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)
Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)
This paper presents results found through searching publicly available U.S. data sources for information about how to handle incidental fndings (IF) in human subjects research, especially in genetics and genomics research, neuroimaging research, and CT colonography research. We searched the Web sites of 14 federal agencies, 22 professional societies, and 100 universities, as well as used the search engine Google for actual consent forms that had been posted on the Internet. Our analysis of these documents showed that there is very (...) little public guidance available for researchers as to how to deal with incidental fndings. Moreover, the guidance available is not consistent. (shrink)
Researchers in the health sciences regularly discover information of potential health importance unrelated to their object of study in the course of their research. However, there appears to be little guidance available on what researchers should do with this information, known in the scientific literature as incidental findings. The study described here was designed to determine the extent of guidance available to researchers from public sources. This empirical study was part of a larger two-year project funded by the National Human (...) Genome Research Institute to generate guidance on how incidental findings should be managed in human subjects research, especially genetics, genomics, and imaging research. We generated empirical analysis of publicly available guidance and consent forms to help guide a multidisciplinary Working Group of experts in their formulation of normative recommendations reported in this symposium. (shrink)
As part of “Nanodiagnostics and Nanotherapeutics: Building Research Ethics and Oversight,” an empirical search was conducted to identify publicly available resources that guided understanding about human subjects issues in nanomedicine or nanotechnology including policy statements, guidance documents, or consent forms. The authors conducted 5,083 internet searches and analyzed 175 documents. Results show that very little guidance is publicly available and most documents focused on occupational and environmental concerns.
Nanotechnology not only offers the promise of new enhancements to existing materials but also allows for the development of new materials and devices. The potential applications of nanotechnology range from medicine to agriculture to health and environmental science and beyond. Nanotechnology is growing at such a rate that Lux Research in 2007 estimated that nanotechnology will be incorporated into 15% of global manufactured goods by 2014. The U.S. National Nanotechnology Initiative defines nanotechnology as the following: “ Research and technology development (...) involving structures with at least one dimension in the range of 1-100 nanometers, frequently with atomic/molecular precision; Creating and using structures, devices, and systems that have unique properties and functions because of their nanoscale dimensions; The ability to control or manipulate on the atomic scale.” Nanomedicine and its subcategories of nanotherapeutics and in vivo nanodiagnostics incorporate nanoscale materials with unique properties that can enable new or improved treatments and diagnostics for many diseases and disorders. (shrink)
The law applicable to genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Although there has been some empirical work in this area, this is the first paper to survey and interview key scientific and legal stakeholders in the field of genomics to help ground identification of the most important legal problems that must be solved to (...) successfully integrate genomics into clinical care. The respondents in this study identified a wide range of interconnected issues, focusing specifically on the need for clear guidelines about how to use these data, fear of liability for those who use these data, and the need to protect patients from use of this information particularly by insurers, while endorsing data sharing. Developing legal strategies to support appropriate use of genomics now and in the future clearly will require making trade-offs, taking into account the full complexity of this legal ecosystem. (shrink)
table ronde du Centre national de la recherche scientifique, Paris, 27-29 mars 1979. Huygens et la France (Paris, Vrin, 1981, p. 99-114) CHRISTIAAN HUYGENS VU PAR LEIBNIZ par Albert HEINEKAMP (*) (Leibniz-Archiv, Hannover) Les ...
One of Moore’s paradoxical sentence types is ‘P, but I believe ~P’. Mooreans have assumed that all tokens of that sentence type are absurd in some way: epistemically, pragmatically, semantically, or assertively. And then they proceed to debate what the absurdity really is. I argue that if one has the appropriate philosophical views, then one can rationally assert tokens of that sentence type, and one can be epistemically reasonable in the corresponding compound belief as well.
