Frequently asked questions

This page contains Frequently Asked Questions which the Ethics and Governance Council has received about its work and its relationship to UK Biobank. In each case we offer a brief answer followed by a fuller explanation. We welcome this kind of interaction with participants and other persons or bodies interested in our work and in the UK Biobank project.

Please do not hesitate to send any additional questions to:

Adrienne Hunt, Council Secretary
Wellcome Trust
215 Euston Road
London NW1 2BE 

E: EGCinfo@wellcome.ac.uk 
T: 0207 611 8335

What is UK Biobank? 
What is the purpose of UK Biobank? 
Who funds UK Biobank?
How can I find out more about UK Biobank?
What is the Ethics and Governance Framework?
What is the Ethics and Governance Council?
Why was the Ethics and Governance Council established?
Who sits on the Ethics and Governance Council?
How are people appointed to the Ethics and Governance Council?
What is the Ethics and Governance Council's relationship with UK Biobank?
What topics has the Ethics and Governance Council discussed?
Does the Ethics and Governance Council engage directly with members of the public?
How does the Ethics and Governance Council protect and maintain its independence?
Are members supposed to be representative of the public or parts of the public?
Does the Ethics and Governance Council have any teeth? What happens if UK Biobank doesn't listen to the Council?
Is there a conflict of interest because UK Biobank and the Ethics and Governance Council are funded by the same bodies?
From where does the Ethics and Governance Council take its ethical legitimacy?
Why should anyone trust the Ethics and Governance Council?
How do I make a complaint?
How can I find out more about the Ethics and Governance Council?

What is UK Biobank?
UK Biobank is a research resource consisting of lifestyle and environmental information, medical history, physical measurements and biological samples from over 500, 000 voluntary participants who were aged between 40 and 69 at the time of recruitment.

What is the purpose of UK Biobank?
The purpose of UK Biobank is to provide a resource for research with the aim of improving the prevention, diagnosis and treatment of illness and promoting health throughout society for public benefit.

Who funds UK Biobank?
The project is funded by the Wellcome Trust, the Medical Research Council, the Department of Health, the Scottish Executive and the Northwest Regional Development Agency.

How can I find out more about UK Biobank?
UK Biobank has a separate website which contains further details regarding the project's purpose and progress.

What is the Ethics and Governance Framework? 
A description of the standards to which UK Biobank will operate during the creation, maintenance and use of the resource.

UK Biobank operates according to an Ethics and Governance Framework. In addition to describing the standard, the framework elaborates on the commitments that are involved, not only to those participating in the project but also to researchers and the public more broadly. The framework is a public document, owned by UK Biobank, which is expected to evolve over time, responding to changes, for example, in the law. It is available to download from UK Biobank's website.

The project's conformity with the standards and commitments described in the framework is overseen by the Ethics and Governance Council.

What is the Ethics and Governance Council?
An independent committee that acts as guardian of the Ethics and Governance Framework (EGF) under which UK Biobank operates.

The EGC offers advice to UK Biobank, helping it to respond to changes in, for example, the law, and acts to safeguard the interests of research participants and the general public in relation to the project. The EGC also provides a monitoring role, checking UK Biobank's conformity to the commitments it has made in the EGF and reporting publicly on this conformity.

The Ethics and Governance Council speaks about UK Biobank not for UK Biobank.

Why was the Ethics and Governance Council established?
To advise and monitor UK Biobank in relation to the Ethics and Governance Framework.

The principal Funders of UK Biobank (the Medical Research Council, the Wellcome Trust and the Department of Health) undertook a number of public consultations during the planning stages of the project. The concept of an Oversight Body for the project arose during these consultations. In 2003 the Funders asked an Interim Advisory Group to consider the elements of the ethical and governance framework under which UK Biobank should be managed, acknowledging the changing social and research environment in which UK Biobank will operate. The idea of an Oversight Body was developed by this group leading to the formation of the Council in November 2004.

The Council's remit is: To act as an independent guardian of the UK Biobank Ethics and Governance Framework (EGF) and advise on its revision; To monitor and report publicly on the conformity of the UK Biobank project with the EGF; To advise more generally on the interests of research participants and the general public in relation to UK Biobank.

