UK Biobank research ethics approval
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 PIAG has since been replaced by the National Information Governance Board for Health & Social Care (NIGB).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.
UK Biobank Ethics and Governance Council
The UK Biobank Ethics and Governance Council (EGC) was established by the UK Biobank funders, the Wellcome Trust and the Medical Research Council, when UK Biobank began the recruitment of its 500,000 participants in 2006.
The function of the EGC was to:
- Act as an independent guardian of the UK Biobank Ethics and Governance Framework (EGF) and advise on its revision
- Monitor and report publicly on the conformity of the UK Biobank project with the EGF
- Advise more generally on the interests of research participants and the general public in relation to UK Biobank.
Over the intervening years, the EGC discharged this role and made a considerable contribution to the UK Biobank resource.
It became apparent that during this period UK Biobank had developed at a considerable pace and, as a consequence, the EGC recommended that its oversight role would be more effectively discharged by better integration within UK Biobank as an advisory committee of the UK Biobank Board. This recommendation was accepted by the UK Biobank funders and by the UK Biobank Board and led to the establishment of the EAC.
The Ethics Advisory Committee (EAC)
The EAC was established in 2018 and replaced the Ethics and Governance Council (EGC) (for further information about the EGC please see below).
The UK Biobank Ethics Advisory Committee (EAC) is a Committee of the UK Biobank Board who’s remit is to provide advice to the Board on ethical issues that arise during the maintenance, development and use of UK Biobank, including:
- Identifying, defining and examining relevant ethical issues
- Providing advice, guidance and recommendations on relevant ethical issues
- Reviewing and advising on policies which have an ethical dimension that are relevant to UK Biobank
- Conducting detailed conceptual and empirical ethics research to ensure that advice is evidence-based, and that UK Biobank maintains its robust ethical justification for current and future activity.