Managing Incidental Findings and Research Results in Genomic Biobanks and Archive

管理基因组生物库和档案中的偶然发现和研究结果

基本信息

批准号：
7736705
负责人：
SUSAN M. WOLF
金额：
$ 41.05万
依托单位：
UNIVERSITY OF MINNESOTA
依托单位国家：
美国
项目类别：
财政年份：
2005
资助国家：
美国
起止时间：
2005-09-26 至 2011-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7736705
关键词：
Address Administrator Advisory Committees Affect American Anxiety Architecture Archives Attention Authorization documentation Authorship Autistic Disorder Back Benefits and Risks Bibliography Biocompatible Materials Bioethics Bioinformatics Biological Blood Blood Pressure Brain California Canada Categories Centers for Disease Control and Prevention (U.S.)Characteristics Chin Church Clinic Clinical Code Cohort Studies Collection Communities Complex Computers Consensus Consent Consent Forms Counseling Country DNA DNA Databases DNA Library DNA analysis Data Data Analyses Data Set Databases Deposition Development Disclosure Disease Distant Educational workshop Electronic Mail England Enrollment Ethics Event Feedback Focus Groups Foundations Freezing Funding Future General Practitioners Genetic Genetic Databases Genetic Research Genetic screening method Genome Genomics Genotype Grant Guidelines Hand Health Health Personnel Health Professional Hospitals Housing Human Human Genetics Human Genome Human Subject Research Image Incidental Findings Individual Informatics Informed Consent Institution International Internet Investigation Journals Knowledge Large-Scale Sequencing Laws Legal Lesion Life Link Literature Measurement Medical Medical Records Medicine Methodology Minnesota Multiple Myeloma National Heart, Lung, and Blood Institute National Human Genome Research Institute Outcome Paper Participant Patient advocacy Pattern Persons Phenotype Physicians Policies Population Population Database Positioning Attribute Principles of law and justice Printing Process Public Health Publications Publishing Recommendation Recontacts Recording of previous events Regulation Reporting Research Research Design Research Ethics Research Ethics Committees Research Personnel Research Project Grants Research Subjects Resources Respondent Risk Sampling Scanning Schools Science Scientist Screening procedure Services Societies Source Specimen Stretching Structure Surveys Testing Time Tissue Sample Tissues To specify Transformed Cell Line Trust Uncertainty United States National Institutes of Health Universities Visit Voice Wolves Work advocacy organizations authority base biobank college common rule cost data sharing database of Genotypes and Phenotypes design feeding genome wide association study human DNA interest meetings melanoma member multidisciplinary neuroimaging non-genetic patient advocacy group population based public health relevance public trust repository reproductive research study sample collection symposium tool web site willingness working group

项目摘要

DESCRIPTION (provided by applicant): This 2-year renewal project builds on our previous NHGRI-funded project on "Managing Incidental Findings in Human Subjects Research" (#1 R01 HG003178-01A1). Using that project's outcomes as a foundation, we now propose a 2-year renewal project to address one of the most pressing issues facing genomic research: What information, if any, about incidental findings (IFs) and individual research results (IRRs) should be offered back to the individuals whose DNA and data are collected and housed in genomic biobanks and archived datasets? We will convene a multidisciplinary Working Group in order to develop normative consensus recommendations on managing IFs and IRRs in genomic research using biobanks and large archives. There are 10 components to this project: (1) identification of U.S. biobanks (defined in this project to include datasets and DNA samples archived for reanalysis) and websites where available; (2) collection of the relevant literature, guidelines, law, and regulations, including international guidelines and statements on biobank management; (3) collection and content analysis of biobank websites (including policy statements, consent forms, FAQs answers, and other informative material) to analyze approaches to IFs and return of IRRs; (4) collection and content analysis of relevant documents by emailing the manager or director of biobanks identified, including those with no or uninformative websites; (5) collection and content analysis of relevant non-U.S. documents from the websites of major international (non-U.S.) biobanks with websites in English and by email to the manager or director of each biobank; (6) development of normative consensus recommendations providing guidance on how to handle IFs and return of IRRs in genomic biobank research and soliciting feedback; (7) authorship of targeted analyses of this problem and the legal aspects; (8) presentation of consensus recommendations and targeted analyses at a public conference for feedback; (9) publication as a symposium in a prominent journal; and (10) development of a publicly available website containing tools for biobanks, their ethics oversight bodies, IRBs, researchers, research participants, scholars, and others on managing IFs and return of IRRs, including an annotated bibliography with web links. To accomplish this, the project will involve 3 methodologies: (A) a normative process to reach consensus on how IFs and IRRs should be managed in genomic research involving biobanks and archived samples and data, supported by (B) empirical and analytic research systematically collecting the relevant literature, guidance documents, regulations, and law, with structured content analysis of (a) the policy, informational, and consent documents publicly available on biobank websites, and (b) additional documents collected by email query from biobank managers and directors, and (C) international comparison of the policies on return of IFs and IRRs among major DNA biobanks with English-speaking websites. PUBLIC HEALTH RELEVANCE: In order to understand the genetic contribution to a host of diseases and conditions of great importance to public health, scientists are increasingly assembling large biobanks archiving many individuals' DNA and health information for scientific reanalysis over time. However, there is no clarity about what individual health information, if any, should be given back to those people generous enough to donate; some prominent biobanks are giving back none at all. This project will convene leading experts on bioethics, genomics, biobanking, and law to recommend ethical policies and practices on return of both incidental findings and individual research results that may have importance for the donor.

