Social scientists have begun elucidating the variables that influence public trust in science, yet little is known about hype in biotechnology and its effects on public trust. Many scholars claim that hyping biotechnology results in a loss of public trust, and possibly public enthusiasm or support for science, because public expectations of the biotechnological promises will be unmet. We argue for the need for empirical research that examines the relationships between hype, public trust, and public enthusiasm/support. We discuss the complexities (...) in designing empirical studies that provide evidence for a causal link between hype, public trust, and public enthusiasm/support, but also illustrate how this may be remedied. Further empirical research on hype and public trust is needed in order to improve public communication of science and to design evidence-based education on the responsible conduct of research for scientists. We conclude that conceptual arguments made on hype and public trust must be nuanced to reflect our current understanding of this relationship. (shrink)

Dependence in nanotechnology on external funding and academic-industry relationships has led to questions concerning its influence on research directions, as well as the potential for conflicts of interest to arise and impact scientific integrity and public trust. This study uses a survey of 193 nanotechnology industry and academic researchers to explore whether they share similar concerns. Although these concerns are not unique to nanotechnology, its emerging nature and the prominence of industry funding lend credence to understanding its researchers’ views, as (...) these researchers are shaping the norms and direction of the field. The results of the survey show general agreement that funding sources are influencing research directions in nanotechnology; many respondents saw this influence in their own work as well as other researchers’ work. Respondents also agreed that funding considerations were likely to influence whether researchers shared their results. Irrespective of their institutional affiliation or funding status, twice as many researchers as not considered financial conflicts of interest a cause for concern, and three times as many respondents as not disagreed financial conflicts of interest in nanotechnology were uncommon. Only a third was satisfied with the way that conflicts of interest are currently managed and believed current procedures would protect the integrity of nanotechnology research. The results also found differences in views depending on researchers’ institutional affiliation and funding status. (shrink)

This essay analyzes the concept of public trust in science and offers some guidance for ethicists, scientists, and policymakers who use this idea defend ethical rules or policies pertaining to the conduct of research. While the notion that public trusts science makes sense in the abstract, it may not be sufficiently focused to support the various rules and policies that authors have tried to derive from it, because the public is not a uniform body with a common set of interests. (...) Well-focused arguments that use public trust to support rules or policies for the conduct of research should specify (a) which public is being referred to (e.g. the general public or a specific public, such as a particular community or group); (b) what this public expects from scientists; (c) how the rule or policy will ensure that these expectations are met; and (d) why is it important to meet these expectations. (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)

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)

Regulatory oversight and public communication are intimately intertwined. Oversight failures, both actual and perceived, quickly galvanize attention from both the media and the public, as has occasionally happened in all of the historical cases with which this symposium is concerned — gene therapy, workplace chemicals, drugs and devices, and genetically modified organisms, especially those used as foods. Some developments, such as GMOs, seem to have more cultural significance or “cultural resonance” than others and are especially likely to garner public attention. (...) Developments in nanotechnology, on the other hand, do not seem to have captured as much popular attention. However, the accelerating convergence between nanotechnology as material science and biotechnology, health, and medicine could easily change this situation. (shrink)

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)

The revolutionary Feynman vision of a powerful and general nanotechnology, based on nanomachines that build with atom-by-atom control, promises great opportunities and, if abused, great dangers. This vision made nanotechnology a buzzword and launched the global nanotechnology race. Along the way, however, the meaning of the word has shifted. A vastly broadened definition of nanotechnology (including any technology with nanoscale features) enabled specialists from diverse fields to infuse unrelated research with the Feynman mystique. The resulting nanoscaletechnology funding coalition has obscured (...) the Feynman vision by misunderstanding its basis, distrusting its promise, and fearing that public concern regarding its dangers might interfere with research funding. In response, leaders of a funding coalition have attempted to narrow nanotechnology to exclude one area of nanoscale technology—the Feynman vision itself. Their misdirected arguments against the Feynman vision have needlessly confused public discussion of the objectives and consequences of nanotechnology research. (shrink)

