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Fast track : the practice of drug development and regulatory innovation in the late twentieth century U.SMessner, Donna A. January 2008 (has links)
This thesis examines the laws and regulations created in the 1980s and 1990s in the U.S. to hasten development, evaluation, and approval of drugs to treat serious and lifethreatening diseases, and to allow access of seriously ill patients to investigational drugs on a pre-market approval basis. Using detailed historical exposition in tandem with the social-theoretic tools of the sociology of scientific knowledge (SSK), and particularly Barnes’s account of meaning finitism, this thesis examines the social origin, definition, and case-by-case application of conceptual categories in the regulatory oversight of drug development and approval. With this approach, rules and standards for drug approval are shown not to be fossilised machinery for decision-making, but rather living, socially produced and maintained, inherently revisable resources for action. Key conclusions from this study are that: the regulatory actions taken to confront AIDS in the 1980s, often considered to be a radical break with previous practice, had their conceptual origins in the 1960s and 1970s; rule-making is often constitutionally related to a creative process of rule-‘breaking’; tacit processes of consensus outside of, and prior to, formal consensus mechanisms for rule-making are often fundamental to the rule-making process, resulting in de facto ‘rules’ on which later, formal rule-writing can be based; as predicted by finitism, newly created categories of action in drug development and approval require reinterpretation of underlying concepts in related existing categories. The thesis also demonstrates the flexibility and revisable nature of existing conceptual resources for application to current circumstances, consistent with a finitist view of knowledge. While the conclusions of this research are based on only one area of regulation, they are suggestive for more general descriptions of regulatory action. Contemporary theories of regulation are typically designed as economic models or are viewed through traditional categories of law and political science. As a result, they tend to abstract reality, ignoring day-to-day administrative practice, idealizing the nature of rule-following and rulemaking, and ignoring tacit processes of consensus. This thesis brings an interdisciplinary perspective to the theory of regulation, suggesting the outlines of a ‘social’ theory of regulation more fully sensitive to the empirical reality of the social process of rule-making and rule-breaking in contemporary regulation.
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Studies in the chemical work of StahlColeby, L. J. M. January 1938 (has links)
This thesis contains a short biography of Stahl together with an account of his experimental researches in chemistry and of his general theoretical ideas. The part played by him in the development and elaboration of the phlogiston theory has been discussed. This was the first comprehensive chemical theory and one which gained almost universal acceptance for half a century, and an endeavour has been made to describe the experimental evidence on which it was based, a point hitherto little realised, and to explain the reasons for its general adoption. Various isolated researches have been investigated which show Stahl to have been a careful and accurate experimentalist over a wide range of subjects. A bibliography of Stahl chemical works is appended.
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Variations on a theme : patterns of congruence and divergence among 18th century chemical affinity theoriesTaylor, Georgette Nicola Lewis January 2006 (has links)
The doctrine of affinity deserves to be recognised by historians of chemistry as the foundational basis of the discipline of chemistry as it was practiced in Britain during the 18th century. It attained this status through its crucial structural role in the pedagogy of the discipline. The importance of pedagogy and training in the practice of science is currently being reassessed by a number of historians, and my research contributes to this historiographical endeavour. My analysis of the variety of theories sheltered under the umbrella term ‘affinity theory’ has emphasised the role of pedagogy in influencing both the structure and the content of knowledge. I have shown that there were wide ranging discrepancies between many of the components of individual affinity theories. Nevertheless, the scope of divergence was limited. This underlying organisation resulted from the unifying hub of affinity theory, the logical common ground. This was the essence of the doctrine of affinity, encompassing the law of affinity and the conceptualisation of the table that brought together the relations described in the law. The doctrine of affinity thus provided a disciplinary common ground between chemists, providing a mediating level of understanding and communication for all those who subscribed to the doctrine of affinity, in spite of their detailed differences.
