This paper discusses strategic decision making in firms pursuing biotechnology innovation and the influence of risk regulation on firm strategy. Data from three research projects, involving interviews with over 60 managers from agricultural and food related biotechnology companies and also over 60 key participants in the regulatory process in the UK and EC, shows a diversity of strategy and opinion. While some industry representatives identified new risk regulations governing the release of genetically manipulated organisms (GMOs) as the (...) primary constraint on biotechnology innovation, the findings of the study painted a more complex picture. The controversies surrounding the issue of risk regulation and its impact on innovation are best understood if viewed in the context of other political and economic factors. We conclude that the actual impact of risk regulation on industry strategies is probably less than the rhetoric of industry lobbyists would suggest. At the same time, the very act of lobbying so forcefully could lead to a public backlash against industry that would be much more damaging than the regulation itself. (shrink)

This article contributes to research on the regulation of technological risks in the form of a case study of the Baltic Sea ferry traffic. The analysis suggests that the social systemic features of an industry heavily influence the relationship between technological failures and risk regulation. The study augments recent work on how regulations affect the handling of technological risks and how failures influence regulatory arrangements. These issues have already been studied in the context of aviation, auto, chemical, (...) nuclear power, and railway industries, but not in shipping. As an extension to previous literature, the authors also explore how different regulatory organizations in this industry act in relation to risks and how they influence each other in risk regulation activities. The study highlights the indirect relationships between technological failures and risk regulation arrangements. It also underlines the influence of the involved actors on the regulatory responses to technological failures. (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)

Approaches aimed at regulating artificial intelligence (AI) include a particular form of risk regulation, i.e. a risk-based approach. The most prominent example is the European Union’s Artificial Intelligence Act (AI Act). This article addresses the challenges for adequate risk regulation that arise primarily from the specific type of risks involved, i.e. risks to the protection of fundamental rights and fundamental societal values. This is mainly due to the normative ambiguity of such rights and societal values (...) when attempts are made to select, interpret, specify or operationalise them for the purposes of risk assessments and risk mitigation. This is exemplified by (1) human dignity, (2) informational self-determination, data protection and privacy, (3) anti-discrimination, fairness and justice, and (4) the common good. Normative ambiguities require normative choices, which are assigned to different actors under the regime of the AI Act. Particularly critical normative choices include selecting normative concepts by which to operationalise and specify risks, aggregating and quantifying risks (including the use of metrics), balancing value conflicts, setting levels of acceptable risks, and standardisation. To ensure that these normative choices do not lack democratic legitimacy and to avoid legal uncertainty, further political processes and scientific debates are suggested. (shrink)

Current nanotechnology regulation is focussed on risks. On the other hand, technical guidelines and other soft law tools are increasingly replacing hard law. This risk reduction approach does not seem to be fully aligned with open principles like sustainable nanotechnology. Indeed, risk optimization tends to be rather a continuous process than a way to settle ultimate lists of risks. There is therefore a need for a more dynamic view: Life cycle assessment contributes to add momentum and context (...) to the models. However, a complementary perspective is here suggested, based on information technologies: nanotechnology platforms. Platforms for nanotechnology governance are supposed to complement and enhance the nano-regulation, adding risk assessment and management. These platforms are mainly offering information, coordination, and context or situational awareness. More recently, some informal platforms appear to play a, certainly limited but still clear, co-regulatory role. Can these informal platforms play a relevant role in nanotechnology governance? In the context of the EU Better Regulation strategy, why not envision some of these informal platforms as future co-regulation tools? The main goal of this paper is to start a discussion on the requirements these informal co-regulatory platforms should fulfill before their hypothetical inclusion in a future better regulation toolbox. (shrink)

In recent years there has been renewed interest in the participation of lay people in regulatory procedures. The debate peaked in the 1980s with the anti-nuclear movements and again more recently as a reaction to the food scandals of the mid-1990s. In the wake of the bovine spongiform encephalopathy (BSE) crisis there has been a proliferation of European Community rules on the production, processing and retailing of food products, along with the multiplication of scientific committees in order to cope with (...) increased ... (shrink)

