Data Release Policies for Genomics: Legal and Ethical Issues

基因组学数据发布政策：法律和道德问题

• 批准号: 7876501
• 负责人: Pilar N. Ossorio
• 金额: $ 7.43万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-28 至 2012-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7876501
• 关键词: Attention; Communities; Confidentiality; Confusion; Consent; Data; Data Set; Direct Costs; Empirical Research; Ethical Issues; Ethics; Funding; Genome; Genomics; Human; Human Genetics; Human Resources; Incentives; Individual; Interview; Investments; Laws; Legal; Monitor; Paper; Participant; Patient advocacy; Persons; Pilot Projects; Policies; Policy Making; Privacy; Process; Public Health; Research; Research Infrastructure; Research Personnel; Research Proposals; Resources; Rights; Scholarship; Science; Scientist; Social Values; Support Groups; United States National Institutes of Health; Work; base; data sharing; design; genome wide association study; human data; improved; innovation; interest; journal article; knowledge base; member; public health relevance; quality assurance; symposium

DESCRIPTION (provided by applicant): A significant number of NIH-funded projects are under the jurisdiction of an explicit data release policy. Such projects include: any project with direct costs of more than $500,00 per year, any genome-wide association study, and most community resource projects. (Community resource projects are large, costly projects designed from the outset to produce data and materials that will be of use to the broader scientific community, in contrast to hypothesis driven research.) Data release policies have generated controversy and confusion among scientists, particularly when the data in question come from human beings. Policies that favor public data release may be contravened by promises of privacy and confidentiality made to human research participants during the consent process. Whole genome data from humans raises particular problems, because it probably cannot be anonymized. Thus, scientists and ethics oversight personnel may view these data as potentially harmful if publicly released. The currently favored option for release of sensitive data involves a "controlled access" mechanism, which involves an administrative infrastructure for ascertaining who wants to use the data and for what purpose, and for communicating data restrictions to users. Each funded project develops its own specific data release plan. This pilot project will generate a variety of options for data release policies and plans, with a particular emphasis on release of whole genome data. It will do so by: (1) conducting approximately 20 interviews among people who have worked to develop data release policies, individuals who implement data release policies/plans, and researchers who work under these policies/plans; (2) using approaches to governance that have been developed by administrative law scholars, generate and evaluate a variety of options for releasing data from humans, particularly genomic data. These policy options will be disseminated in at least two articles, and through presentations at scholarly and public conferences. The data and scholarship generated in this project will provide the basis for larger empirical studies and policy planning conferences. The proposals of this project will pay particular attention to protecting the privacy and confidentiality interests of research participants, and to designing oversight processes that minimize administrative burdens on science. PUBLIC HEALTH RELEVANCE: This project has high public health significance because the utility and social value of large data sets depends on their availability. Data release policies determine the extent to which the large volumes of data that are generated with public funding are available for analysis by a wide variety of researchers. This project will design policies that promote rapid, broad data sharing while protecting the rights and interests of persons from whom the data were generated.

描述（由申请人提供）： 大量NIH资助的项目都有明确的数据发布政策。这些项目包括：每年直接费用超过50万美元的任何项目，任何全基因组关联研究，以及大多数社区资源项目。（社区资源项目是从一开始就设计的大型，昂贵的项目，旨在产生对更广泛的科学界有用的数据和材料，与假设驱动的研究相反。数据发布政策在科学家中引起了争议和困惑，特别是当所讨论的数据来自人类时。在同意过程中向人类研究参与者做出的隐私和保密承诺可能会违反有利于公开数据发布的政策。来自人类的全基因组数据带来了特别的问题，因为它可能无法匿名。因此，科学家和伦理监督人员可能会认为这些数据如果公开发布可能有害。目前较为青睐的敏感数据发布选项涉及“受控访问”机制，该机制涉及一个行政基础设施，用于确定谁想要使用数据以及用于什么目的，并用于向用户传达数据限制。每个受资助的项目都制定了自己的具体数据发布计划。 这一试点项目将为数据发布政策和计划提供多种选择，特别强调全基因组数据的发布。为此，它将：（1）对制定数据发布政策的人员、实施数据发布政策/计划的人员以及根据这些政策/计划工作的研究人员进行约20次访谈;（2）使用行政法学者开发的治理方法，生成并评估各种方案，以发布人类数据，特别是基因组数据。这些政策选择将在至少两篇文章中传播，并通过在学术和公共会议上的演讲进行传播。该项目产生的数据和学术成果将为更大规模的经验研究和政策规划会议提供基础。该项目的建议将特别注意保护研究参与者的隐私和保密利益，并设计监督程序，尽量减少对科学的行政负担。 公共卫生相关性： 该项目具有很高的公共卫生意义，因为大型数据集的实用性和社会价值取决于其可用性。数据发布政策决定了公共资金产生的大量数据在多大程度上可供各种研究人员分析。该项目将制定政策，促进快速、广泛的数据共享，同时保护数据生成者的权利和利益。