Medicines regulators have generally adopted a scientistic view of medicines evaluation, which they present as an exercise that should—and indeed can—be purely “objective,” based only on knowledge produced through validated research protocols. The growing body of social science literature analyzing the regulation of medicines has questioned this pretense of objectivity and underlined the socio-political construction of evidence on the risks and benefits of medicines. But while the European Medicines Agency has become the dominant regulatory body in Europe and a key (...) player at world level, very few studies have investigated its actual practices. Based on interviews with European regulators, but also on direct observations of several meetings of the European Medicines Agency’s main expert committee, this article aims to analyze how regulatory knowledge is defined and then transformed into regulatory decisions. First, it describes the main characteristics of European medicines regulation and the historical definition of what can count as “objective” evidence on the safety and efficacy of medicines. Second, it demonstrates that experts use many different types of knowledge in building their opinions: the results of studies, but also knowledge about firms’ past and present strategies, about patients’ needs and future behavior, about the state of research and clinical practices, and about legal and policy-making issues. Third, it explains why, in spite of the various forms of knowledge involved, experts manage to produce consensual opinions on medicines and why these opinions are considered genuine decisions in the sector. (shrink)

The UK-based deliberations that led up to the legalisation of two new ‘mitochondrial donation’ techniques in 2015, and which continued after that time as regulatory details were determined, featured a division of advisory labour that is common when decisions are made about new technologies. An expert panel was convened by the Human Fertilisation and Embryology Authority, charged with assessing the scientific and technical aspects of these techniques. Meanwhile, the Nuffield Council on Bioethics addressed the ethical issues. While this division of (...) labour was undertaken in the name of thoroughness, I argue here that it can have the unintended consequence that hybrid questions that simultaneously involve ethical and technical aspects—especially questions about where to set evidential thresholds for the acceptance of new technology—do not receive enough attention. (shrink)

Addiction is a significant issue in many aspects but no explanatory closure has been attained. The overemphasis on the brain disease paradigm upheld by the National Institute on Drug Abuse may run serious risks, and the present study intends to counteract this partiality. Drawing on Ludwik Fleck’s notion of thought collectives, this article offers a close reading of the works of sociologists Bingham Dai and Alfred R. Lindesmith vis-à-vis other coeval biomedical approaches. Individuals within the same thought collective, such as (...) Dai and Lindesmith, have different views although they share certain thought styles. As noted in this study, inter-collective communication is not typically antagonistic and may form some liaison under certain circumstances. These findings imply that communication among collectives may facilitate creative liaison, as suggested by Fleck. This study aims to enrich the understanding of addiction by coordinating biomedical and sociological sciences through minimizing, if not erasing, their intellectual antagonism and social distance. (shrink)

This paper puts forward a theoretical framework for the analysis of expertise and experts in contemporary societies. It argues that while prevailing approaches have come to see expertise in various forms and functions, they tend to neglect the broader historical and societal context, and importantly the relational aspect of expertise. This will be discussed with regard to influential theoretical frameworks, such as laboratory studies, regulatory science, lay expertise, post-normal science, and honest brokers. An alternative framework of expertise is introduced, showing (...) the limitations of existing frameworks and emphasizing one crucial element of all expertise, which is their role in guiding action. (shrink)

In recent years, philosophers of science have begun to realize that the clear separation of the creation of models in academia and the application of models outside science is not possible. When these philosophers address hybrid contexts in which science is entwined with policy, business, and other realms of society, these often practically oriented realms no longer represent ‘the surroundings’ of science but rather are considered an essential part of it. I argue—and demonstrate empirically—that the judgement of a theory or (...) model conducted by scientists in such hybrid contexts may contain two parts: one is truth supportive and the other is utility oriented. In relation to the debate on science and values, the article seeks to reinforce the argument in modern philosophy of science that the boundaries between epistemic and non-epistemic values are blurred. The article stresses that non-epistemic values may be also understood as values that contribute to the instrumental success of a theory or model and—in this way—influence scientific practice in the hybrid contexts. (shrink)