Who sits on the Ethics and Governance Council?
Members come from a variety of backgrounds, including ethics, law, medicine, medical science, lay perspective, community and consumer involvement. The current members are:

  • Baroness Helene Hayman (Chair) 
    Cross bench peer, House of Lords
  • Dr Eric Meslin (Vice Chair)
    President and CEO of the Council of Canadian Academies
  • Professor Søren Holm
    Professor of Bioethics at the University of Manchester
  • Professor Nils Hoppe
    Professor of Life Sciences Regulation, Hannover University
  • Dr Sheelagh McGuinness
    University Fellow, Centre for Health Law, Science and Policy, Birmingham University
  • Mr David Walker
    A writer specializing in public policy and management and a public affairs executive
  • Dr Susan Wallace
    Lecturer of Population and Public Health Sciences, Leicester University
  • Ms Adrienne Hunt (Secretary)
    If you would like more information, please see the members' full biographies. 

How are people appointed to the Ethics and Governance Council?
The Chair, Vice Chairs and all members were appointed following public advertisement, through an open appointments process in keeping with the Nolan Principles of Public Life.

What is the Ethics and Governance Council's relationship with UK Biobank? 
The EGC is an independent, arms-length monitoring and advisory body, it is not the project's internal ethics committee.

The responsibility for the ethical management of UK Biobank rests with those responsible for the scientific management of the project. The Council may speak about UK Biobank but it does not speak on behalf of it. The EGC has not been established to promote or defend UK Biobank but to ensure that its actions are in conformity with the Ethics and Governance Framework.

What topics has the Ethics and Governance Council discussed?
Records of the Council's discussions are available in the published meeting minutes.

As a few examples, the EGC has discussed the following aspects of the EGF:

  • Recruitment: Strategy for the identification and invitation of potential participants.
  • Consent: Both the model being used and the materials which are sent to potential participants as part of the invitation and consent process.
  • The policy on the provision of health information to participants generated during the recruitment process.
  • Re-contact for future studies where selection is based on genotype.
  • Reducing barriers to participation by ethnic minorities.
  • Capacity to consent and how this is handled by UK Biobank.
  • Confidentiality - UK Biobank's IT and data management strategy.
  • Access and intellectual property: What policy should UK Biobank adopt? 

Does the Ethics and Governance Council engage directly with members of the public?
Yes.

The Council held a series of annual public meetings from 2005 - 2010. These meetings featured short presentations and a question and answer session when attendees were invited to share their comments and questions with the Council members. The meetings were advertised in the local press and on this website.

In 2010 an expert Review Panel was convened to consider the performance of the Council over the last five years and to make recommendations to the funders over any possible changes required to its operations. The Panel recommended that the Council does not need to place as much emphasis on public engagement in future. Given this, the Council will not continue with its fixed series of annual public meetings. Instead the need for a public meeting will be considered as and when issues arise. Rather than gathering public and participant opinions through its public meetings the Council will instead keep alert to the issues being raised by participants and the public with UK Biobank (for example through reporting in UK Biobank's biannual enquiries and complaints report).

Questions and comments can be directed to the EGC at any time via the Council Secretary, Adrienne Hunt:

Wellcome Trust
215 Euston Road
London NW1 2BE

E: EGCinfo@wellcome.ac.uk
T: 0207 611 8335

How does the Ethics and Governance Council protect and maintain its independence?
Members are selected through an open appointment process and are required to disclose any potential conflicts of interest. The Council maintains an appropriate distance in its relationship with UK Biobank.

The EGC was established to monitoring and advise UK Biobank and as such the Council's work is intricately linked with that of the project. When referring to the EGC's independence, therefore, this relates not to the subject matter of its work but to the way it operates, its thought and its actions. The EGC protects its independence by maintaining an appropriate relationship with UK Biobank (i.e. sufficiently arms-length to maintain independence but sufficiently engaged and informed to fulfil its remit).

Members are selected through an open appointment process in keeping with the Nolan Principles of Public Life (including public advertising of the positions). On an individual level all members are required to declare potential conflicts of interest. This includes a declaration of any relationships with UK Biobank and/or the Funders. Members are required to declare new interests as they arise and to confirm all interests on an annual basis. The discloseable interests are brought to the attention of the Chair of the EGC and made available in summary form on the EGC's website.

Are members supposed to be representative of the public or parts of the public?
No.

EGC members act in their own personal capacity. They do not claim to represent the public or parts of the public, but rather can offer contributions from the perspective of the public to the extent that they themselves are members of the public. While members do not represent a particular interest (for example the interests of their affiliated organisations), members are selected from a variety of disciplines so that the EGC's work can benefit from a range of experience and perspectives.

