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)

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.

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.

In this essay we expand the notion of thinking by emphasizing the provocation and urgency to think and by reconceptualizing thinking as an embodied practice. The aim is to expand Lipman and Sharp’s approach to philosophical inquiry with children and show how other ways of thinking can be included. We strive to unfold a way of “thinking” that is both different from rationality (critical thinking) as well as from creative and caring thinking. In the first part of the paper, we (...) discuss the merits of Lipman and Sharp’s critical, creative and caring thinking within the Community of Philosophical Inquiry (CPI). We then expand Lipman/Sharp’s philosophical method through Ekkehart Marten’s Five-finger Model, which allows for different philosophical approaches. In the second half of the paper, we draw on Martin Heidegger’s What is called thinking? to develop his concept of the “call” to think together with its related notions of provocation and urgency. Building on this, we draw on Maurice Merleau-Ponty to show how this call is not an intellectual activity or mere exercise of the “mind” but rather affects our entire existence. As such, thinking becomes a response to an existential urgency that is an embodied practice. Using concepts like embodiment, affect, and sensibility, we try to widen our conception of thinking in a CPI. Finally, we hope this will allow facilitators to hear the unique voice of every child so that no one is left unheard. (shrink)

Atmosphären zeichnen sich gleichermaßen durch ihre Profanität und ihre Wirkmächtigkeit aus. Wo immer man hinsieht, sind Atmosphären ein bestimmendes, vielleicht sogar das wichtigste Element im menschlichen Leben. Das Ziel des Sammelbandes besteht darin, die Bedeutung der Atmosphären im Gefühlsraum theoretisch und praktisch zu verdeutlichen und das Phänomen der Atmosphären in seinen vielfältigen Facetten, etwa in der Architektur, Kunst, Medizin, Psychiatrie, in der Pädagogik, in der Altenpflege, in Beruf und Privatleben, zu beleuchten.

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

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

Highly portable and accessible MRI technology will allow researchers to conduct field-based MRI research in community settings. Previous guidance for researchers working with fixed MRI does not address the novel ethical, legal, and societal issues (ELSI) of portable MRI (pMRI). Our interdisciplinary Working Group (WG) previously identified 15 core ELSI challenges associated with pMRI research and recommended solutions. In this article, we distill those detailed recommendations into a Portable MRI Research ELSI Checklist that offers practical operational guidance for researchers contemplating (...) using this technology. (shrink)

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.

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 FerrZ. These essays, informed by the insights of FerrZ and coming from manifold perspectives—ethics, philosophy, theology, and environmental studies, advance an ambitious challenge to current intellectual and scholarly fashions.

Emergence of the novel pathogenic coronavirus SARS‐CoV‐2 and its rapid pandemic spread presents challenges that demand immediate attention. Here, we describe the development of a semi‐quantitative high‐content microscopy‐based assay for detection of three major classes (IgG, IgA, and IgM) of SARS‐CoV‐2 specific antibodies in human samples. The possibility to detect antibodies against the entire viral proteome together with a robust semi‐automated image analysis workflow resulted in specific, sensitive and unbiased assay that complements the portfolio of SARS‐CoV‐2 serological assays. Sensitive, specific (...) and quantitative serological assays are urgently needed for a better understanding of humoral immune response against the virus as a basis for developing public health strategies to control viral spread. The procedure described here has been used for clinical studies and provides a general framework for the application of quantitative high‐throughput microscopy to rapidly develop serological assays for emerging virus infections. (shrink)

Balancing Change and Tradition in Global Education Reform is an invaluable resource for policymakers, faculty, students, and anyone interested in how decisions made about the education system ultimately affect the quality of education, educational access, and social justice.

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.

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)

A novel Protocol Ethics Tool Kit (‘Ethics Tool Kit’) has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women9s Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial (...) protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. (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.