In his dissection of the 1998 tobacco settlements, W. Kip Viscusi provides a window on how the ostensibly liberal public philosophy behind the modern American regulatory state betrays its foundational commitments. Animated by a moralizing concern with preventing harm to self, and a leftist antagonism towards corporate capitalism, “progressive liberalism” at first foundered in its war against the tobacco industry in the face of traditional liberal counterarguments about individual autonomy, knowledge of risk, and choice. Only when progressive liberals translated their (...) paternalist impulses into science‐centered arguments about ignorance and addiction, which involve barriers to autonomous choice and harm to others, did they succeed in turning the legal and regulatory tide against smoking. This dynamic raises questions about the future of individual autonomy in a science‐centered, progressive‐liberal modern polity. (shrink)

STS research has devoted relatively little attention to the promotion and reception of science and technology by non-scientific actors and institutions. One consequence is that the relationship of science and technology to political power has tended to remain undertheorized. This article aims to fill that gap by introducing the concept of sociotechnical imaginaries. Through a comparative examination of the development and regulation of nuclear power in the US and South Korea, the article demonstrates the analytic potential of the imaginaries concept. (...) Although nuclear power and nationhood have long been imagined together in both countries, the nature of those imaginations has remained strikingly different. In the US, the state’s central move was to present itself as a responsible regulator of a potentially runaway technology that demands effective containment. In South Korea, the dominant imaginary was of atoms for development which the state not only imported but incorporated into its scientific, technological and political practices. In turn, these disparate imaginaries have underwritten very different responses to a variety of nuclear shocks and challenges, such as Three Mile Island (TMI), Chernobyl, and the spread of the anti-nuclear movement. (shrink)

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene (...) transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology. (shrink)

The Health Council of the Netherlands is an independent scientific advisory board to the Dutch government in matters of public health. In this article we argue that even for an independent body such as the Health Council there seems to be no escape from the increasing intertwinement of scientific and societal processes. In order to produce a serviceable truth for policymaking, the council needs to reflect on what goes on in its socio-political surroundings. On the other hand, how could we (...) ever come to understand the legitimacy of the council when notions of scientific objectivity dissolve in such a reflexive, inherently political stance? In a situation where science and society are thoroughly interrelated, the Health Council somehow succeeds in bringing about or re-claiming some sense of objectivity. Our central question will be how to conceptualise this notion of 'objectivity' without having to rely on idealized notions of objectivity that are criticized in philosophical, sociological and historical studies of science and society. In order to do so, we will regard the objectivity of advisory reports of the Health Council as being constructed out of heterogeneous elements and under complex circumstances. The theoretical point will be empirically underpinned with case material drawn from activities of the Health Council in the period 1985-2002 in predominantly the subject areas healthcare and medical technology. (shrink)

What is the proper role for scientists in policymaking? This paper explores various roles that scientists can play, with an eye to questions that these roles raise about value-neutrality and technocracy. Where much philosophical literature is concerned with the conduct of research or the transmission of research results to policymakers, I am interested in various non-research roles that scientists take on in policymaking. These include raising the alarm on issues, framing and conceptualising problems, formulating potential policies, assessing policy options for (...) expected efficacy, and more. I consider examples from climate change and Covid-19 policymaking. My intention is to encourage philosophers to expand their interest in values in science out from the conduct of research to the wide array of roles that scientists play in policymaking. The paper is therefore an overview of the landscape of potential research questions, rather than a presentation of a single argument. (shrink)

This paper presents a program of action for the philosophy of regulatory science, based on a general theory of social epistemology. Two candidates are considered. The first one, offered by Alvin Goldman, is not fit for our purposes because it is focused on a veritism incompatible with non‐epistemic aims of regulatory science. The second, championed by Steve Fuller, sociologically investigates the existing means of producing knowledge, to modify them with the goal of obtaining democratic aims through action on a legislative (...) meta‐level. The program has been built upon this procedure, instantiated by the identification, characterization, and modification of epistemic policies. (shrink)

