Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how non-utilitarian principles are prominent (...) in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values. (shrink)

This paper analyzes the number of procedural and substantive tension points with which a conscientious whistleblower struggles. Included in the former are such questions as: (1) Am I properly depicting the seriousness of the problem? (2) Have I secured the information properly, analyzed it appropriately, and presented it fairly? (3) Are my motives appropriate? (4) Have I tried fully enough to have the problem corrected within the organization? (5) Should I blow the whistle while still a member of the organization (...) or after having left it? (6) Should I keep anonymity? (7) How ethical is it to assume the role of a judge? (8) How ethical is it to set in motion an act which will likely be very costly to many people? Substantive tension points include such questions as: (1) How fully am I living up to my moral obligations to my organization and my colleagues? (2) Am I appropriately upholding the ethical standards of my profession? (3) How adversely will my action affect my family and other primary groups? (4) Am I being true to myself? (5) How will my action affect the health of such basic values as freedom of expression, independent judgment, courage, fairness, cooperativeness, and loyalty? (shrink)

A tension between the professions' pursuit of autonomy and the public's demand for accountability has led to the development of codes of ethics as both a foundation and guide for professional conduct in the face of morally ambiguous situations. The profession as an institution serves as a normative reference group for individual practitioners and through a code of ethics clarifies, for both its members and outsiders, the norms that ought to govern professional behavior. Three types of codes can be identified (...) — aspirational, educational and regulatory. All codes serve multiple interests and, as a consequence, perform many functions, eight of which are discussed. The process of developing a code of ethics is assessed because of the role it plays in gaining consensus on professional values and ethical norms. After discussing some of the weaknesses in current approaches to professional self-regulation, several new private and public initiatives are proposed. (shrink)

In an attempt to shape the development of nanotechnologies, ethics policy programs promote engagement in the hope of broadening the scope of considerations that scientists and engineers take into account. While enhancing the reflexivity of scientists theoretically implies changes in technoscientific practice, few empirical studies demonstrate such effects. To investigate the real-time effects on engineering research practices, a laboratory engagement study was undertaken to specify the interplay of technical and social considerations during the normal course of research. The study employed (...) an ethnographic invention in the form of a decision model to structure reflection on ongoing social processes. A short series of interactions with one engineering researcher illustrates the deployment of the model in the form of an interview protocol. The cultural embedment of the protocol allowed it to function as a feedback mechanism, creating a more self-critical environment for knowledge production, and perturbing the system in research-tolerable ways. (shrink)

There is little doubt that the development and commercialisation of nanotechnologies is challenging traditional state-based regulatory regimes. Yet governments currently appear to be taking a non-interventionist approach to directly regulating this emerging technology. This paper argues that a large regulatory toolbox is available for governing this small technology and that as nanotechnologies evolve, many regulatory advances are likely to occur outside of government. It notes the scientific uncertainties facing us as we contemplate nanotechnology regulatory matters and then examines the notion (...) of regulation itself, suggesting new ways to frame our understanding of both regulation and the regulatory tools relevant to nanotechnologies. By drawing upon three different conceptual lenses of regulation, the paper articulates a wide range of potential regulatory tools at hand. It also focuses particularly on the ways various tools are currently being used or perhaps may be employed in the future. The strengths and weaknesses characterising these tools is examined as well as the different actors involved. The paper concludes that we will increasingly face debate over what is likely to work most effectively in regulating nano technologies, the legitimacy of these different potential approaches, and the speed at which these different regimes may be employed. (shrink)

This paper reports an analysis of the content of the codes of ethics of 15 professional business organizations in the United States, representing the broad range of disciplines found in business. The analysis was conducted to identify common ethical issues faced by business professionals. It was also structured to highlight ethical issues that are either unique to or of particular importance for business professionals. No attempt is made to make value judgments about either the codes of ethics studied or of (...) their content. General ethical values identified include honesty and integrity, general legal compliance, discreditable or harmful acts, and obligations related to social values. More business-specific issues include confidentiality, responsibilities to employers/clients, obligations to the profession, independence and objectivity, and business-specific legal and technical compliance issues. (shrink)

