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)

This paper, guided by the UNESCO Universal Declaration on Bioethics and Human Rights, assumes that regulators should aim to support the development of nanomedicine while, at the same time, putting in place whatever limits or safeguards are indicated by ethical considerations. Relative to this regulatory objective, it is argued that, notwithstanding the importance of precaution (characteristically, concerning health, safety, and the environment), ethical reflection needs to go both broader and deeper. It is suggested that, by attending to the basic (...) matrix of ethical debate and the “bioethical triangle” through which the matrix is currently articulated, the breadth, depth, and conflictual plurality of ethical concerns about nanomedicine will be clarified. In this light, the conventional thinking about precaution is revisited and concerns about human dignity and informed consent (under conditions of extreme uncertainty) are analysed. The paper concludes that, once the range of ethical pluralism is grasped, the extent of the challenge facing regulators will be more clearly appreciated. (shrink)

This article aims to address challenges of translating emerging scientific technologies into legal terms and incorporate them into the existing North American regulatory regimes. A lack of full scientific knowledge about nanomedicine technologies results in the lack of development in legal discourse to describe products and to clearly set legal standards on their safety and efficacy. The increasing complexity and hybrid nature of technologies negatively impact the functionality of “law in action” leading to a legal uncertainty and ultimately to (...) a public distrust. Nanomedicine is an illustrative example of how law lags behind increasingly fast-paced scientific technologies making it difficult to find a balance between innovation and safety. This article argues that the boundary crossing nature of nanomedicine through different domains of science triggers a methodological and epistemological debate within science and law, suggesting that a critical revision is required in our traditional methods to learn, create, and categorize knowledge from breakthrough scientific advances. The highly disruptive nature of nanomedicine places stress on traditional conceptual frameworks, classifications of knowledge, and existing regulations. The legal challenge to identify definitions or to classify nanoapplications brings to light a conceptual vacuum surrounding nanomedicine. Moving away from confusing policies and obsolete classificatory models, this article suggests to undertake changes that are only the first steps of a more in-depth “epistemological transformation” that addresses knowledge as the process of not only gathering data, but also, as the process of elaborating new conceptual bases to better fulfill the legal language and facilitate the legal task of finding definitions and formulating criteria more adherent with scientific advances. This should compel regulators to explore new paradigms and develop new methodologies to evaluate data on nanomedicine applications in order to provide sustainable bases for a responsible development of nanomedicine. (shrink)

The promises of nanotechnology have been framed by a variety of metaphors, that not only channel the attention of the public, orient the questions asked by researchers, and convey epistemic choices closely linked to ethical preferences. In particular, the image of the ‘therapeutic missile’ commonly used to present targeted drug delivery devices emphasizes precision, control, surveillance and efficiency. Such values are highly praised in the current context of crisis of pharmaceutical innovation where military metaphors foster a general mobilization of resources (...) from multiple fields of cutting-edge research. The missile metaphor, reminiscent of Paul Ehrlich’s ‘magic bullet’, has framed the problem in simple terms: how to deliver the right dose in the right place at the right moment? Chemists, physicists and engineers who design multi-functional devices operating in vitro can think in such terms, as long as the devices are not actually operating through the messy environment of the body. A close look at what has been done and what remains to be done suggests that the metaphor of the “therapeutic missile” is neither sufficient, nor even necessary. Recent developments in nanomedicine suggest that therapeutic efficacy cannot be obtained without negotiating with the biological milieu and taking advantage of what it affords. An ‘oikological’ approach seems more appropriate, more heuristic and more promising than the popular missile. It is based on the view of organism as an oikos that has to be carefully managed. The dispositions of nanocapsules have to be coupled with the affordances of the environment. As it requires dealing with nanoparticles as relational entities (defined by their potential for interactions) rather than as stable substances (defined by intrinsic properties) this metaphor eventually might well change research priorities in nanotechnology in general. (shrink)

Nanomedicine applications are an extension of traditional pharmaceutical drug development that are targeting the most pressing health concerns through improvements to diagnostics, drug delivery systems, therapeutics, equipment, surgery and prosthetics. The benefits and risks to the individual have been extrapolated to include broader societal impacts of nanomedicine with concerns extending to inequitable distribution of benefits accruing to developed, or North countries, rather than developing, or South countries. Analysis reveals a great deal of overlap between the North and South's (...) most serious health priorities which kill millions each year. A significant amount of nanomedicine research activity is also underway for the most pressing South country-specific health concerns. Nanomedicine development promises profound breakthroughs for both North and South countries; however, the existing inequities in pharmaceutical drug development, patenting, access and delivery remain significant barriers for South countries. (shrink)

