Identification of Issues and Expectations of Subjects Participating in Genetic St

描述（由申请人提供）：提交给机构审查委员会（IRB）的基因研究方案在数量和复杂性方面都在增加。此外，现在认识到，要了解遗传易感性，包括与环境因素的相互作用，研究将需要大样本量。对大型研究的需求将导致更多地使用来自存储库和大型疾病登记处的现有数据，并将在伦理委员会批准人类遗传研究方面提出新的问题。虽然了解公众对基因研究看法的努力正在进行中，但人们对已经登记在册的参与者的看法知之甚少，而他们的样本对这些努力将越来越有价值。数据是通过NIH/NHGRI资助的西雅图华盛顿大学和克利夫兰凯斯西储大学的伦理基因组研究卓越中心收集的，以确定IRB成员和基因科学家在基因组研究的新时代面临的问题，重点是确定紧张和共同关注的领域。然而，第三个也是重要的组成部分，即参与人类基因研究的人的观点，却没有得到评估。我们假设，研究参与者的观点和关注点，特别是那些患有具有家族遗传成分的病症或疾病的个人，将与IRB和研究人员的观点和关注点不同。此外，患有遗传成分疾病的个人参与基因研究的动机和关注点可能与一般人群不同。重要的是，这些利益相关者的观点应包括在人类基因研究保护的讨论中。因此，本研究的主要目的是确定癌症登记参与者对参与基因研究的具体关注和期望。拟议项目的结果将为参与正在进行的癌症登记的个人的观点和关切提供关键见解，这些个人的生物样本和个人病史和病史信息将越来越有价值，并在遗传研究中得到寻求。通过将这一重要利益相关者群体的数据添加到最近完成的UW CEER项目中已经获得的IRB专业人员和基因研究人员的数据中，结果可能最终影响基因研究的审查和实施方式。

DESCRIPTION (provided by applicant): Protocols submitted to Institutional Review Boards (IRB) for genetic research are increasing in number and complexity. Further, it is now recognized that to understand genetic susceptibility, including interactions with environmental factors, research studies will require large sample sizes. The need for large studies will result in increased use of existing data from repositories and large disease registries and will present new issues with regard to IRB approval of human genetic studies. While efforts to understand public views of genetic research are underway, there is less known about the views of participants already enrolled in established registries, and whose samples will be increasingly valuable to these efforts. Data was collected through the NIH/NHGRI funded Centers of Excellence for ethical genomic research at the University of Washington in Seattle and Case Western Reserve University in Cleveland to identify issues that IRB members and genetic scientists confront in this new era of genomic research, with an emphasis on identifying areas of tension and common concern. However, a third and important component, the views of those participating in human genetic studies, were not evaluated. We hypothesize that the views and concerns of research participants, particularly those individuals with a condition or disease with a genetic component that runs in families, will differ from those of the IRB and researchers. Further, individuals with diseases with a genetic component may have different motivations for and concerns about participating in genetic research than the general population. It is important that these stakeholder views be included in discussions of protections in human genetic research studies. Thus, the primary purpose of this study is to identify the specific concerns and expectations of cancer registry participants regarding participation in genetic research. The results from the proposed project will provide critical insight into the views and concerns of individuals participating in an ongoing cancer registry whose biological samples and personal and medical history information will be increasingly valuable and sought after for genetic studies. By adding data on this important stakeholder group to data already obtained on IRB professionals and genetic researchers from a recently completed UW CEER project, the results may ultimately affect how genetic research studies are reviewed and conducted.