Risks and burdens in the study participation, as well as an adequate risk-benefit balance, are key concepts for the evaluation of clinical studies by research ethics committees. An adequate assessment and continuous monitoring to ensure compliance of risks and burdens in clinical trials have long been described as a central task in research ethics. However, there is currently no uniform and solid theoretical approach to risk assessment by RECs. Regulatory standards of research ethics such as the Declaration of Helsinki provide (...) only minimal guidance on how risk decisions are considered. Due to discrepancies in the existing literature and guidance documents, adequate risk assessment by RECs remains to be elusive. In this article, we address current definitions of risk and present our own concept of aggregate risk definition. Moreover, we highlight the concept of benefit, the standard of reasonableness with respect to ethics literature and different approaches of risk-benefit assessment. In order to present a comprehensive theoretical approach of risk assessment by RECs, further understanding of the definitions of risk may improve adequate decision-making tasks by RECs. To improve the process of risk assessment by RECs, a dynamic framework will be illustrated, showing step-by-step risk assessment functions. This approach may be a promising tool to ensure adequacy in risk assessment by RECs. (shrink)

Doping in sport counts as a typical example of unfair behaviour and a good illustration of ethical problems produced by enhancement activities. However, there are some authors who argue that enhancement in sport is not intrinsically problematic but only so in those circumstances that make it dangerous for athletes or unfair to competitors, or which give rise to suspicion in the viewing public. In contrast to this, the author of the present article shows that enhancement activities are contradictory to basic (...) requirements and preconditions of sports competitions. These preconditions are, firstly, a basic equality of opportunities for all competitors and, secondly, a clear causal connection between a specific performance and an individual athlete, in the sense of authorship of that performance. It cannot be excluded that there could exist future sports competitions without these qualities, but this would clearly be a fundamentally different kind of sport from nowadays. Therefore, the normative background of the current concept of sports competitions, as such, limits the use of enhancement practices to a rather low level. (shrink)

Nanomedicine plays a prominent role among emerging technologies. The spectrum of potential applications is as broad as it is promising. It includes the use of nanoparticles and nanodevices for diagnostics, targeted drug delivery in the human body, the production of new therapeutic materials as well as nanorobots or nanoprotheses. Funding agencies are investing large sums in the development of this area, among them the European Commission, which has launched a large network for life-sciences related nanotechnology. At the same time government (...) agencies as well as the private sector are putting forward reports of working groups that have looked into the promises and risks of these developments. This paper will begin with an introduction to the central ethical themes as identified by selected reports from Europe and beyond. In a next step, it will analyse the most frequently invoked ethical concerns–risk assessment and management, the issues of human identity and enhancement, possible implications for civil liberties (e.g. nanodevices that might be used for covert surveillance), and concerns about equity and fair access. Although it seems that the main ethical issues are not unique to nanotechnologies, the conclusion will argue against shrugging them off as non-specific items that have been considered before in the context of other biomedical technologies, such as gene therapy or xenotransplantation. Rather, the paper will call on ethicists to help foster a rational, fair and participatory discourse on the different potential applications of nanotechnologies in medicine, which can form the basis for informed and responsible societal and political decisions. (shrink)

ZusammenfassungJeder extrahierte Zahn ist primär Eigentum des betreffenden Patienten und unterliegt dessen autonomiebasiertem Selbstbestimmungsrecht. Diesem weitgehend unstrittigen Sachverhalt steht die praktische Notwendigkeit gegenüber, extrahierte Zähne für Forschung und Lehre bereitzustellen. So ist z. B. die Erprobung neuer Wurzelfüllmaterialien und -techniken ohne den Einsatz extrahierter Zähne ebenso wenig denkbar wie eine zahnbezogene praktische Ausbildung angehender Zahnärzte im Rahmen des universitären Studiums. In jüngster Zeit wurde vermehrt Kritik an der konventionellen Praxis der Rekrutierung und Nutzung extrahierter Zähne geübt. Vor diesem Hintergrund widmet (...) sich der vorliegende Beitrag der Frage nach den ethischen und rechtlichen Voraussetzungen für die Verwendung extrahierter Zähne in Lehre und Forschung. Damit verbunden sind die Fragen nach 1) der Indikationsstellung zur Extraktion, 2) dem Umgang mit Kommerzialisierungsgefahren und äußerem Druck, 3) dem geeigneten Zeitpunkt der Aufklärung, 4) der Reichweite der Aufklärungspflicht und 5) Art und Umfang der Dokumentation. Der Beitrag fußt auf einer ethisch-rechtlichen Analyse der vorgenannten Problemkreise unter Berücksichtigung der einschlägigen rechtlichen Bestimmungen und der verfügbaren Fachliteratur und führt zu dem Ergebnis, dass die Rekrutierung und Nutzung extrahierter Zähne unter bestimmten, klar definierten Rahmenbedingungen ethisch und rechtlich zulässig ist. (shrink)

