Ethics and Governance Framework

 

The Ethics and Governance Framework (EGF) is intended to provide a foundation for trust by publicly specifying the standards to which UK Biobank is managed. The Framework was first published in 2003 and the third version is available on UK Biobank’s website. Responsibility for the Framework rests with UK Biobank, including any revisions that will be required to reflect changes in the technological, legal or ethics landscape.

The EGC acts as independent guardian of the EGF. This means that it has responsibility for advising on revisions and monitoring and reporting publicly on the conformity of the UK Biobank project with the EGF commitments. The primary methods for reporting are through the EGC Annual Reviews and meeting reports.

 

Key sections of the EGF

UK Biobank and participants

  • Affirms the voluntary nature of participation
  • Establishes that consent will be sought ‘to participate in UK Biobank’, based on an explanation and understanding of a number of features of participation (such as the kinds of information and samples that will be collected at enrolment and the possibility of being re-contacted in future by UK Biobank)
  • Affirms the right to withdraw at any time
  • Makes a commitment to protecting the confidentiality of both samples and data.

UK Biobank and researchers

  • Confirms UK Biobank’s role as steward of the resource and legal owner of the database and the sample collection
  • Describes the principles which govern access to the resource by researchers.

UK Biobank and society

  • Describes the arrangements for management and accountability
  • Confirms that this is a research resource and that non-research access, for example by the police, would be allowed only on the strength of a court order (which UK Biobank would rigorously oppose)
  • Describes the broad benefit-sharing that will be required (including the obligatory publication of findings and accessible archiving of data and findings for future use).

 

Revisions

Right to withdraw from UK Biobank: In 2007 the EGF 'No further use' option of withdrawal was revised. This document describes the reasons and process for the revision.