A. Management and Accountability
A.1. Board of Directors
The current directors also serve as charity trustees. There are no members of the original Board still serving. UK Biobank follows good corporate governance rules and adopts an approach that between 5 and 7 years is an appropriate length of service for directors.
A.2. Ethics and Governance Council
Since its inception, the Ethics and Governance Council has provided independent and valuable input and advice to UK Biobank. This role continues, and the EGC retains its remit and functions as set out in the original Ethics and Governance Framework.
A.3. Steering Committee & International Scientific Advisory Board
The membership of the Steering Committee and other advisory committees is set out here: Steering Committee
The membership of the ISAB is set out here: International Scientific Advisory Board
B. External governance
B. 1. Ethics approval
UK Biobank has Research Tissue Bank approval from its Research Ethics Committee and maintains a regular dialogue with its REC and seeks further approval(s) as and when necessary, for example the protocol to conduct an imaging assessment visits.
UK Biobank holds a HTA licence and is registered as a Data Controller with the Information Commissioners and complies with the following ISO standards: ISOQAR to the Quality Management System Standard ISO 9001:2008 and ISO27001:2013 Information Security Management Certification.
B. 2. Compliance with research governance frameworks
UK Biobank is responsible for the use of the resource. By way of the Material Transfer Agreement it ensures that researchers are responsible for the conduct of their research and for their use and storage of UK Biobank data and/or samples.
UK Biobank has not (and does not envisage) sponsoring third party research. Rather UK Biobank views that its remit is to facilitate research and ensure that the resource is as useful as possible to researchers and thus the widest possible research use is made of the resource.
- Benefit sharing
- Dissemination of knowledge
All researchers are obliged to return their data and results to UK Biobank. They are also obliged to publish their results (otherwise UK Biobank will do this for them – although there has been no need to use this provision to date).
C. Benefit Sharing
C.2. Intellectual Property
UK Biobank believes that the current provisions, which relate to Intellectual Property rights strike a fair balance between the need for UK Biobank to maintain the integrity of the resource and at the same time, enable researchers the necessary freedom to use the resource and exploit the developments they discover.
D. Transfer of assets
UK Biobank is in the process of renewing its core funding for the period 2017 – 2022. It does not anticipate that circumstances requiring closure or transfer of assets will arise in the foreseeable future.
RELATIONSHIP WITH SOCIETY
A. MANAGEMENT AND ACCOUNTABILITY
1. Board of Directors
The Board of Directors of UK Biobank are company directors under UK company law, and charity trustees under UK charity law. They are accountable to the Members of the Company (Medical Research Council and Wellcome Trust), and to the Charity Commission for England and Wales, for the performance of their duties as directors and charity trustees, including the duty to act in the interests of UK Biobank. Up to five Board members, including the Chair, will be jointly appointed by the Members of the Company. A further five members may be individually nominated by the Department of Health, the Medical Research Council, The Wellcome Trust, the Scottish Executive and the University of Manchester (which hosts the coordinating Centre). The Board will include persons with relevant scientific knowledge or other relevant expertise who will be selected for their ability to serve as directors and charity trustees of UK Biobank. The Board will adopt this Ethics and Governance Framework and be responsible for making sure that all UK Biobank policies and activities conform to it. The Board will also be responsible for matters of corporate governance, including the management of conflicts of interest within UK Biobank. Potential conflicts of interest among members of the Board and the Chief Executive Officer/ Principal Investigator (CEO/PI) will be recorded. The Board retains overall responsibility for the direction, management and control of UK Biobank, but it delegates day to day management to the CEO/PI.
2. Ethics and Governance Council
The UK Biobank Ethics and Governance Council has been established by the Medical Research Council and the Wellcome Trust in a way that enables it to operate independently of them and of UK Biobank. Terms of reference are attached as Annex 1. The remit of this Council includes: acting as an independent guardian of the Ethics and Governance Framework and advising the Board on its revision; monitoring and reporting publicly on the conformity of the UK Biobank project with this Framework; and advising more generally on the interests of participants and the general public in relation to UK Biobank. In pursuing its remit the Council will engage with, and render accounts to, a number of internal and external audiences. Internal dialogues will be with the Board of Directors, the CEO/PI and the funders. External dialogues could be with participants, regulatory or government bodies, other interested parties, and the general public. The Council will not speak “on behalf of” UK Biobank, as this will be the responsibility of the Board; instead it will speak “about” UK Biobank. In order to be able to fulfil its remit, the Ethics and Governance Council will need to be appropriately knowledgeable about UK Biobank’s continuing activities. It is hoped that effective communication will occur on the basis of mutual respect and cooperation. However, the Council will be able to require from parties involved in UK Biobank whatever information and discussion are necessary to fulfil its remit. Normally the Council will communicate its reflections and criticism informally. If the Council is not satisfied with UK Biobank’s response, it could make a formal statement of concern (e.g. to the Board or funders) or, if necessary, make a public statement that certain actions should or should not be taken. In the extreme, members of the Council could resign in protest and announce this publicly. The Ethics and Governance Council will work in an open and transparent fashion and report to participants and the public. This may be achieved in a variety of ways, such as through publishing reports of its reviews or discussions, occasionally meeting in public, or holding meetings with the public.
3. Steering Committee and International Scientific Advisory Board
The Steering Committee is responsible for advising the CEO/PI on the development of the scientific protocol, and on the direction and scientific objectives of UK Biobank. It is chaired by the CEO/PI, with the lead investigator from each Regional Collaborating Centre as members and UK Biobank’s Executive Director and Chief Scientific Officer as observers. The CEO/PI, Board and funders will also receive independent scientific guidance from an International Scientific Advisory Board, which will meet annually to review UK Biobank’s progress and future plans.