The human body and its parts are widely perceived as matters beyond commercial usage. This belief is codified in several national and European documents. This so-called ‘no-property rule’ is held to be the default position across the countries of the European Union. However, a closer look at the most pertinent national and European documents, and also current practices in the field, reveals a gradual model of commercialisation of human tissue. In particular, we will argue that the ban on commercialisation of (...) body material is not as strict as it may appear at first sight, leaving room for the commercial practice of tissue procurement and transfer. We argue for more transparent information for patients and tissue donors, an intensified ethical debate on commercialisation practices, and a critical review of current normative principles. (shrink)

Genetic predispositions often concern not only individual persons, but also other family members. Advances in the development of genetic tests lead to a growing number of genetic diagnoses in medical practice and to an increasing importance of genetic counseling. In the present article, a number of ethical foundations and preconditions for this issue are discussed. Four different models for the handling of genetic information are presented and analyzed including a discussion of practical implications. The different models’ ranges of content reach (...) from a strictly autonomous position over self-governed arrangements in the practice of genetic counseling up to the involvement of official bodies and committees. The different models show a number of elements which seem to be very useful for the handling of genetic data in families from an ethical perspective. In contrast, the limitations of the standard medical attempt regarding confidentiality and personal autonomy in the context of genetic information in the family are described. Finally, recommendations for further ethical research and the development of genetic counseling in families are given. (shrink)

This volume addresses the interdependencies between visual technologies and epistemology with regard to our perception of the medical body. It explores the relationships between the imagination, the body, and concrete forms of visual representations: Ranging from the Renaissance paradigm of anatomy, to Foucault's "birth of the clinic" and the institutionalised construction of a "medical gaze"; from "visual" archives of madness, psychiatric art collections, the politicisation and economisation of the body, to the post-human in mass media representations. Contributions to this volume (...) investigate medical bodies as historical, technological, and political constructs, constituted where knowledge formation and visual cultures intersect. Contributors are: Axel Fliethmann, Michael Hau, Birgit Lang, Carolyn Lau, Heikki Lempa, Stefanie Lenk, Joanna Madloch, Barry Murnane, Jill Redner, Claudia Stein, Elizabeth Stephens, Corinna Wagner, and Christiane Weller. (shrink)

Objectives: Clinical trials in humans in Germany—as in many other countries—must be approved by local research ethics committees . The current study has been designed to document and evaluate decisions of chairpersons of RECs in the problematic field of non-therapeutic research with minors. The authors’ purpose was to examine whether non-therapeutic research was acceptable for chairpersons at all, and whether there was certainty on how to decide in research trials involving more than minimal risk.Design: In a questionnaire, REC chairpersons had (...) to evaluate five different scenarios with non-therapeutic research. The scenarios described realistic potential research projects with minors, involving increasing levels of risk for the research participants. The chairpersons had to decide whether the respective projects should be approved.Methods: A total of 49 German REC chairpersons were sent questionnaires; 29 questionnaires were returned. The main measurements were approval or rejection of research scenarios.Results: Chairpersons of German RECs generally tend to accept non-therapeutic research with minors if the apparent risk for the participating children is low. If the risk is clearly higher than “minimal”, the chairpersons’ decisions differ widely.Conclusion: The fact that there seem to be different attitudes of chairpersons to non-therapeutic research with minors is problematic from an ethical point of view. It suggests a general uncertainty about the standards of protection for minor research participants in Germany. Therefore, further ethical and legal regulation of non-therapeutic research with minors in Germany seems necessary. (shrink)