First-in-human research has several characteristics that require special attention with respect to ethics and human subjects protections. At least some nanomedical technologies may also have characteristics that merit special attention in clinical research, as other papers in this symposium show. This paper considers how to address these characteristics in the consent form and process for FIH nanomedicine research, focusing principally on experimental nanotherapeutic interventions but also considering nanodiagnostic interventions.It is essential, as a starting point, to recognize that the consent (...) form and process are by no means the primary protectors of human subjects. Instead, consideration of the form and content of informed consent becomes relevant only after a clinical trial has been reviewed and deemed scientifically and ethically acceptable.Two convergent types of challenges to informed consent are posed by nanomedicine FIH research. First, some issues appear generally applicable to FIH research, but have specific nanomedicine implications. (shrink)

The paper is intended to focus on peculiarities of nanomedicine and the importance of social concerns implicated, in order to understand if existing regulations are appropriate to maintain its safety or if a new ad hoc regulatory framework is needed. Consideration of social challenges will underline the crucial role of medical ethics in regulatory discussion.

Nanomedicine offers remarkable options for new therapeutic avenues. As methods in nanomedicine advance, ethical questions conjunctly arise. Nanomedicine is an exceptional niche in several aspects as it reflects risks and uncertainties not encountered in other areas of medical research or practice. Nanomedicine partially overlaps, partially interlocks and partially exceeds other medical disciplines. Some interpreters agree that advances in nanotechnology may pose varied ethical challenges, whilst others argue that these challenges are not new and that nanotechnology basically (...) echoes recurrent bioethical dilemmas. The purpose of this article is to discuss some of the ethical issues related to nanomedicine and to reflect on the question whether nanomedicine generates ethical challenges of new and unique nature. Such a determination should have implications on regulatory processes and professional conducts and protocols in the future. (shrink)

This essay presents some general background on nanomedicine, particularly focusing on some of the investment that is being made in this emerging field. The bulk of the essay, however, consists of explorations of two areas in which the impacts of nanomedicine are likely to be most significant: diagnostics and medical records and treatment, including surgery and drug delivery. Each discussion includes a survey some of the ethical and social issues that are likely to arise in these applications.

As Fritz Allhoff (2009) argues in the target article, the size, interactive, multifunctional, and precision features that nanoscale science and engineering enables is in the process of redefining m...

Nanotechnology, which involves manipulation of matter on a ‘nano’ scale, is considered to be a key enabling technology. Medical applications of nanotechnology are expected to significantly improve disease diagnostic and therapeutic modalities and subsequently reduce health care costs. However, there is no consensus on the definition of nanotechnology or nanomedicine, and this stems from the underlying debate on defining ‘nano’. This paper aims to present the diversity in the definition of nanomedicine and its impact on the translation of (...) basic science research in nanotechnology into clinical applications. We present the insights obtained from exploratory qualitative interviews with 46 stakeholders involved in translational nanomedicine from Europe and North America. The definition of nanomedicine has implications for many aspects of translational research including: fund allocation, patents, drug regulatory review processes and approvals, ethical review processes, clinical trials and public acceptance. Given the interdisciplinary nature of the field and common interest in developing effective clinical applications, it is important to have honest and transparent communication about nanomedicine, its benefits and potential harm. A clear and consistent definition of nanomedicine would significantly facilitate trust among various stakeholders including the general public while minimizing the risk of miscommunication and undue fear of nanotechnology and nanomedicine. (shrink)

Nanomedicine research raises ethical concerns beyond those covered by the Common Rule. Investigators and research institutions should comply with environmental and occupational health laws protect research staff and the environment. Though the IRB should concentrate on risks to human research participants, it should also consider risks to identifiable third parties. Investigators should also address risks to identifiable third parties. Professional and governmental organizations should deal with the long-term social, ethical, and environmental consequences of nanomedicine.

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 review addresses the current and future potential of nanomedicine, and its ethical considerations within the comprehensive framework of the four dimensions of medical ethics: Beneficence, Non-Maleficence, Respect, and Justice. From this perspective, the ethical considerations for nanomedicine are not novel, but have been addressed by precedents throughout the history of medicine. While these ethical challenges are not unique to nanomedicine, some require additional consideration, given the envisioned pervasive impact of nanomedicine on society.