描述（由申请人提供）：这项为期两年的续签项目建立在我们以前由NHGRI资助的项目上建立在“管理人类受试者研究中的偶然发现”的项目（＃1 R01 HG003178-01A1）。现在，我们将该项目的结果作为基础，现在我们提出一个为期两年的更新项目，以解决基因组研究面临的最紧迫的问题之一：有关偶然发现（IFS）和个人研究结果（IRRS）的信息（如果有的话），则应将DNA和数据收集到基因组生物群中和数据组生物群和数据库中的个人和数据库中。我们将召集一个多学科工作组，以制定有关使用生物库和大型档案馆管理基因组研究IF和IRS的规范性共识建议。该项目有10个组成部分：（1）识别美国生物库（该项目中定义为包括数据集和存档以重新分析的DNA样本）和可用的网站；（2）收集相关文献，指南，法律和法规，包括国际生物库管理指南和声明；（3）生物库网站的收集和内容分析（包括政策声明，同意书，常见问题解答答案和其他信息材料），以分析IFS和IRR返回的方法；（4）通过通过电子邮件发送和内容分析的相关文档通过电子邮件发送确定的生物银行的经理或主管，包括没有或不信息网站的文档；（5）从主要国际（非美国）网站的相关非美国文档收集和内容分析，其网站使用英语网站，并通过电子邮件发送给每个生物库的经理或主管；（6）制定规范性共识建议，为如何处理IFS和基因组生物库研究中的IRS返回提供指导；（7）对该问题和法律方面的有针对性分析的作者；（8）在公共反馈会议上提出共识建议和有针对性的分析；（9）在著名期刊中作为研讨会出版；（10）开发一个公开的网站，其中包含用于生物库的工具，他们的道德监督机构，IRB，研究人员，研究参与者，学者以及其他有关管理IFS和返回IRS的人，包括带有Web链接的注释书目。为此，该项目将涉及3种方法：（a）在涉及生物库，归档样本和数据的基因组研究中如何管理IF和IRS的规范过程，并在（b）经验和分析研究中支持，以系统地收集相关文献，指导文献，指导文档，策略和结构性分析（结构性分析）（一项），（A）生物银行网站以及（b）由生物银行经理和董事通过电子邮件查询收集的其他文件，以及（c）在主要的DNA生物库与英语网站中IFS和IRR返回政策的国际比较。公共卫生相关性：为了了解对许多疾病和对公共卫生非常重要的疾病和条件的遗传贡献，科学家越来越多地组装大型生物库来存档许多人的DNA和健康信息，以进行科学重新分析。但是，尚不清楚哪些个人健康信息（如果有的话）应给那些足够慷慨捐赠的人。一些突出的生物库根本没有回馈。该项目将召集有关生物伦理学，基因组学，生物群和法律的领先专家，以推荐有关偶然发现的返回和个人研究结果的道德政策和实践，这可能对捐助者具有重要意义。