Dissertation Research: Decisions at Scientific Agencies: How Do the NIH and the FDA Balance Expert Opinions, Changing Agendas, and Political Pressure?

在一个要求科学机构考虑非科学因素的民主制度下，科学机构如何履行他们的科学任务？为什么NIH和FDA这两个处理医疗政策的科学机构对类似的压力会有不同的反应？这篇科学和技术论文改进拨款研究将考察这两个机构如何平衡与依赖科学专家、改善健康的任务以及它们对来自国会和利益集团的竞争压力的反应相关的相互冲突的紧张关系。分析将集中在1970-2003年期间，并将审查妇女和少数民族健康社会运动、国会监督和机构决策程序对NIH拨款和FDA药品批准决定的影响。假设这些机构对压力的反应是不同的，因为它们在决策过程中存在重要的内部差异，例如它们如何使用专家小组，以及它们利益集团环境的外部差异。这项研究将采用定性和定量的方法，包括与机构、国会和利益集团领导人和工作人员的访谈，对档案材料的审查，以及对机构决策的多变量分析，如新药审查的速度和研究拨款。在整个分析过程中，这两个科学机构之间的比较将突出它们对其政治环境可能做出的相似和不同的反应。本文的贡献主要体现在几个方面。首先，概念分析将分析科学机构的特征，科学机构是一类尚未得到充分审查的机构，并对其行为提出可检验的假设。其次，这项研究将首次研究妇女和少数群体健康运动对科学机构的影响，并将首次探索妇女、少数群体和患者在科学机构中的作用扩大。了解这些机构如何应对这些变化将有助于政策制定者扩大代表性不足群体的参与。第三，这项研究将比较负责生产和利用科学知识的两个联邦机构的优先事项设置。这项研究将是对政治如何影响NIH研究过程的第一次全面分析，并将有助于不断增长的关于FDA监管政治的文献。第四，这篇论文将展示科学机构如何将技术专长与对公众和人口的健康需求的响应相结合。这项研究将解释这些机构在过去33年里是如何解决这一问题的，这对理解科学政策和制定科学政策的过程具有重要意义。

How do scientific agencies fulfill their science mandates in a democracy that asks them to consider non-scientific factors? Why might the NIH and the FDA, both scientific agencies that address medical policy, have different reactions to similar pressure? This Research on Science and Technology Dissertation Improvement Grant will examine how these two agencies balance the conflicting tensions associated with the need to rely on scientific experts, mandates to improve health, and their responses to competing pressures from Congress and interest groups. The analysis will focus on the period 1970-2003 and will examine the impacts of the women's and minority health social movements, Congressional oversight, and agency decision-making processes on NIH grant awards and FDA drug approval decisions. The agencies are hypothesized to respond differently to pressure because of important internal differences in their decision-making processes, such as how they use expert panels, as well as external differences in their interest group environments. The research will employ both qualitative and quantitative methods, including interviews with agency, Congressional, and interest group leaders and staff, review of archival materials, and multivariate analysis of agency decisions such as the speed of new drug review and research grant funding. Throughout the analysis, the comparisons between these two scientific agencies will highlight their potentially similar and differential responses to their political environments. The contribution of this dissertation will be in several areas. First, the conceptual analysis will analyze the characteristics of scientific agencies, a class of agencies that have not been adequately examined, and propose testable hypotheses about their behavior. Second, this study will be the first to examine the impacts of the women's and minority health movements on scientific agencies and will be the first to explore the expanded role of women, minorities, and patients in scientific agencies. Understanding how these agencies responded to these changes will help policymakers broaden the participation of underrepresented groups. Third, this study will compare priority setting at two federal agencies responsible for producing and utilizing scientific knowledge. The study will be the first comprehensive analysis of how politics affect the research process at the NIH and will contribute to the growing literature on the politics of FDA regulation. Fourth, this dissertation will show how scientific agencies combine technical expertise with responsiveness to the public and the health needs of the population. The study will explain how these agencies have resolved this issue over the last 33 years, which has important implications for understanding science policies and the processes that generate science policies.