Large-scale sequencing tests, including whole-exome and whole-genome sequencing, are rapidly moving into clinical use. Sequencing is already being used clinically to identify therapeutic opportunities for cancer patients who have run out of conventional treatment options, to help diagnose children with puzzling neurodevelopmental conditions, and to clarify appropriate drug choices and dosing in individuals. To evaluate and support clinical applications of these technologies, the National Human Genome Research Institute and National Cancer Institute have funded studies on clinical and research sequencing under (...) the Clinical Sequencing Exploratory Research program as well as studies on return of results. Most of these studies use sequencing in real-world clinical settings and collect data on both the application of sequencing and the impact of receiving genomic findings on study participants. They are occurring in the context of controversy over how to obtain consent for exome and genome sequencing. (shrink)

Older adults report high emotional well-being, but age-comparative studies of emotion regulation strategies have not identified systematic age differences. We propose that emotion regulation tactics may be more promising. Emotion regulation tactics involve strategy implementation in a specific situation, and have features shared across strategies involving positive or negative elements (objects/thoughts) in the environment that may be approached or receded from in the regulation attempt (i.e., a valence dimension about the environmental element, and a direction dimension indicating movement toward or (...) away from it). Across several studies, older adults used more positive-approaching than negative-receding tactics. Positive-approaching tactics may also be more effective at regulating mood. We consider implications for aging, as well as group differences in emotion regulation behavior generally. (shrink)

This special edition of JLME celebrates the life of Charity Scott, Professor Emerita and Founding Director of the Center for Law, Health & Society at Georgia State University College of Law.

Growth mindset is an important aspect of children’s socioemotional development and is subject to change due to environmental influence. Orchestral music education may function as a fertile context in which to promote growth mindset; however, this education is not widely available to children facing economic hardship. This study examined whether participation in a program of orchestral music education was associated with higher levels of overall growth mindset and greater change in levels of musical growth mindset among children placed at risk (...) by poverty. After at least 2 years of orchestral participation, students reported significantly higher levels of overall growth mindset than their peers; participating students also reported statistically significant increases in musical growth mindset regardless of the number of years that they were enrolled in orchestral music education. These findings have implications for future research into specific pedagogical practices that may promote growth mindset in the context of orchestral music education and more generally for future studies of the extra-musical benefits of high-quality music education. (shrink)

BackgroundResponsive neurostimulation has been utilized as a treatment for intractable epilepsy. The RNS System delivers stimulation in response to detected abnormal activity, via leads covering the seizure foci, in response to detections of predefined epileptiform activity with the goal of decreasing seizure frequency and severity. While thalamic leads are often implanted in combination with cortical strip leads, implantation and stimulation with bilateral thalamic leads alone is less common, and the ability to detect electrographic seizures using RNS System thalamic leads is (...) uncertain.ObjectiveThe present study retrospectively evaluated fourteen patients with RNS System depth leads implanted in the thalamus, with or without concomitant implantation of cortical strip leads, to determine the ability to detect electrographic seizures in the thalamus. Detailed patient presentations and lead trajectories were reviewed alongside electroencephalographic analyses.ResultsAnterior nucleus thalamic leads, whether bilateral or unilateral and combined with a cortical strip lead, successfully detected and terminated epileptiform activity, as demonstrated by Cases 2 and 3. Similarly, bilateral centromedian thalamic leads or a combination of one centromedian thalamic alongside a cortical strip lead also demonstrated the ability to detect electrographic seizures as seen in Cases 6 and 9. Bilateral pulvinar leads likewise produced reliable seizure detection in Patient 14. Detections of electrographic seizures in thalamic nuclei did not appear to be affected by whether the patient was pediatric or adult at the time of RNS System implantation. Sole thalamic leads paralleled the combination of thalamic and cortical strip leads in terms of preventing the propagation of electrographic seizures.ConclusionThalamic nuclei present a promising target for detection and stimulation via the RNS System for seizures with multifocal or generalized onsets. These areas provide a modifiable, reversible therapeutic option for patients who are not candidates for surgical resection or ablation. (shrink)