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Epistemologies of uncertainty : governing CO2 capture and storage science and technologyEvar, Benjamin January 2014 (has links)
This thesis progresses from a ‘science and technology studies’ (STS) perspective to consider the ways that expert stakeholders perceive and communicate uncertainties and risks attached to carbon dioxide (CO2) capture and storage (CCS) research and development, and how this compares with policy framings and regulatory requirements. The work largely falls within the constructivist tradition in sociology, but also draws on literature from the philosophy of science and policy-‐oriented literature on risk and uncertainty. CCS describes a greenhouse gas (GHG) mitigation technology system that involves the capture, pressurisation, transportation, geological injection and long-‐term storage of CO2 as an alternative to atmospheric emissions. Only few and relatively small applications exist at the moment and research efforts are on going in many countries. The case for developing CCS towards large-‐scale, commercial deployment has largely been presented as follows since the mid-‐ 1990s: climate change mitigation is the developed world’s historical responsibility and must be addressed urgently; chief amongst GHGs is CO2, which makes up more than three quarters of emissions; the vast majority of CO2 is emitted from the combustion and gasification of hydrocarbons – oil, gas and coal – for energy generation; transitioning away from these high-‐CO2 primary energy sources will likely take several decades at the least; therefore, CO2 capture systems should be designed for power and industrial emissions in developed countries, as well as emerging economies where energy suppliers will continue to construct relatively cheap and well understood high-‐CO2 generation plants. The development of large-‐scale CO2 capture has thus arisen from a concern with engineering a technological system to address a CO2 legacy in the developed world, and a high-‐CO2 trajectory in developing/emerging countries, rather than on the back of purely scientific curiosity. And the potential for large-‐scale development has been presented on the back of a variety of scientific and technical evidence, as well as the urgency of the policy objective and related aims. Research activities, often concentrated around technology demonstration projects, are the primary focus of the first part of this thesis. In the second part I consider the extent to which research has shaped policy developments, and how regulations have subsequently informed a more detailed research agenda. I follow a ‘grounded theory’ methodology as developed by Glaser and Strauss (1967) and take additional guidance from Glaser’s (1992) response to Strauss’ later writings as well as Charmaz (2006) and Rennie (2000), and use a mix of qualitative and quantitative analytical methods to assess my data. These include information from 60 semi-‐structured interviews with geoscientists and policy stakeholders; close readings of scientific publications, newspaper articles, policies and regulatory documents; statistical evidence from a small survey; quantitative analysis of newspaper articles; and social network analysis (SNA) of scientific co-‐authorship networks. Theory is drawn from STS literature that has been appropriate to address case study materials across each of the 7 substantive chapters. The first section of the thesis considers expert claims, with a focus on geoscience research, and draws on literature from the closely related ‘social shaping of technology’ (SCOT) and ‘sociology of scientific knowledge’ (SSK) programmes, as well as Nancy Cartwright’s philosophy of science. The second half of the thesis draws on the ‘co-‐production’ framework and Wynne’s (1992) terminology of risk and uncertainty, to assess relations between risk assessment and risk management practices for CCS. I likewise draw on literature from the ‘incrementalist’ tradition in STS to ask whether and how understandings of technology risk, governance and deployment could be improved. Each chapter presents new empirical material analysed with distinct reference to theories covered in the introduction. Chapter 2 provides a general overview of the history, technology, economics and key regulatory issues associated with CCS, which will be useful to assess the theoretically driven arguments in subsequent chapters. Chapter 3 draws on the concept of ‘interpretive flexibility’ (Pinch and Bijker 1984) to assess a range of expert perceptions about uncertainties in science, technology and policy, and I develop a substantive explanation, ‘conditional inevitability’, to account for an epistemic tension between expressions of certitude and the simultaneous acknowledgement of several uncertainties. Chapter 4 continues the enquiry into stakeholder perceptions and draws on Haas’ notion of ‘epistemic communities’ (Haas 1992) to assess geoscientists’ work practices. I complement this framing with a close look at how uncertainty is treated in simulation modelling and how conclusions about storage safety are formulated, by drawing on Nancy Cartwright’s philosophy of science (Cartwright 1999) and Paul Edwards’ account of complex system modelling for climate change (Edwards 2010). The chapter shows how shared understandings of adequate evidence and common analytical tools have been leveraged to present relatively bounded and simple conclusions about storage safety, while geoscientists nevertheless recognise a high degree of uncertainty and contingency in analyses and results. Chapter 5 continues the focus on knowledge production in the geosciences and is supported by SNA data of workflow patterns in the Sleipner demonstration project. The analysis shows how a few actors have had a pivotal role in developing insights related to storage safety particularly on the back of seismic monitoring and other data acquired through industry partnerships. I therefore continue the chapter with a deconstruction of how seismic data has been used to make a case for the safety of CO2 storage, again drawing on Cartwright and others (Glymour 1983) to explain how individual findings are ‘bootstrapped’ when conclusions are formulated. I show how a general case about storage safety has emerged on the back of seismic data from Sleipner as well as a shared understanding among geoscientists of how to account for uncertainties and arrive at probable explanations. Chapter 6 considers to what extent scientific research has given shape to, and in turn been shaped by, CCS policy and regulations in the EU, drawing on Wynne’s (1992) terminology of risk and uncertainty as well as legal scholarship (Heyvaert 2011). I conclude that a ‘rational-‐instrumental’ interpretation of uncertainty and precaution has furnished a compartmentalised understanding of risk assessment and risk management practices. Chapter 7 continues to look at the ways that risk assessment methodologies influence risk management practices through a case study of the Mongstad CCS demonstration project in Norway. I draw on ‘incrementalist’ literature (Lindblom 1979; Woodhouse and Collingridge 1993) to consider alternative conceptualisations of technology development and risk management when expectations clash with scientific uncertainties and criticism. Chapter 8 draws on insights from across STS (Downs 1972; Collingridge and Reeve 1986; Wynne 1992) to create a novel conceptual model that accounts for recent years’ developments in CCS governance. Here I conclude that setbacks and criticisms should be expected when analyses have largely presented CCS as a technical problem rather than a socially contingent system. Following Stirling (2010) I conclude that scientists and policymakers should instead strive to present complexity in their analyses and to engage with wider publics (Yearley 2006) when technical analysis is inseparable from socially mediated indeterminacies (Wynne 1992), to increase the chance of more successful engagement practices (Wynne 2006). The conclusions at the end of the thesis seek to draw out interpretive and instrumental lessons learned throughout.