Participative reforms to risk regulation are often argued to enhance the evidence base, improve the representation of the public interest, and build support for policy processes and outcomes. While rationales and mechanisms for participation have received most scholarly attention, less attention has been paid to the actual impact of participation on policy processes and outcomes. This article, therefore, considers the impacts of participation by examining the UK Food Standards Agency's Consumer Committee, which was created in 2002 to institutionalize (...) consumer representation within policy making, but which was disbanded as a failure in 2005. Using three case studies, the article identifies two broad institutional dimensions of regulation that shaped and constrained the committee's impact on the evidence base, policy outcomes and building support for policy, and contributed to its eventual failure. Those dimensions relate to the design and organization of regulatory regimes, and to the understandings and influence of regulatory actors. (shrink)

Recently, there have been a number of government proposals and reforms seeking to ensure that standard setting in risk regulation is carried out in a more accountable and transparent manner. These proposals were a direct and indirect response to distrust in government both in relation to risk regulation and across government more widely. The problem, however, is that few of these proposals and reforms have been grounded in an understanding of the nature of standard setting in (...) risk regulation. Such standard setting has three significant features. It is directly concerned with normative issues about risk acceptability, is carried out in circumstances of scientific uncertainty, and requires some form of expert judgment. Rather, these proposals were based on a presumption that standard setting is primarily an analytical process which is verifiable and objective. There are a number of likely consequences of the disjunction between the nature of standard setting and these developments which include problems of ossification, the submersion of normative debate, and a fundamental shift in the nature of public administration. These problems provide an excellent example of the dangers of implementing accountability mechanisms without regard to the complexities of the decision-making context. (shrink)

Drug regulation is fraught with inductive risk. Regulators must make a prediction about whether or not an experimental pharmaceutical will be effective and relatively safe when used by typical patients, and such predictions are based on a complex, indeterminate, and incomplete evidential basis. Such inductive risk has important practical consequences. If regulators reject an experimental drug when it in fact has a favourable benefit/harm profile, then a valuable intervention is denied to the public and a company’s material (...) interests are needlessly thwarted. Conversely, if regulators approve an experimental drug when it in fact has an unfavourable benefit/harm profile, then resources are wasted, people are needlessly harmed, and other potentially more effective treatments are underutilized. Given that such regulatory decisions have these practical consequences, non-epistemic values about the relative importance of these consequences impact the way such regulatory decisions are made (similar to the analysis of laboratory studies on the toxic effects of dioxins presented in Douglas [2000]). To balance the competing demands of the pertinent non-epistemic values, regulators must perform what I call an “inductive risk calculus.” At least in the American context this inductive risk calculus is not well-managed. (shrink)

Sharing within communities has gained popularity in recent years. However, taking part in a community also comes with a certain amount of risk. This perceived amount of risk can be contained by regulations within a community as well as by potential participants’ trust in the community and the other members. We argue for a relation between regulation and the willingness to take the risk of joining a sharing community with trust as mediator. Thereby, we distinguish between (...) two kinds of regulation (soft and harsh regulation) and two kinds of trust (implicit and reason-based trust) on two different levels (vertical and horizontal trust). In one laboratory and one online experiment with overall 432 participants, we found that the compound of high soft and low harsh regulation increases participants’ willingness to take the risk of participation and the effect of soft regulation is mediated mainly by vertical and horizontal reason-based trust. Based on our results, we encourage sharing communities to count on soft regulation in order to increase potential members’ trust in the community and therefore take the risk to participate. (shrink)

Polygenic risk scores (PRSs) have recently been used to inform reproductive decision-making in the context of embryonic screening. While this is yet to be widespread, it is contested and raises several challenges. This article provides an overview of some of the ethical considerations that arise with using PRSs for embryo screening and offers a series of regulatory considerations for jurisdictions that may wish to permit this in the future. These regulatory considerations cover possible regulators and regulatory tools, eligibility criteria, (...) information and education requirements and the need for ongoing refinement of the relevant technology, research and consultation. (shrink)

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations (...) have helped IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)

The question of when people may impose risks on each other is of fundamental moral importance. Forms of “quantified risk assessment,” especially risk cost-benefit analysis, provide one powerful approach to providing a systematic answer. It is also well known that such techniques can show that existing resources could be used more effectively to reduce risk overall. Thus it is often argued that some current practices are irrational. On the other hand critics of quantified risk assessment argue (...) that it cannot adequately capture all relevant features, such as “societal concern” and so should be abandoned. In this paper I argue that current forms of quantified risk assessment are inadequate, and in themselves, therefore, insufficient to demonstrate that current practices are irrational. In particular, I will argue that insufficient attention has been given to the cause of a hazard, which needs to be treated as a primary variable in its own right. However rather than reject quantified risk assessment I wish to supplement it by proposing a framework to make explicit the role causation plays in the understanding of risk, and how it interacts with factors which influence perception of risks and other attitudes to risk control. Once an improved description of risk perception is available it will become possible to have a more informed debate about the normative question: how safety should be regulated. (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)

