NHS Digital Data Release Register - reformatted
University Of Edinburgh
Project 1 — DARS-NIC-08472-V9S6K
Opt outs honoured: N
Sensitive: Sensitive, and Non Sensitive
When: 2016/04 (or before) — 2018/05.
Repeats: Ongoing, One-Off
Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012
Categories: Identifiable, Anonymised - ICO code compliant
- MRIS - Cause of Death Report
- Hospital Episode Statistics Admitted Patient Care
- Diagnostic Imaging Dataset
- MRIS - Scottish NHS / Registration
- MRIS - Cohort Event Notification Report
- Mental Health and Learning Disabilities Data Set
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Outpatients
- MRIS - List Cleaning Report
- MRIS - Members and Postings Report
- Bridge file: Hospital Episode Statistics to Diagnostic Imaging Dataset
- Hospital Episode Statistics Critical Care
UK Biobank is a major national health resource, and a registered charity in its own right, with the aim of improving the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses – including cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression and forms of dementia. UK Biobank recruited 500,000 people aged between 40-69 years in 2006-2010 from across the country to take part in this project. They have undergone measures, provided blood, urine and saliva samples for future analysis, detailed information about themselves and agreed to have their health followed. This is an increasingly powerful resource that is helping – and will continue over many years to help - scientists discover why some people develop particular diseases and others do not. UK Biobank has joined other world leaders in research at the launch of the Dementias Platform UK, a powerful new tool for studying dementia. The ground-breaking collaboration between industry and academia has been established by the Medical Research Council (MRC) and bolstered by government funding. UK Biobank will be one of the key resources used to help scientists: • Get a better understanding of who is at risk of developing dementia and why the progression of the disease varies from person to person; • Explore the anatomy of the disease to help develop new medicines and enable more accurate diagnosis • Look into how existing drugs which are used to treat other conditions might help to treat the progression of dementia and improve symptoms. All research projects that have already been completed using UK Biobank are required to be displayed at http://www.ukbiobank.ac.uk/approved-research/ . This shows the many projects achieved using Biobank. Compliance with HSCIC requirements under The 2014 Care Act • As a research resource, the benefits that will be generated from researchers using UK Biobank are potentially very considerable to the population of the United Kingdom and the National Health Service. UK Biobank’s public service remit, which in due course will benefit the UK population and the health care system, is set out unambiguously on the introductory page of its 2007 Ethics and Governance Framework: “UK Biobank aims to build a major resource that can support a diverse range of research intended to improve the prevention, diagnosis, and treatment of illness and the promotion of health throughout society. Lifestyle and environmental information, medical history, physical measurements, and biological samples are to be collected from about 500,000 people aged 40 to 69 at presentation and then, with consent, their health will be followed for many years through medical and other health related records. The biological samples will be stored so that they can be used for a wide range of biochemical and genetic analyses in the future. Scientists have known for many years that our risks of developing different diseases are due to the complex combination of different factors: our lifestyle and environment; our personal susceptibility (genes); and the play of chance (luck). Because UK Biobank will involve thousands of people who develop any particular disease, it will be able to show more reliably than ever before why some people develop that disease while others do not. This should help to find new ways to prevent death and disability from many different conditions. “ • This remit is re-iterated in UK Biobank’s 2012 Access Procedures, which state: “UK Biobank’s purpose is to build a major resource that can support a diverse range of research intended to improve the prevention, diagnosis and treatment of illness and the promotion of health throughout society”. This intent is paraphrased in the Consent Form (www.ukbiobank.ac.uk/consent) and related information materials as being “health-related” and in the “public interest”. Researchers who apply to use the Resource will be required to explain explicitly how their research project supports this stated purpose.” • In the intervening period between 2007 and 2015, the resource has been built, enhanced and has been open to researchers for just over 3 years. There is simply no other resource currently available, which enables researchers to study such a wide range of diseases with such rich and extensive data. What UK Biobank does is to enable researchers to conduct research in a highly cost-effective manner, rather than duplicate spending and effort on sample and case collection.
