Making Every Voice Count: Public Consultation on Genetics, Environment and Health

描述（由申请人提供）：人类基因组计划的完成、独特遗传研究资源的创建以及强大的基因组分析技术的发展，为揭示遗传对健康和疾病的贡献提供了强大的工具。然而，许多人类疾病是基因与环境之间复杂相互作用的产物。 NHGRI 和政府顾问认为，开展一项旨在收集数十万美国人的环境暴露、遗传风险因素、生活方式和医疗经验的美国纵向研究具有独特的价值。从政治上讲，对这种严重性和后果的研究要求公众支持——或者至少不积极反对——其事业。从伦理上讲，这样的研究应该在寻求、适当考虑和解决普通公民的希望和关切之后，与公民合作设计和进行。 该提案的目标是获得广泛的社会投入，为可能的美国大型纵向队列研究的设计和实施提供信息，该研究涉及基因和环境在健康和疾病中的作用。该项目有三个具体目标：1）开发和评估描述大型队列研究的目标和设计考虑因素的信息材料； 2) 评估公众对个人层面上拟定队列研究的态度； 3) 让公民和社区领袖参与评估启动社区对话的态度和试点测试方法。 该试点项目将使用定性和定量方法，对公众的态度进行丰富且具有代表性的评估，并让公众就可能的大型队列研究进行初步对话。该试点将在五个地理和人口统计不同的地点进行，并在全国范围内使用代表性样本。该项目将探讨具体的研究设计要素以及对参与者、社区和社会的感知效益和风险；吸引社区领袖参与；评估促进公民对话和公众咨询的方法；并召集一个公民咨询小组，为大型队列研究提供指导并评估这些方法的有效性。

DESCRIPTION (provided by applicant): The completion of the human genome project, the creation of unique genetic research resources, and the development of robust genome analysis technology, have provided powerful tools to unravel the genetic contribution to health and disease. Yet, many human diseases are the product of complex interactions between genes and environment. The NHGRI and government advisors have identified the creation of a U.S. longitudinal study to collect environmental exposures, genetic risk factors, lifestyle, and medical experiences from hundreds of thousands of Americans as uniquely valuable. Politically, a study of such enormity and consequence requires that the public support - or at least not actively oppose - its undertaking. Ethically, such a study should be designed and undertaken in cooperation with citizens, after the hopes and concerns of ordinary citizens are sought, duly considered, and addressed. The goal of this proposal is to obtain wide societal input to inform the design and implementation of a possible large U.S.-based longitudinal cohort study of the role of genes and environment in health and disease. The project has three specific aims: 1) Develop and evaluate informational materials describing the goals and design considerations of the large cohort study; 2) Assess public attitudes about the proposed cohort study at the individual level; and 3) Engage citizens and community leaders to assess attitudes and pilot test methods of initiating community-based dialogue. This pilot project will use qualitative and quantitative methods to provide a rich and representative assessment of the public's attitudes and to engage the public in an initial dialogue about a possible large cohort study. The pilot will be conducted in five geographically and demographically distinct locations, as well as nationally using a representative sample. The project will explore specific study design elements and the perceived benefits and risks to participants, communities, and society; engage community leaders; evaluate methods of stimulating citizen dialogue and public consultation; and convene a citizens' advisory panel to provide guidance and assess the effectiveness of these methods for a large cohort study.