Toward Ethical Provenance Tracking: The GA4GH Model Data Access Agreement (DAA).

IF 6.2 1区医学 Q1 GENETICS & HEREDITY

Genetics in Medicine Pub Date : 2025-10-01 DOI:10.1016/j.gim.2025.101594

Alexander Bernier, Bartha Maria Knoppers, Jonathan Lawson, Robyn McDougall, Maili Raven-Adams, Vasiliki Rahimzadeh

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引用次数: 0

Abstract

Purpose: Standardizing contractual clauses that govern data access enables research institutions to responsibly steward genomic and related health data while enabling its efficient downstream re-use.

Methods: We describe a document analysis study using both qualitative and comparative law analytical approaches to identify the most common categories of clauses from 29 different data access agreements used by human biomedical research consortia globally. We furthermore characterized the legal positions and standard practices for each common element of the agreement and synthesized across them to develop model clauses. Three discussion sessions were organized virtually to refine the clauses among members of the Ethical Provenance Subgroup of the Global Alliance for Genomics and Health.

Results: We developed 15 unique data access clauses corresponding to the most common legal elements identified in the sampled agreements.

Conclusions: Model clauses can be used to drive administrative efficiencies and institutional compliance for managing access to human genomic data for research. Additional machine-readable consents and software solutions are needed to support traceable 'ethical provenance' of human genomic data and communicate data use conditions throughout data's life-cycle.

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伦理溯源追踪：GA4GH模型数据访问协议（DAA）。

目的：使管理数据访问的合同条款标准化，使研究机构能够负责任地管理基因组和相关健康数据，同时使其能够在下游得到有效再利用。方法：我们描述了一项文献分析研究，使用定性和比较法分析方法，从全球人类生物医学研究联盟使用的29种不同的数据访问协议中确定最常见的条款类别。我们进一步描述了协议中每个共同要素的法律立场和标准做法，并将它们综合起来形成示范条款。在全球基因组学和健康联盟的伦理来源小组成员之间组织了三次虚拟讨论会，以完善这些条款。结果：我们制定了15个独特的数据访问条款，对应于抽样协议中确定的最常见的法律要素。结论：模型条款可用于提高管理效率和机构合规性，以管理用于研究的人类基因组数据的获取。需要额外的机器可读同意书和软件解决方案来支持人类基因组数据的可追溯“道德来源”，并在数据的整个生命周期内传达数据使用条件。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Genetics in Medicine 医学-遗传学

CiteScore

15.20

自引率

6.80%

发文量

857

审稿时长

1.3 weeks

期刊介绍： Genetics in Medicine (GIM) is the official journal of the American College of Medical Genetics and Genomics. The journal''s mission is to enhance the knowledge, understanding, and practice of medical genetics and genomics through publications in clinical and laboratory genetics and genomics, including ethical, legal, and social issues as well as public health. GIM encourages research that combats racism, includes diverse populations and is written by authors from diverse and underrepresented backgrounds.