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 article describes the work of negotiating and reinterpreting "standard" protocols and criteria at the level of local practice, using the example of the procurement of human cadaver organs for transplantation. The tension between efforts to starulardize and globalize biomedical science, on the one hand, and fitting these efforts into everyday practices and understandings of practitioners, on the other, results in new constructions of medical knowledge about bodies and persons.

Commentators continue to weigh in on whether there are ethical, social, and policy issues unique to nanotechnology, whether new regulatory schemes should be devised, and if so, how. Many of these commentaries fail to take into account the historical and political environment for nanotechnologies. That context affects regulatory and oversight systems as much as any new metrics to measure the effects of nanoscale materials, or organizational changes put in place to facilitate data analysis. What comes to count as a technical (...) or social “problem” says much about the sociotechnical and political-historical networks in which technologies exist. This symposium's case studies provide insight into procedural successes and failures in the regulation of novel products, and ethical or social analyses that have attended to implications of novel, disruptive technologies. Yet what may be needed is a more fundamental consideration of forms of governance that may not just handle individual products or product types more effectively, but may also be flexible enough to respond to radically new technological systems. Nanotechnology presents an opportunity to think in transdisciplinary terms about both scientific and social concerns, rethink “knowns” about risk and how best to ameliorate or manage it, and consider how to incorporate ethical, social, and legal analyses in the conceptualization, planning, and execution of innovations. (shrink)

Risk takes center stage in ethical debates over nanomedical technologies. Yet concepts of risk may hold different meanings, and they are embedded within particular political, economic, and social contexts. This article discusses framings of risk in debates over medical innovations such as nanomedicine, and draws attention to organizational and institutional forms of risk which are less visible in bioethical policy debates. While significant, possibly unique risks may exist in specific nano-based products, risk may also arise from the very processes and (...) procedures that develop, test, and oversee any novel technology. This supports recommendations to coordinate efforts through an interagency Working Group and a Secretary-level Advisory Committee to provide flexibility and sensitivity to emerging issues of concern. (shrink)

Risk is the most often cited reason for ethical concern about any medical science or technology, particularly those new technologies that are not yet well understood, or create unfamiliar conditions. In fact, while risk and risk-benefit analyses are but one aspect of ethical oversight, ethical review and risk assessment are sometimes taken to mean the same thing. This is not surprising, since both the Common Rule and Food and Drug Administration foreground procedures for minimizing risk for human subjects and require (...) local IRBs to engage in some sort of risk-benefit analysis in decisions to approve or deny proposed research. Existing ethical review and oversight practices are based on the presumption that risk can be clearly identified within the planned activities of the protocol, that metrics can reasonably accurately predict potential hazards, and that mitigation measures can be taken to deal with unintended, harmful, or catastrophic events. (shrink)

That cacophony you hear is coming from the growing number of commentators addressing ethical, social, and policy issues raised by nanotechnology. Like many novel technologies that disturb the status quo, nanotechnologies raise questions about the adequacy of oversight systems; the extent to which the technologies push legal, moral, and political boundaries; and ultimately, the implications for human health and well-being. Because nanoscale techniques and products challenge our ways of thinking about biology, physics, and chemistry, nanotechnology forces us to reconsider accepted (...) wisdom on toxicity, mutagenicity, contamination, biocompatibility, and other interactions among humans, the environment, and technologies. The sheer scale and reach of nanotechnologies demands institutions, collaborations, and conventions that can cross-link knowledge across organizations, disciplines, and locales. If ever there was an occasion to rethink the limits of disciplinary-specific knowledge, norms about regulatory processes, and societal implications of new technologies, nanotechnologies provide the opportunity. (shrink)