A. Steward of Data and Samples
This is unchanged. As and when recruitment was completed we started work on developing the Access Procedures. Following public consultation, these were completed, along with the IT systems, in early 2012 and access to the resource began in April 2012. We publish details of all approved research applications and published papers on the website.
B. Research access to data and samples
B.1. General principles of access
These are unchanged and are reflected in the Access Procedures, which set out the considerations and the process by which UK Biobank reviews and adjudicates applications.
It is worth highlighting that:
- to date, neither the police nor any other law enforcement agency has asked us to access participant data. Should they do so in the future, the stated approach would be adopted i.e. we would refuse.
- with regard to blood, urine and saliva samples, our approach is to turn this depletable resource into non-depletable data. How we approach this is set out in more detail [link];
- no researcher has been granted preferential or exclusive access to the resource over the past 4 years;
- all researchers are treated in the same way. All researchers have to adhere to the same standards and take on the same obligations;
B.2. Decisions on access and use
The UK Biobank Access Procedures set out how applications are made and adjudicated. The UK Biobank Access Sub Committee reviews and approves applications to UK Biobank.
In light of the ever-increasing use of the resource we are in the process of updating (more of an overhaul) all our access IT systems. At this stage, we will take the opportunity to review and revise the Access Procedures. Any changes will be to streamline internal processes rather than to make any fundamental change to the underlying principles of access.
B.3. Licenses for specific use
To date, all researchers have executed UK Biobank’s Material Transfer Agreement, which is necessary before data or samples are transferred to them. A copy of the MTA can be found here: http://www.ukbiobank.ac.uk/wp-content/uploads/2012/09/Material-Transfer-Agreement.pdf .
There is a small charge for researchers to use the UK Biobank resource. Access fees are set at a level whereby UK Biobank recovers the incremental costs of processing an application. In UK Biobank’s view this encourages and facilitates usage. UK Biobank has taken steps to reduce the charges for applicants from less developed countries and/or students http://www.ukbiobank.ac.uk/scientists-3/ .
B. 4.Sharing of data and finding
All researchers who have used the UK Biobank resource and completed their research project have returned their findings to us and published the results. More detailed guidance for researchers can be found at [link]
The approach to intellectual property rights is set out in both the Access Procedures and the MTA and all research users sign up to this (with no exceptions).
RELATIONSHIP WITH RESEARCH USERS
A. STEWARDSHIP OF DATA AND SAMPLES
UK Biobank Limited will be the legal owner of the database and the sample collection (see Section III.A.1). Such ownership conveys certain rights, such as the right to take legal action against unauthorised use or abuse of the database or samples, and the right to sell or destroy the samples. Participants will not have property rights in the samples. UK Biobank does not intend to exercise all of these rights; for example, it will not sell samples. Rather, UK Biobank will serve as the steward of the resource, maintaining and building it for the public good in accordance with its purpose. This implies both the judicious protecting and sharing of the resource. It also extends to the careful management of any transfer of parts or all of the database or sample collection, as is addressed in Section III.D (Transfer of assets, or closure). UK Biobank will explain the legal status of the database and sample collection to participants, and its committed role as steward of the resource. Even when this legal status is understood clearly, it is likely that many participants will continue to be interested to know how their data and samples are used; for this reason, among others, UK Biobank will inform participants about uses of the resource (see Section I.B.4) and will guarantee the right to withdraw from participation. As well as respecting the commitments made to participants in the consent agreement, UK Biobank will strive to build a relationship of trust with participants and the wider public, in order to foster acceptance of the ways the resource is developed and used. A detailed Access Policy for use of the resource will be developed, with guidance from the Ethics and Governance Council, which will evolve in response to users, participants and the wider public.
B. RESEARCH ACCESS TO DATA AND SAMPLES
1. General principles of access
UK Biobank will retain full control of all access to, and uses of, the resource. UK Biobank will not proscribe any medical or other health related research uses at the outset. However, all proposals will be reviewed by UK Biobank to ensure they are consistent with the participants’ consent and this Framework, and that they have relevant ethics approval. All users, whether employed by universities, government, charities or commercial companies, will be held to the same scientific and ethical standards. Exclusive access to the fully developed resource will not be granted to any party. Use of the biological samples will have to be carefully coordinated and controlled because they are limited and depletable. While the resource is being developed, UK Biobank may use the early data and samples to validate and improve methods of data collection and analysis. Access to the resource by the police or other law enforcement agencies will be acceded to only under court order, and UK Biobank will resist such access vigorously in all circumstances.
2. Decisions on access and use
The UK Biobank Board of Directors will have the overall decision making authority over access to and use of the resource. In practice, the Board may delegate decisions on routine applications to suitable bodies or persons (such as an Access Committee or specially designated UK Biobank Working Groups). UK Biobank will explain, to participants and the public, the policies and procedures for research access. An overall policy and detailed terms of access has been, and will continue to be, developed (i.e. the IP and Access Policy) which addresses fairness and
transparency of decisionmaking, the handling of conflicts of interest and the prioritisation of use of samples. The Ethics and Governance Council will keep use of the resource under review in order to advise on conformance with this Framework and the IP and Access Policy, and to assure itself, and others, that the resource is being used in the public interest.
3. Licences for specific uses
Access to data and/or samples will be granted under licence for scientifically and ethically approved research consistent with UK Biobank’s purpose. Licences will be for specific uses under strict terms and conditions in standard access agreements, including compliance with the consent given, the provisions of this Framework and other policies. Fees will be charged for licences, with the possibility of charges being higher for organisations that might be expected to derive financial benefit from use of the resource.
4. Sharing of data and findings
UK Biobank seeks to augment the value of the resource in order to ensure that the greatest potential benefit for public health may be realised from it. All research users will be required to put results from all analyses made on participants’ data and samples, and any relevant supporting information, in the UK Biobank database so that they are subsequently available to all researchers with appropriate scientific and ethics approval. There will also be a requirement on all research users to place the findings (whether positive or negative) from all research based on UK Biobank in the public domain so that people can benefit from them. Publication should be in the peer reviewed scientific literature whenever possible. UK Biobank will also explore further strategies for
dissemination of findings (such as through accessible electronic archives). Researchers will only be permitted to keep results based on UK Biobank confidential for a limited and reasonable period as described in the IP and Access Policy (for example, while they prepare papers for publication, file patent applications or otherwise pursue reasonable competitive advantage for their efforts). This policy will apply to all research users, whether noncommercial or commercial.
Page last updated 07/06/2016