It is sometimes suggested that new research in such areas as artificial intelligence, nanotechnology and genetic engineering should be halted or otherwise restricted because of concerns about possible catastrophic scenarios. Proponents of such restrictions typically invoke the precautionary principle, understood as a tool of policy formulation, as part of their case. Here I examine the application of the precautionary principle to possible catastrophic scenarios. I argue, along with Sunstein (Risk and Reason: Safety, Law and the Environment. Cambridge University Press, Cambridge, (...) 2002) and Manson (Environmental Ethics, 24: 263–274, 2002), that variants of the precautionary principle that appear strong enough to support significant restrictions on future technologies actually lead to contradictory policy recommendations. Weaker versions of the precautionary principle, which do not have this feature, do not appear strong enough to support restrictions on future technologies. (shrink)

Nanotechnology is an important platform technology which will add new features like improved biocompatibility, smaller size, and more sophisticated electronics to neuro-implants improving their therapeutic potential. Especially in view of possible advantages for patients, research and development of nanotechnologically improved neuro implants is a moral obligation. However, the development of brain implants by itself touches many ethical, social and legal issues, which also apply in a specific way to devices enabled or improved by nanotechnology. For researchers developing nanotechnology such issues (...) are rather distant from their daily work in the lab, but as soon as they use their materials or devices in medical applications such as therapy of brain diseases they have to be aware of and deal with them. This paper is intended to raise sensitivity for the ethical, legal and social aspects (ELSA) involved in applying nanotechnology in brain implants or other devices by highlighting the short term problems of testing and clinical trials within the existing regulatory frameworks (A), the short and medium-term questions of risks in the application of the devices (B) and the long-term perspectives related to problems of enhancement (C). To identify and address such issues properly nanotechnologists should involve ethical, legal and social experts and regulatory bodies in their research as early as possible. This will help to remove pressure from regulatory bodies, to settle public concern and to prevent non-acceptable developments for the benefit of the patients. (shrink)

Risk analysis as a regulatory driver has now become firmly entrenched in public health and environmental protection. Risk analysis at any level essentially has to accommodate two gut feelings of the constituency: whether society should be risk-prone or risk averse, and whether government and its institutions can be trusted to make the necessary decisions with a high or a low degree of discretion. The precautionary principle (or rejection thereof) arguably is the ultimate reflection of the promotion of risk to a (...) societal value. There is no doubt that especially amongst the representatives of the Member States (as opposed to the officials at the European Commission), public (pre)caution with respect to the long-term environmental and public health implications of gene technology influenced the reluctance to allow marketing of GM foods and feeds until a strict regulatory regime had been rolled out. Industry would argue that the delay in regulation, as well as the eventual regime was of such a nature as to stifle the technology. This contribution reviews a number of features of standard EU risk analysis decisions, so as to assess its current propensity towards smothering rather than smoothing the introduction of new technology. The current development of a regulatory framework for nanotechnology serves as a case study. (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.

After years of debate over the importance of ethical conduct in organizations, the federal government has decided to institutionalize ethics as a buffer to prevent legal violations in organizations. The key requirements of the Federal Sentencing Guidelines (FSG) are outlined, and suggested actions managers should adopt to improve ethical compliance are presented. An effective compliance program is more a process and commitment than a specific blueprint for conduct. The organization has the responsibility to create an organizational climate to reduce misconduct. (...) The adoption of a FSG compliance program has the potential to substantially lessen organizational penalties if there is due diligence to prevent misconduct. Federal courts determine the effectiveness of an FSG program after a violation occurs. (shrink)

In the late 1980s there was a series of sensational business scandals in the United Kingdom. There was particular public outrage at the plundering of pension funds by Robert Maxwell, at the failure of auditors to expose the impending bankruptcy of the Bank of Credit and Commerce International, and at the apparently undeserved high pay raises received by senior business executives. The City of London responded by creating a special committee to examine the financial aspects of corporate governance. This paper (...) describes the resulting Code of Best Practice produced by the Cadbury Committee. To reduce the power of executive directors in the boardroom the Code recommends a greater role for non-executive directors, changes in board operations, and a more active role for auditors. The paper reviews the various published reactions to the Cadbury Report, and concludes that the Code is unlikely to halt the incidence of business scandals in the United Kingdom. (shrink)

