Data documenting poor understanding among research participants and real-time efforts to assess comprehension in large-scale studies are focusing new attention on informed consent comprehension. Within the context of biobanking consent, we previously convened a multidisciplinary panel to reach consensus about what information must be understood for a prospective participant’s consent to be considered valid. Subsequently, we presented them with data from another study showing that many U.S. adults would fail to comprehend the information the panel had deemed essential. When asked (...) to evaluate the importance of the information again, panelists’ opinions shifted dramatically in the direction of requiring that less information be understood. Follow-up interviews indicated significant uncertainty about defining a threshold of understanding and what should happen when prospective participants are unable to grasp key information. These findings have important implications for urgently needed discussion of whether... (shrink)

In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

Volume 20, Issue 5, June 2020, Page 26-28.

Research ethics consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being. However, fundamental questions remain, including: What is “research ethics consultation”? And what is its justification beyond the purposes already served by existing entities? We examine how a research ethics consultation service may differ from or complement the role of an institutional review board by offering a definition of research ethics consultation (...) and by exploring the potential scope of a consultation service in terms of types of clients served, questions addressed, and advice provided at various stages of the research process. We then consider the relationship between research ethics consultation services and IRBs, as well as the issues that may arise between them, including possible conflicts of interest. (shrink)

We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues.

Recruiting research participants based on genetic information generated about them in a prior study is a potentially powerful way to study the functional significance of human genetic variation, but it also presents ethical challenges. To inform policy development on this issue, we conducted a survey of U.S. institutional review board chairs concerning the acceptability of recontacting genetic research participants about additional research and their views on the disclosure of individual genetic results as part of recruitment. Our findings suggest there is (...) unlikely to be a “one-size-fits-all” solution, but rather several ethically acceptable approaches to genotype-driven recruitment, depending on context. Disclosures made during the consent process for the original study and the clinical validity of the results are key considerations. Researchers must be prepared to communicate and answer questions in clear lay language about what is known and not known regarding the role of genetics in their proposed area of research. (shrink)

Neither the range of potential results from genomic research that might be returned to participants nor future uses of stored data and biospecimens can be fully predicted at the outset of a study. Informed consent procedures require clear explanations about how and by whom decisions are made and what principles and criteria apply. To ensure trustworthy research governance, there is also a need for empirical studies incorporating public input to evaluate and strengthen these processes.

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.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of (...) research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

Precision medicine research is rapidly taking a lead role in the pursuit of new ways to improve health and prevent disease, but also presents new challenges for protecting human subjects. The extent to which the current “web” of legal protections, including technical data security measures, as well as measures to restrict access or prevent misuse of research data, will protect participants in this context remains largely unknown. Understanding the strength, usefulness, and limitations of this constellation of laws, regulations, and procedures (...) is critical to ensuring not only that participants are protected, but also that their participation decisions are accurately informed. To address these gaps, we conducted in-depth interviews with a diverse group of 60 thought-leaders to explore their perspectives on the protections associated with precision medicine research. (shrink)

To assist in resolving ethical questions surrounding unregulated mHealth research, we conducted in-depth qualitative interviews with experts from four key stakeholder groups: patient/research advocates, researchers, regulatory professionals, and mobile app/device developers. They discussed challenges and potential solutions in the context of two hypothetical scenarios involving unregulated mHealth research, including notifications/permissions for research use of mHealth data, data access procedures, new primary data collection, offering individual research results, and data sharing and dissemination.

Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish (...) identifying data.The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data. In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas. (shrink)

Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the “web” of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying them to realistic research scenarios involving various privacy threats.

Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have responsibility to offer results to the biological relatives of the research participant. In a companion study to one carried out in the United States, we describe the attitudes of Canadian Research Ethics Board chairs to this issue and their opinions as to the role of the REB in developing related policy.

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)

In 1906, Frigyes Riesz introduced a preliminary version of the notion of a topological space. He called it a mathematical continuum. This development can be traced back to the end of 1904 when, genuinely interested in taking up Hilbert’s foundations of geometry from 1902, Riesz aimed to extend Hilbert’s notion of a two-dimensional manifold to the three-dimensional case. Starting with the plane as an abstract point-set, Hilbert had postulated the existence of a system of neighbourhoods, thereby introducing the notion of (...) an accumulation point for the point-sets of the plane. Inspired by Hilbert’s technical approach, as well as by recent developments in analysis and point-set topology in France, Riesz defined the concept of a mathematical continuum as an abstract set provided with a notion of an accumulation point. In addition, he developed further elementary concepts in abstract point-set topology. Taking an abstract topological approach, he formulated a concept of three-dimensional continuous space that resembles the modern concept of a three-dimensional topological manifold. In 1908, Riesz presented his concept of mathematical continuum at the International Congress of Mathematicians in Rome. His lecture immediately won the attention of people interested in carrying on his research. They promoted his ideas, thus assuring their gradual reception by several future founders of general topology. In this way, Riesz’s work contributed significantly to the emergence of this discipline. (shrink)