During the first years of the post-war era, many French scientists travelled in the United States. As they looked for a reference to be used in rebuilding their own scientific landscape, their diaries say as much about the rise of the American biomedical complex as they do about their perception of research in the country. In order to illustrate how the French biologists adopted, competed with, or challenged the American model and how transatlantic exchanges played a critical role in the (...) molecularization of the life sciences, this paper presents three trajectories of laboratories. These include the services respectively led by P. Lepine and J. Monod at the Pasteur Institute, and G. Schapira's biochemical research unit at the Hopital des Enfants Malades. The three studies document the massive transatlantic circulation of materials, techniques, instruments, and people during the scientific reconstruction. The reconstruction however produced highly differentiated characters each operating in his own niche: the biotechnological inventor, the neo-clinician, and the fundamental biologist. The comparison situates the rise of molecular biology within the context of a rapidly expanding biomedical research system. It will help in understanding how, in contrast to the American situation, a logic of ''demedicalization'' became in France a means for developing biology at the molecular level. (shrink)
O episcopado francês e a lei de Separação - Reflexão sobre um processo de reconhecimento ( The French episcopate and the Law of Separation -Reflection on a process of recognition - L`épiscopat français et la loi de Séparation - Retour sur un processus de reconnaissance). O “princípio da modernidade” – introduzido pela Revolução Francesa e ratificado por um conjunto de leis durante o século XIX – rompe com o tradicional “princípio do Estado confessional católico” e estabelece o regime de separação (...) entre a Igreja Católica e o Estado francês. Como a Igreja recebeu o regime de separação entre Igreja e Estado, constituído à sua revelia e, geralmente, contra ela? O artigo propõe-se a responder a pergunta, destacando dois pontos de vista: a) o da ruptura, segundo o qual a instituição católica, marcada pelo princípio do Estado cristão, nutre forte hostilidade contra o regime laico, ainda que estabelecendo com ele acordos práticos; b) e o da continuidade, sob o qual a Igreja acolhe e defende o princípio da “sã laicidade” e justifica a liberdade pública de consciência. Baseado em minuciosa leitura de documentos oficiais da Igreja e do episcopado francês, o artigo dialoga com os dois pontos de vista evocados, analisando seus termos e interpretando criticamente seus pressupostos e suas teses. Palavras-chave: Estado confessional; Estado laico; Laicidade; Episcopado francês.The "principle of modernity" - introduced by the French Revolution and ratified by a set of laws during the nineteenth century - breaks with the traditional "principle of the Catholic confessional state" and establishes the separation between the Catholic Church and the French State. How did the Church receive the system of separation of church and state, made in absentia and generally against the church? This paper seeks to answer that question, highlighting two points of view: a) the break, according to which the Catholic institution, marked by the principle of the Christian State, nourishes strong hostility against the secular regime, although establishing practical agreements with such regime b) the point of view of continuity, under which the Church welcomes and embraces the principle of "healthy secularism" and justifies the public liberty of conscience. Based on careful reading of official documents of the Church and of the French episcopate, this article dialogues with the two mentioned points of view , analyses and interprets in a critical way their terms, assumptions and theses. Keywords : State religion; Secular state; Secularism; French episcopate. Résumé Le “principe de la modernité” – introduit par la Révolution française et ratifié par un ensemble de lois durant le XIXème siècle – rompt avec le traditionnel “principe de l’État confessionnel catholique” et établit le régime de séparation entre l’Église catholique et l’État français. Comment l’Église a-t-elle reçu le régime de séparation entre Église et État, institué malgré elle, et, généralement, contre elle? L’article se propose de répondre à cette question en soulignant deux points de vue: a) celui de la rupture qui fait que l’institution catholique, marquée par le principe de l’État chrétien, nourrit une forte hostilité envers le régime laïque, bien qu’elle passe des accords pratiques avec lui; b) celui de la continuité, qui fait que l’Église accueille et défend le principe de la “saine laïcité” et justifie la liberté publique de conscience. Basé sur une lecture minutieuse de documents officiels de l’Église et de l’Épiscopat français, l’article dialogue avec ces deux points de vue, analyse leurs termes, tout en interprétant de manière critique leurs présupposés et thèses. Mots-clés: État confessionnel. État laïque. Laïcité. Épiscopat français. (shrink)