Feminist philosophers have discussed the prospects for assessing values empirically, particularly given the ongoing threat of sexism and other oppressive values influencing science and society. Some advocates of such tests now champion a “values as evidence” approach, and they criticize Helen Longino’s contextual empiricism for not holding values to the same level of empirical scrutiny as other claims. In this paper, we defend contextual empiricism by arguing that many of these criticisms are based on mischaracterizations of Longino’s position, overstatements of (...) certain claims, and false dichotomies. Her contextual empiricism not only allows for the empirical support and disconfirmation of values, but Longino explicitly discusses when values can be empirically adjudicated and emphasizes the crucial role of the community for standards of evidence. We support contextual empiricism and elaborate a less direct account of “values as heuristics” by reviewing Longino’s theory of evidence and then using a case study from Elisabeth Lloyd on the biology of female orgasm, demonstrating the disconfirmation of androcentric values in evolutionary science. Within Longino’s and Lloyd’s contextual empiricism, values do not get treated as empirical evidence to be directly assessed by individuals, but rather values are heuristic tools to build models whose use can be validated or invalidated by communities based on their empirical fruitfulness in the logic and pragmatics of research questions in specific historical and cultural contexts. (shrink)

In October 2015, the European Union’s Scientific Committee on Consumer Safety issued a Preliminary Opinion on Hydroxyapatite (nano). Past industrial experience with this material and participation in ISO/TC-229, Nanotechnologies, led me to submit comments on the Committee’s interpretations of physico-chemical properties, especially solubility, that in retrospect were also probing of the Committee’s collective understanding of nanomaterials. The Committee’s responses are examined against a background of other Opinions issued in the same time period. The expert’s role and responsibility, whether as an (...) individual or a group member or in representing a scientific discipline, are examined through the concept of epistemic community taken from the public policy literature. A central theme is the Committee’s framing of chemical narratives such that its administrative procedures are projected onto the nanomaterial safety literature that is itself undergoing considerable investigation and revision. Inherent to this analysis is the singular role of toxicologists in the regulatory process. A related exchange by Australian and New Zealand colleagues is examined for its parallels to the SCCS actions, and there is a cursory discussion of later SCCS Opinions regarding Hydroxyapatite (nano). (shrink)

The idea of technocracy has been widely criticized in Western literature in the philosophy and sociology of technology. A common critique of technocracy is that it represents an “antidemocratic” and “dehumanizing” ideology. This paper invites Western scholars to reconsider their oppositions to technocracy by drawing on resources from Confucian ethics. In doing so, this paper synthesizes the major ethical challenges of technocracy mainly concerned by Western scholars in philosophy, political theories, sociology, and policy studies. This paper argues that incorporating Confucian (...) resources such as the rule of virtue into technocracy may be helpful for reexamining these ethical challenges to technocracy that are deeply rooted in Western liberal democratic ideologies. The Confucian rule of virtue means that social policies should be made by the virtuous and capable and these policies need to have impacts on the moral progress of the society. Confucian values provide ethical guidance for technocrats in assessing the moral quality of the sociotechnical systems they build. From the Confucian perspective, sociotechnical systems are often assessed based on the criterion whether and how these sociotechnical systems contribute to a process of harmonization. This paper will introduce some practical cases that demonstrate how technical experts and expertise contribute to organizational and social management. In these cases, virtues and the rule of virtue do play a crucial role: virtues either determine the selection of technocrats and the legitimization of their political power or are embedded in engineering design and affect human behavior in the use context. (shrink)

Scientists have the ability to influence policy in important ways through how they present their results. Surprisingly, existing codes of scientific ethics have little to say about such choices. I propose that we can arrive at a set of ethical guidelines to govern scientists’ presentation of information to policymakers by looking to bioethics: roughly, just as a clinician should aim to promote informed decision-making by patients, a scientist should aim to promote informed decision-making by policymakers. Though this may sound like (...) a natural proposal, I show it offers guidance that conflicts with standard scientific practices. I conclude by considering one cost of the proposal: that it would prevent scientists from acting as advocates in a way that is currently common in certain fields. I accept that the proposal would restrict scientists’ political advocacy rights, but argue that the benefits of adopting it — promoting democratic governance — justify the restriction. (shrink)

