (maqāṣid), “universals” (kulliyyāt), “interest” (maṣlaḥa), “maxims” (qawā`id), “controls” (ḍawābit), “differentiators” (furūq), “preponderization” (tarjīḥ), and “extension” (tafrī`). (shrink)

The experience of the use of applied containerized biomedical software tools in cloud environment is summarized. The reproducibility of scientific computing in relation with modern technologies of scientific calculations is discussed. The main approaches to biomedical data preprocessing and integration in the framework of the intelligent analytical system are described. At the conditions of pandemic, the success of health care system depends significantly on the regular implementation of effective research tools and population monitoring. The earlier the risks of (...) disease can be identified, the more effective process of preventive measures or treatments can be. This publication is about the creation of a prototype for such a tool within the project «Development of methods, algorithms and intelligent analytical system for processing and analysis of heterogeneous clinical and biomedical data to improve the diagnosis of complex diseases», implementted by the V.M. Glushkov Institute of Cybernetics, National Academy of Sciences of Ukraine, together with the United Institute of Informatics Problems, National Academy of Sciences of Belarus. The insurers, entering the market, can insure mostly low risks by facilitating more frequent changes of insurers by consumers and mixing the overall health insurance market. Socio-demographic variables can be risk adjusters. Since age and gender have a relatively small explanatory power, other socio-demographic variables were studied – marital status, retirement status, disability status, educational level, income level. Because insurers have an interest in beneficial diagnoses for their policyholders, they are also interested in the ability to interpret relevant information – upcoding: insurers can encourage their policyholders to consult with doctors more often to select as many diagnoses as possible. Many countries and health care systems use diagnostic information to determine the reimbursement to a service provider, revealing the necessary data. For processing and analysis of these data, software implementations of construction for classifiers, allocation of informative features, processing of heterogeneous medical and biological variables for carrying out scientific research in the field of clinical medicine are developed. The experience of the use of applied containerized biomedical software tools in cloud environment is summarized. The reproducibility of scientific computing in relation with modern technologies of scientific calculations is discussed. Particularly, attention is paid to containerization of biomedical applications, this permits to get reproducibility of the conditions in which the calculations took place, technologies of software pipelining of calculations, that allows to organize flow calculations, and technologies for parameterization of software environment, that allows to reproduce, if necessary, an identical computing environment. The main approaches to biomedical data preprocessing and integration in the framework of the intelligent analytical system are described. The experience of using the developed linear classifier, gained during its testing on artificial and real data, allows us to conclude about several advantages provided by the containerized form of the created application: it permits to provide access to real data located in cloud environment; it is possible to perform calculations to solve research problems on cloud resources both with the help of developed tools and with the help of cloud services; such a form of research organization makes numerical experiments reproducible, i.e. any other researcher can compare the results of their developments on specific data that have already been studied by others, in order to verify the conclusions and technical feasibility of new results; there exists a universal opportunity to use the developed tools on technical devices of various classes from a personal computer to powerful cluster. (shrink)

In this paper we examine the use of companion animals (pets) in studies of drugs and devices aimed at human and animal health and situate it within the context of philosophy of technology. We argue that companion animals serve a unique role in illuminating just what it means to use biological technologies and examine the implications for human-animal relationships. Though philosophers have often treated animals as technologies, we argue that the biomedical use of companion animals presents a new (...) configuration of ethical and technological concerns that deserves more attention. Though it seems that companion animals solve many of the ethical dilemmas caused by the use of laboratory animals, the use of companion animals presents its own set of ethical concerns. This paper contextualizes the use of companion animals in research. (shrink)

The raison d'etre of this dissertation is the Muslim dilemma when confronted with some of the biotechnological innovations which relate to the precautionary measures to prevent the birth of children, technological manipulation in order to overcome infertility and the termination of fetal life. All of these issues are directly related to human life and thus pose serious problems. The Muslim is one whose life is regulated by the teachings of the Qur'an and Sunnah of the Prophet. Hence, his action is (...) considered proper or right if it conforms to their broad teachings and improper or wrong if it contra-dicts the very spirit of their teachings. This study is thus focused on the teachings of the Qur'an and the relevant ahadith pertaining to the beginning of human life, the sanctity of married life, and the sanctions for the termination of human life. The objective is to analyze the relevant injunctions and present them in a systematic way to prepare ground for the assessment of such biotechnological issues so as to ascertain their legality under the Shari'ah. ;In order to comprehend the ethical system envisaged by the Qur'an and Sunnah vis-a-vis the biomedical issues it is essential that we acquaint ourselves with the fundamental concepts pertain- ing to health care, medical treatment and medical ethics. Thereafter, a detailed discussion follows on reproductive control, biotechnical parenting and abortion. Each of these issues are elaborately analyzed in the light of the spirit and principles envisaged by the relevant injunctions. ;Proper grasp of the implications of these issues within the Islamic framework is expected to provide the perplexed Muslims with the necessary guidelines in the event that circumstances demand that they opt for either the contraceptive devices or the modern tech-niques to overcome infertility or abortion. (shrink)

