This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be permitted (...) access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

The siren call of individualism is compelling. And although we have recognized its dangerous allure in the realm of adult decision-making, it has had profound and yet unnoticed dangerous effects in pediatric decision-making as well. Liberal individualism as instantiated in the best interest standard conceptualizes the child as independent and unencumbered and the goal of child rearing as rational autonomous adulthood, a characterization that is both ontologically false and normatively dangerous. Although a notion of the individuated child might have a (...) place in establishing a threshold of care obligated and enforced by the state, beyond this context we should turn our attention more explicitly to the relational interests of children. (shrink)

ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be (...) permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

Freezing is a common sign of panic, a response to accidents or events that overflow our capacity to react. Just as all civil airspace was cleared after the 9/11 attacks, the US-Canada border was also frozen, causing economic slowdowns. Border policies are caught between these two panics: security failures and economic crisis. To escape this paradox, American and Canadian authorities have implemented a series of security measures to make the border ‘smarter’, notably the implementation of biometric identity documents and surveillance (...) by UAV Predator drones. Psychoanalytic theory can help us explain why the Canadian and American governments have invested so much money for so little evident or measurable increase in either security or economic flows. The article uses the notion of phantastic objects to explain these (over-)reactions to risk management at the US-Canada border. (shrink)

In this paper we suggest a revisionist perspective on two significant figures in early modern life science and philosophy: William Harvey and John Locke. Harvey, the discoverer of the circulation of the blood, is often named as one of the rare representatives of the ‘life sciences’ who was a major figure in the Scientific Revolution. While this status itself is problematic, we would like to call attention to a different kind of problem: Harvey dislikes abstraction and controlled experiments (aside from (...) the ligature experiment in De Motu Cordis), tends to dismiss the value of instruments such as the microscope, and emphasizes instead the privileged status of ‘observed experience’. To use a contemporary term, Harvey appears to rely on, and chiefly value, ‘tacit knowledge’. Secondly, Locke’s project is often explained with reference to the image he uses in the Epistle to the Reader of his Essay, that he was an “underlabourer” of the sciences. In fact, despite the significant medical phase of his career, Locke’s ‘empiricism’ turns out to be above all a practical (i.e. ‘moral’) project, which focuses on the delimitation of our powers in order to achieve happiness, and rejects the possibility of naturalizing knowledge. When combined, these two cases suggest a different view of some canonical moments in early modern natural philosophy. (shrink)

Using payment to recruit research subjects is a common practice, but it raises ethical concerns that coercion or undue inducement could potentially compromise participants’ informed consent. This is the first national study to explore the attitudes of IRB members and other human subjects protection professionals concerning whether payment of research participants constitutes coercion or undue influence, and if so, why. The majority of respondents expressed concern that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. (...) Respondents expressed greater acceptance of payment as reimbursement or compensation than as an incentive to participate in research, and most agreed that subjects are coerced if the offer of payment makes them participate when they otherwise would not or when the offer of payment causes them to feel that they have no reasonable alternative but to participate . Views about undue influence were similar. We conclude that human subjects protection professionals hold expansive and inconsistent views about coercion and undue influence that may interfere with the recruitment of research participants and impede valuable research. (shrink)

Although the equally pervasive and abstract concept of space has generated a vast body of disciplines, time, and the related idea of "becoming" (transforming, ...

В первую книгу сборника включены исследования и материалы, посвященные творчеству Сергея Николаевича Дурылина - писателя, поэта, философа и богослова, и творчеству представителей русского культурного ренессанса первой трети XX века.

Standard models of adolescent risk taking posit that the cognitive abilities of adolescents and adults are equivalent, and that increases in risk taking that occur during adolescence are the result of socio emotional differences in impulsivity, sensation seeking, and lack of self-control. Fuzzy-trace theory incorporates these socio emotional differences. However, it predicts that there are also cognitive differences between adolescents and adults, specifically that there are developmental increases in gist-based intuition that reflects understanding. Gist understanding, as opposed to verbatim-based analysis, (...) generally has been hypothesized to have a protective effect on risk taking in adolescence. Gist understanding is also an essential element of informed consent regarding risks in medical decision- making. Evidence thus supports the argument that adolescents’ status as mature minors should be treated as an exception rather than a presumption, because accuracy in verbatim analysis is not mature gist understanding. Use of the exception should be accompanied by medical experts’ input on the bottom-line gist of risks involved in treatment. (shrink)

The article is devoted to the formal aspects of the political power. It examines the nature of power on the basis of the analysis of dreams of her media: Russian statesmen of XIXth and early XXth centuries. The relevance of the topic due to the dynamism of a modern political culture, the inability to identify formal sources of legitimacy of authority. The results indicate the mythologization and mystification of power. Components reviewed in historical Retrospect discourses were inherited from the past (...) sacred images of power, which could not rid ourselves of its carriers. (shrink)