Here we consider two ways that nanomedicine might be disruptive. First, low-end disruptions that are intrinsically unpredictable but limited in scope, and second, high end disruptions that involve broader societal issues but can be anticipated, allowing opportunity for ethical reflection.

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)

Nanomedicine promises unprecedented innovations for diagnosis and therapy as well as for predicting and preventing diseases. On the other hand it raises fears linked to new and unknown characteristics of nanoscale materials. Both, promises and fears, are closely linked to the realm of uncertainty. To a large extent it is currently not known which expectations could become reality and which suspected adverse events might come true. Medicine is quite familiar with decision-making under uncertainty. Rules and regulations for clinical research (...) have been developed to reduce possible harm for research participants without abandoning necessary investigations. Here we examine whether clinical research trials of nanomedicine need new regulations and conclude that the established rules should suffice. (shrink)

The recent progression in AI, nanomedicine and robotics have increased concerns about ethics, policy and law. The increasing complexity and hybrid nature of AI and nanotechnologies impact the functionality of “law in action” which can lead to legal uncertainty and ultimately to a public distrust. There is an immediate need of collaboration between Central Asian biomedical scientists, AI engineers and academic lawyers for the harmonization of AI, nanomedicines and robotics in Central Asian legal system.

While the definitions employed by different governmental agencies and scientific societies differ somewhat, the term “nanotechnology” is generally understood to refer to the manufacturing, characterization, and use of man-made devices with dimensions on the order of 1-100 nanometers. Devices that comprise a fundamental functional element that is nanotechnological are also frequently comprised within nanotechnology, as are manufactured objects with dimensions less than one micrometer. The differences in definition lead to occasional paradoxes, such as the fact that the most widely used (...) nanodrug is labeled a “nanopharmaceutical” by governments of European countries, Canada, and Australia, but it is not a nanotechnology for the U.S. Food and Drug Administration. It is also common in scientific domains to restrict the term “nanotechnology” to objects that possess special, “emerging” properties that only arise because of their nanoscale dimension. (shrink)

Many believe that nanotechnology will be disruptive to our society. Presumably, this means that some people and even whole industries will be undermined by technological developments that nanoscience makes possible. This, in turn, implies that we should anticipate potential workforce disruptions, mitigate in advance social problems likely to arise, and work to fairly distribute the future benefits of nanotechnology. This general, somewhat vague sense of disruption, is very difficult to specify – what will it entail? And how can we responsibly (...) anticipate and mitigate any problems? We can't even clearly state what the problems are anticipated to be. In fact, when we move from sweeping policy statements to more concrete accounts, nanotechnology seems to bifurcate into two divergent streams: one is fairly continuous with current developments, extending extant science in a quantitative way; the other is radically new, and includes science fiction-like dreams of molecular manufacturing and assemblers, with their utopian scenarios of absolute plenty. In these cases, “disruption” takes on the valence of Huxley's brave new world. (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)

The Common Rule is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services, which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A, Subpart B, Subpart C, and Subpart D. The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration has adopted its own regulations for the protection of human participants, which (...) are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board, and the criteria for approving research. (shrink)

Unlike drugs and medical devices, for which long standing and continuously improving quality assurance/quality control infrastructures exist, many nano-based products lack well-defined standards that are useful to manufacturers and regulators. Inherent variabilities in nanoparticle sizes and shapes, their large surface-to-volume ratios, and their mesoscale interactions with subcellular structures, suggest new complexities and challenges that must be met before widespread application of nanomedicines can be expected.

This paper critically examines the volitional normative model of disease and its underlying nanotechnologic vision of medicine both defended by Robert Freitas. Having provided an account of this vision, we explicate the highlight of the model, which is a concept of disease based on individual values and preferences. The model’s normative positions are then critiqued based on our argument that the epistemic basis of Freitas’s vision of nanotechnologic medicine and, by extension, of his volitional normative model of disease is scientifically (...) flawed. An ethical and social critique of the model is then conducted on the basis of the model’s implicit ethical underpinnings. We argue that Freitas fails to justify the normativity of his model by not addressing the ethical issues that permeate it, one of which is the question of responsibility regarding the development of medical nanotechnology and the practice of new forms of medicine such as the one he envisions. We conclude that, due to its radically individualistic position, the model implies an unjustified view of nanoethics and relegates this field of ethics to the periphery of discussions of nanomedicine. (shrink)