A 10 kHz pulsed X-ray generator utilising a hot-cathode triode in conjunction with a new type of grid control device for controlling X-ray duration is described. The energy-storage condenser was charged up to 70 kV by a power supply, and the electric charges in the condenser were discharged to the X-ray tube repetitively by the grid control device. The maximum values of the grid voltage, the tube voltage, and the tube current were −1.5 kV, 70 kV, and 0.4 A, respectively. (...) The duration of the flash X-ray pulse was primarily determined by the time constant of the grid control device and the cut-off voltage of thermoelectrons. The X-ray duration was controlled within a region of less than 1 ms; the X-ray intensity with a pulse width of 0.27 ms, a charged voltage of 70 kV, and a peak tube current of 0.4 A was 0.92 μC kg −1 at 0.5 m per pulse. The maximum repetition rate was about 10 kHz, and the size of the focal spot was about 3.5×3.5 mm. (shrink)

The aim of synthetic biology is to rationally design devices, systems, and organisms with desired innovative and useful functions (Slusarczyk, Lin, and Weiss 2012). To achieve this aim, synthetic biology uses a concept similar to engineering sciences: well-characterized and standardized modular biological building blocks are reassembled in a systematic and rational manner to generate complex devices and systems with a predicted function. In the past, molecular biological research in combination with intense work in new research areas like systems (...) biology and functional genomics revealed a large inventory of multifaceted modular biological parts that are now in the toolboxes of synthetic biologists. Due to .. (shrink)

The following hypothetical case study was developed for bioengineering students and is concerned with choosing between two devices used for development of a pediatric tissue engineered heart valve (TEHV). This case is intended to elicit assessment of the devices, possible future outcomes, and ramifications of the decision making. It is framed in light of two predominant ethical theories: utilitarianism and rights of persons. After the case was presented to bioengineering graduate students, they voted on which device should be (...) released. The results revealed that these bioengineering students preferred the more reliable (and substantially more expensive) design, though this choice precludes the majority of the world from having access to this technology. This case is intended to examine and explore where the balance lies between design, cost, and adequate distribution of biomedical devices. (shrink)

Biomedical devices and biotechnological treatments are different types of health intervention. In general, biomedical devices, such as deep brain stimulators implanted for treatment of movement disorders, can help patients without imposing moral burdens. Biotechnological interventions, on the other hand, require the use of biological substances, which are often obtained by the destruction of human life or unusual tampering with it, as in embryonic stem cell research, cloning, and fetal tissue transplantation. Biotechnology imposes a moral burden on (...) patients, who may not fully understand what it involves and the effects its use might have on them later. This essay is a reflection on the serious losses patients experience before they consider biotechnological options and on their sense of moral burden after they have consented to their use. National Catholic Bioethics Quarterly 9.4 (Winter 2009): 671–679. (shrink)

Explores the practical applicability of the philosophy of science to scientific research, but also considers its relevance to practice within the realms of technology, design, crafts, and even within the world of arts and the humanities. The attempt to engage working scientists with the issues raised by the philosophy of science may profitably be extended to examine its applicability to any other fields of knowledge that encompass a problem-solving dimension. Drawing on his experience as a research and development scientist in (...) the biomedical device industry, the author shows how the principles of the philosophy of science illuminate the research process. The book is structured on the concept of the inspirational text; it consists of short chapters, each of which provides an accessible discussion of an aspect of the philosophy of science. Each chapter concludes with a list of practical pointers towards the development of attitudes and skills which will benefit the student researcher.. (shrink)