The potential to collect brain data more directly, with higher resolution, and in greater amounts has heightened worries about mental and brain privacy. In order to manage the risks to individuals posed by these privacy challenges, some have suggested codifying new privacy rights, including a right to “mental privacy.” In this paper, we consider these arguments and conclude that while neurotechnologies do raise significant privacy concerns, such concerns are—at least for now—no different from those raised by other well-understood data collection (...) technologies, such as gene sequencing tools and online surveillance. To better understand the privacy stakes of brain data, we suggest the use of a conceptual framework from information ethics, Helen Nissenbaum’s “contextual integrity” theory. To illustrate the importance of context, we examine neurotechnologies and the information flows they produce in three familiar contexts—healthcare and medical research, criminal justice, and consumer marketing. We argue that by emphasizing what is distinct about brain privacy issues, rather than what they share with other data privacy concerns, risks weakening broader efforts to enact more robust privacy law and policy. (shrink)

Why is there a felt asymmetry between cases in which agents defer to testifiers for certain moral beliefs, and cases in which agents defer on many other matters? One explanation influential in the literature is that having understanding of a proposition is both in tension with acquiring belief in the proposition by deferring to another's testimony and distinctively important when it comes to moral propositions, as compared with what we might think of as many ‘garden variety’ facts. My project in (...) this paper is to offer a new and more defensible version of this explanation. This will involve re-conceiving understanding as a richer state than it is commonly thought to be, requiring affective and motivational engagement with reasons as well as cognitive facility. I also offer a new explanation of the tension between understanding and deference to testimony. (shrink)

In this comprehensive new study of human free agency, Laura Waddell Ekstrom critically surveys contemporary philosophical literature and provides a novel account of the conditions for free action. Ekstrom argues that incompatibilism concerning free will and causal determinism is true and thus the right account of the nature of free action must be indeterminist in nature. She examines a variety of libertarian approaches, ultimately defending an account relying on indeterministic causation among events and appealing to agent causation only in (...) a reducible sense. Written in an engaging style and incorporating recent scholarship, this study is critical reading for scholars and students interested in the topics of motivation, causation, responsibility, and freedom. In broadly covering the important positions of others along with its exposition of the author’s own view, Free Will provides both a significant scholarly contribution and a valuable text for courses in metaphysics and action theory. (shrink)

The Victorian period in Britain was an “age of reform.” It is therefore not surprising that two of the era’s most eminent intellects described themselves as reformers. Both William Whewell and John Stuart Mill believed that by reforming philosophy—including the philosophy of science—they could effect social and political change. But their divergent visions of this societal transformation led to a sustained and spirited controversy that covered morality, politics, science, and economics. Situating their debate within the larger context of Victorian society (...) and its concerns, _Reforming Philosophy_ shows how two very different men captured the intellectual spirit of the day and engaged the attention of other scientists and philosophers, including the young Charles Darwin. Mill—philosopher, political economist, and Parliamentarian—remains a canonical author of Anglo-American philosophy, while Whewell—Anglican cleric, scientist, and educator—is now often overlooked, though in his day he was renowned as an authority on science. Placing their teachings in their proper intellectual, cultural, and argumentative spheres, Laura Snyder revises the standard views of these two important Victorian figures, showing that both men’s concerns remain relevant today. A philosophically and historically sensitive account of the engagement of the major protagonists of Victorian British philosophy, _Reforming Philosophy_ is the first book-length examination of the dispute between Mill and Whewell in its entirety. A rich and nuanced understanding of the intellectual spirit of Victorian Britain, it will be welcomed by philosophers and historians of science, scholars of Victorian studies, and students of the history of philosophy and political economy. (shrink)

As library collections and services have increasingly moved from print to digital, much of the work that used to be done by libraries themselves with regard to creating, maintaining, and managing the systems that hold collections and facilitate user access to them is now done primarily by vendors. This change to the information services landscape for academic libraries is the occasion not only of technical and procedural challenges, but also some internal conflicts concerning the ethical demands of the library profession. (...) This essay examines the ways in which these conflicts become acute and obvious when attention is paid to the way in which attempts to promote equity, diversity, and inclusion (EDI) are undermined by the handover of library services to vendors, even when—or perhaps especially when—those vendors use their control of content and platforms to commodify diverse content instead of making the necessary systemic changes required by truly effective EDI efforts. (shrink)