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Statistics of the Self: Shaping the Self Through Quantified Self-TrackingRowse, Lauren M 01 January 2015 (has links)
Self-tracking practices are growing in popularity worldwide. From heart-rate monitoring to mood tracking, many believe that wearable technologies are making their users more mindful in exclusively positive ways. However, I will argue that consistent and deliberate self-tracking (with or without portable devices) necessitates a particular understanding of the self with consequences that have yet to be fully explored. Through an analysis of forum posts on a popular self-tracking discussion and informational site, QuantifiedSelf.com, I will claim that self-trackers approach the creation of self-knowledge in a manner that is particular to today’s society. I will discuss how the ubiquitous conflation of numerical identities with objective reasoning feeds into a mindset that supports quantification of the self, and how the views of self exhibited by these self-trackers can be considered a version of creating a “scientific self.” The notion of the scientific self supports both an individual and societal shift in the practice of “being”—a shift that carries with it many possible repercussions that have yet to be widely analyzed. This analysis, I will argue, is key to limiting the destructive potential of understanding people in terms of data, while simultaneously enabling new conceptualizations of self to be practiced in modern society.
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Ecological Restoration's Genetic Culture: Participation and Technology in the Making of LandscapesRossi, Jairus 01 January 2013 (has links)
Practitioners of ecological restoration are increasingly adopting a genetic perspective when recreating historical landscapes. Genes are often endowed with the capacity to reveal specific and distinct relationships between organisms and environments. In this dissertation, I examine how genetic technologies and concepts are shaping ecological restoration practices. This research is based on two and a half years of fieldwork in Chicago. I employed participant observation and semi-structured interviews to compare how restorationists in two plant science institutions employ genetic concepts in their projects. One institution uses high-tech genetic methods to guide practice while the other uses lower-tech genetic approaches. Each group has distinct, yet internally diverse ways of deciding which seeds are ‘local enough’ to be included in a project.
This research theorizes how classification differences regarding native seeds are part of a broader set of genetic logics I refer to as ‘genetic epistemologies’. Specifically, I ask how genetic technologies circumscribe different ways of seeing and making landscapes. I compare how restorationists delineated valid seed sourcing regions for restoration projects based on their genetic definitions of ‘native’ species. Drawing from science & technology studies, political ecology, and cultural landscape geography, I illustrate how restorationists incorporate cultural preferences, funding imperatives, aesthetics, and discourses about nature into their particular genetic epistemology.
From this research, I offer the following conclusions. By incorporating genetic technology into ecological restoration, many practitioners feel their work will achieve more precision. Yet this perspective is typical of those who do not directly use genetic technologies. Scientists using direct genetic analyses are much more reserved about the potential of their technologies to match organisms to environments. Second, individuals or groups often come into conflict when attempting to apply different genetic epistemologies to the same problem. These conflicts are resolved in the course of planning and implementing a restoration project. Finally, direct genetic methods are only useful in restoration work involving rare or endangered species. Despite the limited utility of genetic technology in restoration, this approach is becoming influential. Chicago’s high-tech plant science institution is discursively reshaping the goals and approaches of native plant institutions that do not use these technologies.
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DTC Advertising and Medicalization: Understanding the Way the Pharmaceutical Industry Selectively "Informs" ConsumersGoforth, Laura F 01 April 2013 (has links)
Direct-to-Consumer advertisements allow pharmaceutical companies to advertise prescription drugs directly to consumers. Increasingly, marketing executives employed by pharmaceutical companies are shifting the focus of these advertisements from promoting the drug as a product, to promoting illness in general. Pharmaceutical companies defend this movement saying the advertisements have an educational function to "inform" consumers.