Access to the resource UK Biobank’s access policy is set out in the Ethics and Governance Framework. Its Access Procedures were prepared during 2010 to 2011 and were the subject of extensive discussion and dialogue with its funders, the REC and the EGC. The Access Procedures were also put out to public consultation, including consultation with UK Biobank participants. In summary: - Every researcher has to register and apply to UK Biobank. If successful, they have to execute UK Biobank's Material Transfer Agreement (MTA) (http://www.ukbiobank.ac.uk/wp-content/uploads/2012/09/Material- Transfer-Agreement.pdf ( for information presented to DAAG as document B2). The application process is the same irrespective of the nature of the applicant and the applicant's location. The MTA governs the legal relationship between UK Biobank and each researcher and, inter alia, ensures that the researcher complies with all the applicable data protection requirements relating to all participant data that they receive. In addition to audit provisions (i.e. UK Biobank is entitled to audit any applicant if it transpires that a transgression has or may have taken place) the MTA contains explicit provisions stating that UK Biobank will bar a transgressing institution from any further use of the resource as well as publicly informing its governing bodies, funders et al ; - The criteria are that the applicant must be a bona fide researcher conducting health-related research in the public interest. Note that the researcher may be based internationally, but that the terms under which that international researcher may access the data is set out within the MTA and are the same as those for a UK researcher. The adjudication of each application is made by UK Biobank’s Access and Scientific teams, with independent ethical advice (from the University of Oxford’s multidisciplinary bioethics research centre, Ethox: http://www.ndph.ox.ac.uk/research/ethox-centre) as well as input from UK Biobank’s independent Ethics and Governance Council, and the whole process is overseen by UK Biobank’s Access Sub Committee (http://www.ukbiobank.ac.uk/access-to-the-resource/), which contains both scientific and legal / ethical expertise; - Any data released to researchers is pseudonymised and encrypted. The researcher is only permitted to use the data for a particular (approved) research project for a particular (approved) time frame after which the researcher must securely destroy the data. The results of the research have to come back to UK Biobank – where they are then accessible by other researchers – and the researcher is obliged to publish their work; - In other words, any data supplied by UK Biobank to a researcher can only be used for the research project in question and for a limited time through UK Biobank’s access procedures (http://www.ukbiobank.ac.uk/wp-content/uploads/2012/09/Access-Procedures-2011.pdf, provided for convenience as document B3). Further, any such data cannot be sub-licensed or made available by researchers to any other party under any circumstances. This is all covered in UK Biobank’s MTA, which is non-negotiable.
UK Biobank’s IT infrastructure ensures that the most up-to-date security technology is used to maintain confidentiality of participant data, with regularly up-dated firewalls, antivirus software and other data encryption protocols to ensure on-going compliance with the Data Protection Act and other regulatory requirements. Periodic penetrance testing, as part of a regular security audits, is carried out by an independent third party to ensure that no data can be accessed by unauthorised individuals. Importantly, the main administrative database, which includes identifiable information on participants (allowing for linkage to health-related records, re-contact for further data collection and keeping participants informed of study progress) is located and maintained separately from the research database (which contains all the data of potential interest for researchers but no data from which any participant could be identified). Access to the administrative database is closely monitored and is strictly limited to a very small number of named staff. Data once processed may be provided to researchers according to the UK Biobank access policy and procedures, which were developed through extensive consultation, including public consultation and consultation with UK Biobank participants. Further detail is given within the Outputs section. Any proposed research project, whether led from an academic institution, a company, a charity, or a collaborative combination of any of these, is only approved for access to data held by UK Biobank (which data can only be used for the purposes of approved research project) following a clear demonstration that the primary aim of the project is to generate results that are for the benefit of the public’s health and for the promotion of health throughout society. Since the UK Biobank resource is based on 500,000 UK-based participants (90% of whom were recruited in England and registered with the English NHS), the public health and health promotion benefits arising from the results of approved research based on the UK Biobank resource will be apply most directly to recipients of health services and social care in England, although many of the benefits will also have broader applicability to populations beyond those of England and the UK.