Das Menschliche ist dadurch charakterisiert, dass der Mensch über sich selbst und seine Verfasstheit sowie seine Gemeinschaft und Kultur nachdenken kann, ja, muss. Er ist das Wesen, das sich selber immer wieder zum Problem geworden ist und wird, das nicht selbstverständlich einfach so dahinlebt oder -existiert, sondern in gewisser Weise ein reflektierendes Wesen ist, das sich nach sich selber befragt, nach dem Sinn seiner Existenz, seines Lebens, seiner Verfasstheit als eines geschlechtlichen Wesens usw. Das sind Gesichtspunkte, die natürlich immer nur (...) in einer kulturellen und einer traditions-gesellschaftlichen Welt eingenommen bzw. gewonnen werden können. Aufgabe einer philosophischen Anthropologie ist es nun - so Hans Lenk - das Wissen um die Lage und die Fähigkeiten des Menschen in ein Gesamtbild zu bringen. Mit anderen Worten, sie muss sich interdisziplinär verstehen und die Ergebnisse der Wissenschaften, soweit sie für das Thema Mensch und die umfassende Behandlung und Integration aller Aspekte in diesem Zusammenhang wichtig sind, mit einbeziehen. (shrink)

Vernunft als Idee und Appell -- Reine und pragmatische Vernunft -- Zu ethischen Fragen des Humanexperiments -- Zur Wissenschaftstheorie der Sozialwissenschaften -- Erfolg und Grenzen der Mathematisierung -- Methodologisches zum Verhältnis von Wissenschaft und Technik -- Leistungsprinzip und Sportkritik -- Herakleisch oder prometheisch?

How should you decide what to do when you’re uncertain about basic normative principles? A natural suggestion is to follow some "second-order:" norm: e.g., obey the most probable norm or maximize expected choiceworthiness. But what if you’re uncertain about second-order norms too—must you then invoke some third-order norm? If so, any norm-guided response to normative uncertainty appears doomed to a vicious regress. This paper aims to rescue second-order norms from the threat of regress. I first elaborate and defend the claim (...) some philosophers have made that the regress problem forces us to accept normative externalism, the view that at least one norm is incumbent on all agents regardless of their normative beliefs. But, I then argue, we need not accept externalism about first-order norms, thus closing off any question of how agents should respond to normative uncertainty. Rather, we can head off the threat of regress by ascribing external force to a single second-order norm: the enkratic principle. (shrink)

Les disciplines historiques, littéraires et philosophiques font un emploi abondant des catégories historiographiques. Parmi celles-ci, les termes en ismes sont très fréquents pour référer à une doctrine, un courant artistique, une idéologie ou des événements spécifiques. On fait cependant remarquer que ces désignations posent de nombreux problèmes d’interprétation. En particulier, que l’origine exacte d’une catégorie est souvent méconnue et que sa signification est plus équivoque qu’on ne le croit habituellement. La formation d’un terme en isme s’explique souvent dans un contexte (...) polémique et sert à condamner ou critiquer plutôt qu’à comprendre une pensée, un mouvement ou des faits historiques. Les catégories d’athéisme, de classicisme ou de féminisme en sont de bons exemples. Le présent volume vise à contribuer à l’étude critique des catégories historiographiques et des notions en isme en s’attardant à l’époque moderne (XVI e XVIII e siècles). Il s’agit d’un moment clef de l’histoire européenne pendant laquelle nombre de ces notions apparaissent ou pour laquelle l’historiographie en a fait un emploi abondant. Les chapitres en examinent la valeur théorique par rapport à une origine ou des usages, et déterminent de quelles manières elles contribuent à l’interprétation de l’histoire, de la littérature ou de la philosophie, de la Renaissance jusqu’à la Révolution française. (shrink)

What kind of animals are human beings? And how do our visions of the human shape our theories of social action and institutions? In Moral, Believing Animals>, Christian Smith advances a creative theory of human persons and culture that offers innovative, challenging answers to these and other fundamental questions in sociological, cultural, and religious theory. Smith suggests that human beings have a peculiar set of capacities and proclivities that distinguishes them significantly from other animals on this planet. Despite the (...) vast differences in humanity between cultures and across history, no matter how differently people narrate their lives and histories, there remains an underlying structure of human personhood that helps to order human culture, history, and narration. Drawing on important recent insights in moral philosophy, epistemology, and narrative studies, Smith argues that humans are animals who have an inescapable moral and spiritual dimension. They cannot avoid a fundamental moral orientation in life and this, says Smith, has profound consequences for how sociology must study human beings. (shrink)

