As we look to the future in a world with porous borders and boundaries transgressed by technologies, an inevitable question is:Can there be a single, global bioethics? Intimately intertwined with this question is a second one: How might a global bioethics account for profound - and constantly transforming - sources of cultural difference? Can a uniform, global bioethics be relevant cross-culturally? These are not simple questions, rather, a multi-dimensional answer is required. It is important to distinguish between two meanings of (...) bioethics: the academic discipline of bioethics as opposed to bioethics as a set of practices governing clinical care and scientific research. There is growing evidence to support the notion of a shared global understanding of bioethics as a field of inquiry focused on the moral dimensions of science and biomedicine. (shrink)

As we look to the future in a world with porous borders and boundaries transgressed by technologies, an inevitable question is:Can there be a single, global bioethics? Intimately intertwined with this question is a second one: How might a global bioethics account for profound - and constantly transforming - sources of cultural difference? Can a uniform, global bioethics be relevant cross-culturally? These are not simple questions, rather, a multi-dimensional answer is required. It is important to distinguish between two meanings of (...) bioethics: the academic discipline of bioethics as opposed to bioethics as a set of practices governing clinical care and scientific research. There is growing evidence to support the notion of a shared global understanding of bioethics as a field of inquiry focused on the moral dimensions of science and biomedicine. (shrink)

Paul Appelbaum and colleagues propose four models of informed consent to research that deploys whole genome sequencing and may generate incidental findings. They base their analysis on empirical data that suggests that research participants want to be offered incidental findings and on a normative consensus that researchers incur a duty to offer them. Their models will contribute to the heated policy debate about return of incidental findings. But in my view, they do not ask the foundational question, In the context (...) of genome sequencing, how much work can consent be asked to do? (shrink)

A basic assumption in current western medicine is that good healthcare involves informed choices. Indeed, making informed choices is not only viewed as “good practice” but a right to which each individual is entitled, a perspective only recently developed in the medical field.Moreover, in the case of ethical decisions, much of the discussion on the role of the family is cast within the autonomy paradigm of contemporary bioethics; that is, family members provide emotional support but do not make decisions for (...) the competent adult patient. The family Is uniformly viewed as an Important proxy decision maker for incompetent patients; but most bioethicists would eschew any decision-making role for the family of mentally competent adult patients. Underlying the discussion of autonomy is the basic assumption in western medicine that good healthcare Involves choices by Informed individuals. (shrink)

To understand public discourse in the United States on genetic causation of behavioral disorders, we analyzed media representations of genetic research on addiction published between 1990 and 2010. We conclude first that the media simplistically represent biological bases of addiction and willpower as being mutually exclusive: behaviors are either genetically determined, or they are a choice. Second, most articles provide only cursory or no treatment of the environmental contribution. A media focus on genetics directs attention away from environmental factors. Rhetorically, (...) media neglect the complexity underlying the etiology the addiction and direct focus back toward individual causation and responsibility. (shrink)

Cultural difference has been largely ignored within bioethics, particularly within the end-of-life discourses and practices that have developed over the past two decades in the U.S. healthcare system. Yet how should culturebe taken into account?

The two target articles in this issue bring into focus the struggle for governance over biomedical interventions that may offer some families more agency—the capacity to act—in the context of many...

Biological kin share up to half of their genetic material, including predisposition to disease. Thus, variants of clinical significance identified in each individual’s genome can implicate an exponential number of relatives at potential risk. This has renewed the dilemma over family access to research participant’s genetic results, since prevailing US practices treat these as private, controlled by the individual. These individual-based ethics contrast with the family-based ethics – in which genetic information, privacy, and autonomy are considered to be familial – (...) endorsed in UK genomic medicine and by participants in a multi-method study of US research participants presented here. The dilemma reflects a conflict between US legal and ethical frameworks that privilege “the individual” and exclude “the family” versus actual human genetics that are simultaneously individual and familial. Can human genetics succeed in challenging bioethics’ hegemonic individualism to recognize and place the family at the center of the room where bioethics happens? (shrink)

