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Protecting personal data in epidemiological research: DataSHIELD and UK law
Susan E Wallace1, Amadou Gaye, Osama Shoush
1Department of Health Sciences, University of Leicester, Leicester, UK.
Public Health Genomics
|April 2, 2014
Summary
DataSHIELD technology enables secure sharing of individual-level biomedical data for research. It protects participant confidentiality according to UK legal standards, ensuring data privacy during analysis.
Area of Science:
- Biomedical data sharing
- Bioinformatics
- Data privacy
Background:
- Individual-level data from biobanks and cohort studies are increasingly shared for complex research.
- Data protection principles are crucial during data sharing.
- DataSHIELD queries individual-level data in situ, returning anonymous results, raising confidentiality concerns.
Purpose of the Study:
- To assess the ethico-legal compliance of DataSHIELD for protecting participant confidentiality.
- To evaluate DataSHIELD's ability to safeguard sensitive biomedical data.
Main Methods:
- An ethico-legal analysis was performed.
- The analysis examined DataSHIELD's process against UK case law, regulations, and guidance.
Main Results:
- DataSHIELD meets UK standards for biomedical data protection.
- Personal data processing occurs within secure study environments.
- Participating studies have necessary scientific, ethics, and data access approvals.
- Participant consent and information on anonymisation are confirmed.
Conclusions:
- DataSHIELD offers a flexible method for data interrogation.
- It effectively protects participant confidentiality in line with legislation and guidance.
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