Biomedical research using data from participants’ mobile devices borrows heavily from the ethos of the “citizen science” movement, by delegating data collection and transmission to its volunteer subjects. This engagement gives volunteers the opportunity to feel like partners in the research and retain a reassuring sense of control over their participation. These virtues, in turn, give both grass-roots citizen science initiatives and institutionally sponsored mHealth studies appealing features to flag in recruiting participants from the public. But while grass-roots (...) citizen science projects are often community-based, mHealth research ultimately depends on the individuals who own and use mobile devices. This inflects the ethos of mHealth research towards a celebration of individual autonomy and empowerment, at the expense of its implications for the communities or groups to which its individual participants belong. But the prospects of group harms — and benefits — from mHealth research are as vivid as they are in other forms of data-intensive “precision health” research, and will be important to consider in the design of any studies using this approach. (shrink)

mHealth devices and applications, with their wide accessibility and ease of use, have the potential to address persistent inequities in biomedical research participation. Yet, while mHealth technologies may facilitate more inclusive research participation, negative features of some unregulated use in research — misleading enrollment practices, the promotion of secondary mHealth applications, discriminatory profiling, and poorer quality feedback due to dependencies on biased data and algorithms — may threaten the trust and engagement of underrepresented individuals and communities. To maximize (...) the participation of currently disenfranchised groups, those involved in unregulated mHealth research must become aware of potential risks, adopt targeted education policies, audit algorithms for hidden biases, and engage citizen scientists and other community members to identify and forestall possible harms. (shrink)

Biomedical research on humans is an important part of medical progress. But, when lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. IRB members face difficult decisions every day. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the (...) issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the lives of human participants. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes. Based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process. (shrink)

Representing the kinetic state of a patient (posture, motion, and activity) during vital sign measurement is an important part of continuous monitoring applications, especially remote monitoring applications. In contextualized vital sign representation, the measurement result is presented in conjunction with salient measurement context metadata. We present an automated annotation system for vital sign measurements that uses ontologies from the Open Biomedical Ontology Foundry (OBO Foundry) to represent the patient’s kinetic state at the time of measurement. The annotation system is (...) applied to data generated by a wearable personal status monitoring (PSM) device. We demonstrate how annotated PSM data can be queried for contextualized vital signs as well as sensor algorithm configuration parameters. (shrink)

Biomedical advances of the past 20 years have stimulated a renewed interest in medical ethics. Transplantation of multiple human organs, implantation of artificial devices, advances in genetics, and stem cell research are a few of the medical procedures and discoveries that have awakened in both professionals and the public an awareness that medical discoveries often raise important ethical and societal issues. Today, members of the medical profession face issues that did not seem so pressing to their predecessors, and (...) physician conduct in response to many of these issues involves decision-making based on ethical principles. Issues of informed consent, gifts from pharmaceutical companies, and patient rights to privacy were not of great concern to most physicians a generation ago. However, these and other topics that involve a physician's ethical conduct have become increasingly pertinent to the practice of medicine.A renewed emphasis on ethics has been voiced by leaders in the field of medicine. (shrink)

Biomedical advances of the past 20 years have stimulated a renewed interest in medical ethics. Transplantation of multiple human organs, implantation of artificial devices, advances in genetics, and stem cell research are a few of the medical procedures and discoveries that have awakened in both professionals and the public an awareness that medical discoveries often raise important ethical and societal issues. Today, members of the medical profession face issues that did not seem so pressing to their predecessors, and (...) physician conduct in response to many of these issues involves decision-making based on ethical principles. Issues of informed consent, gifts from pharmaceutical companies, and patient rights to privacy were not of great concern to most physicians a generation ago. However, these and other topics that involve a physician's ethical conduct have become increasingly pertinent to the practice of medicine.A renewed emphasis on ethics has been voiced by leaders in the field of medicine. (shrink)

Ethical analyses of biomedical human enhancement often consider the issue of authenticity — to what degree can the accomplishments of those utilizing biomedical enhancements be considered authentic or worthy of praise? As research into Brain-Computer Interface technology progresses, it may soon be feasible to create a BCI device that enhances or augments natural human intelligence through some invasive or noninvasive biomedical means. In this article we will review currently existing BCI technologies and to what extent these can (...) be said to enhance or augment the capabilities of the respective users, describe one hypothetical type of BCI device that could augment or enhance a specific aspect of human knowledge — namely, mathematical ability, and relate these concepts to the active externalism view of the extended mind as espoused by Clark and Chalmers in order to argue that knowledge of mathematics derived from the usage of a BCI and the application thereof constitutes authentic knowledge and achievement. (shrink)