Humans appear to follow normative rules of inductive reasoning in "premise diversity tasks" that is, they know that dissimilar rather than similar evidence is better for generalising hypotheses. In three experiments, we use a "hypothesis limitation task" to compare a related inductive reasoning skill knowing how to limit hypotheses by using a negative test strategy. Participants are told that one category member has some property (e.g. Dogs have a merocrine gland) and are asked what evidence they would test to ensure (...) that either all (generalisation) or only (limitation) category members have that property (e.g. All/Only mammals have merocrine glands; tests: wolf, bull, crocodile). Despite participants' reluctance to use negative tests in the Wason 2-4-6 task and other reasoning tasks, participants do use normatively correct negative tests in the hypothesis limitation task as often as they use diverse positive tests in the premise diversity task. Moreover, when given a hypothesis limitation task before a rule evaluation task (similar to the 2-4-6 task), the use of negative tests increases. Thus, when testing hypotheses, people can and do use the right kind of test strategy for the task. (shrink)

Conversational negation often behaves differently from negation as a logical operator: when rejecting a state of affairs, it does not present all members of the complement set as equally plausible alternatives, but it rather suggests some of them as more plausible than others (e.g., “This is not a dog, it is a wolf/*screwdriver”). Entities that are semantically similar to a negated entity tend to be judged as better alternatives (Kruszewski et al., 2016). In fact, Kruszewski et al. (2016) show (...) that the cosine similarity scores between the distributional semantics representations of a negated noun and its potential alternatives are highly correlated with the negated noun-alternatives human plausibility ratings. In a series of cloze tasks, we show that negation likewise restricts the production of plausible alternatives to similar entities. Furthermore, completions to negative sentences appear to be even more restricted than completions to an affirmative conjunctive context, hinting at a peculiarity of negation. (shrink)

In light of scientific advances such as genomics, predictive diagnostics, genetically engineered agriculture, nuclear transfer cloning, and the manipulation of stem cells, the idea that genes carry predetermined molecular programs or blueprints is pervasive. Yet new scientific discoveries—such as rna transcripts of single genes that can lead to the production of different compounds from the same pieces of dna—challenge the concept of the gene alone as the dominant factor in biological development. Increasingly aware of the tension between certain empirical results (...) and interpretations of those results based on the orthodox view of genetic determinism, a growing number of scientists urge a rethinking of what a gene is and how it works. In this collection, a group of internationally renowned scientists present some prominent alternative approaches to understanding the role of dna in the construction and function of biological organisms. Contributors discuss alternatives to the programmatic view of dna, including the developmental systems approach, methodical culturalism, the molecular process concept of the gene, the hermeneutic theory of description, and process structuralist biology. None of the approaches cast doubt on the notion that dna is tremendously important to biological life on earth; rather, contributors examine different ideas of how dna should be represented, evaluated, and explained. Just as ideas about genetic codes have reached far beyond the realm of science, the reconceptualizations of genetic theory in this volume have broad implications for ethics, philosophy, and the social sciences. Contributors. Thomas Bürglin, Brian C. Goodwin, James Griesemer, Paul Griffiths, Jesper Hoffmeyer, Evelyn Fox Keller, Gerd B. Müller, Eva M. Neumann-Held, Stuart A. Newman, Susan Oyama, Christoph Rehmann-Sutter, Sahotra Sarkar, Jackie Leach Scully, Gerry Webster, Ulrich Wolf. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Ethics & the Environment 8.2 (2003) 106-125 [Access article in PDF] Leopold's NovelThe Land Ethic in Barbara Kingsolver's Prodigal Summer Peter S. Wenz Introduction Like many good novels, Prodigal Summer's 1 account of love, tragedy, conflict, and choice in human relationships conveys an overall message about how life should be lived. In this case the message corresponds to Aldo Leopold's call for "a land ethic [that] changes the (...) role of Homo sapiens from conqueror of the land-community to plain member and citizen of it." People should "respect... fellow-members and also... the community as such." 2 Barbara Kingsolver explains Leopold's key ideas and updates the Land Ethic by showing how it might guide people today. The present paper selectively displays this relationship, and then suggests some pedagogical advantages of fiction.Prodigal Summer tells three interconnected stories that take place from May through July one year in contemporary rural Kentucky. One story features Deanna Wolfe, who has spent the last 25 months working for the U.S. Forest Service in a wilderness area on Zebulon Mountain where she restores trails and impedes illegal hunting. She has just discovered that coyotes have arrived, but so has Eddie Bondo, a handsome man from the West who hates coyotes because they sometimes kill livestock. [End Page 106]Another story features Lusa Landowski and her husband Cole Widener. Lusa is an entomologist who taught at the University of Kentucky before marrying Cole and moving to his family's tobacco farm that adjoins the national forest where Deanna works. Cole dies early in the novel and Lusa tries to save the family farm.Finally, Nannie Rawley is a senior citizen who grows organic apples nearby and has conflicts with her more senior neighbor, Garnett Walker, who wants to kill weeds with chemicals to keep his property looking neat. Garnett's goal is to cross-fertilize chestnut trees to create an American chestnut that is immune to chestnut blight. Ecocentrism, Hunting, the Biotic Pyramid, and Exotic Species Aldo Leopold's Land Ethic is famously holistic and ecocentric. The ecosystem, a holistic entity, has value over and above, and in most cases more than, the value of its individual components. This ecocentric perspective is summed up in the maxim: "A thing is right when it tends to preserve the integrity, stability, and beauty of the biotic community. It is wrong when it tends otherwise" (1970, 262).Ecocentrism explains Leopold's attitude toward hunting. In many passages, such as the October account of hunting ruffed grouse (58-62) and partridge (62-69), Leopold describes the hunt with approval. However, he disapproves of programs to eradicate keystone predators because their elimination impoverishes ecosystems. His classic account, "Thinking Like a Mountain," concerns wolf eradication. He writes, "I thought that because fewer wolves meant more deer, that no wolves would mean hunters' paradise" (138). But he found that wolf eradication harms mountains, that is, ecosystems. I have watched the face of many a newly wolfless mountain, and seen the south-facing slopes wrinkle with a maze of new deer trails. I have seen every edible bush and seedling browsed, first to anaemic desuetude, and then to death. I have seen every edible tree defoliated to the height of a saddle horn.... In the end the starved bones of the hoped-for deer herd, dead of its own too-much, bleach with the bones of the dead sage, or molder under the high-lined junipers. (139-40) Leopold's concept of a biotic pyramid explains why wolf eradication harms ecosystems. According to Leopold, the energy that plants absorb from the sun: [End Page 107]... flows through a circuit called the biota, which may be represented by a pyramid consisting of layers. The bottom layer is the soil. A plant layer rests on the soil, an insect layer on the plants, a bird and rodent layer on the insects, and so on up through the various animal groups to the apex layer, which consists of the larger carnivores.... Proceeding upward, each successive layer decreases in numerical... (shrink)

