Data Release Policies for Genomics: Legal and Ethical Issues

描述(由申请人提供)： 美国国立卫生研究院资助的许多项目都受到明确的数据发布政策的管辖。这类项目包括：任何每年直接成本超过50万美元的项目，任何全基因组关联研究，以及大多数社区资源项目。(与假设驱动的研究不同，社区资源项目从一开始就是为了产生对更广泛的科学界有用的数据和材料而设计的，是成本高昂的大型项目。)数据发布政策在科学家中引起了争议和困惑，特别是当问题数据来自人类时。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，科学家和道德监督人员可能会认为，如果公开这些数据，可能会造成潜在危害。目前受欢迎的敏感数据发布选择涉及“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，以及向用户传达数据限制。每个获得资助的项目都制定了自己的具体数据发布计划。该试点项目将为数据发布政策和计划产生各种选择，特别强调全基因组数据的发布。它将通过以下方式做到这一点：(1)对曾致力于制定数据发布政策的人、实施数据发布政策/计划的个人以及在这些政策/计划下工作的研究人员进行约20次访谈；(2)利用行政法学者开发的治理方法，生成和评估各种发布人类数据，特别是基因组数据的选项。这些政策选择将在至少两篇文章中传播，并通过在学术会议和公开会议上发表演讲来传播。该项目产生的数据和学术成果将为更大规模的实证研究和政策规划会议提供基础。该项目的提案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，最大限度地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，因为大型数据集的效用和社会价值取决于它们的可用性。数据发布政策决定了利用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，同时保护数据创建者的权益。

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.