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)

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)

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)

Portable MRI (pMRI) technology, which promises to transform brain imaging research by facilitating scanning in new geographic areas and the participation of new, diverse populations, raises many ethical, legal, and societal issues (ELSI). To understand this emerging pMRI ELSI landscape, we surveyed expert stakeholder views on ELSI challenges and solutions associated with pMRI research.

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)

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 lieu of an abstract, here is a brief excerpt of the content:Full Collection of Personal NarrativesAustin Morris, Lisa P., Jeanne Kerwin, Jean Watson, Eve Makoff, Brent R. Carr, Anonymous One, Michelle Prong, Laura J. Hoeksema, Tracy R. Wilson, Frances Rieth Maynard, Laura A. Katers, and Maggie Taylor• Against Their Wishes: The Gift of a Goodbye• Lisa’s Story• Unbefriended• The Clinical Ethics Consult: Transforming Ambivalence to Action• Side Stepping The Issues: Disappointment With An Ethics Consult For A Medically High (...) Risk Patient• My Father Dies Alone• Whose Voice Matters? The Role of Ethics Consultation in Supporting the 16-Year-Old Healthcare Decision-Maker of a Critically Ill Neonate• The Healing Power of an Ethics Consult• Clinical Ethicists: Can They Help Families in Their Times of Need?• “It’s All Personal”• Fault Lines• Difficult, Difficult, Lemon, DifficultCopyright © 2024 Johns Hopkins University Press... (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 ...

Introduction: representationalismMost theorists of cognition endorse some version of representationalism, which I will understand as the view that the human mind is an information-using system, and that human cognitive capacities are representational capacities. Of course, notions such as ‘representation’ and ‘information-using’ are terms of art that require explication. As a first pass, representations are “mediating states of an intelligent system that carry information” (Markman and Dietrich 2001, p. 471). They have two important features: (1) they are physically realized, and so (...) have causal powers; (2) they are intentional, in other words, they have meaning or representational content. This presumes a distinction between a representational vehicle—a physical state or structure that has causal powers and is responsible for producing behavior—and its content. Consider the following characterization of a device that computes the addition functionReaders will recognize the similarity t. (shrink)

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)

I’m going to argue for a set of restricted skeptical results: roughly put, we don’t know that fire engines are red, we don’t know that we sometimes have pains in our lower backs, we don’t know that John Rawls was kind, and we don’t even know that we believe any of those truths. However, people unfamiliar with philosophy and cognitive science do know all those things. The skeptical argument is traditional in form: here’s a skeptical hypothesis; you can’t epistemically neutralize (...) it, you have to be able to neutralize it to know P; so you don’t know P. But the skeptical hypotheses I plug into it are “real, live” scientific-philosophical hypotheses often thought to be actually true, unlike any of the outrageous traditional skeptical hypotheses (e.g., ‘You’re a brain in a vat’). So I call the resulting skepticism Live Skepticism. Notably, the Live Skeptic’s argument goes through even if we adopt the clever anti-skeptical fixes thought up in recent years such as reliabilism, relevant alternatives theory, contextualism, and the rejection of epistemic closure. Furthermore, the scope of Live Skepticism is bizarre: although we don’t know the simple facts noted above, many of us do know that there are black holes and other amazing facts. (shrink)

Suppose you know that someone is your epistemic peer regarding some topic. You admit that you cannot think of any relevant epistemic advantage you have over her when it comes to that topic; you admit that she is just as likely as you to get P's truth-value right. Alternatively, you might know that she is your epistemic superior regarding the topic. And then after learning this about her you find out that she disagrees with you about P. In those situations (...) it appears that the confidence with which one holds one's belief should be significantly reduced. My primary goal in this essay is to present and reflect upon a set of cases of disagreement that have not been discussed in the literature but are vital to consider. I argue that in the new cases one is reasonable in not lowering one?s confidence in the belief. Then I articulate and defend an ambitious principle, the Disagreement Principle, meant to answer the question 'Under what conditions am I epistemically blameworthy in retaining my belief with the same level of confidence after I have discovered recognized peers or superiors who disagree with me?'. (shrink)

Kripke’s puzzle has puts pressure on the intuitive idea that one can believe that Superman can fly without believing that Clark Kent can fly. If this idea is wrong then many theories of belief and belief ascription are built from faulty data. I argue that part of the proper analysis of Kripke’s puzzle refutes the closure principles that show up in many important arguments in epistemology, e.g., if S is rational and knows that P and that P entails Q, then (...) if she considers these two beliefs and Q, then she is in a position to know that.. (shrink)

Millianism is reasonable; that is, it is reasonable to think that all there is to the semantic value of a proper name is its referent. But Millianism appears to be undermined by the falsehood of Substitutivity, the principle that interchanging coreferential proper names in an intentional context cannot change the truth value of the resulting belief report. Mary might be perfectly rational in assenting to ‘Twain was a great writer’ as well as ‘Clemens was not a great writer’. Her confusion (...) does not seem to preclude her from assenting to those sentences in a normal, understanding manner. That is, Assent-for-Mary is true: Mary can knowingly assent to ‘Twain was a great writer’ and ‘Clemens was not a great writer’. By Disquotation—the rough principle that if in ordinary circumstances one assents to “P”, then one believes that P—Mary believes that Twain was a great writer and she believes that it’s not the case that Clemens was a great writer. If Substitutivity were true, then since ‘Mary believes that Twain was a great writer’ is true, ‘Mary believes that Clemens was a great writer’ would have to be true too. But then Mary would amount to a refutation of the plausible principle Consistency that, roughly put, no rational adult can have occurrently held and reflectively considered and compared contradictory beliefs. Since Disquotation, Assent-for-Mary, and Consistency are true, Substitutivity has to go. (shrink)