Considerations for ethics review of big data health research: A scoping review.
Considerations for ethics review of big data health research: A scoping review.
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DOI：
10.1371/journal.pone.0204937
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发表时间：
2018
期刊：
影响因子：
3.7
通讯作者：
Vayena E
中科院分区：
文献类型：
--
作者：
Ienca M;Ferretti A;Hurst S;Puhan M;Lovis C;Vayena E
生物医学和健康研究中的大数据趋势使得异构数据源能够进行大规模、多维度的聚合和分析，最终可能带来预防、诊断和治疗的益处。大数据健康研究的方法新颖性和计算复杂性给伦理审查提出了新的挑战。在这项研究中，我们使用五个数据库对文献进行了范围审查，以确定和绘制道德审查委员会 (ERC) 或类似机构审查委员会健康相关大数据的主要挑战。初步确定了 1093 篇出版物，其中 263 篇由两名研究人员独立进行摘要和全文筛选后纳入最终综合。对综合中包含的所有文章的全文进行了描述性数字总结和主题分析。我们的研究结果表明，虽然生物医学的大数据趋势具有推进临床研究、改善预防和优化医疗保健服务的潜力，但需要仔细考虑一些认知、科学和规范方面的挑战。这些挑战与 ERC 的组成以及 ERC 成员在评估健康相关大数据研究的方法和伦理可行性时应采用的评估标准相关。基于此分析，我们就 ERC 如何适应性应对这些挑战提供了一些初步建议。这项探索旨在为参与健康相关大数据研究开展和/或评估的研究人员、ERC 和相关机构综合有用信息。
Big data trends in biomedical and health research enable large-scale and multi-dimensional aggregation and analysis of heterogeneous data sources, which could ultimately result in preventive, diagnostic and therapeutic benefit. The methodological novelty and computational complexity of big data health research raises novel challenges for ethics review. In this study, we conducted a scoping review of the literature using five databases to identify and map the major challenges of health-related big data for Ethics Review Committees (ERCs) or analogous institutional review boards. A total of 1093 publications were initially identified, 263 of which were included in the final synthesis after abstract and full-text screening performed independently by two researchers. Both a descriptive numerical summary and a thematic analysis were performed on the full-texts of all articles included in the synthesis. Our findings suggest that while big data trends in biomedicine hold the potential for advancing clinical research, improving prevention and optimizing healthcare delivery, yet several epistemic, scientific and normative challenges need careful consideration. These challenges have relevance for both the composition of ERCs and the evaluation criteria that should be employed by ERC members when assessing the methodological and ethical viability of health-related big data studies. Based on this analysis, we provide some preliminary recommendations on how ERCs could adaptively respond to those challenges. This exploration is designed to synthesize useful information for researchers, ERCs and relevant institutional bodies involved in the conduction and/or assessment of health-related big data research.
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DOI：
10.1097/ede.0b013e31823b66b8
发表时间：
2012-01
期刊：
Epidemiology (Cambridge, Mass.)
影响因子：
--
作者：
DellaValle CT;Triche EW;Leaderer BP;Bell ML
通讯作者：
Bell ML
影响因子：
9.7
作者：
Bates, David W.;Saria, Suchi;Escobar, Gabriel
通讯作者：
Escobar, Gabriel
DOI：
10.1109/jbhi.2015.2450362
发表时间：
2015-07-01
影响因子：
7.7
作者：
Andreu-Perez, Javier;Poon, Carmen C. Y.;Yang, Guang-Zhong
通讯作者：
Yang, Guang-Zhong
DOI：
10.1186/s12940-015-0057-0
发表时间：
2015-08-27
期刊：
Environmental health : a global access science source
影响因子：
--
作者：
Ito K;Weinberger KR;Robinson GS;Sheffield PE;Lall R;Mathes R;Ross Z;Kinney PL;Matte TD
通讯作者：
Matte TD
影响因子：
2.9
作者：
Dimitrov DV
通讯作者：
Dimitrov DV