Ethical Legal and Social Dimensions of Human Microbiome Research

描述（由申请人提供）：我们提出一项探索性调查，与人类微生物组计划（HMP）平行，涉及与人类微生物组研究相关的新兴伦理，法律和社会问题。我们将通过对HMP主要利益相关者的深度访谈来实施这项研究，包括被招募到HMP但拒绝参与的个人，研究参与者，以及参与计划实施HMP第一阶段的调查员和项目负责人。该项目的总体目标是识别和分析与人类微生物组研究相关的伦理、法律和社会问题，并为在未来的研究中管理这些问题制定合乎伦理的、经验丰富的策略。本项目有三个具体目标：(1)描述新兵和参与者对HMP的想法（以及参与者对HMP的经历），因为它与他们的身体，社会和文化以及与他们的健康和疾病概念有关；(2)描述从NIH的研究调查员和项目负责人的角度进行HMP的伦理，法律和社会挑战；(3)提供一个论坛，与具有代表性的利益相关者（包括研究参与者）进行跨学科交流；研究小组成员，以及外部专家)为具体目标1和2中确定的道德、法律和社会问题的负责任管理提出建议。公共卫生相关性：人类微生物组计划（HMP）是一项大型研究，旨在更多地了解生活在我们体内和体表的细菌、病毒和其他微小生物的集合。我们将采访三组人：(1)那些被要求参加HMP但拒绝的人，以找出他们拒绝的原因；(2)那些决定参加HMP的人，以探索他们对项目的想法和参与项目的经历；(3)进行HMP的科学家，以了解与这种类型的研究相关的伦理或社会问题。我们还将举办一个研讨会，由我们的研究团队成员、研究参与者和外部专家讨论在访谈中发现的问题，并提出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.