Devices that record from and stimulate the brain are currently available for consumer use. The increasing sophistication and resolution of these devices provide consumers with the opportunity to engage in do-it-yourself brain research and contribute to neuroscience knowledge. The rise of do-it-yourself (DIY) neuroscience may provide an enriched fund of neural data for researchers, but also raises difficult questions about data quality, standards, and the boundaries of scientific practice. We administered an online survey to brain–computer interface (BCI) researchers (...) to gather their perspectives on DIY brain research. While BCI researcher concerns about data quality and reproducibility were high, the possibility of expert validation of data generated by citizen neuroscientists mitigated concerns. We discuss survey results in the context of an established ethical framework for citizen science, and describe the potential of constructive collaboration between citizens and researchers to both increase data collection and advance understanding of how the brain operates outside the confines of the lab. (shrink)

Discussion of uses of biomedical data often proceeds on the assumption that the data are generated and shared solely or largely within the health sector. However, this assumption must be challenged because increasingly large amounts of health and well-being data are being gathered and deployed in cross-sectoral contexts such as social media and through the internet of things and wearable devices. Cross-sectoral sharing of data thus refers to the generation, use and linkage of biomedical data beyond the (...) health sector. This paper considers the challenges that arise from this phenomenon. If we are to benefit fully, it is important to consider which ethical values are at stake and to reflect on ways to resolve emerging ethical issues across ecosystems where values, laws and cultures might be quite distinct. In considering such issues, this paper applies the deliberative balancing approach of the Ethics Framework for Big Data in Health and Research to the domain of cross-sectoral big data. Please refer to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end. (shrink)

Recent developments in AI programming allow for new applications: individualized chatbots which mimic the speaking and writing behaviour of one specific living or dead person. ‘Deathbots’, chatbots of the dead, have already been implemented and are currently under development by the first start-up companies. Thus, it is an urgent issue to consider the ethical implications of deathbots. While previous ethical theories of deathbots have always been based on considerations of the dignity of the deceased, I propose to shift the focus (...) on the dignity and autonomy of the bereaved users of deathbots. Drawing on theories of internet-scaffolded affectivity and on theories of grief, I argue that deathbots may have a negative impact on the grief process of bereaved users and therefore have the potential to limit the emotional and psychological wellbeing of their users. Deathbot users are likely to become dependent on their bots which may make them susceptible to surreptitious advertising by deathbot providing companies and may limit their autonomy. At the same time, deathbots may prove to be helpful for people who suffer from prolonged, severe grief processes. I caution against the unrestricted usage of deathbots and suggest that they should be classified as medical devices. This classification would not the least mean that their non-harm, as well as their helpfulness for people suffering from prolonged grief needs to be proven and that their potential for autonomy infringements is reduced. (shrink)

The last decade has seen rise in technologies that allow humans to send and receive intimate touch across long distances. Drawing together platform studies, digital intimacy studies, phenomenology of touch, and ethics of technology, we argue that these new haptic communication devices require specific ethical consideration of consent. The paper describes several technologies, including Kiiroo teledildonics, the Kissenger, the Apple Watch, and Hey Bracelet, highlighting how the sense of touch is used in marketing to evoke a feeling of connection (...) within the digital sphere. We then discuss the ambiguity of skin-to-skin touch and how it is further complicated in digital touch by remediation through platforms, companies, developers, manufacturers, cloud storage sites, the collection and use of data, research, satellites, and the internet. Lastly, we raise concerns about how consent of data collection and physical consent between users will be determined, draw on examples in virtual reality and sex-robotics, and ultimately arguing for further interdisciplinary research into this area. (shrink)

This paper provides a justificatory rationale for recommending the inclusion of imagined future use cases in neurotechnology development processes, specifically for legal and policy ends. Including detailed imaginative engagement with future applications of neurotechnology can serve to connect ethical, legal, and policy issues potentially arising from the translation of brain stimulation research to the public consumer domain. Futurist scholars have for some time recommended approaches that merge creative arts with scientific development in order to theorise possible futures toward which current (...) trends in technology development might be steered. Taking a creative, imaginative approach like this in the neurotechnology context can help move development processes beyond considerations of device functioning, safety, and compliance with existing regulation, and into an active engagement with potential future dynamics brought about by the emergence of the neurotechnology itself. Imagined scenarios can engage with potential consumer uses of devices that might come to challenge legal or policy contexts. An anticipatory, creative approach can imagine what such uses might consist in, and what they might imply. Justifying this approach also prompts a co-responsibility perspective for policymaking in technology contexts. Overall, this furnishes a mode of neurotechnology’s emergence that can avoid crises of confidence in terms of ethico-legal issues, and promote policy responses balanced between knowledge, values, protected innovation potential, and regulatory safeguards. (shrink)

