de Vries Jantina, Williams Thomas N, Bojang Kalifa, Kwiatkowski Dominic P, Fitzpatrick Raymond, Parker Michael
Department of Medicine, University of Cape Town, Anzio Road Observatory, Cape Town 7925, South Africa.
BMC Med Ethics. 2014 Aug 13;15:62. doi: 10.1186/1472-6939-15-62.
The practice of making datasets publicly available for use by the wider scientific community has become firmly integrated in genomic science. One significant gap in literature around data sharing concerns how it impacts on scientists' ability to preserve values and ethical standards that form an essential component of scientific collaborations. We conducted a qualitative sociological study examining the potential for harm to ethnic groups, and implications of such ethical concerns for data sharing. We focused our empirical work on the MalariaGEN Consortium, one of the first international collaborative genomics research projects in Africa.
We conducted a study in three MalariaGEN project sites in Kenya, the Gambia, and the United Kingdom. The study entailed analysis of project documents and 49 semi-structured interviews with fieldworkers, researchers and ethics committee members.
Concerns about how best to address the potential for harm to ethnic groups in MalariaGEN crystallised in discussions about the development of a data sharing policy. Particularly concerning for researchers was how best to manage the sharing of genomic data outside of the original collaboration. Within MalariaGEN, genomic data is accompanied by information about the locations of sample collection, the limitations of consent and ethics approval, and the values and relations that accompanied sample collection. For interviewees, this information and context were of important ethical value in safeguarding against harmful uses of data, but is not customarily shared with secondary data users. This challenged the ability of primary researchers to protect against harmful uses of 'their' data.
We identified three protective mechanisms--trust, the existence of a shared morality, and detailed contextual understanding--which together might play an important role in preventing the use of genomic data in ways that could harm the ethnic groups included in the study. We suggest that the current practice of sharing of datasets as isolated objects rather than as embedded within a particular scientific culture, without regard for the normative context within which samples were collected, may cause ethical tensions to emerge that could have been prevented or addressed had the 'ethical metadata' that accompanies genomic data also been shared.
将数据集公开以供更广泛的科学界使用的做法已牢固地融入基因组科学之中。围绕数据共享的文献中一个显著差距在于，它如何影响科学家维护构成科学合作重要组成部分的价值观和道德标准的能力。我们开展了一项定性社会学研究，考察对族群造成伤害的可能性，以及此类伦理问题对数据共享的影响。我们将实证研究聚焦于疟疾基因组学联盟（MalariaGEN Consortium），这是非洲最早的国际合作基因组学研究项目之一。
我们在肯尼亚、冈比亚和英国的三个疟疾基因组学项目地点开展了研究。该研究包括对项目文件的分析以及对实地工作者、研究人员和伦理委员会成员的49次半结构化访谈。
在关于制定数据共享政策的讨论中，如何最好地应对疟疾基因组学中对族群造成伤害的可能性这一问题变得明晰起来。研究人员特别关注的是，如何最好地管理原始合作之外的基因组数据共享。在疟疾基因组学联盟内部，基因组数据伴随着样本采集地点的信息、同意和伦理批准的局限性，以及样本采集时的价值观和关系。对于受访者而言，这些信息和背景在防止数据被有害使用方面具有重要的伦理价值，但通常不会与二次数据使用者共享。这对主要研究人员保护“他们的”数据不被有害使用的能力构成了挑战。
我们确定了三种保护机制——信任、共享道德的存在以及详细的背景理解——它们共同可能在防止以可能伤害研究中所涵盖族群的方式使用基因组数据方面发挥重要作用。我们建议，当前将数据集作为孤立对象而非嵌入特定科学文化中进行共享的做法，且不考虑样本采集时的规范背景，可能会引发本可通过共享基因组数据所附带的“伦理元数据”而得以预防或解决的伦理紧张关系。
