title: DataSHIELD: an ethically robust solution to multiple-site individual-level data analysis.
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.
  
  
  CONCLUSIONS
  DataSHIELD can provide an innovative and robust solution for addressing commonly encountered ethics-related data-sharing concerns.
authors.affiliation: Division of Epidemiology, Department of Genes and Environment, Norwegian Institute of Public Health, Oslo, Norway.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Budin-Ljøsne
authors.forename: Paul
authors.initials: P
authors.lastname: Burton
authors.forename: Julia
authors.initials: J
authors.lastname: Isaeva
authors.forename: Amadou
authors.initials: A
authors.lastname: Gaye
authors.forename: Andrew
authors.initials: A
authors.lastname: Turner
authors.forename: Madeleine J
authors.initials: MJ
authors.lastname: Murtagh
authors.forename: Susan
authors.initials: S
authors.lastname: Wallace
authors.forename: Vincent
authors.initials: V
authors.lastname: Ferretti
authors.forename: Jennifer R
authors.initials: JR
authors.lastname: Harris
mesh_terms: D022126:Access to Information; D035843:Biomedical Research / Q000941:ethics* / Q000379:methods; D003219:Confidentiality / Q000941:ethics; D003625:Data Collection / Q000941:ethics / Q000379:methods; D016208:Databases, Factual / Q000941:ethics*; D028744:Ethics Committees, Research; D006801:Humans; D033181:Information Dissemination / Q000941:ethics / Q000379:methods