Biobank donation in search of public benefits and the potential impact of intellectual property rights over access to health-technologies developed: A focus on the bioethical implications.

The availability of biomaterials is a key component of health research and the development of new health-technologies (including, diagnostics, medicines, and vaccines). People are often encouraged by biobanks to donate samples altruistically to such biobanks. While empirical evidence suggests many donors are motivated by the desire to contribute towards developing new health-technologies for society. However, a tension can arise as health-technologies whose development is contributed to by donors' biomaterials will often be protected by intellectual property rights (IPRs), including patents. Patents give rightsholders control over how patented technologies are used and can be used in a way that impedes public access to technologies developed. Yet, there are no binding European legal obligations mandating disclosure to donors of how IPRs can operate over downstream health-technologies and how they could impact access to health-technologies developed, nor are there legally binding obligations to ensure public accessibility of technologies developed. Focusing on the bioethical implications posed, this article argues that the current situation can impact donors' autonomy and dignity interests. A more holistic approach is needed for biobank donation, which embeds a consideration of donors' expectations/interests from the point of donation through to how such samples are used and how health-technologies developed are accessed. We put forward avenues that seek to address such issues.

European stem cell patents: taking the moral high road?

A European law that prevents the patenting of discoveries that contravene morality is causing confusion when it comes to human embryonic stem cells. The ensuing debate is markedly different from the one in the United States, where the scope of stem cell patents and their licensing are under challenge.

Materialized Oppression in Medical Tools and Technologies.

It is well-known that racism is encoded into the social practices and institutions of medicine. Less well-known is that racism is encoded into the material artifacts of medicine. We argue that many medical devices are not merely biased, but materialize oppression. An oppressive device exhibits a harmful bias that reflects and perpetuates unjust power relations. Using pulse oximeters and spirometers as case studies, we show how medical devices can materialize oppression along various axes of social difference, including race, gender, class, and ability. Our account uses political philosophy and cognitive science to give a theoretical basis for understanding materialized oppression, explaining how artifacts encode and carry oppressive ideas from the past to the present and future. Oppressive medical devices present a moral aggregation problem. To remedy this problem, we suggest redundantly layered solutions that are coordinated to disrupt reciprocal causal connections between the attitudes, practices, and artifacts of oppressive systems.

Privacy-Oriented Technique for COVID-19 Contact Tracing (PROTECT) Using Homomorphic Encryption: Design and Development Study.

BACKGROUND: Various techniques are used to support contact tracing, which has been shown to be highly effective against the COVID-19 pandemic. To apply the technology, either quarantine authorities should provide the location history of patients with COVID-19, or all users should provide their own location history. This inevitably exposes either the patient's location history or the personal location history of other users. Thus, a privacy issue arises where the public good (via information release) comes in conflict with privacy exposure risks. OBJECTIVE: The objective of this study is to develop an effective contact tracing system that does not expose the location information of the patient with COVID-19 to other users of the system, or the location information of the users to the quarantine authorities. METHODS: We propose a new protocol called PRivacy Oriented Technique for Epidemic Contact Tracing (PROTECT) that securely shares location information of patients with users by using the Brakerski/Fan-Vercauteren homomorphic encryption scheme, along with a new, secure proximity computation method. RESULTS: We developed a mobile app for the end-user and a web service for the quarantine authorities by applying the proposed method, and we verified their effectiveness. The proposed app and web service compute the existence of intersections between the encrypted location history of patients with COVID-19 released by the quarantine authorities and that of the user saved on the user's local device. We also found that this contact tracing smartphone app can identify whether the user has been in contact with such patients within a reasonable time. CONCLUSIONS: This newly developed method for contact tracing shares location information by using homomorphic encryption, without exposing the location information of patients with COVID-19 and other users. Homomorphic encryption is challenging to apply to practical issues despite its high security value. In this study, however, we have designed a system using the Brakerski/Fan-Vercauteren scheme that is applicable to a reasonable size and developed it to an operable format. The developed app and web service can help contact tracing for not only the COVID-19 pandemic but also other epidemics.

Progress bias versus status quo bias in the ethics of emerging science and technology.

How should we handle ethical issues related to emerging science and technology in a rational way? This is a crucial issue in our time. On the one hand, there is great optimism with respect to technology. On the other, there is pessimism. As both perspectives are based on scarce evidence, they may appear speculative and irrational. Against the pessimistic perspective to emerging technology, it has been forcefully argued that there is a status quo bias (SQB) fuelling irrational attitudes to emergent science and technology and greatly hampering useful development and implementation. Therefore, this article starts by analysing the SQB using human enhancement as a case study. It reveals that SQB may not be as prominent in restricting the implementation of emergent technologies as claimed in the ethics literature, because SQB (a) is fuelled by other and weaker drivers than those addressed in the literature, (b) is at best one amongst many drivers of attitudes towards emergent science and technology, and (c) may not be a particularly prominent driver of irrational decision-making. While recognizing that SQB can be one driver behind pessimism, this article investigates other and counteracting forces that may be as strong as SQB. Progress bias is suggested as a generic term for the various drivers of unwarranted science and technology optimism. Based on this analysis, a test for avoiding or reducing this progress bias is proposed. Accordingly, we should recognize and avoid a broad range of biases in the assessment of emerging and existing science and technology in order to promote an open and transparent deliberation.