UK Biobank, a registered charity, is one of the world’s largest medical research resources http://www.ukbiobank.ac.uk/. It was established in 2003. It is funded by the Wellcome Trust, the Department of Health and the Medical Research Council. The recruitment of its 500,000 participants, aged between 45 and 69, took place between 2007 and 2010, whose health is now being followed long term. Access to the resource opened in 2012, since which time there have been over 330 applications and almost 2,000 researchers have registered to use the resource. The overall purpose of the research is to create a prospective epidemiological resource of 500,000 people aged 45 -69 from around the UK. The methods to be used for the identification, invitation and assessment of participants have been developed following extensive consultation with leading research groups in the UK and internationally, and with research participants and representatives of the general population. All participants in the UK Biobank study have given fully informed consent for access to and long-term storage of information from their medical and other health-related records, and use of this and other information for health-related research purposes; long-term storage and use of their blood and urine samples for health-related research purpose; and recontact by UK Biobank to invite them (but without any obligation) to answer further questions or take part in further assessments. A copy of the consent form is available in the DAAG pack. UK Biobank is a unique resource, because of the combination of its very large size and the range and detail of data that it contains on its participants, including extensive phenotype and genotype information on each of them. Further, rather than recruiting participants with specific diseases or risk factors, UK Biobank is a prospective population-based resource established to support research into the causes of a wide range of diseases affecting people in middle and older age. Thus, the ability to link to participant’s health records, so that specific outcomes occurring during long-term follow-up of the participants can be identified and appropriate disease-based research carried out, is critical. UK Biobank’s priority is to combine extensive and precise measurement of exposures, along with the detailed and rigorous follow-up for a wide range of health related outcomes, and to promote innovative science by maximising secure access to deidentified data. Participants are now being followed through fully approved linkages to death and cancer registries. Flagging of the cohort with these data sources in England Wales and Scotland has been performed with the data provision ongoing. UK Biobank obtained at baseline and holds identifiable information on its participants (with an appropriately high level of security and monitored restricted access to a few, named and approved individuals). It is very important for UK Biobank to be able to maintain as accurate information as possible about participants contact details (including postal address) and registered GP practice (which were up to date for the whole cohort at the time of recruitment but there will be undoubtedly have been changes since then. There are several reasons for this requirement: - Ongoing approved linkages to primary care data require accurate information about registered GP practice (as practice as well as PCT level) to ensure that data about a particular participant are requested from the correct practice. - Direct contact with GPs may be required to seek further details about particular health related outcomes identified through linkages to coded primary care data. - To enable GPs to be confident in their assessing primary care data about participants registered in their practices, Biobank will need to be able to provide GP practices with up to date listings of UK Biobank participants in their practices, and – where requested – evidence of their consent. - Follow-up in a cohort study needs to be as complete as possible. This is to avoid both unnecessary reduction in size of the cohort (which reduces statistical power of data analyses), and loss-to-follow-up bias (which can cause misleading research results). Part of UK Biobank’s follow-up strategy relies on intermittent re-contact with Biobank’s participants to invite them to complete brief questionnaires about health related exposures or outcomes. It is important that Biobank have correct and up-to-date participant contact details for this. Although Biobank encourage participants to inform Biobank when they move, this is not a failsafe method of ensuring the most accurate information. - Biobank are committed to ensuring participants continue to be kept aware of progress and developments in UK Biobank, to obtaining their opinions on proposed enhancements to the study, and to providing them with information on how to contact Biobank should they have any questions. Biobank do this in part through Biobank’s annual newsletter, sent via e-mail and/or regular mail. Clearly, Biobank need up to date contact details (especially postal address) to do this. Biobank wish to avoid contacting participants at the wrong address, as this may cause confusion or even occasional distress. - Important potential research questions about the effects of environmental exposures on health require information about current and previous postal address since this allows these exposures to be estimated (from postcodes). These include, for example, valuable studies of the health effects of living close to power cables, aspects of the local environment such as nearby local public amenities and green space, and exposure to background radiation.