Last updated: 19 May 2025
1. Membership
The Chair of the Ethics Advisory Committee (EAC) shall be a member of the UK Biobank Board. The composition of the EAC shall be up to 3 Board members (including the Chair), up to 4 external members and up to 2 participants members. All of the members shall be independent of the day-to-day management of UK Biobank.
Members of the EAC shall be selected and appointed by the Board. EAC members shall between them have relevant expertise in research ethics and consent, participant and public engagement, communications, science and epidemiology, sociological science, ethical philosophy, law, information technology, health issues effecting participants in older age and ethical issues in a clinical setting.
Only members of the EAC and the Secretary (with representatives of the principal funders as observers) have the right to attend its meetings. Other members of the UK Biobank Executive Management Team (EMT) and others (such as external ethics or scientific experts) may be invited to attend meetings on a recurring or one-off basis.
Appointments to the EAC shall be for a period of up to 3 years. Members of the EAC may serve a second term of up to 3 years and (exceptionally) a third term of up to 3 years, provided the member still meets the criteria for membership of the EAC.
2. Remit
The general remit of the EAC is to advise and make recommendations to the Board and the Access Committee (AC) on ethics issues which relate to the development, maintenance, and use of the UK Biobank resource, including as such issues impact on the participants.
This remit will include:
- identifying, defining and examining relevant ethical issues;
- providing advice, guidance and recommendations on relevant ethical issues;
- reviewing and advising on policies which have a relevant ethical dimension; and
- advice in relation to communication and participant engagement.
Matters which may be considered by the EAC can either be:
- matters which the EAC determines that they wish to review, and/or
- matters which the Board, AC, Information Governance Committee (IGC) or EMT specifically asks the EAC to review which may have an impact on UK Biobank or its participants.
The Board is ultimately responsible for ensuring that all UK Biobank policies and activities conform to the Ethics and Governance Framework (EGF) and is responsible for its review and revision. Specific items which fall under the remit of the EAC include providing advice on:
- the activities of UK Biobank as they relate to, and conform with, the participants’ consent and the EGF;
- policies developed by UK Biobank, including on access to data and samples and on re-contact of participants;
- updates to the EGF that may be required (in light of UK Biobank’s actual and proposed activities), and the way in which such updates are communicated to participants;
- horizon scanning and the ethical implications of developments in science or technology, and changes in the regulatory, social or legal framework as they may relate to UK Biobank; and
- ethical issues surrounding the design and implementation of UK Biobank projects/initiatives which enhance the UK Biobank resource.
In order to ensure that there is no overlap with the working of other internal and external committees, there are certain items which fall outside the remit of the EAC, such as:
- the North West Research Ethics Committee (REC), which is the responsible REC for UK Biobank (although the EAC is entitled to review a determination of the REC and to seek advice through the UK Biobank PI from the REC); and/or
- review of individual access applications (which is the role of the AC) unless either asked to do so by the AC or where the EAC considers that a clear and important ethical or legal issue is at stake in relation to a particular application.
The EAC may, from time to time, interact with the ethics committees of other large population studies in order to discuss matters within its remit.
3. Secretary
The Company Secretary, or their nominee, shall act as the secretary of the EAC and is responsible for ensuring that it receives relevant information and papers in a timely manner to enable full and proper consideration to be given to issues.
4. Quorum
The quorum necessary for the transaction of business shall be 3, of which at least 1 should be a member of the UK Biobank Board. A duly convened meeting of the EAC at which a quorum is present shall be competent to exercise all or any of the authorities, powers and discretions vested in or exercisable by the EAC. Meetings may be held by remote means.
5. Frequency of meetings
The EAC shall meet quarterly unless the amount of business (as determined by the Chair of the EAC), requires more frequent meetings. Ad hoc meetings may be called by the EAC Chair in response to a request from the Board for advice on a specific issue. In general, the EAC will aim to meet a reasonable period of time before the next upcoming Board meeting to enable it to provide a contemporaneous report to the Board.
Outside the formal meeting programme, the EAC Chair will maintain a dialogue with key individuals involved in the determination of UK Biobank’s ethical issues, including the Board Chair, the Chief Executive/Principal Investigator, the Chair of the AC, and the Chair of the IGC.
6. Notice of meetings
Meetings of the EAC shall be called by the Chair of the EAC in consultation with the Secretary and/or at the request of any of its members.
Unless otherwise agreed, notice of each meeting confirming the venue, time and date, together with an agenda of items to be discussed and supporting papers, shall be forwarded to each member of the EAC no later than 5 working days before the date of the meeting. The meeting schedule will be agreed, as far as possible, on an advance rolling 12-month basis.
7. Minutes of meetings
The Company Secretary, or their nominee, shall minute the proceedings, including recording the names of those present and in attendance.
Once approved by the EAC, minutes shall be distributed to the Board in the relevant circulation for its next meeting.
8. Other matters
The EAC shall:
- have access to sufficient resources in order to carry out its duties, including access to the company secretariat for assistance as required;
- give due consideration to laws and regulations relevant to UK Biobank;
- liaise, as necessary, with other Board committees (in particular, the AC and IGC) and, if requested, work with the PI and/or the EMT on a particular issue; and
- members will be reimbursed for all reasonable costs for attending meetings.
EAC members shall comply with the UK Biobank policy on Conflicts of Interest.
9. Resources available
The EAC is authorised by the Board to:
- obtain, at UK Biobank’s expense, such reasonable external ethics, legal or other advice on matters as it may reasonably see fit within its terms of reference;
- subject to agreement in advance with the EMT, PI and/or the Board (as appropriate), commission specific research on topics relevant to its remit;
- seek any information it reasonably requires from any employee of the company in order to perform its duties; and
- request any employee of the company to attend a meeting of the EAC to address such questions as may be reasonably required.
These terms of reference will be reviewed annually.