The literature on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises concerns that these technologies may affect personality, mood, and behavior. We conducted semi-structured interviews with researchers (n = 23) involved in developing next-generation DBS systems, exploring their perspectives on ethics and policy topics including whether DBS/aDBS can cause such changes. The majority of researchers reported being aware of personality, mood, or behavioral (PMB) changes in recipients of DBS/aDBS. Researchers offered varying estimates of the frequency of PMB changes. A (...) smaller majority reported changes in personality specifically. Some expressed reservations about the scientific status of the term ‘personality,’ while others used it freely. Most researchers discussed negative PMB changes, but a majority said that DBS/aDBS can also result in positive changes. Several researchers viewed positive PMB changes as part of the therapeutic goal in psychiatric applications of DBS/aDBS. Finally, several discussed potential causes of PMB changes other than the device itself. (shrink)

Background: Genomic analysis may reveal both primary and secondary findings with direct relevance to the health of probands’ biological relatives. Researchers question their obligations to return findings not only to participants but also to family members. Given the social value of privacy protection, should researchers offer a proband’s results to family members, including after the proband’s death? Methods: Preferences were elicited using interviews and a survey. Respondents included probands from two pancreatic cancer research resources, plus biological and nonbiological family members. (...) Hypothetical scenarios based on actual research findings from the two cancer research resources were presented; participants were asked return of results preferences and justifications. Interview transcripts were coded and analyzed; survey data were analyzed descriptively. Results: Fifty-one individuals (17 probands, 21 biological relatives, 13 spouses/partners) were interviewed. Subsequently, a mailed survey was returned by 464 probands, 1,040 biological family members, and 399 spouses/partners. This analysis highlights the interviews, augmented by survey findings. Probands and family members attribute great predictive power and lifesaving potential to genomic information. A majority hold that a proband’s genomic results relevant to family members’ health ought to be offered. While informants endorse each individual’s choice whether to learn results, most express a strong moral responsibility to know and to share, particularly with the younger generation. Most have few concerns about sharing genetic information within the family; rather, their concerns focus on the health consequences of not sharing. Conclusions: Although additional studies in diverse populations are needed, policies governing return of genomic results should consider how families understand genomic data, how they value confidentiality within the family, and whether they endorse an ethics of sharing. A focus on respect for individual privacy—without attention to how the broad social and cultural context shapes preferences within families—cannot be the sole foundation of policy. (shrink)

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

The expansion of research on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises important neuroethics and policy questions related to data sharing. However, there has been little empirical research on the perspectives of experts developing these technologies. We conducted semi-structured, open-ended interviews with aDBS researchers regarding their data sharing practices and their perspectives on ethical and policy issues related to sharing. Researchers expressed support for and a commitment to sharing, with most saying that they were either sharing their data (...) or would share in the future and that doing so was important for advancing the field. However, those who are sharing reported a variety of sharing partners, suggesting heterogeneity in sharing practices and lack of the broad sharing that would reflect principles of open science. Researchers described several concerns and barriers related to sharing, including privacy and confidentiality, the usability of shared data by others, ownership and control of data (including potential commercialization), and limited resources for sharing. They also suggested potential solutions to these challenges, including additional safeguards to address privacy issues, standardization and transparency in analysis to address issues of data usability, professional norms and heightened cooperation to address issues of ownership and control, and streamlining of data transmission to address resource limitations. Researchers also offered a range of views on the sensitivity of neural activity data (NAD) and data related to mental health in the context of sharing. These findings are an important input to deliberations by researchers, policymakers, neuroethicists, and other stakeholders as they navigate ethics and policy questions related to aDBS research. (shrink)

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can (...) meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance. (shrink)

Meaningful participant engagement has been identified as a key contributor to the success of efforts to share data via a “Medical Information Commons”. We present findings from expert stakeholder interviews aimed at understanding barriers to engagement and the appropriate role of MIC participants. Although most interviewees supported engagement, they distinguished between individual versus collective forms. They also noted challenges including representation and perceived inefficiency, prompting reflection on political aspects of engagement and efficiency concerns.