Does the Ethics and Governance Council have any teeth? What happens if UK Biobank doesn't listen to the Council?
The EGC is an advisory committee with no formal power of veto over UK Biobank's actions. It can, however, make public statements of concern about the project.

The governance arrangement was established in this way so that decisions regarding the ethical management of the project ultimately rest on those responsible for the scientific management of the project, that is, with UK Biobank itself, and not with some external third party (such as the EGC).

The role of the EGC is to advise, monitor and report publicly on the activities of UK Biobank. The Council normally communicates its reflections informally to UK Biobank and a Memorandum of Understanding is in place which lays out respective obligations of both parties. Part of these obligations require UK Biobank to respond to all reasonable requests from the EGC. If the Council is not satisfied with UK Biobank's response, it would make a formal statement of concern (e.g. to the UK Biobank Board of Directors or Funders) or, if necessary, make a public statement about UK Biobank's conduct and recommend that certain actions should or should not be taken.

The power and impact of a public statement from an independent body such as the EGC should not be under-estimated. A public EGC statement has the potential to undermine the trust participants place in the project with a possible result of withdrawals from the project or a serious down-turn in recruitment. Given that the success of UK Biobank depends on long-term participation, it is in UK Biobank's interest to maintain and strengthen the trust relationship between it and the participants and for this relationship to remain healthy. This is well-recognised by UK Biobank and the EGC and both endeavour to engage in active communication to resolve matters as they arise. There has never been a need for the Council to issue a public statement.

Is there a conflict of interest because UK Biobank and the Ethics and Governance Council are funded by the same bodies?
This potential conflict of interest is carefully managed through the appointment and funding process and the integrity of the Council members.

The Funders established the EGC in such a way as to promote its independence from UK Biobank and from themselves. This included selecting members through an open appointment process in keeping with the Nolan Principles of Public Life (including public advertising of the positions). Once appointed each member is required to act in good faith in the interests of the EGC and to maintain high standards of probity within the Council. Moreover, from late 2007, the Council itself became responsible for its own recruitment processes, with the exception of appointment of a new Chair. While individual appointments continue to require approval from the Funders, this new process allows the Council to act more autonomously.

The EGC was initially allocated an 'envelope' of funding for a three year term, allowing flexibility and independence in the way it works during this period. The 2010 review of the Council's activities resulted in the confirmation of funding through to 2013 and this was subsequently extended to 2015. The majority of funds are dedicated to the administrative running costs of the Council. In addition members are provided with a modest honorarium of £200 per meeting. 

From where does the Ethics and Governance Council take its 'ethical' legitimacy? 
From the professional and personal experiences of its members and the process of forming a Council view through open reflection, discussion and informed debate.

Members of the Council are drawn from a range of disciplines including ethics, law, medicine, medical science, lay perspective, community and consumer involvement. Beyond the contributions that individuals make from their formal training, all members act in their personal capacity as engaged members of the public. This group works to form a Council view on any given issue through open reflection, discussion and informed debate. In providing advice to UK Biobank the Council endeavours to reflect on the interests of the general public and participants in relation to the project. The Council's work programmes and practices are transparent and open to public scrutiny.

Why should anyone trust the Ethics and Governance Council?
The Council does not expect to be 'blindly' trusted by UK Biobank or members of the public and understands that it must work to earn and maintain trust.

EGC members act in their own personal capacity and do not represent a particular interest (for example the interests of their affiliated organisations). The Council endeavours to advise UK Biobank while reflecting on the interests of the general public in relation to the project. All actual or potential conflicts of interests on the part of members are publicly declared.

The Council strives to instil trust through the rigour and openness of its decision-making and advice-giving processes. As such, the Council welcomes any comments or questions about its advice-giving or operations.

How do I make a complaint? 
The Council handles complaints that relate to its own activities through its complaints procedure.

The Council does not deal with complaints relating to UK Biobank's activities (for example, your experience at the assessment centre) but instead monitors how complaints are handled by the project team.

How can I find out more about the Ethics and Governance Council? 
Various materials are available on the EGC's website including meeting minutes, annual reviews and details of membership.

In addition, questions and comments can be directed to the Council's Secretary, Adrienne Hunt, who can be contacted at: 
E: EGCinfo@wellcome.ac.uk