Enhancing body awareness has been described as a key element or a mechanism of action for therapeutic approaches often categorized as mind-body approaches, such as yoga, TaiChi, Body-Oriented Psychotherapy, Body Awareness Therapy, mindfulness based therapies/meditation, Feldenkrais, Alexander Method, Breath Therapy and others with reported benefits for a variety of health conditions. To better understand the conceptualization of body awareness in mind-body therapies, leading practitioners and teaching faculty of these approaches were invited as well as their patients to participate in focus (...) groups. The qualitative analysis of these focus groups with representative practitioners of body awareness practices, and the perspectives of their patients, elucidated the common ground of their understanding of body awareness. For them body awareness is an inseparable aspect of embodied self awareness realized in action and interaction with the environment and world. It is the awareness of embodiment as an innate tendency of our organism for emergent self-organization and wholeness. The process that patients undergo in these therapies was seen as a progression towards greater unity between body and self, very similar to the conceptualization of embodiment as dialectic of body and self described by some philosophers as being experienced in distinct developmental levels. (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.

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)

Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the parents (...) will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing”, PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant. (shrink)

In “Meeting the Moment: Bioethics in the Time of Black Lives Matter,” Camisha Russell calls for transforming “bioethics-as-usual” with help from “outsiders”. Prior scholars agree...

Stem cell science, using both embryonic and a variety of tissue-specific stem cells, is advancing rapidly and offers promise to improve medical care in the future. Yet, with the notable exception of hematopoietic stem cell transplantation, a long-established approach to treating certain cancers of the blood system, this promise is long term and most stem cell research focuses on basic scientific questions or the collection of pre-clinical data. Although some clinical trials are underway, most are focused on safety, and novel (...) effective therapy is likely a long way off. Despite the preliminary nature of most stem cell research, however, numerous clinics around the world offer stem cell “therapies” to patients today outside the context of a clinical trial. Although the number of patients who have received these stem cell-based interventions is unknown, anecdotal reports suggest a substantial population of patients is willing to try them, despite unresolved questions about their safety and efficacy. (shrink)

SEX AND GENDER: A SPECTRUM OF VIEWS provides a medium for discussion and debate about today's most provocative issues concerning human sexuality and the relationships between masculinity and femininity. Including a spectrum of views that ranges from the stridently conservative to the progressively feminist, this anthology engages students in these subjects using a wider range of standpoints than is typical of such readers.

Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission. However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are infected (...) perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves. (shrink)

The newest addition to the Point/Counterpoint Series, Abortion: Three Perspectives features a debate between four noted philosophers - Michael Tooley, Celia Wolf-Devine, Philip E. Devine, and Alison M. Jaggar - presenting different perspectives on one of the most socially and politically argued issues of the past 30 years. The three main arguments include the "liberal" pro-choice approach, the "communitarian" pro-life approach, and the "gender justice" approach. Divided into two parts, the text features the authors' ideas, developed in depth, and (...) their responses to one another within each framework. As philosophers, the authors have special skills in critical analysis and thinking systematically about values. The text is appropriate for advanced courses in ethics, bioethics, sex and gender issues, and contemporary moral issues. (shrink)

Cells are capable of overcoming the randomizing effect of lateral diffusion in order to regionally differentiate their surfaces. Such local structural specializations are of major significance to cellular function. In some cases, they may be explained by diffusion rates that are insufficient to completely randomize surface gradients over biologically relevant times scales. However, in other cases, absolute and permanent regionalizations are also observed. Mechanistically, the problem is analogous to equilibrium across a dialysis bag: either an absolute barrier exists or the (...) chemical potential between two adjacent regions must be equal. The interactive nature of the system, where localizations of one component lead to localization of others, are also considered here. (shrink)

This study examined how research conducted at several federally funded institutions designated as Clinical Research Centers or Specialized Programs of Research Excellence addressed the issues of consent, control over biological materials, confidentiality, and disclosure of results in protocols and consent forms for genetic research with stored biological materials. Although a majority of the documents reviewed addressed most of the issues raised in the research ethics literature, topics identified in the literature that were missing include the return of research results, the (...) right to withdraw from research involving biological materials, and the consent of children when they become legal adults. If typical, these findings suggest greater educational efforts may be needed to prompt investigators and IRBs to consider these and other issues that were either not addressed in the protocols or consent forms or were addressed inadequately. (shrink)