What Do We Have to Lose? Offloading Through Moral Technologies: Moral Struggle and Progress.

Moral bioenhancement, nudge-designed environments, and ambient persuasive technologies may help people behave more consistently with their deeply held moral convictions. Alternatively, they may aid people in overcoming cognitive and affective limitations that prevent them from appreciating a situation's moral dimensions. Or they may simply make it easier for them to make the morally right choice by helping them to overcome sources of weakness of will. This paper makes two assumptions. First, technologies to improve people's moral capacities are realizable. Second, such technologies will actually help people get morality right and behave more consistently with whatever the 'real' right thing to do turns out to be. The paper then considers whether or not humanity loses anything valuable, particularly opportunities for moral progress, when being moral is made much easier by eliminating difficult moral deliberation and internal moral struggle. Ultimately, the worry that moral struggle has value as a catalyst for moral progress is rejected. Moral progress is understood here as the discovery and application of new values or sensitization to new sources of harm.

Regulation of Stem Cell Technology in Malaysia: Current Status and Recommendations.

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and effectiveness of the current Guideline for Stem Cell Research and Therapy (2009) are examined. The study's findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation (2016) of the International Society for Stem Cell Research (ISSCR) containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders.

Treating or Killing? The Divergent Moral Implications of Cardiac Device Deactivation.

In this article, I argue that there is a moral difference between deactivating an implantable cardioverter defibrillator (ICD) and turning off a cardiac pacemaker (CP). It is, at least in most cases, morally permissible to deactivate an ICD. It is not, at least in most cases, morally permissible to turn off a pacemaker in a fully or significantly pacemaker-dependent patient. After describing the relevant medical technologies-pacemakers and ICDs-I continue with contrasting perspectives on the issue of deactivation from practitioners involved with these devices: physicians, nurses, and allied professionals. Next, I offer a few possible analyses of the situation, relying on recent work in medical ethics. Considerations of intention, responsibility, and replacement support my distinguishing between ICDs and CPs. I conclude by recommending a change in policy of one of the leading cardiac societies.

Ethical issues related to the use of gerontechnology in older people care: A scoping review.

BACKGROUND: Demographic trends indicate growth of population aged 65 and older in Western countries. One of the greatest challenges is to provide high-quality care for all. Technological solutions designed for older people, gerontechnology, can somewhat balance the gap between resources and the increasing demand of healthcare services. However, there are also ethical issues in the use of gerontechnology that need to be pointed out. PURPOSE: To describe what ethical issues are related to the use of gerontechnology in the care of community-dwelling older people. METHODS: A scoping review was performed to identify and analyse studies concerning ethical issues when using gerontechnology in the home care of older people. The literature search was limited to studies published after 1990 and addressed to the electronic databases CINAHL, PubMed, Cochrane, Medic, IEEE Explore and Web of Science. The search was performed in July-August 2018. Data from empirical studies were analysed using thematic analysis. ETHICAL CONSIDERATIONS: This scoping review was conducted in accordance with good scientific practice. The work of other researchers was respected and cited appropriately. RESULTS: A total of 17 studies were identified. Two main themes were found. 'Balancing between the benefits of using gerontechnology and the basic rights of older people', consisted of the subthemes safety, privacy and autonomy. The other main theme, 'Gerontechnology as a risk of insecurity for older people', included the subthemes fear of losing human contact and concern and fear. Surveillance and monitoring technologies were mainly studied. CONCLUSION: These results suggest that there may be ethical issues related to the use of gerontechnology and they must therefore be taken into consideration when implementing technology in the care of community-dwelling older people.

Knowledge development, technology and questions of nursing ethics.

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

Psychosis, vulnerability, and the moral significance of biomedical innovation in psychiatry. Why ethicists should join efforts.