In public debate over agricultural biotechnology, at issue hasbeen its self-proclaimed aim of further industrializingagriculture. Using languages of ’risk‘, critics and proponentshave engaged in an implicit ethics debate on the direction oftechnoscientific development. Critics have challenged thebiotechnological R&D agenda for attributing socio-agronomicproblems to genetic deficiencies, while perpetuating the hazardsof intensive monoculture. They diagnosed ominous links betweentechnological dependency and tangible harm from biotechnologyproducts.In response to scientific and public concerns, theEuropean Community enacted precautionary legislation for theintentional release of genetically modified organisms (...) (GMOs). Inits implementation, choices for managing and investigatingbiotechnological risk involve an implicit environmental ethics.Yet the official policy language downplays the inherent valuejudgments, by portraying risk regulation as a matter of’objective‘ science.In parallel with safety regulation, thestate has devised an official bioethics that judges where to’draw the line‘ in applying biotechnological knowledge, as ifthe science itself were value-free. Bioethics may also judge howto ’balance‘ risks and benefits, as if their definition were notan issue. This form of ethics serves to compensate for theunacknowledged value-choices and institutional commitmentsalready embedded in R&D priorities.Thus the state separates’risk‘ and ’ethics‘, while assigning both realms to specialists.The risk/ethics boundary encourages public deference to theexpert assessments of both safety regulators and professionalethicists. Biotechnology embodies a contentious model of controlover nature and society, yet this issue becomes displaced andfragmented into various administrative controls. At stake arethe prospects for democratizing the problem-definitions thatguide R&D priorities. (shrink)

Artificial Intelligence (AI) has the potential to influence people’s lives in various ways as it is increasingly integrated into important decision-making processes in key areas of society. While AI offers opportunities, it is also associated with risks. These risks have sparked debates about how AI should be regulated, whether through government regulation or industry self-regulation. AI-related risk perceptions can be shaped by national cultures, especially the cultural dimension of uncertainty avoidance. This raises the question of whether people (...) in countries with higher levels of uncertainty avoidance might have different preferences regarding AI regulation than those with lower levels of uncertainty avoidance. Therefore, using Hofstede’s uncertainty avoidance scale and data from ten European countries (N = 7.855), this study investigates the relationships between uncertainty avoidance, people’s AI risk perceptions, and their regulatory preferences. The findings show that people in countries with higher levels of uncertainty avoidance are more likely to perceive AI risks in terms of a lack of accountability and responsibility. While people’s perceived AI risk of a lack of accountability exclusively drives their preferences for government regulation of AI, the perceived AI risk of a lack of responsibility can foster people’s requests for government regulation and/or industry self-regulation. This study contributes to a better understanding of which mechanisms shape people’s preferences for AI regulation. (shrink)

Regulation and governance of medical research is frequently criticised by researchers. In this paper, we draw on Everett Hughes’ concepts of professional licence and professional mandate, and on contemporary sociological theory on risk regulation, to explain the emergence of research governance and the kinds of criticism it receives. We offer explanations for researcher criticism of the rules and practices of research governance, suggesting that these are perceived as interference in their mandate. We argue that, in spite of (...) their complaints, researchers benefit from the institutions of governance and regulation, in particular by the ways in which regulation secures the social licence for research. While it is difficult to answer questions such as: “Is medical research over-regulated?” and “Does the regulation of medical research successfully protect patients or promote ethical conduct?”, a close analysis of the social functions of research governance and its relationship to risk, trust, and confidence permits us to pose these questions in a more illuminating way. (shrink)