Decision-making under normative uncertainty requires an agent to aggregate the assessments of options given by rival normative theories into a single assessment that tells her what to do in light of her uncertainty. But what if the assessments of rival theories differ not just in their content but in their structure -- e.g., some are merely ordinal while others are cardinal? This paper describes and evaluates three general approaches to this "problem of structural diversity": structural enrichment, structural depletion, and multi-stage (...) aggregation. All three approaches have notable drawbacks, but I tentatively defend multi-stage aggregation as least bad of the three. (shrink)

The perception of meaningful patterns in random arrangements and unrelated events takes place in our everyday lives, coined apophenia, synchronicity, or the experience of meaningful coincidences. However, we do not know yet what predicts this phenomenon. To investigate this, we re-analyzed a combined data set of two daily diary studies with a total of N = 169 participants (mean age 29.95 years; 54 men). We investigated if positive or negative affect (PA, NA) predicts the number of meaningful coincidences on the (...) following day (or vice versa). By means of a cross-lagged multilevel modelling approach (Bayesian estimation) we evaluated with which of two theoretical assumptions the data are more in line. First, if meaningful coincidences are facilitated by a broader and more flexible thinking style, PA should positively predict meaningful coincidences at the following day. However, if the experience of meaningful coincidences signifies a strategy to cope with negative feeling states, NA should predict the experience of meaningful coincidences during the following day. In favour of a more flexible thinking style, we found that PA predicted the number of perceived coincidences the following day. We did not find any effect for NA, and therefore, no evidence arguing for the coping mechanism hypothesis of meaningful coincidences. (shrink)

At its heart, The Dialectic of Counter-Enlightenment is a plea not to take doubt at its word—a plea for the return of a vanished philosophical intelligence..

The principle that rational agents should maximize expected utility or choiceworthiness is intuitively plausible in many ordinary cases of decision-making under uncertainty. But it is less plausible in cases of extreme, low-probability risk (like Pascal's Mugging), and intolerably paradoxical in cases like the St. Petersburg and Pasadena games. In this paper I show that, under certain conditions, stochastic dominance reasoning can capture most of the plausible implications of expectational reasoning while avoiding most of its pitfalls. Specifically, given sufficient background uncertainty (...) about the choiceworthiness of one's options, many expectation-maximizing gambles that do not stochastically dominate their alternatives "in a vacuum" become stochastically dominant in virtue of that background uncertainty. But, even under these conditions, stochastic dominance will not require agents to accept options whose expectational superiority depends on sufficiently small probabilities of extreme payoffs. The sort of background uncertainty on which these results depend looks unavoidable for any agent who measures the choiceworthiness of her options in part by the total amount of value in the resulting world. At least for such agents, then, stochastic dominance offers a plausible general principle of choice under uncertainty that can explain more of the apparent rational constraints on such choices than has previously been recognized. (shrink)

Franciscus de Prato hat sich immer wieder mit der Philosophie Ockhams auseinandergesetzt. Diese Arbeit zeigt auf, wie bedeutsam fur beide Philosophen die Sprachtheorie ist. Der Angelpunkt ist dabei die Annahme entweder eines Satzes im Geiste oder einer Proposition, die aus Dingen besteht. Diese Entscheidung wirkt sich dann auf verschiedenste Gebiete der Philosophie aus. Am Beispiel der Kategorienlehre wird dies deutlich: Kategorien sind Aussagbares. In Satzen aussagbar sind aber fur Ockham nur mentale Begriffe, keine Dinge. Also ist fur ihn die Kategorienordnung (...) keine Ordnung von extramentalen Dingen, sondern nur von mentalen Zeichen. Anders Franciscus: Fur ihn sind Gegenstande, nicht Zeichen primar aussagbar. Also ist fur ihn die kategoriale Ordnung eine reale Hierarchie. Welches Licht wirft diese Auseinandersetzung auf das Verstandnis der Philosophie Ockhams und der des Franciscus? Weitaus wichtiger als der universalientheoretische Unterschied zwischen Nominalismus und Realismus ist fur beide Denker ihre satztheoretische Ausrichtung. Ausgezeichnet mit dem Preis an Studierende der Ruhr-Universitat Bochum. (shrink)