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: 8235826
• 负责人: KAREN L EDWARDS
• 金额: $ 38.36万
• 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/8235826
• 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. 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)进行基因研究的方案在数量和复杂性上都在增加。此外，现在人们认识到，要了解遗传易感性，包括与环境因素的相互作用，研究将需要大量样本。对大型研究的需要将导致更多地使用来自储存库和大型疾病登记机构的现有数据，并将在IRB批准人类基因研究方面提出新的问题。虽然正在努力了解公众对基因研究的看法，但人们对已经在现有登记中登记的参与者的看法知之甚少，他们的样本对这些努力将越来越有价值。数据是通过西雅图华盛顿大学和克利夫兰凯斯西部储备大学由NIH/NHGRI资助的伦理基因组研究英才中心收集的，以确定IRB成员和基因科学家在这个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，即那些参与人类基因研究的人的观点，没有得到评估。我们假设，研究参与者的观点和担忧将与IRB和研究人员的观点和担忧不同，特别是那些患有家族遗传成分的疾病或疾病的人。此外，带有基因成分的疾病患者参与基因研究的动机和担忧可能与普通人群不同。重要的是，这些利益相关者的观点应包括在人类基因研究中关于保护的讨论中。因此，这项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切和期望。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重要的洞察，该登记的生物样本以及个人和病史信息将在基因研究中越来越有价值和受到追捧。通过将关于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，结果可能最终会影响对基因研究研究的审查和进行方式。 公共卫生相关性：这个项目的潜在好处是更好地理解参与研究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观点，结果可能最终会影响基因研究研究的审查和进行方式。