Bioethicists have long been concerned that seriously ill patients entering early phase (‘phase I’) treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members’ attitudes toward communication of potential benefits and risks (...) of early phase studies to potential subjects. We surveyed the members of two U.S. research ethics committees using a phase I gene transfer study scenario, and compared the results to a previous survey of potential subjects’ perceptions and attitudes toward benefit and risk for the same protocol. The results show that there is indeed a gap between the subjects’ perceptions and the committee members’ views on what is appropriate to be communicated to research subjects. This discrepancy is the product of both the commonly assumed optimism of the subjects and to a “protective pessimism” of the research ethics committee members. We discuss this discrepancy using “frameworks of trust” and demonstrate the need to incorporate these frameworks into the existing model of informed consent. (shrink)

Subjects enrolled in studies testing high risk interventions for incurable or progressive brain diseases may be vulnerable to deficiencies in informed consent, such as the therapeutic misconception. However, the definition and measurement of the therapeutic misconception is a subject of continuing debate. Our qualitative pilot study of persons enrolled in a phase I trial of gene transfer for Parkinson disease suggests potential avenues for both measuring and preventing the therapeutic misconception. Building on earlier literature on the topic, we developed and (...) tested an interview guide that focuses on how the subjects decided to participate, emphasizing the integration of subjects’ various statements that are relevant to assessing the therapeutic misconception, rather than evaluating them as isolated statements. The results indicate that a subject’s understanding of the purpose of research is best explored in juxtaposition to the subject’s motivation for participating. (shrink)

During the set-up phase of an international study of genetic influences on outcomes from sepsis, we aimed to characterise potential differences in ethics approval processes and outcomes in participating European countries. Between 2005 and 2007 of the FP6-funded international Genetics Of Sepsis and Septic Shock project, we asked national coordinators to complete a structured survey of research ethic committee approval structures and processes in their countries, and linked these data to outcomes. Survey findings were reconfirmed or modified in 2017. Eighteen (...) countries participated in the study, recruiting 2257 patients from 160 ICUs. National practices differed widely in terms of composition of RECs, procedures and duration of the ethics approval process. Eight countries used a single centralised process for approval, seven required approval by an ethics committee in each participating hospital, and three required both. Outcomes of the application process differed widely between countries because of differences in national legislation, and differed within countries because of interpretation of the ethics of conducting research in patients lacking capacity. The RECs in four countries had no lay representation. The median time from submission to final decision was 1.5 months; in nine approval was received within 1 month; six took over 6 months, and in one 24 months; had all countries been able to match the most efficient approvals processes, an additional 74 months of country or institution-level recruitment would have been available. In three countries, rejection of the application by some local RECs resulted in loss of centres; and one country rejected the application outright. The potential benefits of the single application portal offered by the European Clinical Trials Regulation will not be realised without harmonisation of research ethics committee practices as well as national legislation. (shrink)

Henri J. Renard, S. J.: a sketch, by J. P. Jelinek.--The good as undefinable, by M. Childress.--Gottlieb Söhngen's sacramental doctrine on the mass, by J. F. Clarkson.--Christ's eucharistic action and history, by B. J. Cooke.--Objective reality of human ideas: Descartes and Suarez, by T. J. Cronin.--A medieval commentator on some Aristotelian educational themes, by J. W. Donohue.--God as sole cause of existence, by M. Holloway.--Knowledge, commitment, and the real, by R. O. Johann.--John Locke and sense realism, by H. R. (...) Klocker.--The being of nonbeing in Plato's Sophist, by Q. Lauer.--Ethics and verification, by R. McInerny.--Analogy and the fourth way, by J. J. O'Brien.--Love and being, by W. L. Rossner.--Complexity in human knowledge: its basis in form/matter composition, by E. L. Rousseau.--Toward a more dynamic understanding of substance and relation, by J. M. Somerville.--The origin of participant and of participated perfections in Proclus' Elements of theology, by L. Sweeney. (shrink)

In an era dominated by information and communication technologies, when science continues to amaze us with its discoveries and technological applications, and when social media are controlling part of our lives and social relationships, does philosophy still make sense? Is humanistic knowledge still necessary today as an indispensable part of our human world?

Les trente dernières années du XX e siècle ont été marquées par une très forte inflation des règles du droit du travail visant à protéger l’emploi. Ces règles encadrent notamment le licenciement et tentent d’endiguer le recours aux contrats précaires. Mais on s’aperçoit aujourd’hui qu’il n’existe pas de rapport mécanique entre les objectifs poursuivis (protéger l’emploi), leur traduction législative et les résultats produits qui sont décevants. Prenant acte de son impuissance le législateur entend désormais changer de paradigme en concentrant ses (...) efforts sur la protection des transitions professionnelles. Toutefois les lois les plus récentes qui s’inscrivent dans cette perspective connaissent de nombreux déboires, et pour l’instant il ne semble pas évident que la prospection sur ces nouvelles terres donne plus de résultats que ceux obtenus sur les anciennes. (shrink)

The economic crisis has been the main topic of all news resources in recent months. Today, Christian churches and other religious organizations, both in Ukraine and in the world, do not stand aside from this problem. We learn from various sources that financial difficulties have increased the number of parishioners of religious institutions by several times. In particular, people visit those religious institutions where they hold so-called "anti-crisis prayer services." One of the first places to pray for overcoming the crisis (...) was the Cathedral of St. Michael's Cathedral in Zhytomyr, where, according to Father Alexander Trofimlyuk, the number of people attending Sunday worship increased from 200-300 parishes to 500-600. (shrink)

Branner, H.C. Humanismens krise.--Hansen, Martin A. Eneren og massen.

This essay argues that schooling in Israel is tied too closely to ideology. This results in an indoctrinary orientation that contributes to divisiveness and imperils Israeli democracy. After reviewing and critiquing the roots of this orientation, I advance an alternative that understands education as an agent of the good rather than ideology. Israeli schooling requires a vision of goodness broad enough to encompass competing conceptions of Jewish life espoused by the majority as well as non-Jewish orientations affirmed by various minorities. (...) Such a vision can be grounded, I contend, in a democratic Jewish theology that emphasizes God as teacher rather than tyrant. (shrink)

El estudio de la epigrafía votiva evidencia que la mezcla de elementos romanos e indígenas resulta característica de la religiosidad de las mujeres hispanorromanas del territorio castellano-leonés, como igualmente lo es de las estructuras onomásticas y sociales de todo el tercio norte peninsular, pero, en todo caso, estas manifiestan sus creencias a través de las formas religiosas locales que les son más familiares, preferentemente en un culto de tipo privado y familiar, a menudo ligado a medios rurales, que se inclina (...) por las divinidades salutíferas y protectoras. Las implicadas muestran un importante grado de latinización y romanización onomástica, que sin embargo no acaba de consolidarse como mayoritario o absoluto, y un nivel socioeconómico medio o modesto, con escasas excepciones. (shrink)