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: 8041136
• 负责人: KAREN L EDWARDS
• 金额: $ 42.57万
• 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 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8041136
• 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; 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. PUBLIC HEALTH RELEVANCE: The potential benefit of this project is a better understanding of the views and concerns of the individuals who are participating in research studies. By including the views of this stakeholder group, 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）的遗传研究方案的数量和复杂性都在增加。 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储存库和大型疾病登记处的现有数据，并将提出关于IRB批准人类遗传研究的新问题。 虽然正在努力了解公众对遗传研究的看法，但对已登记的参与者的看法知之甚少，而这些参与者的样本对这些努力将越来越有价值。 通过NIH/NHGRI资助的位于西雅图的华盛顿大学和克利夫兰的凯斯西储大学的伦理基因组研究卓越中心收集数据，以确定IRB成员和遗传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，即参与人类遗传研究的人的观点，没有得到评估。 我们假设，研究参与者的观点和担忧，特别是那些患有家族遗传成分疾病的个体，将与IRB和研究人员的观点和担忧不同。 此外，与一般人群相比，患有具有遗传成分的疾病的个人可能对参与遗传研究有不同的动机和关注。 重要的是，这些利益攸关方的意见应纳入关于人类遗传研究保护问题的讨论。 因此，本研究的主要目的是确定癌症登记参与者对参与遗传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注提供重要的见解，这些个人的生物样本和个人及病史信息将越来越有价值，并为遗传研究所追捧。 通过将这一重要利益相关者群体的数据添加到从最近完成的UW CEER项目中获得的IRB专业人员和遗传研究人员的数据中，结果可能最终影响遗传研究的审查和进行。 公共卫生相关性：该项目的潜在好处是更好地了解参与研究的个人的观点和关切。 通过纳入这一利益相关者群体的意见，结果可能最终影响遗传研究的审查和进行。