When managing their emotions, individuals often recruit the help of others; however, most emotion regulation research has focused on self-regulation. Theories of emotion and aging suggest younger and older adults differ in the emotion regulation strategies they use when regulating their own emotions. If how individuals regulate their own emotions and the emotions of others are related, these theorised age differences may also emerge for interpersonal emotion regulation. In two studies, younger and older adults’ intrapersonal and interpersonal emotion regulation strategy (...) choices were examined via self-report and behavioural assessments of regulating the emotions of another participant (Study 1; N = 80) and of a virtual human (Study 2; N = 100). Across both studies, younger adults reported greater intrapersonal suppression but not greater reappraisal. Younger and older adults were generally similar (supported by Bayesian analyses) for both self-reported and behavioural interpersonal emotion regulation strategies. Behavioural interpersonal emotion regulation was not related to self-reported intra- and interpersonal preferences. These results suggest interpersonal emotion regulation in ageing may show distinct patterns from theorised age differences in intrapersonal emotion regulation. (shrink)

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to (...) largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. (shrink)

The U.S. Department of Health and Human Services has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking, entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects (...) research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers. (shrink)

Spiritual Taxonomies and Ritual Authority recounts how philosophers of the late third century C.E. organized the spirit world into hierarchies, positioning themselves as high priests in the process. By establishing themselves as experts on sacred matters, they fortified their authority, prestige, and reputation.

In this thorough compendium, nineteen accomplished scholars explore, in some manner the values they find inherent in the world, their nature, and revelence through the thought of Frederick Ferré. These essays, informed by the insights of Ferré and coming from manifold perspectives—ethics, philosophy, theology, and environmental studies, advance an ambitious challenge to current intellectual and scholarly fashions.

There is a gap between health economic evaluation methods and the value judgments of coverage decision makers, at least in Germany. Measuring preference satisfaction has been claimed to be inappropriate for allocating health care resources, e.g. because it disregards medical need. The existing methods oriented at medical need have been claimed to disregard non-consequentialist fairness concerns. The aim of this article is to propose a new, contractarian argument for justifying needs-based economic evaluation. It is based on consent rather than maximization (...) of some impersonal unit of value to accommodate the fairness concerns. This conceptual paper draws upon contractarian ethics and constitution economics to show how economic evaluation can be viewed as an institution to overcome societal conflicts in the allocation of scarce health care resources. For this, the problem of allocating scarce health care resources in a society is reconstructed as a social dilemma. Both disadvantaged patients and affluent healthy individuals can be argued to share interests in a societal contract to provide technologies which ameliorate medical need, based on progressive funding. The use of needs-based economic evaluation methods for coverage determination can be interpreted as institutions for conflict resolution as far as they use consented criteria to ensure the social contract’s sustainability and avoid implicit rationing or unaffordable contribution rates. This justifies the use of needs-based evaluation methods by Pareto-superiority and consent. The view of economic evaluation presented here may help account for fairness concerns in the further development of evaluation methods. This is because it directs the attention away from determining some unit of value to be maximized towards determining those persons who are most likely not to consent and meeting their concerns. Following this direction in methods development is likely to increase the acceptability of health economic evaluation by decision makers. (shrink)

Ziel dieses Buches ist es, ein Nachdenken (idealerweise eine Diskussion) über ein grundlegendes, methodologisches Problem in der Wissenschaft von der Logistik anzuregen (gelegentlich auch zu provozieren) - ein Problem, über das niemand spricht, obwohl es für die Fortentwicklung dieser Disziplin von grundlegender Bedeutung ist. Dieser Disziplin mangelt es an einer kritischen Reflexion der Erfolgsvoraussetzungen und Grenzen des eigenen Forschens, und das gilt im Grundsatz für alle drei hier beleuchteten Forschungsansätze. Dementsprechend kann eine solche Reflexion auch große Chancen erschließen, für die (...) Wissenschaft und für die Praxis. (shrink)

The story of Sosipatra of Pergamon (4th century C.E.) as told by her biographer, Eunapius of Sardis in his Lives of the Philosophers and Sophists, is a remarkable tale. It is the story of an elite young girl from the area of Ephesus, who was educated by traveling spirits (daemons), and who grew up to lead her own philosophy school on the west coast of ancient Asia Minor. She was also a prophet of sorts, channeling divine messages to her students, (...) family, and friends, capable of mentally viewing events that were happening in other locations, and foretelling the future. This volume is the first sustained, book length, attempt to tell the story of this mysterious woman. It presents a rich contextualization of the brief, sketchy, and highly fictionalized portrait provided by Eunapius. (shrink)