Watch the video below to hear from Professor Roger Brownsword, chair of the UK Biobank Ethics and Governance Council (EGC) between 2011 – 2015, discussing the role of the EGC within the project.
Read the latest annual report from the Ethics and Governance Council: Annual review 2015
Since the idea of establishing a powerful national population blood-based resource for researchers was first proposed in May 1999, the detailed protocols and ethics and governance aspects of the project have been subject to the very highest degree of scrutiny, consultation and review.
The UK Biobank funders are aware that the analysis of health data and biological materials in such depth by many projects over time raises a number of ethical concerns. They developed a public Ethics and Governance Framework (EGF) to set standards for the project, and to ensure that safeguards are in place for scientifically and ethically approved research. The EGF went through a public consultation process.
UK Biobank has approval from the North West Multi-centre Research Ethics Committee (MREC), which covers the UK. It also sought the approval in England and Wales from the Patient Information Advisory Group (PIAG) for gaining access to information that would allow it to invite people to participate. PIAG has since been replaced by the National Information Governance Board for Health & Social Care (NIGB). In Scotland, UK Biobank has approval from the Community Health Index Advisory Group (CHIAG).
UK Biobank possesses a Human Tissue Authority (HTA) licence, so a separate HTA licence is not required by researchers who receive samples from the resource, so long as residual samples are destroyed or returned at the end of the research project, and applicants do not transfer the samples to third party premises without the specific approval of UK Biobank.
Instead of requiring each applicant to obtain separate ethics approval, UK Biobank has sought generic Research Tissue Bank (RTB) approval, which should cover the large majority of research using the resource. This approach is recommended by the National Research Ethics Service and UK Biobank’s governing Research Ethics Committee (REC), which approved the application in 2010. Researchers should check the UK Biobank Access Procedures for more detail.
Further information about the consultations that have taken place can be found under the Resources section of this website.
Ethics & Governance Framework (EGF)
The Ethics and Governance Framework (EGF) sets standards for the UK Biobank project so that all necessary safeguards are in place to ensure that the data and samples are only used for scientifically and ethically approved research. The first public draft of the Ethics and Governance Framework (EGF) was developed with the advice of an Interim Advisory Group which met three times between February and July 2003. The group included experts in research ethics, philosophy, law, science and social science, and consumer representation, and was chaired by Dr William Lowrance, a consultant in health policy and ethics. The document went out to public consultation. A revised draft EGF was developed by UK Biobank in 2006, and agreed by the Board and the EGC. The EGF is expected to evolve through the course of the UK Biobank project, adapting to scientific, ethical, legal and other developments.