Incidental fndings of potential medical signifcance are seen in approximately 5-8 percent of asymptomatic subjects and 16 percent of symptomatic subjects participating in large computed tomography colonography studies, with the incidence varying further by CT acquisition technique. While most CTC research programs have a well-defned plan to detect and disclose IFs, such plans are largely communicated only verbally. Written consent documents should also inform subjects of how IFs of potential medical signifcance will be detected and reported in CTC research studies.

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

Health research increasingly relies on organized collections of health data and biological samples. There are many types of sample and data collections that are used for health research, though these are collected for many purposes, not all of which are health-related. These collections exist under different jurisdictional and regulatory arrangements and include: 1) Population biobanks, cohort studies, and genome databases 2) Clinical and public health data 3) Direct-to-consumer genetic testing 4) Social media 5) Fitness trackers, health apps, and biometric data (...) sensors Population biobanks, cohort studies, and genome databases Clinical and public health data Direct-to-consumer genetic testing Social media Fitness trackers, health apps, and biometric data sensors Ethical, legal, and social challenges of such collections are well recognized, but there has been limited attention to the broader societal implications of the existence of these collections. Although health research conducted using these collections is broadly recognized as beneficent, secondary uses of these data and samples may be controversial. We examine both documented and hypothetical scenarios of secondary uses of health data and samples. In particular, we focus on the use of health data for purposes of: Forensic investigations Civil lawsuits Identification of victims of mass casualty events Denial of entry for border security and immigration Making health resource rationing decisions Facilitating human rights abuses in autocratic regimes Forensic investigations Civil lawsuits Identification of victims of mass casualty events Denial of entry for border security and immigration Making health resource rationing decisions Facilitating human rights abuses in autocratic regimes Current safeguards relating to the use of health data and samples include research ethics oversight and privacy laws. These safeguards have a strong focus on informed consent and anonymization, which are aimed at the protection of the individual research subject. They are not intended to address broader societal implications of health data and sample collections. As such, existing arrangements are insufficient to protect against subversion of health databases for non-sanctioned secondary uses, or to provide guidance for reasonable but controversial secondary uses. We are concerned that existing debate in the scholarly literature and beyond has not sufficiently recognized the secondary data uses we outline in this paper. Our main purpose, therefore, is to raise awareness of the potential for unforeseen and unintended consequences, in particular negative consequences, of the increased availability and development of health data collections for research, by providing a comprehensive review of documented and hypothetical non-health research uses of such data. (shrink)

A medical information commons is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.

Advances in technologies and biomedical informatics have expanded capacity to generate and share biomedical data. With a lens on genomic data, we present a typology characterizing the data-sharing landscape in biomedical research to advance understanding of the key stakeholders and existing data-sharing practices. The typology highlights the diversity of data-sharing efforts and facilitators and reveals how novel data-sharing efforts are challenging existing norms regarding the role of individuals whom the data describe.

Data are lacking with regard to participants' perspectives on return of genetic research results to relatives, including after the participant's death. This paper reports descriptive results from 3,630 survey respondents: 464 participants in a pancreatic cancer biobank, 1,439 family registry participants, and 1,727 healthy individuals. Our findings indicate that most participants would feel obligated to share their results with blood relatives while alive and would want results to be shared with relatives after their death.

