Identification of Issues and Expectations of Subjects Participating in Genetic St

参与遗传研究的受试者的问题和期望的确定

• 批准号: 8444604
• 负责人: KAREN L EDWARDS
• 金额: $ 11.15万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-01 至 2013-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8444604
• 关键词: Affect; Area; Biological; Confidentiality; Consensus; DNA; Data; Databases; Disease; Enrollment; Ensure; Environmental Risk Factor; Ethics; Family; First Degree Relative; Funding; General Population; Genes; Genetic; Genetic Predisposition to Disease; Genetic Research; Genomics; Hereditary Disease; Human Genetics; Individual; Institution; Institutional Review Boards; Interview; Malignant Neoplasms; Medical History; Motivation; National Human Genome Research Institute; Online Systems; Participant; Policies; Process; Protocols documentation; Recontacts; Registries; Relative (related person); Research; Research Personnel; Research Project Grants; Resolution; Risk; Running; Sample Size; Sampling; Scientist; Surveys; Translations; United States National Institutes of Health; Universities; Washington; Work; cancer genetics; cancer type; cost effective; data sharing; database of Genotypes and Phenotypes; disease registry; expectation; experience; insight; member; multidisciplinary; neoplasm registry; novel; public health relevance; repository; research study; response

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.

描述（由申请人提供）：提交给机构审查委员会（IRB）的基因研究方案的数量和复杂性都在增加。 此外，现在人们认识到，为了了解遗传易感性，包括与环境因素的相互作用，研究将需要大量样本。 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 IRB 批准人类遗传学研究方面提出新问题。 虽然人们正在努力了解公众对基因研究的看法，但人们对已经在既定登记处登记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伦理基因组研究卓越中心收集的，旨在确定 IRB 成员和遗传科学家在基因组研究新时代面临的问题，重点是确定紧张和共同关心的领域。 然而，第三个重要组成部分，即参与人类遗传学研究的人的观点，却没有得到评估。 我们假设研究参与者的观点和担忧，特别是那些患有具有家族遗传成分的病症或疾病的个体，将与 IRB 和研究人员的观点和担忧不同。 此外，患有具有遗传成分的疾病的个体可能对参与基因研究有与一般人群不同的动机和担忧。 重要的是，将这些利益相关者的观点纳入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担忧提供重要的见解，这些个人的生物样本以及个人和病史信息将越来越有价值并受到基因研究的追捧。 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华盛顿大学 CEER 项目中已获得的 IRB 专业人员和基因研究人员的数据中，结果可能最终会影响基因研究的审查和进行方式。