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

Isabelle Budin-Ljøsne*, Paul Burton, Julia Isaeva, Amadou Gaye, Andrew Turner, Madeleine J. Murtagh, Susan Wallace, Vincent Ferretti, Jennifer R. Harris

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

13 Citations (Scopus)
344 Downloads (Pure)

Abstract

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 multidisciplinary 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.

Original languageEnglish
Pages (from-to)87-96
Number of pages10
JournalPublic health genomics
Volume18
Issue number2
DOIs
Publication statusPublished - 6 Mar 2015

Bibliographical note

Accepted: October 8, 2014
Published online: December 13, 2014

Keywords

  • Biobank
  • Data sharing
  • DataSHIELD
  • Epidemiological research
  • Ethics
  • IRB review
  • Statistical analysis

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