Many scientists and doctors hope that affordable genome sequencing will lead to more personalized medical care and improve public health in ways that will benefit children, families, and society more broadly. One hope in particular is that all newborns could be sequenced at birth, thereby setting the stage for a lifetime of medical care and self‐directed preventive actions tailored to each child's genome. Indeed, commentators often suggest that universal genome sequencing is inevitable. Such optimism can come with the presumption that (...) discussing the potential limits, cost, and downsides of widespread application of genomic technologies is pointless, excessively pessimistic, or overly cautious. We disagree. Given the pragmatic challenges associated with determining what sequencing data mean for the health of individuals, the economic costs associated with interpreting and acting on such data, and the psychosocial costs of predicting one's own or one's child's future life plans based on uncertain testing results, we think this hope and optimism deserve to be tempered.In the analysis that follows, we distinguish between two reasons for using sequencing: to diagnose individual infants who have been identified as sick and to screen populations of infants who appear to be healthy. We also distinguish among three contexts in which sequencing for either diagnosis or screening could be deployed: in clinical medicine, in public health programs, and as a direct‐to‐consumer service. Each of these contexts comes with different professional norms, policy considerations, and public expectations. Finally, we distinguish between two main types of genome sequencing: targeted sequencing, where only specific genes are sequenced or analyzed, and whole‐exome or whole‐genome sequencing, where all the DNA or all the coding segments of all genes are sequenced and analyzed.In a symptomatic newborn, targeted or genome‐wide sequencing can help guide other tests for diagnosis or for specific treatment that is urgently needed. Clinicians use the infant's symptoms (or phenotype) to interrogate the sequencing data. These same complexities and uncertainties, however, limit the usefulness of genome‐wide sequencing as a population screening tool. While we recognize considerable benefit in using targeted sequencing to screen for or detect specific conditions that meet the criteria for inclusion in newborn screening panels, use of genome‐wide sequencing as a sole screening tool for newborns is at best premature. We conclude that sequencing technology can be beneficially used in newborns when that use is nuanced and attentive to context. (shrink)

Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...) negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

Obtaining informed consent, an ethical obligation of nurses and other health care providers, occurs routinely when patients make health care decisions. The values underlying informed consent (promotion of patients’ well-being and respect for their self-determination) are embedded in the dominant American culture. Nurses who apply the USA’s cultural values of informed consent when caring for patients who come from other cultures encounter some ethical dilemmas. This descriptive study, conducted with Latino, Chinese and Anglo-American cancer patients in a large, public, west-coast (...) clinic, describes constraints on the informed consent process in a multicultural setting, including language barriers, the clinical environment, control in decision making, and conflicting desired health outcomes for health care providers and patients, and suggests some implications for nursing practice. (shrink)

The capacity of next-generation closed-loop or adaptive deep brain stimulation devices to read and write shows great potential to effectively manage movement, seizure, and psychiatric disorders, and also raises the possibility of using aDBS to electively modulate mood, cognition, and prosociality. What separates aDBS from most neurotechnologies currently used for enhancement is that aDBS remains an invasive, surgically-implanted technology with a risk-benefit ratio significantly different when applied to diseased versus non-diseased individuals. Despite a large discourse about the ethics of enhancement, (...) no empirical studies yet examine perspectives on enhancement from within the aDBS research community. We interviewed 23 aDBS researchers about their attitudes toward expanding aDBS use for enhancement. A thematic content analysis revealed that researchers share ethical concerns related to safety and security; enhancement as unnecessary, unnatural or aberrant; and fairness, equality, and distributive justice. Most researchers felt that enhancement applications for DBS will eventually be technically feasible and that attempts to develop such applications for DBS are already happening. However, researchers unanimously felt that DBS ideally should not be considered for enhancement until researchers better understand brain target localization and functioning. While many researchers acknowledged controversies highlighted by scholars and ethicists, such as potential impacts on personhood, authenticity, autonomy and privacy, their ethical concerns reflect considerations of both gravity and perceived near-term likelihood. (shrink)