Zum Alltag gehort, dass nicht immer alles glatt lauft. Uberraschendes passiert, Routinen greifen nicht mehr, das Selbstverstandliche wird problematisch. Wie reagieren Menschen auf solche Irritationen, die aus dem "plotzlichen Einbruch des Neuen" (H. Schmitz) resultieren? Wie es scheint, haufig spontan, intuitiv, improvisierend. Was aber heisst Improvisation und wie gelingt sie? Und wie spielen Irritation und Improvisation in alltaglichen und beruflichen Situationen konkret zusammen? Die Beitrage des Buches behandeln diese Fragen aus der Perspektive der Neuen Phanomenologie. Mit Beitragen von Heinz Becker, (...) Walter Burger, Sabine Dorpinghaus, Jurgen Hasse, Henning Hintze, Robby Jacob, Robert Josef Kozljanic, Gudula Linck, Hermann Schmitz, Klaudia Schultheis, Viola Straubenmuller und Barbara Wolf. (shrink)

The topic of self-interest raises large and intractable philosophical questions–most obviously, the question “In what does self-interest consist?” The concept, as opposed to the content of self-interest, however, seems clear enough. Self-interest is interest in one's own good. To act self-interestedly is to act on the motive of advancing one's own good. Whether what one does actually is in one's self-interest depends on whether it actually does advance, or at least, minimize the decline of, one's own good. Though it may (...) be difficult to tell whether a person is motivated by self-interest in a particular instance, and difficult also to determine whether a given act or decision really is in one's self-interest, the meaning of the claims in question seems unproblematic. My main concern in this essay is to make a point about the content of self-interest. Specifically I shall put forward the view that meaningfulness, in a sense I shall elaborate, is an important element of a good life. It follows, then, that it is part of an enlightened self-interest that one wants to secure meaning in one's life, or, at any rate, to allow and promote meaningful activity within it. Accepting this substantial conception of self-interest, however, carries with it a curious consequence: the concept of self-interest which formerly seemed so clear begins to grow fuzzy. Fortunately, it comes to seem less important as well. In Reasons and Persons, Derek Parfit distinguishes three sorts of theories about self-interest–hedonistic theories, preference theories, and what he calls “objective-list theories." Hedonistic theories hold that one's good is a matter of the felt quality of one's experiences. (shrink)

Previously issued as author's dissertation, 1999/2000, Universiteat Berlin.