Nanomedicine has the potential to transform medical therapy and diagnosis. Its technologies predict improved drug delivery systems with site-specific treatment, precise new surgical techniques that would reduce patient trauma and treatment cause, and even cellular repair that would make age-related conditions such as Alzheimer’s disease a thing of the past. Currently, nanomedicine products are reaching the world market with an annual growth rate of twenty-five percent. However, like any emerging new technology, along with doomsday scenarios of nanoparticles gone (...) amuck, nanomedicine raises serious ethical, moral, and social issues that may potentially limit its technological developments. In this essay, I briefly evaluate some of these issues, and argue that ethical and epistemic issues should be considered prior to research and development. By examining three crucial epistemic challenges in nanomedicine—toxicity, nanodrugs and drug delivery systems, and clinical trials—I argue that by implementing a multi-criterion decision analysis framework as outlined by Linkov, Satterstorm and Corey, these challenges can bridge the knowledge gap between R&D and the introduction of nanomedicine technologies into the market. (shrink)

In prominent funding and policy statements, a particle with at least one dimension in the 1-300 nm size range must have novel physicochemical properties to count as a “nanoparticle.” Size is thus only one factor. Novelty of a particle's properties is also essential to its “nano” classification. When particles in this size range are introduced into living systems, they often interact with their host in novel ways that require some modification of existing methods and models used by pharmaceutical scientists and (...) toxicologists for assessing their efficacy and safety. It is not clear, however, whether the novelty of the intended physicochemical properties is in any way related to the novel behavior of those particles when their toxicity is evaluated. In fact, when considering toxicity, much of the concern about nanoparticles relates to the unanticipated or poorly understood interactions. (shrink)

Nanotechnology research is beginning to see widespread coverage in the media and popular science literatures, but discussions of hopes and fears about nanotechnology have already become polarised into utopian and dystopian visions. More moderate discussions focus on the near-term applications of nanotechnologies, and on potential benefits and harms. However, in exploring the social and ethical implications of nanotechnology, important lessons should be learned from experiences in other fields. In particular, studies of the ethical, legal, and social issues of genetics research (...) have successfully mapped out many of the issues that arise when new technologies are deployed. It is our contention that, for the most part, the ethical and social issues arising in nanomedicine are not altogether new, and thus do not require novel ethical principles or frameworks, nor a massive investment in ‘NELSI’ research. Instead, what is needed is support for the development of a culture of ethics amongst scientists and clinicians, basic scientific and medical knowledge for bioethicists, and a social competency for citizens to participate actively in debates about the implications of new technologies in general. (shrink)

This article draws out some key themes and offers responses to commentaries on "The Coming Era of Nanomedicine" (Allhoff 2009).

Public values failure occurs when the market and the public sector fail to provide goods and services required to achieve the core values of society such as equity (Bozeman 2007). That public policy for emerging health technologies should address intrinsic societal values such as equity is not a novel concept. However, the ways that the public values discourse of stakeholders is structured is less clear and rarely studied through the lens of public interests. This is especially true in the health (...) sciences discourse. Using the public value mapping (PVM) model I present a case study of the intrinsic value of equity in nanomedicine for cancer and the imperatives for translational research, an instrumental value to achieve equity. After reviewing and coding nearly 700 value statements from several hundred public documents, I find that that the discourse on values varies between documents that address basic research and documents that address the application of the knowledge produced in basic research, with some especially notable disconnections. This paper demonstrates the importance of further refinement of methods for testing the PVM framework if the societal goal is to improve consistency of the public value discussion by those involved in developing and applying new technologies. The paper also demonstrates the value of a PVM approach for complex science policy analysis, especially for emerging technologies like nanomedicine. (shrink)

