English The 1999 Review of biotechnology regulation required the policy community of human genetics to introduce a new and open approach to governance. In implementing this policy of self-reform, the policy community is obliged to reconcile conflicting political demands from the policy networks of civil society, science and industry as it seeks to establish and maintain the legitimacy of the new regulatory apparatus. Drawing on documentary and interview evidence, this article explores how policy community change may be limited and structured by its existing culture and policy networks in ways not predicted by existing theory.
Experts have recognized for decades that the complexity of coastal systems-involving land and sea effects, multiple affected industries, and multiple regulatory jurisdictions-necessitates integrated coastal management (ICM). (These challenges are explored in detail in Mercer Clarke 2010.) The need for integration requires that knowledge of coastal systems must not only be generated, but also be incorporated sufficiently in decisions by resource users, resource managers, and policy makers. In light of the highly polarized opinion camps on coastal conservation issues, reliance on overly simplistic information gathering and interpretation, especially when it leads to confirming existing narrowness and biases, creates a significant barrier to leaders who want to ensure that stakeholders have adequate knowledge about complex issues. Therefore, it is desirable for such information providers to induce stakeholders to engage in more active, systematic information seeking, as opposed to rudimentary information acquisition-or not seeking relevant information at all.
The chapters in this volume are prefaced by a common understanding that the health of our oceans matters. The collection provides rich accounts dealing with how scientific information is used to build a research base and collaboratory networks to exchange, manage, signal risk, influence, and govern policy-and decision-making. For these authors, water matters in anCONTENTS14.1 Introduction .............................................................................................. 325 14.2 Weaving the Technical, Relational, and Political into aParliament of Evidence-Based Knowledge .......................................... 328 14.3 Indication and Intellectual Property Creep .........................................330 14.4 Moving to a Solution: Some Questions First ........................................ 33114.4.1 Case 1: International Regulatory Practices and Policies for Emerging Health Products: Efficacy and Safety ............. 33214.4.2 Case 2: Global Vaccine Development and Implementation Platforms. Equity. Developing Vaccines for the Global South ..................................................33614.5 Integrating Knowledge from All Levels in a Parliament of Evidence .................................................................................................. 33714.6 Modernization, Risks, and Regulatory Science ................................... 339 14.7 A Symmetrical Approach: Constructivist Accountability,
Standardization is critical to scientists and regulators to ensure the quality and interoperability of research processes, as well as the safety and efficacy of the attendant research products. This is perhaps most evident in the case of "omics science," which is enabled by a host of diverse high-throughput technologies such as genomics, proteomics, and metabolomics. But standards are of interest to (and shaped by) others far beyond the immediate realm of individual scientists, laboratories, scientific consortia, or governments that develop, apply, and regulate them. Indeed, scientific standards have consequences for the social, ethical, and legal environment in which innovative technologies are regulated, and thereby command the attention of policy makers and citizens. This article argues that standardization of omics science is both technical and social. A critical synthesis of the social science literature indicates that: (1) standardization requires a degree of flexibility to be practical at the level of scientific practice in disparate sites; (2) the manner in which standards are created, and by whom, will impact their perceived legitimacy and therefore their potential to be used; and (3) the process of standardization itself is important to establishing the legitimacy of an area of scientific research.
Abstract Taking Biobank UK as its centrepiece, this paper analyses the politics of legitimation accompanying the emergence of population-based genetic databases and the contribution of bioethics to the power play therein. First, it explores the nature of the legitimation problem experienced by biotechnology and considers the extent to which bioethics can be regarded as an epistemic community capable of responding to that problem through a regulatory contribution. Second, drawing on a range of documentary and internet sources, it examines the ethical content of the policy discourse of biobank regulation in four countries in terms of the balance of power expressed therein between the rights of citizens, science, industry and the state in relation to the control of genetic information. Third, the analysis deals with the contribution of the international discourse and networks of bioethics to the policy debate of biobank regulation and the disciplinary identity of this divided epistemic community.
We argue that, while there is general agreement within the field of proteomics that standards are important to science, the goals of the researchers, depending on their research type (discovery, methods or clinical [see Table 3.1]), determine whether they see laboratory quality standards as a necessity or as a potential barrier to scientific creativity and innovation.
BACKGROUND Electronic medical record (EMR) adoption among Canadian primary care physicians continues to grow. In Ontario, >80% of primary care providers now use EMRs. Adopting an EMR does not guarantee better practice management or patient care; however, EMR users must understand how to effectively use it before they can realize its full benefit. OntarioMD developed an EMR Practice Enhancement Program (EPEP) to overcome challenges of clinicians and staff in finding time to learn a new technology or workflow. EPEP deploys practice consultants to work with clinicians onsite to harness their EMR toward practice management and patient care goals. OBJECTIVE This paper aims to illustrate the application of the EPEP approach to address practice-level factors that impede or enhance the effective use of EMRs to support patient outcomes and population health. The secondary objective is to draw attention to the potential impact of this practice-level work to population health (system-level), as priority population health indicators are addressed by quality improvement work at the practice-level. METHODS EPEP’s team of practice consultants work with clinicians to identify gaps in their knowledge of EMR functionality, analyze workflow, review EMR data quality, and develop action plans with achievable tasks. Consultants establish baselines for data quality in key clinical indicators and EMR proficiency using OntarioMD-developed maturity assessment tools. We reassessed and compared postengagement, data quality, and maturity. Three examples illustrating the EPEP approach and results are presented to illuminate strengths, limitations, and implications for further analysis. In each example, a different consultant was responsible for engaging with the practice to conduct the EPEP method. No standard timeframe exists for an EPEP engagement, as requirements differ from practice to practice, and EPEP tailors its approach and timeframe according to the needs of the practice. RESULTS After presenting findings of the initial data quality review, workflow, and gap analysis to the practice, consultants worked with practices to develop action plans and begin implementing recommendations. Each practice had different objectives in engaging the EPEP; here, we compared improvements across measures that were common priorities among all 3—screening (colorectal, cervical, and breast), diabetes diagnosis, and documentation of the smoking status. Consultants collected postengagement data at intervals (approximately 6, 12, and 18 months) to assess the sustainability of the changes. The postengagement assessment showed data quality improvements across several measures, and new confidence in their data enabled practices to implement more advanced functions (such as toolbars) and targeted initiatives for subpopulations of patients. CONCLUSIONS Applying on-site support to analyze gaps in EMR knowledge and use, identify efficiencies to improve workflow, and correct data quality issues can make dramatic improvements in a practice’s EMR proficiency, allowing practices to experience greater benefit from their EMR, and consequently, improve their patient care.
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