I examine how Heather Douglas’ account of values in science applies to the assessment of actual cases of scientific practice. I focus on the case of applied toxicologists’ acceptance of molecular evidence-gathering methods and evidential sources. I demonstrate that a set of social and institutional processes plays a philosophically significant role in changing toxicologists’ inductive risk judgments about different kinds of evidence. I suggest that Douglas’ inductive risk framework can be integrated with a suitable account of evidence, such as Helen (...) Longino’s contextual empiricism, to address the role of social context in the cases like the one examined here. I introduce such an integrated account and show how Longino’s contextual empiricism and inductive risk framework fruitfully complement each other in analyzing the novel aspects of the toxicology case. (shrink)

In recent years, scholars in science and technology studies have examined the advice that experts make for the governance of biomedicine. This STS scholarship, however, has not yet explained how the credibility of ethics expertise in public bioethics is produced from particular conditions and extended to different settings. This article describes how a bioethics commission created the ethical principle of justice and examines how the ethics expertise established public credibility on the justice principle. The findings suggest that the principle of (...) justice was first explored as the diverse concepts of “equality” with reference to the review of fetal research, redefined as “fairness” or “desert” from theoretical viewpoints, and then circulated as a standard framework in local settings. The credibility of ethics expertise, based on the coproduction of material and moral orders, was made possible by reaching common ground among different data, principles, and background theories. (shrink)

In an unusual instance of lay participation in biomedical research, U.S. AIDS treatment activists have constituted themselves as credible participants in the process of knowledge construction, thereby bringing about changes in the epistemic practices of biomedical research. This article examines the mechanisms or tactics by which these lay activists have constructed their credibility in the eyes of AIDS researchers and government officials. It considers the inwlications of such interventions for the conduct of medical research; examines some of the ironies, tensions, (...) and limitations in the process; and argues for the importance of studying social movements that engage with expert knowledge. (shrink)

In 1959, the Charles Darwin Station and the Galápagos National Park were established, formally inaugurating conservation on the archipelago. In the same year, a utopian colony from the United States arrived. Whereas scholars have dismissed the latter and focused on the former, this essay unveils the science-inspired utopianism common to both enterprises. Investing science with the exclusive role of producing all knowledge and steering politics, leaders of the two initiatives aspired not only to protect nature but also to forge a (...) new humanity. Describing how such ambitions burst along lines of race, class, and nationality, I argue that these enterprises consolidated the current understanding of the Galápagos as “pristine”: a site fit for research and tourism but unhospitable to people. Drawing on archival and historical documents, this essay aims to reinvigorate two conversations: one between science and technology studies and conservation, and the other between STS and utopian studies. If recent attempts at bridging the divide between science and imagination have emphasized how powerful actors shape human society, this essay considers the long-lasting effects of scientific imaginaries on a politics of nature. (shrink)

The proper role of non-epistemic values such as moral, political, and social values in practices of justification of policy-relevant hypotheses has recently become one of the central questions in philosophy of science. This strand of research has yielded conceptual clarifications and significant insight into the complex and notoriously contentious issue of the proper relationship between science, non-epistemic values, and policymaking. A central part of this discussion revolves around whether scientists should aspire for the value-free ideal, according to which non-epistemic values (...) are unacceptable in the justification of hypotheses. By so doing, scientists can... (shrink)

