Toward a Framework for Policy Analysis of Microbiome Research

描述（由申请人提供）：人们认识到，对人类微生物组的研究对于其潜在的科学和医学影响是重要的。然而，微生物组研究的复杂性可能会改变遗传学研究和理解的方式，因为它需要一个更复杂、更细致的框架来定义和证明因果关系。对人类微生物组的理解也可能破坏关于物种、自我、疾病和正常的定义的传统假设。人们还认识到，微生物组研究可能引发伦理、法律和社会问题。在这个阶段，研究人类微生物组研究的ELSI问题的任务隐含地包含了预防性或预防性生物伦理学的概念。这种方法虽然有用，但如果它与科学界分开发生，或者是以抽象和一般的方式进行，而不是与计划或正在进行的研究的实际特点联系起来，则在确定伦理和社会问题和尽量减少危害方面可能不如预期的有效。我们的总体目标是设计一种方法来检查与微生物组研究相关的ELSI问题。我们建议使用建设性技术评估和价值敏感设计的框架，因为它们旨在评估特别纳入社会背景和价值观的研究，并且非常适合评估快速移动和挑战边界的技术，例如微生物组研究中使用的技术。我们建议使用风险的双重概念作为工具，将有关价值和社会影响的抽象问题的讨论与研究的具体特征联系起来。该分析将用于确定潜在的研究设计方案，这些方案可以最大限度地减少价值冲突，并可能更广泛地推广到其他基因组和生物医学研究中。我们的具体目标是：为了分析在有助于理解人类微生物组及其应用的研究中如何概念化风险和收益，通过：A)微生物组相关研究的科学文章的内容分析B)非专业媒体AIM 2中微生物组文章的内容分析。确定微生物组研究问题或设计、风险和收益概念以及社会价值之间的关系，以便通过以下方式为研究行为提供信息：A)与微生物组研究、技术评估以及伦理和社会分析方面的专家进行扩展的、结构化的跨学科对话；B)撰写和传播白皮书和文章。公共卫生相关性：我们的总体目标是设计一种方法来检查与微生物组研究相关的ELSI问题。我们建议使用建设性技术评估和价值敏感设计的框架，因为要评估具体纳入社会背景和价值观以及风险和利益概念的研究，将其作为一种工具，将有关价值观和社会影响的抽象问题的讨论与研究的具体特征联系起来。

DESCRIPTION (provided by applicant): It is recognized that research on the human microbiome is important for its potential scientific and medical impact. The complexity of microbiome research, however, could change the way that genetics is studied and understood because it calls for a more complex, nuanced framework for defining and demonstrating causality. The understanding of the human microbiome could also disrupt traditional assumptions about definitions of species, self, disease and normality. It is also recognized that microbiome research can raise ethical, legal, and social issues. The mandate to study the ELSI issues of human microbiome research at this stage implicitly embraces the concept of preventive or prophylactic bioethics. While useful, such an approach can be less effective than desired at identifying ethical and social issues and minimizing harm if it occurs separately from the scientific community, or is conducted in the abstract and general rather than linked to actual features of planned or ongoing research. Our overall goal is to devise an approach to examine the ELSI issues associated with microbiome research. We propose to use the frameworks of Constructive Technology Assessment and Value-Sensitive Design because they are designed to evaluate research specifically incorporating social context and values, and are well suited to evaluating rapidly-moving and boundary-challenging technologies such as those used in microbiome research. We propose to use a dual concept of risk as a tool to link discussions of abstract questions about values and social implications with specific features of research. This analysis will be used to identify potential research design alternatives that could minimize value conflicts and could potentially be generalized to other genomic and biomedical research more broadly. Our specific aims are: AIM 1. To analyze how risk and benefit are conceptualized in research contributing to the understanding of the human microbiome and its applications, through: A) content analysis of scientific articles about microbiome-related research B) content analysis of microbiome articles in the lay media AIM 2. Determine the relationship between microbiome research questions or design, concepts of risk and benefit, and societal values, in order to inform research conduct, through: A) extended, structured interdisciplinary dialog with experts in microbiome research, technology assessment, and ethical and social analysis B) writing and disseminating white papers and articles PUBLIC HEALTH RELEVANCE: Our overall goal is to devise an approach to examine the ELSI issues associated with microbiome research. We propose to use the frameworks of Constructive Technology Assessment and Value-Sensitive Design because to evaluate research specifically incorporating social context and values and the concepts of risk and benefit as a tool to link discussions of abstract questions about values and social implications with specific features of research.