Supernumerary robotic limbs are innovative devices in the field of wearable robotics which can provide humans with unprecedented sensorimotor abilities. However, scholars have raised awareness of the ethical issues that would arise from the large adoption of technologies for human augmentation in society. Most negative attitudes towards such technologies seem to rely on an allegedly clear distinction between therapy and enhancement in the use of technological devices. Based on such distinction, people tend to accept technologies when used for (...) therapeutic purposes (e.g., prostheses), but tend to raise issues when similar devices are used for upgrading a physical or cognitive ability (e.g., supernumerary robotics limbs). However, as many scholars have pointed out, the distinction between therapy and enhancement might be theoretically flawed. In this paper, we present an alternative approach to the ethics of supernumerary limbs which is based on two related claims. First, we propose to conceive supernumerary limbs as tools that necessarily modify our psychological and bodily identity. At the same time, we stress that such a modification is not ethically bad in itself; on the contrary, it drives human interaction with the environment. Second, by comparing our view with the extended mind thesis, we claim that the mediation through tools is crucial for the formation of novel meanings and skills that constitute human interaction with the world. We will relate the latter claim to enactivism as a helpful theoretical perspective to frame issues related to artificial limbs and, more in general, to technologies for augmentation. Based on this approach, we finally sketch some suggestions for future directions in the ethics of supernumerary limbs. (shrink)

This paper critically examines the extent to which health promoting wearable technologies can provide people with greater autonomy over their health. These devices are frequently presented as a means of expanding the possibilities people have for making healthier decisions and living healthier lives. We accept that by collecting, monitoring, analysing and displaying biomedical data, and by helping to underpin motivation, wearable technologies can support autonomy over health. However, we argue that their contribution in this regard is limited and (...) that—even with respect to their ‘autonomy enhancing’ potential—these devices may deliver costs as well as benefits. We proceed by rehearsing the distinction that can be drawn between procedural autonomy and substantive-relational autonomy. While the information provided by wearable technologies may support deliberation and decision-making, in isolation these technologies do little to provide substantive opportunities to act and achieve better health. As a consequence, wearable technologies risk generating burdens of anxiety and stigma for their users and reproducing existing health inequalities. We then reexamine the extent to which wearable technologies actually support autonomous deliberation. We argue that wearable technologies that subject their users to biomedical and consumerist epistemologies, norms and values also risk undermining processes of genuinely autonomous deliberation. (shrink)

Animal research has long been a source of biomedical aspirations and moral concern. Examples of both hope and concern are abundant today. In recent months, as is common practice, monkeys have served as test subjects in promising preclinical trials for an Ebola vaccine or treatment 1 , 2 , 3 and in controversial maternal deprivation studies. 4 The unresolved tension between the noble aspirations of animal research and the ethical controversies it often generates motivates the present issue of the (...) Cambridge Quarterly of Healthcare Ethics. As editors of this special section, we hope that these original and timely articles will push the professional discussion of animal research ethics in a positive direction that will benefi t research scientists and others interested in moral problems in animal research. We also look forward to a day when animal research will genuinely meet both appropriate scientifi c and appropriate ethical criteria—criteria that themselves can be improved by critical scrutiny. Animal research—that is, the use of live animals as experimental subjects in biomedical and behavioral fi elds of learning—has been deeply entrenched for well over half a century. One signal development was the enactment in the late 1930s of federal product safety legislation in the United States and other nations that required animal testing of food, drugs, and medical devices prior to use by human subjects or consumers. 5 Another development was the publication of codes of research ethics that called for animal research prior to human research. The Nuremberg Code, published by an American military tribunal in 1947–48 after scrutiny of Nazi medical atrocities, stated that experiments involving the use of human subjects should be " based on the results of animal experimentation. " 6 The Declaration of Helsinki, fi rst published in 1964, reaffi rmed this assumption and added, rather imprecisely, that " the welfare of animals used for research must be respected. " 7 Against the background of such statements, the institutionalization and widespread acceptance of animal research in the twentieth century rested on two basic assumptions, one factual and one moral. The factual assumption was that animal research is suffi ciently reliable as a basis for predicting the effects of drugs, products, and other materials on human beings that animal trials can be expected to yield signifi cant scientifi c conclusions and medical benefi ts to humanity. (shrink)