The study of the neuroscience and genomics of mental illness are increasingly intertwined. This is mostly due to the translation of medical technologies into psychiatry and to technological convergence. This article focuses on psychosis. I argue that the convergence of neuroscience and genomics in the context of psychosis is morally problematic, and that ethics scholarship should go beyond the identification of a number of ethical, legal, and social issues. My argument is composed of two strands. First, I argue that we should respond to technological convergence by developing an integrated, patient-centred approach focused on the assessment of individual vulnerabilities. Responding to technological convergence requires that we (i) integrate insights from several areas of ethics, (ii) translate bioethical principles into the mental health context, and (iii) proactively try to anticipate future ethical concerns. Second, I argue that a nuanced understanding of the concept of vulnerability might help us to accomplish this task. I borrow Florencia Luna's notion of 'layers of vulnerability' to show how potential harms or wrongs to individuals who experience psychosis can be conceptualised as stemming from different sources, or layers, of vulnerability. I argue that a layered notion of vulnerability might serve as a common ground to achieve the ethical integration needed to ensure that biomedical innovation can truly benefit, and not harm, individuals who suffer from psychosis.

The Ethics of Emergent Health Technologies: Implications of the 21st Century Cures Act for Nursing.

The 21st Century Cures Act, passed in December 2016 by the United States Congress, is a public law aimed at accelerating the time it takes to get pharmaceutical drugs and medical devices into the market, in addition to shifting connected review processes from randomized controlled trials to real-world efficacy tests. As of December 2019, efforts are underway to introduce a "Cures Act 2.0" bill, with particular attention to the implementation of digital health within health systems. Research on the development of emergent health technologies is nascent; research examining health technology implications of 21st Century Cures Act for the health care workforce is nonexistent. This article fills a crucial gap in public awareness, discussing ethical implications of the 21st Century Cures Act and centering nursing. Nursing is a profession frequently acknowledged as practicing on "the front lines of care" and frequently responsible for the trialing of products in clinical settings. The article summarizes and evaluates key components of the 21st Century Cures Act related to health technology development. Discrete health technologies addressed are (a) breakthrough devices, (b) digital health software, and (c) combination products. It then connects these provisions to ethical considerations for nursing practice, research, and policy. The article concludes by discussing the relevance of emerging digital health technologies to the crafting of a "Cures 2.0" bill, with particular attention to this moment in light of digital care precedents set during the COVID-19 pandemic.

New Technologies, New Challenges for Human Rights? The Work of the Council of Europe.

Convergence of emerging technologies (e.g. biotechnologies, information and cognitive technologies) has opened new perspectives for progress with regard to human health. However, these technologies also open new possibilities for interventions on human beings, which may be more invasive, and possibly affect and modify individuals. Established practices in the field of biomedicine are also evolving in a way that exerts pressure on existing protective mechanisms. Thus, consideration is required as to whether existing human rights provisions are still fit for purpose or whether there is a need to re-examine, clarify or re-enforce them or even a need to identify new human rights and protective measures. This article gives an overview of the main issues considered by the Committee on Bioethics of the Council of Europe to develop a Strategic Action Plan aimed at ensuring appropriate protection of human rights in the developments in biomedicine, promoting thereby progress for human health.

A failure in solidarity: Ethical challenges in the development and implementation of new tuberculosis technologies.

Prominent tuberculosis (TB) actors are invoking solidarity to motivate and justify collective action to address TB, including through intensified development and implementation (D&I) of technologies such as drugs and diagnostics. We characterize the ethical challenges associated with D&I of new TB technologies by drawing on stakeholder perspectives from 23 key informant interviews and we articulate the ethical implications of solidarity for TB technology D&I. The fundamental ethical issue facing TB technological D&I is a failure within and beyond the TB community to stand in solidarity with persons with TB in addressing the complex sociopolitical contexts of technological D&I. The failure in solidarity relates to two further ethical challenges raised by respondents: skewed power dynamics that hinder D&I and uncertainties around weighing risks and benefits associated with new technologies. Respondents identified advocacy and participatory research practices as necessary to address such challenges and to motivate sustained collective action to accelerate toward TB elimination. We present the first empirical examination of bioethical accounts of solidarity in public and global health. Our study suggests that solidarity allows us better to understand and address the ethical challenges that arrest the D&I of new TB technologies. Solidarity lends credence to policies and practices that address the relational nature of illness and health through collective action.

Neuroscience Fiction as Eidolá: Social Reflection and Neuroethical Obligations in Depictions of Neuroscience in Film.

Neuroscience and neurotechnology are increasingly being employed to assess and alter cognition, emotions, and behaviors, and the knowledge and implications of neuroscience have the potential to radically affect, if not redefine, notions of what constitutes humanity, the human condition, and the "self." Such capability renders neuroscience a compelling theme that is becoming ubiquitous in literary and cinematic fiction. Such neuro-SciFi (or "NeuroS/F") may be seen as eidolá: a created likeness that can either accurately-or superficially, in a limited way-represent that which it depicts. Such eidolá assume discursive properties implicitly, as emotionally salient references for responding to cultural events and technological objects reminiscent of fictional portrayal; and explicitly, through characters and plots that consider the influence of neurotechnological advances from various perspectives. We argue that in this way, neuroS/F eidolá serve as allegorical discourse on sociopolitical or cultural phenomena, have power to restructure technological constructs, and thereby alter the trajectory of technological development. This fosters neuroethical responsibility for monitoring neuroS/F eidolá and the sociocultural context from which-and into which-the ideas of eidolá are projected. We propose three approaches to this: evaluating reciprocal effects of imaginary depictions on real-world neurotechnological development; tracking changing sociocultural expectations of neuroscience and its uses; and analyzing the actual process of social interpretation of neuroscience to reveal shifts in heuristics, ideas, and attitudes. Neuroethicists are further obliged to engage with other discourse actors about neuroS/F interpretations to ensure that meanings assigned to neuroscientific advances are well communicated and more fully appreciated.