ZusammenfassungDieser Artikel beschäftigt sich mit Geschlechterstereotypen in psychiatrischen Gerichtsgutachten während des Deutschen Kaiserreichs 1871–1914. Wie gezeigt werden wird, lassen sich in diesen Gutachten vier auf das Geschlecht bezogene Narrative identifizieren. Einerseits wurden Frauen und Männer beschrieben, die den Geschlechterstereotypen der Zeit nicht entsprachen. Für diese nonkonformen Angeklagten wurde in den hier betrachteten Gutachten die Erklärung zur Unzurechnungsfähigkeit empfohlen. Andererseits wurden aber auch Männer und Frauen beschrieben, die sich konform zu den entsprechenden Stereotypen verhielten. Allerdings wurden in diesen Fällen „weibliche“ Frauen (...) weiterhin tendenziell für unzurechnungsfähig erklärt, während „männliche“ Männer der Simulation einer Geisteskrankheit bezichtigt wurden, um einer Strafe zu entgehen. Ich werde argumentieren, dass diese Ergebnisse Grundannahmen der Feministischen Epistemologie stärken: sie zeigen erstens, dass psychiatrische Vorstellungen von Zurechnungsfähigkeit eng verbunden waren mit der der Norm des „männlichen“ Mannes, und zweitens, dass ein doppelter Standard bei der Beurteilung des Geisteszustands von Männern und Frauen angelegt wurde. (shrink)

In the decades since the Science Wars of the 1990s, climate science has become a crucible for the negotiation of claims about reality and expertise. This negotiation, which has drawn explicitly on the ideas and techniques of science and technology studies, has taken place in genres of fiction as well as non-fiction, which intersect in surprising ways. In this case study, I focus on two interwoven strands of this history. One follows Michael Crichton’s best-selling 2004 novel, State of Fear and (...) its reception by neo-conservatives as a commentary on the mis-uses of facts to stoke fear about anthropogenic climate change. The other considers Naomi Oreskes and Erik M. Conway’s 2010 publishing success Merchants of Doubt as the inverse, a demonstration of the forms of disinformation that have been used to undermine scientific consensus around climate change. I show that both Crichton’s as well as Oreskes and Conway’s approaches were critiqued by academic STS even as their accounts constituted the most high-profile performances of its stakes and the politics of knowledge since the Science Wars. In highlighting the STS practices deployed by each, as well as how those practices were differently linked to accusations of fear-mongering and a perversion of the purity of STS, I demonstrate the need for a reflexive history of STS. Such an approach, I argue, can better consider the social life of STS ideas and practices amidst calls for more politically-engaged approaches to knowledge production. (shrink)

The term “genetic load” first emerged in a paper written in 1950 by the geneticist H. Muller. It is a mathematical model based on biological, social, political and ethical arguments describing the dramatic accumulation of disadvantageous mutations in human populations that will occur in modern societies if eugenic measures are not taken. The model describes how the combined actions of medical and social progress will supposedly impede natural selection and make genes of inferior quality likely to spread across populations – (...) a process which in fine loads their progress. Genetic load is based on optimal fitness and emerges from a “typological view” of evolution. This model of evolution had previously, however, been invalidated by Robert Wright and Theodosius Dobzhansky who, as early as 1946, showed that polymorphism was the rule in natural populations. The blooming and persistence of the concept of genetic load, after its theoretical basis had already expired, are a historical puzzle. This persistence reveals the intricacy of science and policy-making in eugenic matters. The Canguilhemian concept of ‘scientific ideology’ is used along with the concept of ‘immutable mobile’ and compared with the concept of ‘co-production’, to provide complementary perspectives on this complex phenomenon. (shrink)

How can technological development, economic development, and the claims from society be reconciled? How should responsible innovation be promoted? The “responsible social uses” approach proposed here was devised with these considerations in view. In this article, a support procedure for promoting responsible social uses is set out and presented. First, the context in which this procedure emerged, which incorporates features of both the user-experience approach and that of ethical acceptability in technological development, is specified. Next, the characteristic features of the (...) procedure are presented, that is, its purpose, fundamental orientation, and component parts as experimented by partners. Third, the RSU approach is compared with other support approaches and considered in term of how each approach assumes responsible innovation. Briefly, the RSU procedure is a way of addressing the issue of responsible innovation through an effective integration of social concerns. (shrink)

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to (...) guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview. (shrink)

