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)

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)

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...

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 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)

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.

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)

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)

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)

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.

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.

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.

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)

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.

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)

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.

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)

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)

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)

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)

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.

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)

Der Vergleich einer modernen Rechts- und Gesellschaftstheorie anhand von Hayeks «Recht, Gesetz und Freiheit» mit einer postmodernen anhand Ladeurs «Der Staat gegen die Gesellschaft» fördert verblüffende Parallelen im Ausgangspunkt, der Argumentation und der Prognose respektive Diagnose einer institutionell bedingten postmodernen Krise von Staat und Gesellschaft zutage. Die Analyse der modernen Theorie ist zugleich eine umfassende und verständliche Einführung in von Hayeks Werk. Fundiert arbeitet die Schrift die Theorie als die in der Moderne gelegte Basis der postmodernen Gesellschaft heraus und gleicht (...) sie ab mit den Untersuchungen Ladeurs zur Postmoderne in dessen Streitschrift für die «Privatrechtsgesellschaft». Anknüpfend an den von beiden analog begründeten Weg in die Krise und die Wege zu ihrer Bewältigung zeigt die Autorin eine über diese Zeitspanne hinaus weisende kongruente liberale rechts-, staats- und gesellschaftspolitische Theorie auf. (shrink)

Prologue: love of children lost and found for teacher educators -- The seed of play -- The seed of hope -- The seed of imaginative voice -- The seed of change -- The seed of unmasking -- The seed of inner awareness -- The seed of freedom -- The seed of love.

The purpose of this paper is to examine the various guidelines presented in the literature for instituting an ethics curriculum and to empirically study their effectiveness. Three questions are addressed concerning the trainability of ethics material and the proper integration and implementation of an ethics curriculum. An empirical study then tested the effect of ethics training on moral awareness and reasoning. The sample consisted of two business classes, one exposed to additional ethics curriculum (experimental), and one not exposed (control). For (...) the experimental group, ethics exercises and discussion relevant to each topic were completed. Findings suggested gender differences such that, relative to other groups, women in the experimental group showed significantly improved moral awareness and decision-making processes. An explanation of the underlying cognitive processes is presented to explain the gender effect. (shrink)

The confusion/non-consequential thinking explanation proposed by Newstead, Girotto, and Legrenzi (1995) for poor performance on Wason's THOG problem (a hypothetico-deductive reasoning task) was examined in three experiments with 300 participants. In general, as the cognitive complexity of the problem and the possibility of non-consequential thinking were reduced, correct performance increased. Significant but weak facilitation (33-40% correct) was found in Experiment 1 for THOG classification instructions that did not include the indeterminate response option. Substantial facilitation (up to 75% correct) was obtained (...) in Experiment 2 with O'Brien et al.'s (1990) one-other-THOG classification instruction. In Experiment 3, a revised version of O'Brien et al.'s pre-test problem format also led to substantial facilitation, even with the use of the standard three-choice THOG classification instruction. These findings are discussed in terms of Newstead et al.'s theoretical proposal and possible attentional factors. (shrink)

The theme of this special issue is Post-truth. No doubt it was my exasperation with the terminological state of our collective situation that incited me in the spring of 2017 to settle upon it. What, exactly, does the hyphenated couplet mean or to what does it refer? What is its significance or sense? How is it being used, by whom, for what purpose, and with what consequences—for whom? And if, as was being asserted on nearly every side, we currently find (...) ourselves in post-truth, how might we ever get out, presuming we may one day want as much? The original contributions by Sarah Burgess, James Crosswhite, Jason David Myres, Bradford Vivian, and Eric King Watts published herein go a long way toward answering these... (shrink)

Children deserve optimal medical care. Although prescription drugs play a prominent and essential role in pediatric health care delivery, health care providers often must make prescribing decisions for their young patients based on imperfect or absent safety and efficacy data for pediatric populations. Until relatively recently, the Food and Drug Administration made surprisingly little effort to improve the quality or quantity of clinical research data for this patient group. Despite recent agency efforts to improve the situation, only one-third of drugs (...) prescribed to children currently have been studied for safety and efficacy in pediatric populations. Moreover, recent agency initiatives to encourage pediatric drug research have generated mixed results and unintended consequences. The complex of issues surrounding the testing and prescribing of prescription drugs used for children will require that pharmaceutical companies, the FDA, and health care providers examine current practices, acknowledge their shortcomings, and consider cooperative, creative solutions. (shrink)

The nuclear DNA of eukaryotes is organized into a series of loops each topologically anchored by elements of the nuclear matrix. Evidence is reviewed which indicates that the anchorage points of the loops are formed by transcriptionally active genes and that individual loops function as replicons. The data suggests a specific model for coupling of DNA replication and transcription in eukaryotes.