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The Gatekeeping Paradigm and the Constructivist AlternativeSung, Kijin 22 June 2012 (has links)
Science and technology have become indispensable elements of virtually every public debate. While nations strive to employ the best experts to make timely decisions, discontented citizens increasingly demand better accountability and democratic legitimacy through broad and direct public consultation. Participatory decision-making, on the other hand, is often met by the worry that sound science might drown in a sea of ignorance. As science and technology studies (STS) attempts to navigate these conflicting concerns, it sometimes draws heavily, albeit often uncritically, upon contemporary political philosophy. In this dissertation, I explore links between H. M. Collins and Robert Evans’s account of the appropriate role of public participation in technical policy debates, and Amy Gutmann and Dennis Thompson’s liberal theory of deliberative democracy. Both views exemplify what I call the “gatekeeping paradigm”, a tendency to employ rigid constraints on admissible inputs as the primary means to direct democratic processes toward outcomes that are independently judged to be desirable. I argue that such an approach not only fails to account for the complexi-ties of public discourse in modern societies, but also reflects an impoverished conception of deliberative democracy as a black box. As an alternative to the gatekeeping paradigm, I develop and defend a social construc-tivist theory of democratic governance based on the ideas of Alan Irwin, Sheila Jasanoff, and Brian Wynne in STS; and John Dryzek in political philosophy. The constructivist view focuses less on externally imposed input-constraints and more on internal processes of self-regulation within shifting and heterogeneous discourses. Although this approach will need to be further developed and augmented with much empirical research before its efficacy can be determined, I suggest that constructivism offers a promising framework for the governance of science and technology as well as for thinking about deliberative democracy generally. / Thesis (Ph.D, Philosophy) -- Queen's University, 2012-06-21 16:54:31.171
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Constructing 'the ethical' in the development of biofuelsSmith, Robert David Jonathan January 2016 (has links)
In the past fifty years, a need to address the ethical and social dimensions in the biosciences has become pervasive. To this end, notions of bioethics, and an associated range of methodologies have been institutionalised throughout the UK biosciences; talk of research ethics, public engagement, various forms of technology assessment, and recently notions of responsible innovation in technoscientific worlds is increasingly commonplace. A desire to unpack discourse and action surrounding these practices sits at the heart of this thesis. Of particular interest are the ways that different groups construct the ethical dimensions of biofuel development and deployment and then distribute responsibility for addressing them. To achieve this, I find analytic power by deploying theory from the interpretative social sciences, namely the sociology of bioethics and science and technology studies. Empirically, I use controversy about the development and deployment of biofuels as a means to analyse, primarily through documentary analysis and qualitative interview, how three prominent groups (non-governmental organisations, public research funders and scientists) construct understandings of ethics and then distribute responsibility for addressing those issues. This approach makes it possible to see that the constitution of ethical issues (their ‘form’) and the ways that they are addressed (the ‘task’ of ethics) are both tightly coupled to the situations from which they arise. They are thus fundamentally multiple, locally contingent and often unpredictable. Using a range of discursive strategies and actions, actors are able to negotiate, blurring in and out of focus, what counts as an appropriate issue of concern, who should be addressing it and how. Dominant traditions of theory and practice have a tendency to standardise the form and task of ethics, such as in terms of issue types (e.g. ‘Playing God’) and the methods for addressing them (e.g. public engagement). I argue that ethical dimensions’ situated nature should be acknowledged rather than ignored and is fundamental to making research more ‘socially robust’. However, this tension between dominant institutionalised forms and lived experiences is not easily resolved because it forces an engagement with the roles of those who are tasked with steering knowledge production. Hope is, however, offered by new approaches that have explicitly sought to deal with such tensions in new forms of knowledge production and new models of collaboration.
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Uniquely Structured: Debating Concepts of Science, from the Two Cultures to the Science WarsCohen, Benjamin R. 24 May 2001 (has links)
The purpose of this thesis is to compare the science wars of the 1990s with the two-culture debate of the 1960s. It is a work in the history of intellectual debates, focusing on contested concepts of science. Over the past decade, there have been numerous references made in science wars literature that evoke comparisons to the two-culture controversy. I intend to show that while these comparisons have merit for their popular cultural reference, they are not valid when we consider the structures and contexts of the two debates. Thus, I will compare those structures, summarizing the main points of argument between the relevant actors in each instance, to illustrate the differences. The thesis advanced by C.P. Snow in 1959, and responded to most pointedly by F.R. Leavis in 1962, was predicated on the existence of foundational differences between science and humanities. The broader issues then were what validity a distinction between forms of knowledge had and which domain had the more reliable claim to knowledge. Just as the two-culture controversy called into question the credibility of literary knowledge, the credibility of science studies scholarship was ultimately at stake in the science wars, and is of central concern in this thesis. My contention is that recognizing the differences between the two-culture debate and the science wars can help guide the future of science studies, since those differences demonstrate the importance and validity of STS scholarship. When scholars ignore those differences, and presume that the two debates are comparable, they unintentionally give credibility to those who defend science against perceived assaults by STS scholars. / Master of Science
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