“You are interested in ethics,” the clinician said, “there are problems with medical ethics in Taiwan.” It was 2005, shortly after I had moved to Taiwan. A little later, a professor told me of a university hospital that served as a site for a transnational clinical trial run by a pharmaceutical company. He said that since no informed consent procedure was in place at that time, the hospital had simply obtained employer consent. “That’s why companies want to come to Taiwan (...) to do clinical testing, because you can do anything here—things that can’t be done in the US. That’s why everyone wants to come to Taiwan.” These statements may seem, at first, to indicate a lack of concern in Taiwan for medical and scientific... (shrink)

This paper argues for the theoretical and practical validity of similarity as a useful epistemological tool in scientific knowledge generation, specifically in chemistry. Classical analyses of similarity in philosophy of science do not account for the concept’s practical significance in scientific activities. We recur to examples from chemistry to counter the claim of authors like Quine or Goodman to the effect that similarity must be excluded from scientific practices . In conclusion we argue that more recent conceptualizations of the notion (...) of similarity, particularly Giere’s one, are appropriate for a philosophical analysis that considers scientific practices on equal terms with scientific theory. (shrink)

The ArgumentThis paper provides a historical perspective to one of the liveliest debates in common law courts today — the one over scientific expert testimony. Arguing against the current tendency to present the problem of expert testimony as a late twentieth-century predicament which threatens to spin out of control, the paper shows that the phenomena of conflicting scientific testimonies have been perennial for at least two centuries, and intensely debated in both the legal and the scientific communities for at least (...) 150 years. (shrink)

Research on the influence of industry on chemical regulation has mostly been conducted within the framework of the production of ignorance. This special issue extends this research by looking at how industry asserts its interests––not just in the scientific sphere but also at other stages of policy-making and regulatory process––with a specific focus on the types of tools or instruments industry has used. Bringing together sociologists and historians specialized in Science and Technology Studies, the articles of the special issue study (...) the arenas in which instruments and practical guidelines for public policy are negotiated or used. The aim is to observe the devices in the making or in action, from the selection of actors to the production of thresholds, criteria, and other technical regulations. The introduction highlights how industry influence on expertise and regulation is undoubtedly far more pervasive and multifarious than has been conceptualized to date by social scientists. Putting this issue back at the heart of both the STS and social sciences research agendas is increasingly urgent and could lead to new inquiries able to highlight these logics even more widely, using fresh empirical examples. (shrink)

This article addresses issues of regulatory convergence and Europeanization as they have developed within the agrochemicals sector. Taking the United Kingdom as a case study, the article considers the continuing importance of local and national factors within systems that are ostensibly international and standardized. In particular, the article shows how the embedded social relations of regulatory science in the United Kingdom, including institutional practices, judgments of expertise, and established relationships of trust, result in a “nation centeredness” and divergence of regulatory (...) cultures despite the putative development of a harmonized European framework. It is argued that, as a consequence, the claimed universalism of scientific culture in this area is in tension with the local conditions of its practice and enactment. (shrink)

This article proposes the term “safety logics” to understand attempts within the European Union to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to (...) explore the types of “safety” produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape. (shrink)

The commercialization of transgenic crops has engendered significant resistance from environmental groups and defensive responses from industry. A part of this struggle entails the politicization of science as groups gather evidence from the scholarly literature to defend a supportive or opposing position to transgenic crop commercialization. The authors argue that novel technology development and associated scientific uncertainty have led to two competing approaches to risk management: precaution and ex post trial and error. In this paper we use the controversies over (...) currently commercialized transgenic crops to analyze the debate over these competing approaches. We also suggest a hybrid approach that incorporates a precautionary selection process, but also relies on ex post trial and error after commercialization. This approach is labeled precaution through experience since the development of a technology’s characteristics would ideally take into account previous experience with similar technologies, or rather technologies with similar applications. The authors argue that substantial public participation and dialogue is needed to identify socially desirable crop traits to guide research and development. Policy tools are also recommended that provide incentives to private-sector firms to engineer the identified traits into crops. (shrink)