Outlaw emotions are emotions that stand in tension with one’s wider belief system, often allowing epistemic insight one may have otherwise lacked. Outlaw emotions are thought to play crucial epistemic roles under conditions of oppression. Although the crucial epistemic value of these emotions is widely acknowledged, specific accounts of their epistemic role(s) remain largely programmatic. There are two dominant accounts of the epistemic role of emotions: The Motivational View and the Justificatory View. Philosophers of emotion assume that these dominant ways (...) of accounting for the epistemic role(s) of emotions in general are equipped to account for the epistemic role(s) of outlaw emotions. I argue that this is not the case. I consider and dismiss two responses that could be made on behalf of the most promising account, the Justificatory View, in light of my argument, before sketching an alternative account that should be favoured. (shrink)

The aim of this article is to contribute to understanding the changing role of government in promoting corporate social responsibility (CSR). Over the last decade, governments have joined other stakeholders in assuming a relevant role as drivers of CSR, working together with intergovernmental organizations and recognizing that public policies are key in encouraging a greater sense of CSR. This paper focuses on the analysis of the new strategies adopted by governments in order to promote, and encourage businesses to adopt, CSR (...) values and strategies. The research is based on the analysis of an explanatory framework, related to the development of a relational analytical framework, which tries to analyze the vision, values, strategies and roles adopted by governments, and the integration of new partnerships that governments establish in the CSR area with the private sector and social organizations. The research compares CSR initiatives and public policies in three European countries: Italy, Norway and the United Kingdom, and focuses on governmental drivers and responses. The preliminary results demonstrate that governments are incorporating a common statement and discourse on CSR, working in partnership with the private and social sectors. For governments, CSR implies the need to manage a complex set of relationships in order to develop a win–win situation between business and social organizations. However, the research also focuses on the differences between the three governments when applying CSR public policies. These divergences are based on the previous cultural and political framework, such as the welfare state typology, the organizational structures and the business and social and cultural background in each country. (shrink)

In this article I argue that characterizations of anger as a hostile emotion may be mistaken. My project is empirically informed and is partly descriptive, partly diagnostic. It is descriptive in that I am concerned with what anger is, and how it tends to manifest, rather than with what anger should be or how moral anger is manifested. The orthodox view on anger takes it to be, descriptively, an emotion that aims for retribution. This view fits well with anger being (...) a hostile emotion, as retribution is punitive. I will argue that a different view of anger deserves our attention. On this alternative view, anger aims for recognition of harms done, rather than for the punishment of those who have committed them. I argue that we have reason to favour a strong view that excludes retribution from anger’s main aims. In addition, I offer a diagnosis of the reasons that led the retributive view of anger to become, and remain, orthodoxy. This diagnosis provides indirect reason to give my descriptive proposal serious consideration, for it highlights that the orthodox view has dominated folk and philosophical conceptions of anger for reasons that do not speak in favour of the view’s veracity. The view that anger is a hostile emotion will therefore emerge as in need of serious scrutiny. (shrink)

ABSTRACTRecent research suggests that impaired emotion regulation may play an important role in the development of youth psychopathology. However, little research has explored the effects of ER strategies on affect in early adolescents. In Study 1, we examined if early adolescents are able to use distraction and whether the effects of this strategy are similar to talking to one’s mother. In Study 2, we compared the effects of distraction, cognitive reappraisal, acceptance, and rumination. In both studies, participants received instructions on (...) how to regulate their emotions after a standardised negative mood induction. In general, the results indicated that distraction, but also cognitive reappraisal and acceptance, had promising short-term effects on positive and negative affect in early adolescents. These findings suggest that targeting adaptive ER skills, such as distraction, acceptance, and cognitive reappraisal, may be an important strategy to prevent or treat psychological pro... (shrink)

How does violence shape citizens’ preferences for conflict termination? The existing literature has argued that violence either begets sympathy for more violence or drives support for making peace. Focusing on the 2016 Colombian Peace Agreement, this article finds that victimhood dissociation strongly shapes these preferences. With victimhood dissociation, a discrepancy exists between objective and subjective victimization, and the effect of violence on peace attitudes depends on citizens’ subjective interpretations of their personal experiences of violence. Citizens who do not experience violence (...) often see themselves as victims of the conflict and vice versa. Victimhood dissociation is linked to cultural stereotypes of victimhood as portrayed in elite narratives concerning the conflict. In Colombia, political leaders framed victimhood around rurality, business entrepreneurship, kidnapping, extortion, and disappearance. In 2016, this widespread narrative was instrumental for politicians opposing the peace agreement. Citizens who disassociated their personal experiences of violence from their self-understanding as victims were instrumental to the failure of the peace plebiscite. (shrink)

Anti-individualists claim that concepts are individuated with an eye to purely external facts about a subject's environment about which she may be ignorant or mistaken. This paper offers a novel reason for thinking that anti-individualistic concepts are an ineliminable part of commonsense psychology. Our commitment to anti-individualism, I argue, is ultimately grounded in a rational epistemic agent's commitment to refining her own representational practices in the light of new and surprising information about her environment. Since anti-individualism is an implicit part (...) of responsible epistemic practices, we cannot abandon it without compromising our own epistemic agency. The story I tell about the regulation of one's own representational practices yields a new account of the identity conditions for anti-individualistic concepts. (shrink)

