Ethical Legal and Social Dimensions of Human Microbiome Research

描述(由申请人提供)：我们建议对与人类微生物组研究相关的紧急伦理、法律和社会问题进行探索性调查，与人类微生物组计划(HMP)平行。我们将通过与氟氯烃管理计划的关键利益攸关方的深入访谈来实施这项研究，这些利益攸关方包括被招募到氟氯烃管理计划但拒绝参加的个人、研究参与者以及参与规划开展氟氯烃管理计划第一阶段的调查人员和项目负责人。该项目的总体目标是确定和分析与人类微生物组研究有关的伦理、法律和社会问题，并制定在未来研究中管理这些问题的伦理上合理和经验丰富的策略。该项目有三个具体目标：(1)描述招募人员和参与者对氟氯烃淘汰管理计划的看法(以及参与者对氟氯烃淘汰管理计划的经验)，因为它与他们的身体、社会和文化相关，以及它与他们的健康和疾病概念有关；(2)从国家卫生研究院研究人员和项目负责人的角度描述实施氟氯烃淘汰管理计划的伦理、法律和社会挑战；以及(3)提供一个与有代表性的利益相关者(包括研究参与者、研究团队成员和外部专家)进行跨学科交流的论坛，以制定负责任的伦理、法律、与公共健康的相关性：人类微生物组项目(HMP)是一项大型研究，旨在更多地了解生活在我们体内和身体上的细菌、病毒和其他微小生物体的集合。我们将采访三组人：(1)被要求参加氟氯烃淘汰管理计划但拒绝的人，以找出他们拒绝的原因；(2)决定参加氟氯烃淘汰管理计划的人，以探索他们对该项目的想法和参与该项目的经验；以及(3)正在实施该项目的科学家，以了解与此类研究相关的伦理或社会问题。我们还将与我们的研究团队成员、研究参与者和外部专家举办研讨会，讨论访谈中发现的问题，并制定管理这些问题的建议。

DESCRIPTION (provided by applicant): We propose an exploratory survey, parallel to the Human Microbiome Project (HMP), of the emergent ethical, legal, and social issues associated with human microbiome research. We will implement this study using in- depth interviews with key stakeholders in the HMP, including individuals who are recruited to the HMP but decline participation, study participants, and investigators and project leaders involved in planning for an conducting the first phases of the HMP. The overall goal of this project is to identify and analyze ethical, legal, and social issues related to human microbiome research and to develop ethically sound and empirically informed strategies for managing these issues in future research. This project has three Specific Aims: (1) Describe recruits and participants' ideas about the HMP (and participants' experiences of the HMP) as it relates to them physically, socially, and culturally and as it relates to their notions of health and disease, (2) Describe the ethical, legal, and social challenges of conducting the HMP from the perspective of study investigators and project leaders at the NIH, and (3) Provide a forum for interdisciplinary exchange with representative stakeholders (including study participants, members of the research team, and outside experts) to develop recommendations for the responsible management of ethical, legal, and social issues identified in Specific Aims 1 and 2. PUBLIC HEALTH RELEVANCE: The Human Microbiome Project (HMP) is a large study to learn more about the collections of bacteria, viruses and other tiny organisms that live in and on our bodies. We will interview three groups of people: (1) those who are asked to participate in the HMP but say no, in order find out why they said no, (2) those who decide to participate in the HMP, in order to explore their thoughts about the project and their experience with participating in the project, and (3) scientists who are conducting the HMP, in order to understand what ethical or social issues are related to this type of research. We will also host a workshop with members of our research team, study participants, and outside experts to discuss the issues that were identified in the interviews and develop recommendations for managing them.