The availability of new genetic testing technologies to identify individuals as at risk for a particular disease has inspired tremendous concern that individuals with gene mutations will soon be universally identified, for both insurance and employment purposes, as a genetic underclass. Scholarship in science and technology studies, however, suggests that understandings of genetic knowledge might be locally contingent, while research in comparative politics helps us understand how national context might play an important role in framing approaches to the (...) class='Hi'>regulation of genetic information. What role does national context play in defining genetic risk and shaping approaches to the privacy of genetic information? Using data from interviews, document analysis, and ethnographic observation, the author follows debates among advocacy groups, insurers, and governments in the United States and Britain about the appropriate use of genetic information in insurance underwriting to understand how national context frames the definition of genetic risk as well as its regulation. (shrink)

This open peer commentary examines the regulation of home birth in Australia from a relational autonomy perspective. The authors argue that rather than focusing solely on risk-based judgments or individual decision-making, a relational approach that emphasizes supportive relationships and communication between pregnant women and healthcare providers offers a better framework. Drawing on recent cases in Australia, the commentary suggests that fostering respectful dialogue and principled compromise between women and caregivers can help balance autonomy with safety concerns while keeping (...) women engaged with the healthcare system, even in high-risk situations. (shrink)

Sunstein argues that heuristics misguide moral judgments. Principles that are normally sound falter in unusual cases. In particular, heuristics generate erroneous judgments about regulation of risks. Sunstein's map of moral reasoning omits some prominent contours. The simple heuristics he suggests neglect a reasoner's attempt to balance the pros and cons of regulating a risk.

Nanotechnology has revolutionized various industries and has become a notable catalyst for economic growth. The emerging issues of human health and safety associated with nanotechnology development have raised regulatory concerns worldwide. In occupational settings, the same novel characteristics of nanomaterials that are utilized for innovation may also be the source of toxins with adverse health effects for workers. The existing regulatory framework may function effectively to regulate chemical substances in their conventional forms but may not be adequate with regard to (...) the specific issues of nanoform substances. A foundation of knowledge concerning properties of nanomaterials, and risk management approaches for these materials have been established, but conclusive results remain elusive. It is difficult for lawmakers to regulate nanotechnology-related activities effectively if conventional regulatory mechanisms are applied. The present article analyses in a country study the adequacy of existing Malaysian occupational safety and health law with regard to the specific issues presented by nanotechnology. The applicable regulatory approaches are examined to justify the adoption of soft law instruments as regulatory mechanisms for nanotechnology. A number of soft law best practices are briefly discussed as a basis to recommend practical solutions to close the existing regulatory gap. (shrink)

There are certain kinds of risk for which governments, rather than individual actors, are increasingly held responsible. This article discusses how regulatory institutions can ensure an equitable distribution of risk between various groups such as rich and poor, and present and future generations. It focuses on cases of risk associated with technological and biotechnological innovation. After discussing various possibilities and difficulties of distribution, this article proposes a non-welfarist understanding of risk as a burden of cooperation.

The debate over environmental, health, and safety regulation has reached a new crescendo in the 104th Congress. So impassioned is the debate on occasion, and so high the feelings, that even the tools of regulatory analysis have become part of the combat.To some, the term cost-benefit analysis, for example, is virtually a swearword, a nefarious tool used by big business to undermine regulations aimed at benefiting the people at large. To others, it is the mechanism for achieving more effective (...) regulation at less cost.This new book on the subject of reforming regulation is aimed at increasing the light and turning down the heat. It consists of an introduction and nine chapters written by scientists, public policy analysts, and economists on various aspects of regulation and regulatory analysis.The book advances the latest knowledge and evidence on risk analysis, cost-benefit analysis, and related techniques for improving regulation--all based on experience and data accumulated over the quarter century since regulation in the areas of environment, health, and safety became a major player on the governmental stage. The strengths and limitations of those analytical tools are an important part of the portrait that is painted, but a common thesis is that, properly used, the tools can be helpful in getting better regulatory results. (shrink)

Xenotransplantation - the transfer of living tissue between species - has long been heralded as a potential solution to the severe organ shortage crisis experienced by the United Kingdom and other 'developed' nations. However, the significant risks which accompany this biotechnology led the United Kingdom to adopt a cautious approach to its regulation, with the establishment of a non-departmental public body - UKXIRA - to oversee the development of this technology on a national basis. In December 2006 UKXIRA was (...) quietly disbanded and replaced with revised guidance, which entrusts the regulation of xenotransplantation largely to research ethics committees. In this article we seek to problematize this new regulatory framework, arguing that specialist expertise and national oversight are necessary components of an adequate regulatory framework for a biotechnology which poses new orders of risk, challenges the adequacy of traditional understandings of autonomy and consent, and raises significant animal welfare concerns. We argue for a more considered and holistic approach, based on adequate consultation, to regulating biotechnological developments in the United Kingdom. (shrink)