When intense public controversy erupted around agricultural biotechnology in the late 1990s, critics found opportunities to challenge risk assessment criteria and test methods for genetically modified products. In relation to GM food, they criticized the concept of substantial equivalence, which European Union and United States regulators had adopted as the basis for a harmonized, science-based approach to risk assessment. Competing policy agendas framed scientific uncertainty in different ways. Substantial equivalence was contested and eventually recast to accommodate some criticisms. To explain (...) how the concept changed, this article links two analytical perspectives. Regulatory-science perspectives illuminate how the scientification of politics and politicization of science led to shifts in the boundary between science and policy. Governance perspectives illuminate how the collective problem for policy was redefined to provide a new common ground for some stakeholders. Overall, substantial equivalence was recast to govern the social conflict and address legitimacy problems of regulatory procedures. (shrink)

How do institutions respond to expert contests over epistemologies of sex and gender? In this article, I consider how epistemological ascendancy in debates over the regulation of women athletes with high testosterone is established within a legal setting. Approaching regulation as an institutional act that defines forms of embodied difference, the legitimacy of which may be called into question, I show how sexed bodies are enacted through and as part of determinations of expertise. I focus on proceedings from 2015 when (...) the Court of Arbitration for Sport was asked to decide whether an Indian sprinter, Dutee Chand, could compete as a female athlete. Despite acknowledging that sexed bodies are unruly, the court ultimately endorsed the use of testosterone as seemingly essential to women’s athletic performance, thereby reasserting a two-category model of biological difference. The legitimacy of these regulatory efforts was established through the concurrent narrowing of expertise and the body, a process that is also revealed to be gendered. (shrink)

Philosophers of science now broadly agree that doing good science involves making non-epistemic value judgments. I call attention to two very different normative standards which can be used to evaluate such judgments: standards grounded in ethics and standards grounded in political philosophy. Though this distinction has not previously been highlighted, I show that the values in science literature contain arguments of each type. I conclude by explaining why this distinction is important. Seeking to determine whether some value-laden determination meets substantive (...) ethical standards is a very different endeavor from seeking to determine if it is politically legitimate. (shrink)

Technology assessment has been evolving as a research-based and anticipatory field of scientific policy-advice for more than fifty years. Its position at the interface between science and policy-making has caused several debates on its adequate roles. Proposals reach from the position of a neutral and distant observer of ongoing developments up to taking an active role in transformation processes fueled by the technological advance, e.g. in favor of sustainable development. In this paper, several role concepts of TA will be discussed (...) against the background of a new framework concept on technology assessment. It will be shown, that TA usually has to take the role of an Honest Broker in assessing new technologies as an umbrella role concept. The specific manifestations of this umbrella role, however, can vary from context to context. The role concept of the Honest Broker serves as an orientation to determine the more specific roles in the tension between assumed neutrality and the obligation to create impact. (shrink)

Notions of research quality are contextual in many respects: they vary between fields of research, between review contexts and between policy contexts. Yet, the role of these co-existing notions in research, and in research policy, is poorly understood. In this paper we offer a novel framework to study and understand research quality across three key dimensions. First, we distinguish between quality notions that originate in research fields and in research policy spaces. Second, drawing on existing studies, we identify three attributes (...) considered important for ‘good research’: its originality/novelty, plausibility/reliability, and value or usefulness. Third, we identify five different sites where notions of research quality emerge, are contested and institutionalised: researchers themselves, knowledge communities, research organisations, funding agencies and national policy arenas. We argue that the framework helps us understand processes and mechanisms through which ‘good research’ is recognised as well as tensions arising from the co-existence of conflicting quality notions. (shrink)