The ‘Precautionary Principle’ provides a somewhat ill-defined guide, often of uncertain normative status, for those exercising administrative decision-making power in circumstances where that may create potential risks to human health or the environment. This paper seeks to explore to what extent the precautionary principle should have been and was in fact utilised by the Australian Therapeutic Goods Administration (TGA) in its decision to approve the marketing of sunscreens containing titanium dioxide (TiO2) and zinc oxide (ZnO) in nanoparticulate form. In particular, (...) this article assesses to what extent better application of that principle might have altered the TGA’s decision that TiO2 and ZnO ENPs in sunscreens do not require new safety testing, because they are considered to be functionally equivalent to their bulk counterparts. (shrink)

I argue that the title question needs to be taken seriously because there are important questions about how the scientific agenda should be set. Natural answers to the question – declarations of the proper autonomy of science or expressions of faith in market forces – are found inadequate. Instead, I propose a form of democracy with respect to scientific research that will avoid the obvious dangers of a tyranny of ignorance. I conclude with some modest proposals about how the ideal (...) of a democratic science might be implemented and with a response to common objections. (shrink)

This contribution discusses the United Kingdom (UK) government’s regulatory activities related to nanotechnological development. The central question is what other prudent public regulation can learn from the UK government’s regulatory strategy, its regulatory attitude and its large variety of regulatory measures. Other public regulators can learn from the interactive and integrative UK regulatory approach. They can also draw lessons from the critique on the UK government’s regulatory attitude and its problems to cope with specific nanotechnological challenges. These lessons are based (...) on an evaluation of the UK government’s regulatory activities from the viewpoint of prudent regulation. The notion of responsive regulation, which provides basic ideas for the evaluation methodology, refers to a view on prudence that focuses on moral constitutional values. Interestingly, a similar view on prudence has been discussed in nanoethics. (shrink)

This study examines the effects of nationality (U.S. vs. China) and personal values on managers’ responses to the Perceived Role of Ethics and Social Responsibility (PRESOR) scale. Evidence that China’s transition to a socialist market economy has led to widespread business corruption, led us to hypothesize that People’s Republic of China (PRC) managers would believe less strongly in the importance of ethical and socially responsible business conduct. We also hypothesized that after controlling for national differences, managers’ personal values (more specifically, (...) self-transcendence values) would have a significant impact on PRESOR responses. The hypotheses were tested using a sample of practicing managers enrolled in part-time MBA programs in the two countries. The results indicate that nationality did not have a consistent impact on PRESOR responses. After controlling for national differences, self-transcendence values had a significant positive impact on two of the three PRESOR dimensions. Conservation values such as conformity and tradition also had a significant association with certain dimensions of the PRESOR scale. (shrink)

In recent years, in the UK and elsewhere, scientists and science policymakers have grappled with the question of how to reap the benefits of nanotechnologies while minimising the risks. Having recognised the importance of public support for future innovations, they have placed increasing emphasis on ‘engaging’ ‘the public’ during the early phase of technology development. Meaningful engagement suggests some common ground between experts and lay publics in relation to the definition of nanotechnologies and of their benefits and risks. However, views (...) on nanotechnologies are likely to vary according to where actors stand in the technology production/consumption/assessment cycle. Drawing on data from a recent UK-based study, this article examines how scientists (‘upstream’ and ‘downstream’) and policymakers portray the benefits and risks of nanotechnologies, particularly as they relate to two major areas of predicted application, namely medicine/public health and environmental sustainability. The findings reveal that, in the main, scientists and science policymakers held a positive conception of nanotechnologies and see imminent applications, although they acknowledged particular risks, including adverse public reaction. While definitions of ‘benefit’ and ‘risk’ varied, most saw the benefits as outweighing the risks and believed that the risks could be adequately regulated once they were assessed. The difficulties of assessing risk, however, were acknowledged. The study raises a number of questions that will need to be addressed if regulations are to be developed that not only protect people’s heath and wellbeing and the environment but also engender public trust in nanotechnologies. (shrink)

More and more organisations formulate a code of conduct in order to stimulate responsible behaviour among their members. Much time and energy is usually spent fixing the content of the code but many organisations get stuck in the challenge of implementing and maintaining the code. The code then turns into nothing else than the notorious "paper in the drawer", without achieving its aims. The challenge of implementation is to utilize the dynamics which have emerged from the formulation of the code. (...) This will support a continuous process of reflection on the central values and standards contained in the code. This paper presents an assessment method, based on the EFQM model, which intends to support this implementation process. (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)