Bioethics has paid surprisingly little attention to the special problems faced by women and to feminist analyses of current health care issues other than ...

It is now well-known that Newton–Cartan theory is the correct geometrical setting for modelling the quantum Hall effect. In addition, in recent years edge modes for the Newton–Cartan quantum Hall effect have been derived. However, the existence of these edge modes has, as of yet, been derived using only orthodox methodologies involving the breaking of gauge-invariance; it would be preferable to derive the existence of such edge modes in a gauge-invariant manner. In this article, we employ recent work by Donnelly (...) and Freidel in order to accomplish exactly this task. Our results agree with known physics, but afford greater conceptual insight into the existence of these edge modes: in particular, they connect them to subtle aspects of Newton–Cartan geometry and pave the way for further applications of Newton–Cartan theory in condensed matter physics. (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)

The current explosion of genetic knowledge and the rapid proliferation of genetic tests has rightly provoked concern that we are approaching a future in which people will be labeled and disadvantaged based on genetic information. Indeed, some have already suffered harm, including denial of health insurance. This concern has prompted an outpouring of analysis. Yet almost all of it approaches the problem of genetic disadvantage under the rubric of “genetic discrimination.”This rubric is woefully inadequate to the task at hand. It (...) ignores years of commentary on race and gender demonstrating the limits of antidiscrimination analysis as an analytic framework and corrective tool. Too much discussion of genetic disadvantage proceeds as if scholars of race and gender had not spent decades critiquing and developing antidiscrimination theory.Indeed, there are multiple links among race, gender, and genetics. Dorothy Roberts has discussed the historical links between racism and genetics, while she and others have begun to map connections between gender and genetics. (shrink)

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene (...) transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology. (shrink)

February 21st will mark the two-hundred-and-fiftieth anniversary of the death of Spinoza, which occurred on February 21st, 1677. The visitor to the Hague may still see, in the Paviljoensgragt, the small two-storied house in the top rooms of which Spinoza spent the last six years of his short life. A tablet placed under the top windows commemorates the fact. It was in these rooms that Spinoza completed his Ethica, which may perhaps be regarded as the greatest masterpiece in the history (...) of Metaphysics. The house is in danger of being pulled down, and the Spinoza Society is endeavouring to secure it as a memorial to Spinoza, and a centre of philosophic studies. It is not so long since the house-breakers I had their way with the home of Erasmus in Rotterdam. It would be sad indeed if the abode of another of the greatest Humanists were to meet with a like fate. It is to be hoped that the revived I interest in Spinoza which we are witnessing now may take the I practical form of saving this precious relic, which may well serve to promote the peace and goodwill among men which Spinoza had so much at heart. (shrink)

Prof. Dr. Frieder Otto Wolf, President of the Humanistischer Verband Deutschlands, provides an overview of the main currents of modern humanism in Germany. He describes the central stream of German humanism as practical, in that it combines the principled imperative to overcome all structures and situations in which people are not treated as human beings with seeking to widen the horizons of humane existence in the arts and sciences and in capabilities of leading a fulfilling life. This humanism compels (...) resort to other criteria than nature, such as those logical, emotive, cultural, in order to gauge the acceptability of value claims. The practical efforts to humanize society and widen human horizons requires engagement in public policy debates and social organizing and programming on consensus issues. Accordingly, the HVD works on such diverse issues as strengthening the rights to bodily integrity and sexual autonomy, preventing economic collapse, accommodating immigrants, protecting personal privacy, limiting the use of military force, building intra- and international peace, and exposing anti-humanist prejudice. (shrink)