U.S. regulations do not afford consistent protections to human research subjects. One complaint is that they focus on federally sponsored research, with private research covered only if it falls under the jurisdiction of the Food and Drug Administration. This paper examines a deeper problem: Even when the regulations do apply, they still do not afford consistent standards of protection. The U.S. Common Rule and related FDA regulations lack a workable regulatory control mechanism.

Delivering high quality genomics-informed care to patients requires accurate test results whose clinical implications are understood. While other actors, including state agencies, professional organizations, and clinicians, are involved, this article focuses on the extent to which the federal agencies that play the most prominent roles — the Centers for Medicare and Medicaid Services enforcing CLIA and the FDA — effectively ensure that these elements are met and concludes by suggesting possible ways to improve their oversight of genomic testing.

The individual right of access to one’s own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA’s right of access to one’s own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals’ ability to find out how much data is being stored and how (...) it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA’s investigational device exemption requirements. (shrink)

Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.

Andrea Wiggins and John Wilbanks offer a rich and nuanced description of citizen science, which they define as “a range of participatory models for involving non-professionals as collaborators in s...

The genetic testing industry is in a period of potentially major structural change driven by several factors. These include weaker patent protections after Association for Molecular Pathology v. Myriad Genetics and Mayo Collaborative Services v. Prometheus Laboratories, Inc.; a continuing shift from single-gene tests to genome-scale sequencing; and a set of February 2014 amendments to the Clinical Laboratory Improvement Amendments of 1988 regulations and the Health Insurance Portability and Accountability Act Privacy Rule. This article explores the nature of these changes (...) and why they strain existing regulatory frameworks for protecting patients, research subjects, and other consumers who receive genetic testing.Oversight of genetic testing has, at least to date, had two major thrusts: privacy and ethical protections and traditional consumer health and safety regulations. Examples of the first are the Genetic Information Nondiscrimination Act and the HIPAA Privacy Rule, which after 2013 amendments expressly protects genetic privacy as well as other medical privacy. (shrink)

In this paper, planning models developed in artificial intelligence are applied to the kind of planning that must be carried out by participants in a conversation. A planning mechanism is defined, and a short fragment of a free‐flowing videotaped conversation is described. The bulk of the paper is then devoted to an attempt to understand the conversation in terms of the planning mechanism. This microanalysis suggests ways in which the planning mechanism must be augmented, and reveals several important conversational phenomena (...) that deserve further investigation. (shrink)

Microphysical laws are time reversible, but macrophysics, chemistry and biology are not. This paper explores how this asymmetry arises due to the cosmological context, where a non-local Direction of Time is imposed by the expansion of the universe. This situation is best represented by an Evolving Block Universe, where local arrows of time emerge in concordance with the Direction of Time because a global Past Condition results in the Second Law of Thermodynamics pointing to the future. At the quantum level, (...) the indefinite future changes to the definite past due to quantum wave function collapse events. (shrink)

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)

The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent.

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.

Psychiatry is rapidly adopting digital phenotyping and artificial intelligence/machine learning tools to study mental illness based on tracking participants’ locations, online activity, phone and text message usage, heart rate, sleep, physical activity, and more. Existing ethical frameworks for return of individual research results (IRRs) are inadequate to guide researchers for when, if, and how to return this unprecedented number of potentially sensitive results about each participant’s real-world behavior. To address this gap, we convened an interdisciplinary expert working group, supported by (...) a National Institute of Mental Health grant. Building on established guidelines and the emerging norm of returning results in participant-centered research, we present a novel framework specific to the ethical, legal, and social implications of returning IRRs in digital phenotyping research. Our framework offers researchers, clinicians, and Institutional Review Boards (IRBs) urgently needed guidance, and the principles developed here in the context of psychiatry will be readily adaptable to other therapeutic areas. (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)

In this paper, we explore the perspectives of expert stakeholders about who owns data in a medical information commons and what rights and interests ought to be recognized when developing a governance structure for an MIC. We then examine the legitimacy of these claims based on legal and ethical analysis and explore an alternative framework for thinking about participants' rights and interests in an MIC.

Given the negative costs of exclusion and the relevance of belongingness for humans, the experience of exclusion influences social affiliation motivation, which in turn is a relevant predictor of prosocial behavior. Skin conductance is a typical measure of the arousal elicited by emotions. Hence, we argued that both inclusion and exclusion will increase skin conductance level due to the increase of either positive affect or anger affects, respectively. Moreover, we argued that emotional arousal is also related to social affiliation motivation (...) and prosocial behavior. A total of 48 students were randomly allocated to either an inclusionary or exclusionary condition and their skin conductance levels were recorded during an experiment in which they completed an online questionnaire and played the game “Cyberball.” Results indicated that (a) individuals who perceived high exclusion felt angrier than individuals perceiving high inclusion, who feel positive affect; (b) no differences were evidenced in terms of skin conductance between exclusion and inclusion situations; (c) over-aroused individuals were less motivated to affiliate; and (d) individuals with lower affiliation motivation behaved in a less prosocial way. The results were congruent to the argument that behaving prosocially may be a way to gain the desired affiliation. (shrink)

We describe and report on results of employing a new method for analyzing lay conceptions of intentional and unintentional action. Instead of asking people for their conceptual intuitions with regard to construed scenarios, we asked our participants to come up with their own scenarios and to explain why these are examples of intentional or unintentional actions. By way of content analysis, we extracted contexts and components that people associated with these action types. Our participants associated unintentional actions predominantly with bad (...) outcomes for all persons involved and linked intentional actions more strongly to positive outcomes, especially concerning the agent. People’s conceptions of intentional action seem to involve more aspects than commonly assumed in philosophical models of intentional action that solely stress the importance of intentions, desires, and beliefs. The additional aspects include decisions and thoughts about the action. In addition, we found that the criteria that participants generated for unintentional actions are not a mere inversion of those used in explanations for intentional actions. Associations between involuntariness and unintentional action seem to be stronger than associations between aspects of voluntariness and intentional action. (shrink)