Brain-Computer Interface is a set of technologies that are of increasing interest to researchers. BCI has been proposed as assistive technology for individuals who are non-communicative or paralyzed, such as those with amyotrophic lateral sclerosis or spinal cord injury. The technology has also been suggested for enhancement and entertainment uses, and there are companies currently marketing BCI devices for those purposes as well as health-related purposes. The unprecedented direct connection created by BCI between human brains and computer hardware raises (...) various ethical, social, and legal challenges that merit further examination and discussion. To identify and characterize the key issues associated with BCI use, we performed a scoping review of biomedical ethics literature, analyzing the ethics concerns cited across multiple disciplines, including philosophy and medicine. Based on this investigation, we report that BCI research and its potential translation to therapeutic intervention generate significant ethical, legal, and social concerns, notably with regards to personhood, stigma, autonomy, privacy, research ethics, safety, responsibility, and justice. Our review of the literature determined, furthermore, that while these issues have been enumerated extensively, few concrete recommendations have been expressed. We conclude that future research should focus on remedying a lack of practical solutions to the ethical challenges of BCI, alongside the collection of empirical data on the perspectives of the public, BCI users, and BCI researchers. (shrink)

The last two decades have witnessed a crescendo of allegations that clinical translation is rife with waste and inefficiency. Patient advocates argue that excessively demanding regulations delay access to life‐saving drugs, research funders claim that too much basic science languishes in academic laboratories, journal editors allege that biased reporting squanders public investment in biomedical research, and drug companies (and their critics) argue that far too much is expended in pharmaceutical development.But how should stakeholders evaluate the efficiency of translation and (...) proposed reforms to drug development? Effective reforms require an accurate model of the systems they aspire to improve—their components, their proper functions, and their pathologies. However, there is currently no explicit and well‐developed model of translation for evaluating such criticisms.In what follows, we offer an explicit model of clinical translation. Many discussions of clinical translation and its pathologies presume that its main output is tangible: new drugs, vaccines, devices, and diagnostics. We disagree. We argue that the principal output of clinical translation is information—in particular, information about the coordinated set of materials, practices, and constraints needed to safely unlock the therapeutic or preventive activities of drugs, biologics, and diagnostics. To develop this information calls for a process far different from a simple linear progression of clinical trials; it requires exploratory sampling of many different elements in this set. Our model points to some limitations and liabilities of influential proposals for reforming research. It also reveals some underrecognized opportunities for improving the efficiency of clinical translation. (shrink)

Current COVID-19 pandemic and previous SARS/MERS outbreaks have caused a series of major crises to global public health. We must integrate the large and exponentially growing amount of heterogeneous coronavirus data to better understand coronaviruses and associated disease mechanisms, in the interest of developing effective and safe vaccines and drugs. Ontologies have emerged to play an important role in standard knowledge and data representation, integration, sharing, and analysis. We have initiated the development of the community-based Coronavirus Infectious Disease Ontology (CIDO). (...) As an Open Biomedical Ontology (OBO) library ontology, CIDO is an open source and interoperable with other existing OBO ontologies. In this article, the general architecture and the design patterns of the CIDO are introduced, CIDO representation of coronaviruses, phenotypes, anti-coronavirus drugs and medical devices (e.g. ventilators) are illustrated, and an application of CIDO implemented to identify repurposable drug candidates for effective and safe COVID-19 treatment is presented. (shrink)

This paper examines the nature of model-based reasoning in the interplay between theory and experiment in the context of biomedical engineering research laboratories, where problem solving involves using physical models. These "model systems" are sites of experimentation where in vitro models are used to screen, control, and simulate specific aspects of in vivo phenomena. As with all models, simulation devices are idealized representations, but they are also systems themselves, possessing engineering constraints. Drawing on research in contemporary cognitive science (...) that construes cognition as occurring in a complex distributed system comprising people and artifacts, I argue that reasoning with model systems is a constraint satisfaction process involving co-construction, manipulation, and revision of mental and physical models. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that (...) now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that (...) now are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

This article examines how the formation of markets in bottled water has relied on assembling a particular subject: the subject of hydration. The discourse of hydration is a conspicuous feature of efforts to market bottled water, allowing companies to appeal to scientifically framed principles and ideas of health in order to position the product as an essential component in self-health and healthy lifestyles. Alongside related principles, such as the ‘8 × 8 rule’, hydration has done much to establish new practices (...) of water drinking and consumption in which the consumer appears to be always at risk of dehydration and must engage in practices of ‘frequent sipping’. This article traces the emergence of the concept of hydration from its origins in exercise science and explores its circulation, contemporary uses and purchase. I argue that the appeal to biomedical languages and concepts found in the discourse of hydration connects with much broader ways of conceiving and acting upon the self that have become prevalent in contemporary society – what Rose and Novas call ‘biological citizenship’ – indicating how the ensemble of hydration participates in wider-ranging transformations in forms of rule. The story of hydration reveals how biomedical techniques of the self can be made to double up as ‘market devices’ by offering specific procedures for assessing the self and calculating the body’s needs. In order to grasp these developments, I position the health sciences, and health and fitness in particular, as a potent site of popular culture in which bodies learn to be affected by the procedures of scientific experiment. A critical grasp of this context is best enabled, I argue, by situating the producers and consumers of scientific principles and commercial products as embodied and looking at their interconnection in processes of emergence. Through these means, we can begin to develop a fully materialized account of the question: how have we become so thirsty? (shrink)

