title: Protecting personal data in epidemiological research: DataSHIELD and UK law.
abstract: BACKGROUND
  Data from individual collections, such as biobanks and cohort studies, are now being shared in order to create combined datasets which can be queried to ask complex scientific questions. But this sharing must be done with due regard for data protection principles. DataSHIELD is a new technology that queries nonaggregated, individual-level data in situ but returns query data in an anonymous format. This raises questions of the ability of DataSHIELD to adequately protect participant confidentiality.
  
  
  METHODS
  An ethico-legal analysis was conducted that examined each step of the DataSHIELD process from the perspective of UK case law, regulations, and guidance.
  
  
  RESULTS
  DataSHIELD reaches agreed UK standards of protection for the sharing of biomedical data. All direct processing of personal data is conducted within the protected environment of the contributing study; participating studies have scientific, ethics, and data access approvals in place prior to the analysis; studies are clear that their consents conform with this use of data, and participants are informed that anonymisation for further disclosure will take place.
  
  
  CONCLUSIONS
  DataSHIELD can provide a flexible means of interrogating data while protecting the participants' confidentiality in accordance with applicable legislation and guidance.
authors.affiliation: Department of Health Sciences, University of Leicester, Leicester, UK.
authors.forename: Susan E
authors.initials: SE
authors.lastname: Wallace
authors.forename: Amadou
authors.initials: A
authors.lastname: Gaye
authors.forename: Osama
authors.initials: O
authors.lastname: Shoush
authors.forename: Paul R
authors.initials: PR
authors.lastname: Burton
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000379:methods / Q000592:standards*; D015331:Cohort Studies; D016494:Computer Security / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards*; D003219:Confidentiality / Q000941:ethics* / Q000331:legislation & jurisprudence* / Q000592:standards; D016208:Databases, Factual; D016021:Epidemiologic Studies; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D012107:Research Design; D006113:United Kingdom