B. EXTERNAL GOVERNANCE
1. Ethics approval by relevant ethics committees
The core scientific protocol and operational procedures of the UK Biobank resource, as well as proposed uses of it, will have approval from appropriate ethics committees in accordance with guidance from relevant bodies (such as the Central Office of Research (Ethics) and with relevant provisions (such as the Research Governance Frameworks of England, Wales, and Scotland; Governance Arrangements and Supplementary Operational Guidelines for NHS Research Ethics Committees). Participants will be told that such independent ethics approval will be obtained.
2. Compliance with Research Governance Frameworks
With respect to the core protocol, UK Biobank will assume the responsibilities stipulated by the Research Governance Framework for Health and Social Care in England and the corresponding frameworks in Wales and Scotland. In England, for example, at present these responsibilities are as follows:
- Sponsor is the Board of UK Biobank Limited: responsible for confirming that
proper arrangements are in place for initiating, managing, monitoring and financing the project.
- Principal Investigator is the Chief Executive (CEO): responsible for the design of the project, seeking approvals from the MREC, managing activities in the Coordinating Centre, Regional Collaborating Centres and assessment centres, and liaising with researchers (and, in all of this, accountable to the Sponsor).
- Coordinating Centre: responsible for the daytoday conduct of the project and ensuring it follows the protocol, and for training and monitoring of all staff involved in its conduct.
- Regional Collaborating Centres: responsible for scientific input to the development of the study protocol and procedures through the Steering Committee, and for carrying out key aspects of project delivery on behalf of the Coordinating Centre. Typically, external researchers will act as the sponsor of particular research using the resource and will take on the relevant responsibilities. But, if UK Biobank acts as the sponsor of some research then it will take on these responsibilities. As required under the Human Tissue Act 2004, UK Biobank will be licensed by the Human Tissue Authority to store biological samples for research.
C. BENEFIT SHARING
1. Dissemination of knowledge generally
The purpose of UK Biobank is to learn from the collective health experience of the participants over time, in order to generate and disseminate new knowledge to benefit the health of the public in the UK and elsewhere. Knowledge derived from studies based on UK Biobank will be:
- Published in the world’s scientific and medical literature;
- Communicated to UK Biobank participants, the NHS, and others (as appropriate);
- Accumulated and made available by UK Biobank as a resource for further research (e.g. via archives of the findings of studies). Such knowledge may also be applied to the development or improvement of healthcare techniques, technologies, materials or routines.
2. Intellectual property, income generation and royalties
Intellectual property and access policies are being developed to help ensure that the UK Biobank resource is accessible to all bona fide research users, but is not exploited improperly or used in any way that inappropriately constrains use by others. Terms of access will be embodied in legal agreements that reflect UK Biobank’s objectives. UK Biobank is not expected in itself to lead to patentable inventions that return significant income either to researchers or UK Biobank, but it is expected to become a valuable common resource for research. Nevertheless, there is some chance that research conducted using the resource (which might be conducted by researchers in the public or commercial sector, as well as the academic and charity sector) will subsequently support the development of an invention that returns a profit. The biotechnology and pharmaceutical industries can play an important role in realising health benefits in a practical sense by developing and improving the use of biomedical products. Commercial companies and other research endeavours that stand to make a profit will, therefore, be allowed access to UK Biobank if their proposal falls within the UK Biobank purpose and complies with the usual scientific and ethics requirements. Any income that UK Biobank secures from access fees or intellectual property will be reinvested in the resource.
D. TRANSFER OF ASSETS, OR CLOSURE
A detailed strategy is being developed for handling contingencies in the event that the UK Biobank charitable company has to close or make other substantial transitions in the holdings or control of the resource. This will address the possibility of partial or full transfer of the resource, whether elective or as a result of insolvent liquidation. The objective will be to ensure that the protection and respect for the rights of the participants provided by this Framework continue to be maintained, and that the Ethics and Governance Council is consulted by the Company on the proposed terms before any such transitions or transfers are made. Information about such measures will be made available to participants.
IV. ADOPTION, IMPLEMENTATION AND REVISION
The Ethics and Governance Framework is a core reference document against which UK Biobank policies and activities will be judged.
The Board of Directors has adopted this Framework and will be responsible for ensuring that all UK Biobank policies and activities conform to it.
The Coordinating Centre, under the direction of the CEO/PI, will be responsible for implementing the Framework. Compliance with it will be a condition of continued
funding of UK Biobank by the Funders.
The Board of Directors, the Ethics and Governance Council, the Funders and other interested parties (including participants and members of the wider public) may propose amendments or revisions of the Framework. In particular, the Ethics and Governance Council will advise on outstanding issues, and may propose adjustments in response to new developments. Adoption of any amendment or revision will rest with the Board of Directors.
ANNEX: UK Biobank Ethics and Governance Council terms of reference The UK Biobank Ethics and Governance Council (EGC) is an independent committee established by the Medical Research Council and the Wellcome Trust.
- 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 (“UK Biobank”) with the EGF;
- To advise more generally on the interests of research participants and the general public in relation to UK Biobank.
1. To keep the creation, maintenance and use of the resource under review in order to advise and report publicly on the conformity of UK Biobank’s activities with the EGF;
2. To consider and advise on revisions to the EGF that may be required to respond to changes in the legislative or regulatory context, developments in ethics or advances in
science or technology;
3. To advise on UK Biobank policies that relate to or flow from the EGF (such as those on recruitment, access, or complaints handling);
4. To keep under review applications for access to the resource with regard to the interests of research participants and in accordance with the Intellectual Property and Access
5. To approve any transfer of the resource (or substantial parts of it) to a third party, for example, in the event of a liquidation, as set out in the Memorandum and Articles of
Association of UK Biobank Limited.
Page last updated 09/12/2016