Businesses that produce bioscience products—gene tests and therapies, pharmaceuticals, vaccines, and medical devices—are regularly confronted with ethical issues concerning these technologies. Conflicts exist between those who support advancements in bioscience and those who fear the consequences of unfettered scientific license. As the debate surrounding bioscience grows, it will be increasingly important for business managers to consider the larger consequences of their work. This groundbreaking book follows industry research, development, and marketing of medical and bioscience products across a variety of (...) fields, including biotechnology, pharmaceuticals, and bio-agriculture. Compelling and current case studies highlight the ethical decisions business managers frequently face. With the increasing visibility and public expectation placed on businesses in this sector, managers need to understand the ethical and social issues. This book addresses that need and provides a framework for incorporating ethical analysis in business decision making. (shrink)

Anthropological insights into the use of race/ethnicity to explore genetic contributions to disparities in health were developed using in-depth qualitative interviews with editorial staff from nineteen genetics journals, focusing on the methodological and conceptual mechanisms required to make race/ethnicity a genetic variable. As such, these analyses explore how and why race/ethnicity comes to be used in the context of genetic research, set against the background of continuing critiques from anthropology and related human sciences that focus on the social construction, structural (...) correlates and limited genetic validity of racial/ethnic categories. The analyses demonstrate how these critiques have failed to engage geneticists, and how geneticists use a range of essentially cultural devices to protect and separate their use of race/ethnicity as a genetic construct from its use as a societal and social science resource. Given its multidisciplinary, biosocial nature and the cultural gaze of its ethnographic methodologies, anthropology is well placed to explore the cultural separation of science and society, and of natural and social science disciplines. Anthropological insights into the use of race/ethnicity to explore disparities in health suggest that moving beyond genetic explanations of innate difference might benefit from a more even-handed critique of how both the natural and social sciences tend to essentialize selective elements of race/ethnicity. Drawing on the example of HIV/AIDS, this paper demonstrates how public health has been undermined by the use of race/ethnicity as an analytical variable, both as a cipher for innate genetic differences in susceptibility and response to treatment, and in its use to identify at greater risk of becoming infected and infecting others. Clearly, a tendency for biological reductionism can place many biomedical issues beyond the scope of public health interventions, while socio-cultural essentialization has tended to stigmatize and the communities where these are more prevalent. (shrink)

In the rapidly expanding field of bioethics, philosophers and critics have taken on the task of attempting to understand the ethical implications related to the development of enhancement technologies. A term which itself is still hotly contested in the field, “enhancement technologies” refer generally to the application of biotechnological devices aimed at augmenting human physical and mental traits. According to the President’s Council on Bioethics, which was commissioned in 2001 to “advise the President on bioethical issues that may emerge (...) as a consequence of advances in biomedical science and technology,” enhancement technologies are broadly defined as “those well-meaning and strictly voluntary uses of .. (shrink)