Abstract Environmental and public health-focused sciences are increasingly characterised as constituting an emerging discipline—planetary medicine. From a governance perspective, the ethical components of that discipline may usefully be viewed as bestowing upon our ailing natural environment the symbolic moral status of a patient. Such components emphasise, for example, the origins and content of professional and social virtues and related ethical principles needed to promote global governance systems and policies that reduce ecological stresses and pathologies derived from human overpopulation, selfishness and (...) greed—such as pollution, loss of biodiversity, deforestation and greenhouse gas emissions, as well as provide necessary energy, water and food security. Less well explored in this context, however, is the ethics that should underpin global use of emerging technologies such as nanotechnology as forms of planetary therapeutics. Nanotechnology may be particularly important, for instance, as a mechanism for improving upon photosynthesis and engineering it into human structures for localised production of carbon-neutral hydrogen based-fuel and carbohydrate-based food and fertilizer. Artificial photosynthesis, because of its unique and widespread public and environmental benefits in this period of human history, may even be termed the moral culmination of nanotechnology, assisting this planet to move beyond the Anthropocene epoch to that of the Sustainocene. This paper explores practical steps towards planetary nanomedicine involving governance of artificial photosynthesis, including a UNESCO Universal Declaration on the Bioethics and Human Rights of Natural and Artificial Photosynthesis (Global Solar Fuels and Foods ). Content Type Journal Article Category Original Paper Pages 1-13 DOI 10.1007/s11569-012-0144-4 Authors Thomas Faunce, College of Medicine, Biology and the Environment and College of Law (joint Appointment), Australian National University, Acton, Australia Journal NanoEthics Online ISSN 1871-4765 Print ISSN 1871-4757. (shrink)

Medical technologies, including nanomedicine products, are intended to improve health but in many cases may also create their own health risks. Medical products that create their own health risks differ from most other risk-creating technologies in that the very purpose of the medical technology is to prevent or treat health risks. This paradox of technologies intended to reduce existing risks that may have the effect of creating new risks has two conflicting implications. On one hand, we may be more (...) tolerant of health risks from medical technologies because these products are intended to, and often do, reduce overall health risks and improve our health. The health benefits of a medical technology may outweigh the unavoidable adverse effects of that same technology in an individual patient or in the overall treated population. (shrink)

Clinical testing of nanomedicines presents two challenges to prevailing, human subject-centered frameworks governing research ethics. First, some nanomedical applications may present risk to persons other than research subjects. Second, pressures encountered in testing nanomedicines may present threats to the kinds of collaborations and collective activities needed for supporting clinical translation and redeeming research risk. In this article, I describe how similar challenges were encountered and addressed in gene transfer, and sketch policy options that might be explored in the nanomedicine (...) translation arena. (shrink)

Research on ethical, legal and social aspects of life sciences and new technologies has mainly been focused on impacts and consequences, while the emerging framework of Responsible Research and Innovation focuses rather on increased involvement and reflexivity in research processes to foster science and technology that better answers the needs of society. I argue that philosophy of science should be a central feature of RRI and demonstrate how the philosophy of science can contribute in this sense. I show how investigating (...) basic assumptions in research, here exemplified by reductive assumptions in causal modeling, can have important ethical and societal implications. (shrink)

Clinical trials of nanotechnology medical products present complex risk management challenges that involve many uncertainties and important risk-risk trade-offs. This paper inquires whether the precautionary principle can help to inform risk management approaches to nanomedicine clinical trials. It concludes that prudent precaution may be appropriate for ensuring the safety of such trials, but that the precautionary principle itself, especially in its more extreme forms, does not provide useful guidance for specific safety measures.

Much contemporary nanotoxicology, nanotherapeutic and nanoregulatory research has been characterised by a focus on investigating how delivery of engineered nanoparticles (ENPs) to cells is dictated primarily by components of the ENP surface. An alternative model, some implications of which are discussed here, begins with fundamental physicochemical research into the interaction of a dynamic nanoparticle-protein corona (NPC) with biological systems. The proposed new model also requires, however, that any such fresh NPC physicochemical research approach should involve integration and targeted collaboration from (...) the earliest stages with nanotoxicology, nanotherapeutics and nanoregulatory expertise. The justification for this integrated approach, we argue, relates not just to efficiency and promotion of innovation, but to an acknowledgement that public-funded basic physicochemical research in particular should now be accepted to incorporate strong higher order public goods elements from its inception, not merely after product development at the technology transfer stage. Issues, in other words, such as university research co-operation, commercialization and intellectual property (IP) protection, safety and cost-effectiveness regulatory assessment, as well as technology transfer should not be viewed as second tier considerations even in a ‘blue sky’ NPC basic research agenda. (shrink)

Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of (...) protection around the latter.As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence. (shrink)