The basic question for risk assessment is not "What are the risks?" but "How safe is safe enough?" Its ambitious goal is to make risk management a scientific enterprise. In order to succeed, not only must risks be quantified but also the many kinds of costs and benefits associated with technology and its control must be quantified and we must find a common metric for comparing these different factors. The risks of risk assessment include the possibility of (...) distorting values in the quest for general comparability and also the problem of responding rationally to different kinds of uncertainty. The problems discussed include comparing novel events to statistically frequent events, comparing different distributions of risk, and quantifying the value of saving human lives. (shrink)

Federal regulations require that the level of risk posed by pediatric research be classified as “minimal,” “greater than minimal,” or “a minor increase over minimal.” Interpretation of the meaning of the levels has produced a significant literature exploring the ethical basis for making these determinations. This article examines the ethical basis of a variety of approaches proposed in the literature for classifying pediatric research risk. These approaches strive to take into account how society decides which risks are routinely (...) accepted for children outside of research. It is concluded that ways of classifying risk should compare research risks to normal risks for children without special disability and take into account the concerns of the research subject’s community. (shrink)

In debates over the regulation of communication related to dual-use research, the risks that such communication creates must be weighed against against the value of scientific autonomy. The censorship of such communication seems justifiable in certain cases, given the potentially catastrophic applications of some dual-use research. This conclusion however, gives rise to another kind of danger: that regulators will use overly simplistic cost-benefit analysis to rationalize excessive regulation of scientific research. In response to this, we show how institutional (...) design principles and normative frameworks from free speech theory can be used to help extend the argument for regulating dangerous dual-use research beyond overly simplistic cost-benefit reasoning, but without reverting to an implausibly absolutist view of scientific autonomy. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 29-31, June 2011.

This paper tests Harry Arthur's theory that there is an “ethical economy“ of lawyer regulation in Canada, in which Canadian law societies use their regulatory powers only in high reward/low risk cases - ie, where the practitioner is less likely to resist their authority and the offence is morally unambiguous. Analysing reported cases from 2009 in British Columbia, Alberta, Saskatchewan, Manitoba and Nova Scotia the paper concludes that Arthurs' description still accurately characterises the regulation of lawyers by (...) Canadian law societies. The paper then conducts a case study of law society and court cases related to one Canadian lawyer, Anthony Merchant, to assess whether the ethical economy is inevitable, or whether a different approach to lawyer regulation can and should be undertaken. (shrink)

States are in the process of creating controversial legislation aimed at subjecting ‘harmful’ online communication on social media and search engines to new regulatory regimes. Critics argue that these measures are serious threats to the right to freedom of expression and freedom from surveillance. This article first draws on elements of systems theory to reframe the right to freedom of expression in democracy as a means of protecting the value of generalised second-order observation. Taking the UK’s Online Safety bill as (...) the paradigm example of the new laws, the article analyses the concept of harmful communication at three levels: society, organisation, and subject. It identifies a shift in the law’s epistemic approach to communication, by which individuals are reconfigured from agential subjects into contingent users, whose capacities are determined by the structure of online communication platforms. In this configuration, norms previously considered indispensible are relegated to second-order effects of the affordances of media. Arguing that it is insufficient to merely reaffirm subjective rights in light of this shift, the article suggests systems theoretical analysis as a means of identifying lines of critique. (shrink)

This paper addresses three questions central to the ethical analysis of risks and potential benefits in human subjects research: 1. How was the ethical analysis of risk understood by the members of the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission)? 2. What conceptual framework should guide the ethical analysis of risk? 3. What changes to U.S. regulations would the implementation of such a framework require?