At the Centre for Ecological and Evolutionary Synthesis (CEES, University of Oslo), a group of biologists has been working for decades to disentangle the complex mechanisms of plague epizootics and epidemics in places where extant wild rodent reservoirs are present. These questions have been approached through ecological and climatic studies, mathematic modeling, as well as genomics and epidemiology. In 2013-2018, the Centre hosted the ERC-project MedPlag, which explored past pandemics through the lenses of additional disciplines, like archaeogenomics (ancient DNA), anthropology, (...) archaeology, and evolution, always against the background of historical information. Here, we reflect on the end of plague in Europe based on the most recent studies on plague carried out in these different disciplines. (shrink)

To gain insight into human nature philosophers often discuss the inferior performance that results from deficits such as blindsight or amnesia. Less often do they look at superior abilities. A notable exception is Herbert Dreyfus who has developed a theory of expertise according to which expert action generally proceeds automatically and unreflectively. We address one of Dreyfus’s primary examples of expertise: chess. At first glance, chess would seem an obvious counterexample to Dreyfus’s view since, clearly, chess experts are engaged in (...) deep strategic thought. However, Dreyfus’s argument is subtle. He accepts that analysis and deliberation play a role in chess, yet he thinks that all such thought is predicated on intuitive, arational expert perception, and action. We argue that even the so-called intuitive aspect of chess is rational through and through. (shrink)

Daw-Nay N. R. Evans - Nietzsche and Rée: A Star Friendship - Journal of the History of Philosophy 44:4 Journal of the History of Philosophy 44.4 672-673 Muse Search Journals This Journal Contents Reviewed by Daw-Nay N. R. Evans, Jr. DePaul University Robin Small. Nietzsche and Rée: A Star Friendship. Oxford: Clarendon Press, 2005. Pp. xxiv + 247. Cloth, $45.00. Nietzsche attracts a wide range of scholarly enthusiasts. There are those who take Nietzsche seriously as a philosopher and (...) study his works for their own sake, while others seek to mine his works for philosophical gold to determine what he might have to offer their particular area of specialization . On the other hand, there are those who seek to sensationalize Nietzsche by making him.. (shrink)

The accuracy of corporate mission statements has not been well explored. In this study, the authors investigate the relationship between mission statement content and stakeholder management actions. Findings indicate that although social issues such as the environment and diversity are less frequently included, their mention in mission statements is significantly associated with behaviors regarding these issues. The study found no relationship between firms with mission statements that mention specific stakeholder groups (employees, customers, and community) and behaviors regarding these stakeholders. This (...) suggests that the inclusion of specific stakeholder groups in missions is likely the result of institutional pressures, while specifying social issues in missions is related to policy decisions. (shrink)

In the past two to three decades health behavior scientists have increasingly emphasized affect-related concepts in their attempts to understand and facilitate change in important health behaviors, such as smoking, eating, physical activity, substance abuse, and sex. This article provides a narrative review of this burgeoning literature, including relevant theory and research on affective response, incidental affect, affect processing, and affectively charged motivation. An integrative dual-processing framework is presented that suggests pathways through which affect-related concepts may interrelate to influence health (...) behavior. (shrink)

Throughout the sixteenth century, learned physicians across Europe performed a diverse array of “trials” of phenomena and published reports about them. This essay traces the phrase “periculum facere” (“to make a trial”) and related terms through natural history investigations, drug testing, chymical analysis, and anatomical discoveries. Physicians used ancient precedents, their learned expertise, and pedagogical authority to anchor the epistemic status of their trials and incorporated the historical narratives of their trial-making within arguments to factual and causal knowledge, even philosophical (...) scientia. Developed from engagement with things, ancient texts, other healers, and students, this lively tradition of contrived, first-person empirical trials flourished in some academic institutions, especially the University of Padua. The frequency and visibility of sixteenth-century medical trials, especially in the education of hundreds of students annually, is essential evidence for understanding how experimentation came to be widespread in early modern Europe. (shrink)

The Rainbow Ramsey Theorem is essentially an "anti-Ramsey" theorem which states that certain types of colorings must be injective on a large subset (rather than constant on a large subset). Surprisingly, this version follows easily from Ramsey's Theorem, even in the weak system RCA₀ of reverse mathematics. We answer the question of the converse implication for pairs, showing that the Rainbow Ramsey Theorem for pairs is in fact strictly weaker than Ramsey's Theorem for pairs over RCA₀. The separation involves techniques (...) from the theory of randomness by showing that every 2-random bounds an ω-model of the Rainbow Ramsey Theorem for pairs. These results also provide as a corollary a new proof of Martin's theorem that the hyperimmune degrees have measure one. (shrink)

Of the measures for resolving work—family conflict proposed by Janet Gornick and Marcia Meyers, government programs that provide or pay for nonparental child care would advance gender equality. However, paid parental leaves of six months for both parents, and the encouragement of part-time work, would retard it, and possibly reverse some of the advances toward gender equality that have been made in the home and the workplace. Female jobholders would increase their time at home to a much greater extent than (...) would male jobholders, increasing the share women do of child care, cleaning, cooking, and laundry. In the workplace, employers would become more reluctant to place women in nonroutine jobs, where substitution of one worker for another is difficult. Finally, recent studies of the effect on young children of nonparental care are reviewed. They can be interpreted in more than one way, and the lessons drawn from them depend crucially on the opinions of those doing the analysis. (shrink)