International Data Sharing in Practice: New Technologies Meet Old Governance
International Data Sharing in Practice: New Technologies Meet Old Governance
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DOI：
10.1089/bio.2016.0002
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发表时间：
2016-06-01
影响因子：
1.6
通讯作者：
Burton, Paul R.
中科院分区：
文献类型：
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作者：
Murtagh, Madeleine J.;Turner, Andrew;Burton, Paul R.
管理数据/样本发布的社会结构旨在保护队列研究参与者的机密性和隐私（没有他们就没有数据或样本），并通过优化这些队列的科学使用实现社会效益。然而，在涉及多个队列和生物库的合作中，地方、国家和超国家的机构和法律的研究指南（产生了多种数据访问治理结构和指南）有可能阻碍作为这些联盟存在理由的科学。我们提出了一个民族志研究，研究了认知和非认知价值驱动的数据访问及其后果的背景下，试点的综合方法来共同分析数据的决定。我们展示了这种方法所提供的潜在分析灵活性是如何在当代数据访问治理下丢失的。我们确定了三个主导价值观：保护研究参与者，保护研究，保护研究人员。这些价值观既得到公益论点的支持，也与公益论点并列，每一个价值观都被用作促进和抑制数据共享的理由。虽然保护研究参与者是访问许可的核心，但决定也注意到研究人员希望看到他们建立人口生物库和群组的努力以科学产出的形式实现的愿望。我们的结论是，在大型联盟中管理和实现数据访问的系统需要（1）保护研究参与者信息或身份的披露，（2）确保研究参与者的特定期望得到满足，（3）体现透明的审查系统，不受特定利益相关者群体的特定利益的影响，及（4）促进及时及有效率的查阅资料程序。迫切需要切实可行的解决办法。数据访问治理的新方法应该在利益相关者的投入和讨论下进行试验（和正式评估）。
The social structures that govern data/sample release aim to safeguard the confidentiality and privacy of cohort research participants (without whom there would be no data or samples) and enable the realization of societal benefit through optimizing the scientific use of those cohorts. Within collaborations involving multiple cohorts and biobanks, however, the local, national, and supranational institutional and legal guidelines for research (which produce a multiplicity of data access governance structures and guidelines) risk impeding the very science that is the raison d'etre of these consortia. We present an ethnographic study, which examined the epistemic and nonepistemic values driving decisions about data access and their consequences in the context of the pilot of an integrated approach to co-analysis of data. We demonstrate how the potential analytic flexibility offered by this approach was lost under contemporary data access governance. We identify three dominant values: protecting the research participant, protecting the study, and protecting the researcher. These values were both supported by and juxtaposed against a public good argument, and each was used as a rationale to both promote and inhibit sharing of data. While protection of the research participants was central to access permissions, decisions were also attentive to the desire of researchers to see their efforts in building population biobanks and cohorts realized in the form of scientific outputs. We conclude that systems for governing and enabling data access in large consortia need to (1) protect disclosure of research participant information or identity, (2) ensure the specific expectations of research participants are met, (3) embody systems of review that are transparent and not compromised by the specific interests of one particular group of stakeholders, and (4) facilitate data access procedures that are timely and efficient. Practical solutions are urgently needed. New approaches to data access governance should be trialed (and formally evaluated) with input from and discussion with stakeholders.