Regulation by design (RBD) is a growing research field that explores, develops, and criticises the regulative function of design. In this article, we provide a qualitative thematic synthesis of the existing literature. The aim is to explore and analyse RBD’s core features, practices, limitations, and related governance implications. To fulfil this aim, we examine the extant literature on RBD in the context of digital technologies. We start by identifying and structuring the core features of RBD, namely the goals, regulators, (...) regulatees, methods, and technologies. Building on that structure, we distinguish among three types of RBD practices: compliance by design, value creation by design, and optimisation by design. We then explore the challenges and limitations of RBD practices, which stem from risks associated with compliance by design, contextual limitations, or methodological uncertainty. Finally, we examine the governance implications of RBD and outline possible future directions of the research field and its practices. (shrink)

This article presents a model for regulating cognitive enhancement devices. Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing (...) medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions. (shrink)

The risks of uncontrolled dissemination of GMOs has made it clear that biosafety is a very relevant matter that goes beyond the State boundaries. This approach has had its corresponding reflection at the policy level, which reveals that the public powers and the legislators have been sensitive to this existing preoccupation in ever-growing sectors of society. From the European regulations, one can deduce a set of principles, which must guide the decisions of the public powers in matters related to biosafety: (...) precaution, authorisation and inspection, “step by step”, “case by case”, traceability and transparency, among other. (shrink)

In this paper, we argue that patients who are subjects of Artificial Intelligence (AI)-supported diagnosis and treatment planning should have a right to a second opinion, but also that this right should not necessarily be construed as a right to a physician opinion. The right to a second opinion could potentially be satisfied by another independent AI system. Our considerations on the right to second opinion are embedded in the wider debate on different approaches to the regulation of AI, (...) and we conclude the article by providing a number of reasons for preferring a rights-based approach over a risk-based approach. (shrink)

Ethical principles play an important part not only in the promulgation of regulations but also in their application, i.e., enforcement and adjudication. While traditional ethical principles – promotion of welfare, freedom, and fairness – play an important role in both elements of regulation, some other kinds of ethical principles are significant as well. Principles governing the structure of decision processes should shape the structure and actions of agencies; principles of wise application should govern the work of those whose responsibility (...) it is to apply regulatory language to particular situations. These points are demonstrated by investigating a case study: federal regulations designed to protect children involved in scientific research applied to a placebo study of the effects of recombinant human growth hormone on children of extremely short stature. Keywords: ethics, interpretation, regulation, research CiteULike Connotea Del.icio.us What's this? (shrink)

ABSTRACT Capital regulations stemming from the Basel accords created incentives for banks to securitize mortgages, even risky ones; hold them at a correspondingly low Basel risk weight; or shift them off of banks' balance sheets to obtain even greater leverage. Securitization was praised by economists and regulators for dispersing risks to investors across the world, providing greater resilience to the financial system. However, since in reality banks tended to hold onto securitized assets—either on their balance sheets or off of (...) them, in off‐balance‐sheet entities—the accumulated credit risk remained with the banks, especially in the “shadow banking sector.” This explains the heightened vulnerability of the financial system to a sudden collapse. (shrink)

Before embarking on a discussion of the regulation of artificial intelligence (AI), it is first necessary to define the subject matter regulated. Defining artificial intelligence is a difficult endeavour, and many definitions have been proposed over the years. Although more than 70 years have passed since it was adopted, the most convincing definition is still nonetheless that proposed by Turing; in any case, it is important to be mindful of the risk of anthropomorphising artificial intelligence, which may arise (...) in particular from its very definition. Once we have established the subject matter regulated, we must ask ourselves whether lawmakers should pursue an approach that seeks to regulate artificial intelligence as a whole, or whether by contrast they should regulate applications of artificial intelligence in specific sectors or individual areas. The proposal for a regulation on artificial intelligence published on 21 April 2021 implements the former approach whilst also pursuing geopolitical goals. After providing an initial overview of the notion of artificial intelligence, this article investigates the geopolitical context to the proposal for a regulation, and then goes on to illustrate the regulatory model embraced by the proposal as well as related critical aspects. (shrink)

As products of the "new biotechnology," genetically modified organisms have provoked a wide-ranging risk debate on potential harm, especially from herbicide-tolerant crops. In response to this legitimacy problem, the European Community adopted precautionary legislation, which left open the definition of environmental harm. When the U.K. proposed Europe-wide market approval of a herbicide-tolerant oilseed rape, the proposal encountered dissent from some countries and environmentalist groups. Further debate on normative judgments became necessary to implement the precaution ary legislation. In dispute were (...) several regulatory boundaries—of administrative re sponsibility, causality, acceptability, and evidence. The boundary disputes expressed divergentframings of biotechnological risk, each with its implicit model of the socionatu ral order. In this way, the disputes can illuminate the sorts of risk framings that have already become embedded and standardized in other regulatory sectors. (shrink)