Riassunto: Nell’ambito delle associazioni simbiotiche ha acquisito credito crescente la cosiddetta prospettiva “olobiontica”, secondo cui animali e piante non dovrebbero più essere considerati entità autonome, con confini chiaramente delimitati, ma li si dovrebbe vedere come unità funzionali che consistono di reti inter-relazionali tra specie diverse. In quest’ottica le funzioni precedentemente attribuite a un singolo componente devono essere riviste alla luce della prospettiva relazionale e considerate quindi come prodotto di un’unità funzionale, ossia dell’olobionte. Nella prospettiva funzionalista, il noto concetto di mente (...) estesa considera la possibilità per cui il veicolo della cognizione possa andare oltre il cervello e anche oltre i limiti del corpo, mediante dispositivi artificiali. Questo lavoro intende offrire una variante della teoria della mente estesa intesa non solo come possibilità teoretica ma anche come ipotesi compatibile con alcuni recenti sviluppi nella ricerca biologica e biomedica. Si sosterrà quindi che l’attività del microbiota umano svolgono un ruolo funzionale nella regolazione dei nostri processi cognitivi, suggerendo che il microbiota costituisce un’estensione funzionale del sistema cognitivo precedentemente descritto come “umano”. La revisione e l’estensione dell’individuo biologico in favore dell’olobionte come unità funzionale porta anche alla necessità di aggiornare i confini dell’individuo come agente cognitivo. Parole chiave: Microbiota; Cognizione estesa; Olobionte; Simbiosi; Funzionalismo The individuated extended mind: A symbiotic perspective: In the framework of symbiotic associations, the so-called “holobiontic” perspective has increasingly emerged, according to which animals and plants should no longer be considered as autonomous entities, delimited by clear boundaries, but should rather be seen as functional units, consisting of inter-relational networks of different species. From this perspective, the functions that were previously ascribed to a single component, must be updated in the light of this relational perspective and rather judged as a product of the functional unit, that is, the holobiont. In a functionalist perspective, the famous conception of the extended mind investigates the hypothesis that the vehicle of cognition can extend not only outside the brain but also beyond the limits of the body, through artificial devices. The present work aims to offer a variant of the extended theory of mind not only as a theoretical possibility but also in accordance with some recent developments in biological and biomedical research. It will therefore be argued that the activity of the human microbiota plays a functional role in the regulation of our cognitive processes suggesting that the microbiota constitutes a functional extension of the cognitive system previously described as “human”. The revision and extension of the biological individual in favor of the holobiont as a functional unit also leads to the need to update the boundaries of the individual as a cognitive agent. Keywords: Microbiota; Extended Cognition; Holobiont; Symbiosis; Functionalism. (shrink)

The discovery and development of new therapeutics has always been central to improving health worldwide. However, there is ongoing concern regarding the current state of medical innovation. Output from the pharmaceutical industry has been criticized for not being “transformative,” that is, offering substantial improvements in patient outcomes over existing therapeutics. While the cost of drug development continues to rise, breakthrough therapies remain elusive and one half of Phase 3 studies fail. Venture capital, a traditional source of funding for new breakthrough (...) biomedical innovations, has decreased investment by 30% in the biotechnology and medical device sectors from 2007 to 2013. Stakeholders question whether the new drugs approved each year by the FDA —many criticized as marginal improvements over existing therapies — justify the enormous investment. (shrink)

This article explores histories of the science of stress and its measurement from the mid 19th century, and brings these into dialogue with critical sociological analysis of emerging responses to work stress in policy and practice. In particular, it shows how the contemporary development of biomedical and consumer devices for stress self-monitoring is based on selectively rediscovering the biological determinants and biomarkers of stress, human functioning in terms of evolutionary ecology, and the physical health impacts of stress. It (...) considers how the placement of the individual body and its environment within particular spatio-temporal configurations renders it subject to experimental investigation through standardized apparatus, electricity, and statistical normalization. Examining key themes and processes such as homeostasis, metricization, datafication, and emotional governance, we conclude that the figure of the ‘body electric’ plays a central limiting role in current technology-supported approaches to managing work stress, and that an historical account can usefully open these to collective scrutiny. (shrink)

We have been studying cognition and learning in research laboratories in the field of biomedical engineering. Through our combining of ethnography and cognitive-historical analysis in studying these settings we have been led to understand these labs as comprising evolving distributed cognitive systems and as furnishing agentive learning environments. For this paper we develop the theme of 'models-in-action,' a variant of what Knorr Cetina has called 'knowledge-in-action.' Among the epistemically most salient objects in these labs are so called "model systems," (...) which are designs that blend engineering with the study and use of biological systems for purposes of simulative model-based reasoning. We portray the prevalent design-orientation in this engineering specialty and how the prevailing activity of cell-culturing in these labs transitions into a design activity for the bio-medical engineers, leading them to work with 'wet' devices. We discuss how devices, 'wet' and 'dry,' situate model-based understandings and how they participate in model systems in these labs. Models tend to come in clusters or configurations, and the model systems in these labs are epistemically salient junctures of interlocking models. Model systems in these labs evolve thereby consolidating what we want to call a 'fabric of interlocking models,' which functions as point of stability and departure in these labs. We convey a taste of such a 'fabric' for a tissue-engineering lab. We conjecture that through this 'fabric' extended developments in technology and methodology have a 'situated' presence in the workings of these labs. (shrink)