Toward a Framework for Policy Analysis of Microbiome Research

建立微生物组研究政策分析框架

• 批准号: 7743698
• 负责人: Mildred K. Cho
• 金额: $ 39.58万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-26 至 2012-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7743698
• 关键词: Address; Benefits and Risks; Bioethics; Biomedical Research; Categories; Clinical Trials; Communities; Complex; Conflict (Psychology); Discrimination; Disease; Drug Formulations; Ethical Issues; Ethics; Etiology; Future; Genetic; Genomics; Goals; Human; Human Microbiome; Individual; Informed Consent; Lead; Left; Link; Medical; Methods; Nature; Paper; Persons; Policy Analysis; Policy Maker; Preventive; Process; Recording of previous events; Research; Research Design; Research Personnel; Research Project Grants; Risk; Science Policy; Scientist; Shapes; Social Environment; Staging; Structure; Technology; Technology Assessment; Virus; Work; Writing; abstracting; design; ethical legal social implication; falls; microbiome; microorganism; prophylactic; public health relevance; social; social implication; tool

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.

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很重要。但是，微生物组研究的复杂性可能会改变遗传学的研究和理解方式，因为它要求建立一个更复杂，细微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有关物种，自我，疾病和正常性的定义的传统假设。还认识到，微生物组研究可以提出道德，法律和社会问题。在此阶段，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或预防性生物伦理学的概念。尽管有用，但这种方法在确定道德和社会问题并将危害与科学界分开发生，或以抽象和一般性进行，而不是与计划中或正在进行的研究的实际特征相关联，这种方法的有效性不如识别道德和社会问题所需的效率。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，因为它们旨在评估专门纳入社会环境和价值的研究，并且非常适合评估快速移动和边界挑战技术，例如微生物组研究中使用的技术。我们建议将风险双重概念用作工具，以将有关价值观和社会影响的抽象问题与研究的特定特征联系起来。该分析将用于确定可能最小化价值冲突的潜在研究设计替代方法，并可能更广泛地将其推广到其他基因组和生物医学研究。 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,与微生物组研究，技术评估以及道德和社会分析专家的结构化跨学科对话b）写作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研究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，因为评估研究专门纳入了社会背景和价值观以及风险和收益的概念，以将关于价值和社会影响的抽象问题讨论与研究的特定特征联系起来。