Emerging technologies with potential for objectively evaluating speech recognition skills.

Work-related exposure to noise and other ototoxins can cause damage to the cochlea, synapses between the inner hair cells, the auditory nerve fibers, and higher auditory pathways, leading to difficulties in recognizing speech. Procedures designed to determine speech recognition scores (SRS) in an objective manner can be helpful in disability compensation cases where the worker claims to have poor speech perception due to exposure to noise or ototoxins. Such measures can also be helpful in determining SRS in individuals who cannot provide reliable responses to speech stimuli, including patients with Alzheimer's disease, traumatic brain injuries, and infants with and without hearing loss. Cost-effective neural monitoring hardware and software is being rapidly refined due to the high demand for neurogaming (games involving the use of brain-computer interfaces), health, and other applications. More specifically, two related advances in neuro-technology include relative ease in recording neural activity and availability of sophisticated analysing techniques. These techniques are reviewed in the current article and their applications for developing objective SRS procedures are proposed. Issues related to neuroaudioethics (ethics related to collection of neural data evoked by auditory stimuli including speech) and neurosecurity (preservation of a person's neural mechanisms and free will) are also discussed.

Epigenetics in the Neoliberal "Regime of Truth": A Biopolitical Perspective on Knowledge Translation.

Recent findings in epigenetics have been attracting much attention from social scientists and bioethicists because they reveal the molecular mechanisms by which exposure to socioenvironmental factors, such as pollutants and social adversity, can influence the expression of genes throughout life. Most surprisingly, some epigenetic modifications may also be heritable via germ cells across generations. Epigenetics may be the missing molecular evidence of the importance of using preventive strategies at the policy level to reduce the incidence and prevalence of common diseases. But while this "policy translation" of epigenetics introduces new arguments in favor of public health strategies and policy-making, a more "clinical translation" of epigenetics is also emerging. It focuses on the biochemical mechanisms and epigenetic variants at the origin of disease, leading to novel biomedical means of assessing epigenetic susceptibility and reversing detrimental epigenetic variants. In this paper, we argue that the impetus to create new biomedical interventions to manipulate and reverse epigenetic variants is likely to garner more attention than effective social and public health interventions and therefore also to garner a greater share of limited public resources. This is likely to happen because of the current biopolitical context in which scientific findings are translated. This contemporary neoliberal "regime of truth," to use a term from Michel Foucault, greatly influences the ways in which knowledge is being interpreted and implemented. Building on sociologist Thomas Lemke's Foucauldian "analytics of biopolitics" and on literature from the field of science and technology studies, we present two sociological trends that may impede the policy translation of epigenetics: molecularization and biomedicalization. These trends, we argue, are likely to favor the clinical translation of epigenetics-in other words, the development of new clinical tools fostering what has been called "personalized" or "precision" medicine. In addition, we argue that an overemphasized clinical translation of epigenetics may further reinforce this biopolitical landscape through four processes closely related to neoliberal pathways of thinking: the internalization and isolation (aspects of liberal individualism) of socioenvironmental determinants of health and increased opportunities for commodification and technologicalization (aspects of economic liberalism) of health care interventions.

Psychological aspects of individualized choice and reproductive autonomy in prenatal screening.

Probably the main purpose of reproductive technologies is to enable people who choose to do so to avoid the birth of a baby with a disabling condition. However the conditions women want information about and the 'price' they are willing to pay for obtaining that information vary enormously. Individual women have to arrive at their own prenatal testing choices by 'trading off' means and ends in order to resolve the dilemmas facing them. We know very little about how individuals make these trade-offs, so it is difficult to predict how new technologies will affect their choices and preferences. Uptake decisions can be expected to change, especially in the group of women who now are put off by some aspect of the current screening approach, where the avoidance of miscarriage risk may have provided a kind of 'psychological shelter', protecting a lot of people from having to make other decisions. Technologies such as Pre-implantation Genetic Diagnosis may remove a second 'psychological shelter' because they offer the means of avoiding the birth of an affected child without terminating a pregnancy. Even if new technologies will make some decisions easier in terms of their cognitive demands, they will also create new dilemmas and decision making will not necessarily become less stressful in emotional terms. Key challenges concern information and decision-making.