I Norge har vi hatt kontroverser omkring regulering avhumanmedisinsk bioteknologi siden 1980-tallet. Denneartikkelen analyserer et lite utsnitt av disse reguleringsdebattene,nærmere bestemt kontroversen omkring forskningpå befruktede egg. Med utgangspunkt i skriftlig materialeknyttet til tre reguleringsrunder undersøker vi her hvordan ulike aktører arbeidet forå ramme inn denne kontroversen, bl.a. ved hjelp av ulikevitenskapelige og politiske representasjoner av det befruktedeegget.Vi finner at det i perioden 1987–2007 ble arbeidet medulike innramminger som utgangspunkt for retoriske ogpolitiske strategier: På den ene siden ser vi forsøk på (...) å innrammekontroversen i et risikorammeverk som først ogfremst fokuserte på de potensielle negative sidene vedhumanmedisinsk bioteknologi, og som spesielt vektlarespekten for det ufødte liv. På den andre siden ser vi atman arbeidet med en forventningsinnramming som lahovedvekten på håpet om nye behandlingsregimer foralvorlig syke mennesker.Forbudet mot forskning på befruktede egg som ble vedtatti 1987, ble opprettholdt i 1994 og 2003. Med lovendringeni 2008 fikk vi imidlertid et markant brudd i dennorske lovgivningspraksisen, da forskning på befruktedeegg ble tillatt på visse premisser. Vi argumenterer for at den viktigste årsaken til denne lovendringen var Mehmet-saken, en sak som medførtesåkalte «oversvømmelser» i begge innrammingsforsøkenesom er omtalt ovenfor. Mehmet-saken eksponerte samtidig et generelt demokratiskdilemma. Saken illustrerte hvor sårbare lovregler og etiske prinsippkan være for det som for allmennheten fremstår som helt urimelig, og dennesaken etterspør slik sett mer hybride måter å tenke forholdet mellom det universelleog det partikulære, mellom prinsipiell etikk og lekmannsskjønn, mellomfakta og verdier som utgangspunkt for politikkutforming.Nøkkelord: humanmedisinsk bioteknologi, forskning på befruktede egg,kontrovers, representasjoner, Mehmet-sakenEnglish abstract: Effective representations? Concerns and expectationsregarding research on fertilized eggsSince the 1980s, there have been several debates and controversies concerningthe regulation of medical biotechnology. In this article, we analyze three suchinstances in Norway, mainly the debates concerning research on fertilizedeggs. Analyzing the debates surrounding the regulations of 1994, 2003/2004and 2008, we investigate how different stakeholders strived to mobilize whatwe call different framings of the controversy, utilizing the different scientificand political representations of the fertilized egg.Framing involves creating baselines for rhetorical and political stratagems.Two framings appear more pronounced than others in the Norwegian debate.On one hand, we find attempts of framing the controversy in a risk centricframework, which mostly emphasizes the potential negative effects of medicalbiotechnology as it focuses on the universal reverence for the unborn life. Onthe other hand, we see attempts to mobilize a positive frame of expectationthat emphasizes on the hope of finding new and effective treatment options forthe severely ill.The ban against research on fertilized eggs that was passed in Norway in1987 was repeated in 1994 and 2003. However, with the changes introducedto the law in 2008, there was a noticeable shift in Norwegian legislation, asresearch on fertilized eggs became permissible if specific conditions were met.We argue that the turning point in this regulative change was the Mehmentcase, a particular case that entailed the so-called «overflowing» in both the negative and the positive frame. The Mehmet case exposed a moregeneral democratic and political dilemma. In our opinion, it illustrates howvulnerable can regulation that is based on general ethical principles be in theface of what appears to the laity as unreasonable. Thus, we argue that thisactualizes the need for more hybridized ways to view the relationship betweenthe universal and the particular, between principle-based ethics and theunderstandings of lay people, between facts, and values and actual cases inpolicy shaping and practice. (shrink)

This article analyzes the conditions for mobilizing the science base for development of public policy. It does so by focusing upon the science-policy interface, specifically the processes of direct interaction between scientists and scientifically trained experts, on the one hand, and agents of policymaking organizations, on the other. The article defines two dimensions – cognitive distance and expert autonomy – which are argued to influence knowledge exchange, in such a way as to shape the outcome. A case study on the (...) implementation of congestion charges in Stockholm, Sweden, illustrates how the proposed framework pinpoints three central issues for understanding these processes: Differentiating the roles of, e.g., a science-based consultancy firm and an academic environment in policy formation; Examining the fit between the organizational form of the science-policy interface and the intended goals; and Increasing our understanding of when policymaker agents themselves need to develop scientific competence in order to interact effectively with scientific experts. (shrink)