DataSHIELD: An Ethically Robust Solution to Multiple-Site Individual-Level Data Analysis

被引：26

作者：

Budin-Ljosne, Isabelle ^{[1
]}

Burton, Paul ^{[2
,3
]}

Isaeva, Julia ^{[1
]}

Gaye, Amadou ^{[2
,3
]}

Turner, Andrew ^{[2
,3
]}

Murtagh, Madeleine J. ^{[2
,3
]}

Wallace, Susan ^{[3
]}

Ferretti, Vincent ^{[4
]}

Harris, Jennifer R. ^{[1
]}

机构：

[1] Norwegian Inst Publ Hlth, Dept Genes & Environm, Div Epidemiol, NO-0403 Oslo, Norway

[2] Univ Bristol, Sch Social & Community Med, Bristol, Avon, England

[3] Univ Leicester, Dept Hlth Sci, Leicester, Leics, England

[4] Ontario Inst Canc Res MaRS Ctr, Toronto, ON, Canada

来源：

PUBLIC HEALTH GENOMICS | 2015年 / 18卷 / 02期

基金：

英国惠康基金;

关键词：

Biobank; Data sharing; DataSHIELD; Epidemiological research; Ethics; IRB review; Statistical analysis; RESEARCH PARTICIPANTS PERSPECTIVES; GENOME-WIDE ASSOCIATION; INCIDENTAL FINDINGS; PRIVACY; EXPERIENCE; BIG; EPIDEMIOLOGY;

D O I：

10.1159/000368959

中图分类号：

Q3 [遗传学];

学科分类号：

071007 ; 090102 ;

摘要：

Background: DataSHIELD (Data Aggregation Through Anonymous Summary-statistics from Harmonised Individual levEL Databases) has been proposed to facilitate the co-analysis of individual-level data from multiple studies without physically sharing the data. In a previous paper, we investigated whether DataSHIELD could protect participant confidentiality in accordance with UK law. In this follow-up paper, we investigate whether DataSHIELD addresses a broader range of ethics-related data-sharing concerns. Methods: Ethics-related data-sharing concerns of Institutional Review Boards, ethics experts, international research consortia and research participants were identified through a literature search and systematically examined at a multi-disciplinary workshop to determine whether DataSHIELD proposes mechanisms which can address these concerns. Results: DataSHIELD addresses several ethics-related data-sharing concerns related to privacy, confidentiality, and the protection of the research participant's rights while sharing data and after the data have been shared. The data remain entirely under the direct management of the study that collected them. Data processing commands are strictly supervised, and the data are queried in a protected environment. Issues related to the return of individual research results when data are shared are eliminated; the responsibility for return remains at the study of origin. Conclusion: DataSHIELD can provide an innovative and robust solution for addressing commonly encountered ethics-related data-sharing concerns. (C) 2014 S. Karger AG, Basel

引用

页码：87 / 96

页数：10

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