It is widely thought that focusing on highly skilled movements while performing them hinders their execution. Once you have developed the ability to tee off in golf, play an arpeggio on the piano, or perform a pirouette in ballet, attention to what your body is doing is thought to lead to inaccuracies, blunders, and sometimes even utter paralysis. Here I re-examine this view and argue that it lacks support when taken as a general thesis. Although bodily awareness may often interfere (...) with well-developed rote skills, like climbing stairs, I suggest that it is typically not detrimental to the skills of expert athletes, performing artists, and other individuals who endeavor to achieve excellence. Along the way, I present a critical analysis of some philosophical theories and behavioral studies on the relationship between attention and bodily movement, an explanation of why attention may be beneficial at the highest level of performance and an error theory that explains why many have thought the contrary. Though tentative, I present my view as a challenge to the widespread starting assumption in research on highly skilled movement that at the pinnacle of skill attention to one's movement is detrimental. (shrink)

According to David Chalmers , 'we have good reason to suppose that consciousness has a fundamental place in nature' . This, he thinks is because the world as revealed to us by fundamental physics is entirely structural -- it is a world not of things, but of relations -- yet relations can only account for more relations, and consciousness is not merely a relation . Call this the 'structural argument against physicalism.' I shall argue that there is a view about (...) the relationship between mind and body, what I call, 'Russellian physicalism' that is consistent with the premises of the structural argument yet does not imply that consciousness is fundamental. (shrink)

How should biological behaviour be modelled? A relatively new approach is to investigate problems in neuroethology by building physical robot models of biological sensorimotor systems. The explication and justification of this approach are here placed within a framework for describing and comparing models in the behavioural and biological sciences. First, simulation models – the representation of a hypothesis about a target system – are distinguished from several other relationships also termed “modelling” in discussions of scientific explanation. Seven dimensions on which (...) simulation models can differ are defined and distinctions between them discussed: 1. Relevance: whether the model tests and generates hypotheses applicable to biology. 2. Level: the elemental units of the model in the hierarchy from atoms to societies. 3. Generality: the range of biological systems the model can represent. 4. Abstraction: the complexity, relative to the target, or amount of detail included in the model. 5. Structural accuracy: how well the model represents the actual mechanisms underlying the behaviour. 6. Performance match: to what extent the model behaviour matches the target behaviour. 7. Medium: the physical basis by which the model is implemented. No specific position in the space of models thus defined is the only correct one, but a good modelling methodology should be explicit about its position and the justification for that position. It is argued that in building robot models biological relevance is more effective than loose biological inspiration; multiple levels can be integrated; that generality cannot be assumed but might emerge from studying specific instances; abstraction is better done by simplification than idealisation; accuracy can be approached through iterations of complete systems; that the model should be able to match and predict target behaviour; and that a physical medium can have significant advantages. These arguments reflect the view that biological behaviour needs to be studied and modelled in context, that is, in terms of the real problems faced by real animals in real environments. Key Words: animal behaviour; levels; models; neuroethology; realism; robotics; simulation. (shrink)

I am going to argue that it is time to come to terms with the difficulty of understanding what it means to be physical and start thinking about the mind-body problem from a new perspective. Instead of construing it as the problem of finding a place for mentality in a fundamentally physical world, we should think of it as the problem of finding a place for mentality in a fundamentally nonmental world, a world that is at its most fundamental level (...) entirely nonmental. The mind-body problem, I want to argue, is the problem of determining whether mentality can be accounted for in terms of nonmental phenomena. In other words, it is the question, ‘is mentality a fundamental feature of the world’. (shrink)

Physicalism is thought to entail that mental properties supervene on microphysical properties, or in other words that all God had to do was to create the fundamental physical properties and the rest came along for free. In this paper, we question the all-god-had-to-do reflex.

Physicalism is thought to entail that mental properties supervene on microphysical properties, or in other words that all God had to do was to create the fundamental physical properties and the rest came along for free. In this paper, we question the all-god-had-to-do reflex.