: Although "brain death" and the dead donor rule—i.e., patients must not be killed by organ retrieval—have been clinically and legally accepted in the U.S. as prerequisites to organ removal, there is little data about public attitudes and beliefs concerning these matters. To examine the public attitudes and beliefs about the determination of death and its relationship to organ transplantation, 1351 Ohio residents ≥18 years were randomly selected and surveyed using random digit dialing (RDD) sample frames. The RDD telephone survey (...) was conducted using computer-assisted telephone interviews. The survey instrument was developed from information provided by 12 focus groups and a pilot study of the questionnaire. Three scenarios based on hypothetical patients were presented: "brain dead," in a coma, or in a persistent vegetative state (PVS). Respondents provided personal assessments of whether the patient in each scenario was dead and their willingness to donate that patient's organs in these circumstances. More than 98 percent of respondents had heard of the term "brain death," but only one-third (33.7%) believed that someone who was "brain dead" was legally dead. The majority of respondents (86.2%) identified the "brain-dead" patient in the first scenario as dead, 57.2 percent identified the patient in a coma as dead (Scenario 2), and 34.1 percent identified the patient in a PVS as dead (Scenario 3). Nearly one-third (33.5%) were willing to donate the organs of patients they classified as alive for at least one scenario, in seeming violation of the dead donor rule. Most respondents were not willing to violate the dead donor rule, although a substantial minority was. However, the majority of respondents were unaware, misinformed, or held beliefs that were not congruent with current definitions of "brain death." This study highlights the need for more public dialogue and education about "brain death" and organ donation. (shrink)

This paper proposes a new relational account of concepts and shows how it is particularly well suited to characterizing normative concepts. The key advantage of our ‘connectedness’ model is that it explains how subjects can share the same normative concepts despite radical divergences in the descriptive or motivational commitments they associate with them. The connectedness model builds social and historical facts into the foundations of concept identity. This aspect of the model, we suggest, reshapes normative epistemology and provides new resources (...) for a vindication of realism in ethics. (shrink)

It's widely accepted that social facts about an individual's linguistic community can affect both the reference of her words and the concepts those words express. Theorists sympathetic to the internalist tradition have sought to accommodate these social dependence phenomena without altering their core theoretical commitments by positing deferential reference-fixing criteria. In this paper, we sketch a different explanation of social dependence phenomena, according to which all concepts are individuated in part by causal-historical relations linking token elements of thought.

Although the view that sees proper names as referential singular terms is widely considered orthodoxy, there is a growing popularity to the view that proper names are predicates. This is partly because the orthodoxy faces two anomalies that Predicativism can solve: on the one hand, proper names can have multiple bearers. But multiple bearerhood is a problem to the idea that proper names have just one individual as referent. On the other hand, as Burge noted, proper names can have predicative (...) uses. But the view that proper names are singular terms arguably does not have the resources to deal with Burge’s cases. In this paper I argue that the Predicate View of proper names is mistaken. I first argue against the syntactic evidence used to support the view and against the predicativist’s methodology of inferring a semantic account for proper names based on incomplete syntactic data. I also show that Predicativism can neither explain the behaviour of proper names in full generality, nor claim the fundamentality of predicative names. In developing my own view, however, I accept the insight that proper names in some sense express generality. Hence I propose that proper names—albeit fundamentally singular referential terms—express generality in two senses. First, by being used as predicates, since then they are true of many individuals; and second, by being referentially related to many individuals. I respond to the problem of multiple bearerhood by proposing that proper names are polyreferential, and also explain the behaviour of proper names in light of the wider phenomenon I called category change, and show how Polyreferentialism can account for all uses of proper names. (shrink)

Naked Science is about contested domains and includes different science cultures: physics, molecular biology, primatology, immunology, ecology, medical environmental, mathematical and navigational domains. While the volume rests on the assumption that science is not autonomous, the book is distinguished by its global perspective. Examining knowledge systems within a planetary frame forces thinking about boundaries that silence or affect knowledge-building. Consideration of ethnoscience and technoscience research within a common framework is overdue for raising questions about deeply held beliefs and assumptions we (...) all carry about scientific knowledge. We need a perspective on how to regard different science traditions because public controversies should not be about a glorified science or a despicable science. Contributors are: Ward Goodenough, Eloisa and Brent Berlin, Colin Scott, Jean Lave, Emily Martin, Troy Duster, Hugh Gusterson, Charles Schwartz, Joan Fujimura, Sharon Traweek, Estellie Smith, Ellen Bielawaski, David Jacobon, Charles Ziegler, Pamela Asquith. (shrink)