Despite their crucial role in the translation of pre-clinical research into new clinical applications, phase 1 trials involving patients continue to prompt ethical debate. At the heart of the controversy is the question of whether risks of administering experimental drugs are therapeutically justified. We suggest that prior attempts to address this question have been muddled, in part because it cannot be answered adequately without first attending to the way labor is divided in managing risk in clinical trials. In what follows, (...) we approach the question of therapeutic justification for phase 1 trials from the viewpoint of five different stakeholders: the drug regulatory authority, the IRB, the clinical investigator, the referring physician, and the patient. Our analysis shows that the question of therapeutic justification actually raises multiple questions corresponding to the roles and responsibilities of the different stakeholders involved. By attending to these contextual differences, we provide more coherent guidance for the ethical negotiation of risk in phase 1 trials involving patients. We close by discussing the implications of our argument for various perennial controversies in phase 1 trial practice. (shrink)

Nanomedicine is a rapidly growing field in the academic as well as commercial arena. While some had predicted nanomedicine sales to reach $20.1 billion in 2011, the actual growth was much more rapid, with the global nanomedicine market being valued at $53 billion in 2009, and forecast to increase at an annual growth rate of 13.5% to reach more than $100 billion in 2014. In 2006, more than 130 nanotechnology-based drugs and delivery systems had entered preclinical, clinical, or commercial development. (...) The European Medicines Agency reviewed 18 marketing authorization applications for nanomedicines in 2010. In 2011, 22 drugs that had been approved by the FDA, and 87 Phase I and Phase II clinical trials were listed in the U.S. National Institutes of Health data base, www.clinicaltrials.gov. Although the fastest growing areas of nanomedicine are applications in medical imaging and diagnosis using contrast-enhancing agents, most nanomedicine research and commercialization is in the area of cancer drug therapy, including nano gold shells. (shrink)

As public attitude research evolves, often becoming more complex and variable, we are coming to understand that public attitudes are also more complex and variable than can often be captured by a single opinion poll, and more sophisticated forms of analyses are needed that look not just at a breadth of attitudes, but at a breadth of publics. The Australian Department of Industry undertook a public attitude study in 2012 that was not only longitudinal, looking at changes in attitudes towards (...) nanotechnologies, but also looking at the values or worldviews that influence attitudes. The findings allowed for a segmentation of the public, into four key segments, with distinct homogenous attitudes. This allows for not just a deeper understanding of the diversity of views that exist and the worldviews that influence them, but challenges engagement practitioners to ensure they have a broad representation of participants with different attitudes and do not favour one or two segments only. (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.

The aims of this article are to consider (1) whether there are medical and societal differences among diseases regarding which patient groups should be asked to participate in first-in-human (FIH) trials of stem-cell-based therapies; (2) any differences in the light of values generally endorsed by different types of ethical theories, since the question in the title of this article is value laden, and its answer depends on which values one wants to promote and protect, and how they are ranked in (...) importance; (3) whether the answer to that question is disease-specific, or whether it depends on factors common to several diseases. To illustrate these problems, we use Parkinson’s disease (PD) and Huntington’s disease (HD), between which there are important medical and societal differences. Moreover, research on stem-cellbased therapies for these diseases is being translated from research to practice. This approach to the problem can be applied to decision making about similar problems raised by other diseases that exhibit the same types of differences. (shrink)

First-in-human clinical trials represent a critical juncture in the translation of laboratory discoveries. However, because they involve the greatest degree of uncertainty at any point in the drug development process, their initiation is beset by a series of nettlesome ethical questions [1]: has clinical promise been sufficiently demonstrated in animals? Should trial access be restricted to patients with refractory disease? Should trials be viewed as therapeutic? Have researchers adequately minimized risks? The resolution of such ethical questions inevitably turns on claims (...) about future events like harms, therapeutic response, and clinical translation. Recurrent failures in clinical translation, like Eli Lilly's Alzheimer candidate semagacestat, highlight the severe limitations of current methods of prediction. In this case, patients in the active arm of the placebo-controlled trial had earlier onset of dementia and elevated rates of skin cancer [2]. Various authoritative accounts of human research ethics state that decision-making about risk and benefit should be careful, systematic, and non-arbitrary [3]–[5]. Yet, these sources provide little guidance about what kinds of evidence stakeholders should use to ensure their estimates of such events ground responsible ethical decisions. In this article, we suggest that investigators, oversight bodies, and sponsors often base their predictions on a flawed and inappropriately narrow preclinical evidence base. (shrink)