Dans cet article, je soutiens que les métaphores « missile » et « ciblage » dans la recherche sur les médicaments à base de nanoparticules jouent différents rôles. Je soutiens que le « missile » joue un rôle scientifique marginal et un rôle plus central dans la communication, tandis que le « ciblage» est devenu une métaphore organisatrice dans le domaine de la recherche. La raison, je le suggère, est que le ciblage est l’explanandum principal du domaine et que cette (...) métaphore continue d’être pertinente même lorsque la nanomédecine mûrit pour s’attaquer à des problèmes plus complexes. Enfin, je discute des suggestions récentes de nouvelles métaphores axées sur la complexité, et je suggère que le rôle significatif des modèles simplificateurs et le besoin réel de tels modèles peuvent expliquer pourquoi les métaphores de complexité n’ont pas retenu l’attention des chercheurs. (shrink)

Dans cet article, je soutiens que les métaphores « missile » et « ciblage » dans la recherche sur les médicaments à base de nanoparticules jouent différents rôles. Je soutiens que le « missile » joue un rôle scientifique marginal et un rôle plus central dans la communication, tandis que le « ciblage» est devenu une métaphore organisatrice dans le domaine de la recherche. La raison, je le suggère, est que le ciblage est l’explanandum principal du domaine et que cette (...) métaphore continue d’être pertinente même lorsque la nanomédecine mûrit pour s’attaquer à des problèmes plus complexes. Enfin, je discute des suggestions récentes de nouvelles métaphores axées sur la complexité, et je suggère que le rôle significatif des modèles simplificateurs et le besoin réel de tels modèles peuvent expliquer pourquoi les métaphores de complexité n’ont pas retenu l’attention des chercheurs. (shrink)

Dans cet article, je soutiens que les métaphores « missile » et « ciblage » dans la recherche sur les médicaments à base de nanoparticules jouent différents rôles. Je soutiens que le « missile » joue un rôle scientifique marginal et un rôle plus central dans la communication, tandis que le « ciblage» est devenu une métaphore organisatrice dans le domaine de la recherche. La raison, je le suggère, est que le ciblage est l’explanandum principal du domaine et que cette (...) métaphore continue d’être pertinente même lorsque la nanomédecine mûrit pour s’attaquer à des problèmes plus complexes. Enfin, je discute des suggestions récentes de nouvelles métaphores axées sur la complexité, et je suggère que le rôle significatif des modèles simplificateurs et le besoin réel de tels modèles peuvent expliquer pourquoi les métaphores de complexité n’ont pas retenu l’attention des chercheurs. (shrink)

Legal regulation has a substantial impact on the development of technologies. Depending on its scope, structure, and effectiveness, regulation can essentially shape the research, development, production, commercialization, and consumption of emerging technologies in various ways. The lack of regulation, or of corresponding enforcement, can lead to the infringement of rights, harm to workers, consumers, and the environment, and to the neglect of the public interest. On the other hand, too strict regulations, based on incomplete information or excessive caution, may equally (...) cause harm by omitting the potential benefits or by distorting and delaying the technological development. At the current stage, nanotechnologies affect many areas of law: occupational health and safety, environ-. (shrink)

The assessment of nanotechnology applications such as nanocarrier-based targeted drug delivery has historically been based mostly on toxicological and safety aspects. The use of nanocarriers for TDD, a leading-edge nanomedical application, has received little study from the angle of experts’ perceptions and acceptability, which may be reflected in how TDD applications are developed. In recent years, numerous authors have maintained that TDD assessment should also take into account impacts on ethical, environmental, economic, legal, and social issues in order to lead (...) to socially responsible innovation. Semi-structured interviews were conducted with French and Canadian researchers and research trainees with diverse disciplinary backgrounds and involved in research related to emerging technologies. The interviews focussed on scenarios presenting two types of TDD nanocarriers in two contexts of use. Content and inductive analyses of interviews showed how facets of perceived impacts such as health, environment, social cohabitation, economy, life and death, representations of the human being and nature, and technoscience were weighed in acceptability judgments. The analyses also revealed that contextual factors related to device, to use, and to user influenced the weighting assigned to perceived impacts and thus contributed to variability in interviewees’ judgments of acceptability. Giving consideration to researchers’ perspective could accompany first steps of implementation and development of nanomedicine by producing a first, but wide, picture of the acceptability of nanocarrier-based TDD. (shrink)