UK Biobank research ethics approval
UK Biobank has approval from the North West Multi-centre Research Ethics Committee (MREC) as a Research Tissue Bank (RTB) approval. This approval means that researchers do not require separate ethical clearance and can operate under the RTB approval (there are certain exceptions to this which are set out in the Access Procedures, such as re-contact applications).
This RTB approval was granted initially in 2011 and it is renewal on a 5-yearly cycle: hence UK Biobank successfully applied to renew it in 2016 and 2021. UK Biobank will in due course apply for renewal effective in 2026. These renewal applications and approvals are shown on the website.
UK Biobank also possesses a Human Tissue Authority (HTA) licence, so a separate HTA licence is not required by researchers who receive samples from the resource. As such UK Biobank imposes certain obligations through the MTA on researchers using samples - such as residual samples are destroyed or returned at the end of the research project, and samples cannot be transferred to third party premises without the specific approval of UK Biobank - which are consistent with its obligations under its HTA licence.
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.