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：
7938783
负责人：
SUSAN M. WOLF
金额：
$ 49.6万
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/7938783
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.

描述（由申请人提供）：这个为期 2 年的更新项目建立在我们之前由 NHGRI 资助的“管理人类受试者研究中的偶然发现”项目 (#1 R01 HG003178-01A1) 的基础上。以该项目的成果为基础，我们现在提出一个为期 2 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：关于偶然发现 (IF) 和个人研究结果 (IRR) 的哪些信息（如果有）应该被记录在案。提供给那些 DNA 和数据被收集并存放在基因组生物库和存档数据集中的个人？我们将召集一个多学科工作组，以便就使用生物样本库和大型档案管理基因组研究中的 IF 和 IRR 制定规范性共识建议。该项目由 10 个组成部分组成：(1) 确定美国生物库（本项目中定义为包括存档用于再分析的数据集和 DNA 样本）和网站（如果有）；（2）相关文献、指南、法律法规的收集，包括生物样本库管理的国际指南和声明； (3) 生物样本库网站的收集和内容分析（包括政策声明、同意书、常见问题解答和其他信息材料），以分析 IF 和 IRR 回报的方法； (4) 通过向已确定的生物样本库经理或主管发送电子邮件收集相关文件并进行内容分析，包括那些没有网站或信息不丰富的生物样本库；（5）从主要国际（非美国）生物样本库的英文网站收集相关非美国文件并进行内容分析，并通过电子邮件发送给每个生物样本库的经理或董事； (6) 制定规范性共识建议，为基因组生物库研究中如何处理 IF 和 IRR 回报提供指导并征求反馈；（7）对该问题及其法律方面进行针对性分析的作者；（八）在公开会议上提出共识建议和针对性分析以征求反馈； (9) 在著名期刊上发表研讨会论文； (10) 开发一个公开网站，其中包含供生物样本库、其道德监督机构、IRB、研究人员、研究参与者、学者和其他人使用的有关管理 IF 和 IRR 返还的工具，包括带有网络链接的带注释的参考书目。为了实现这一目标，该项目将涉及 3 种方法：(A) 规范流程，就如何在涉及生物样本库和存档样本和数据的基因组研究中管理 IF 和 IRR 达成共识，并得到 (B) 系统收集的实证和分析研究的支持相关文献、指导文件、法规和法律，并对 (a) 生物样本库网站上公开提供的政策、信息和同意文件，以及 (b) 通过电子邮件查询从生物样本库经理和董事处收集的其他文件进行结构化内容分析， (C) 主要 DNA 生物样本库与英文网站的 IF 和 IRR 返还政策的国际比较。