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

描述(申请人提供)：人类基因组计划的完成，独特的基因研究资源的创建，以及强大的基因组分析技术的发展，为揭示基因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和环境之间复杂相互作用的产物。NHGRI和政府顾问认为，创建一项美国纵向研究，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，具有独特的价值。在政治上，研究如此巨大的规模和后果需要公众支持--或者至少不是积极反对--其承诺。从道德上讲，这种研究应该在寻求、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。 这项建议的目标是获得广泛的社会投入，为设计和实施一项可能的美国大型纵向队列研究提供信息，研究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)编写和评价描述大型队列研究的目标和设计考虑因素的信息材料；2)在个人一级评估公众对拟议的队列研究的态度；3)让公民和社区领导人评估发起社区对话的态度和试点测试方法。 这一试点项目将使用定性和定量的方法，对公众的态度提供丰富和有代表性的评估，并让公众就可能进行的大规模队列研究进行初步对话。试点将在五个地理和人口统计截然不同的地点进行，并在全国范围内使用具有代表性的样本。该项目将探索具体的研究设计要素以及对参与者、社区和社会的预期益处和风险；让社区领导人参与；评估刺激公民对话和公众咨询的方法；并召集公民咨询小组，为大型队列研究提供指导和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.