UK Biobank

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UK Biobank is a large long-term biobank study in the United Kingdom (UK) which is investigating the respective contributions of genetic predisposition and environmental exposure (including nutrition, lifestyle, medications etc.) to the development of disease. It began in 2007.

Based in Stockport, Greater Manchester, it is incorporated as a limited company[1] and registered charity[2] in England and Wales, and registered as a charity[3] in Scotland.

Design

The study is following about 500,000 volunteers in the UK, enrolled at ages from 40 to 69. Initial enrollment took place over four years from 2006, and the volunteers will be followed for at least 25 years thereafter.

Prospective participants were invited to visit an assessment centre, at which they completed an automated questionnaire and were interviewed about lifestyle, medical history and nutritional habits; basic variables such weight, height, blood pressure etc. were measured; and blood and urine samples were taken. These samples have been preserved so that it is possible to later extract DNA and measure other biologically important substances. During the whole duration of the study it is intended that all disease events, drug prescriptions and deaths of the participants are recorded in a database, taking advantage of the centralized UK National Health Service.[4][5]

During the initial physical examination, basic feedback was provided to the participant regarding their weight, height, BMI, blood pressure, lung vital capacity, bone density and intra-ocular pressure; however if any other medical problems were detected, neither the participant nor their physician would be notified. Problems detected later, such as genetic risk factors, were not conveyed to either participant or physician ("to ensure that volunteers are not penalised by insurance companies, for example, which may require customers to disclose the results of any genetic tests.").[6]

From 2012, researchers were able to apply to use the database (though they are not given access to the volunteers, who will remain strictly anonymous). A typical study using the database might compare a sample of participants who developed a particular disease, such as cancer, heart disease, diabetes or Alzheimer's disease, with a sample of those that did not, in an attempt to measure the benefits, risk contribution and interaction of specific genes, lifestyles, and medications.

Development

An incremental approach was adopted to developing the study procedures and technology, using systems designed and developed by the Clinical Trial Service Unit. This consisted of a series of pilot studies of increasing complexity and sophistication with interludes for assessment of results and additional scientific input. In-house trials were conducted during 2005, and a fully integrated clinic was run at Altrincham, Manchester throughout Spring 2006 where 3,800 individuals were assessed. On August 22, 2006, it was announced that the main programme would recruit men and women aged between 40 and 69 based from up to 35 regional centres.,[7] however recruitment proved more efficient than hoped and only 22 centres were actually required.

Initial information collected

The study was initially launched with a visit consisting of the following:

  • A paperless consent process
  • A touchscreen questionnaire on lifestyle and general health
  • Touchscreen tests of memory
  • An interview with a nurse on detailed medical history
  • Measurement of blood pressure
  • Measurement of sitting and standing heights
  • Measurement of weight
  • Body composition measurement using impedance
  • Measurement of grip-strength
  • Breath spirometry
  • Ultrasound bone densitometry of ankle
  • Collection of blood and urine samples

Once the visit-based assessment method was proven, the range of investigations was extended to include:

  • Test of hearing discrimination
  • Measurement of arterial pulse-wave velocity
  • Measurement of visual acuity
  • Measurement of intra-ocular pressure
  • Lens refractometry
  • Fundus image of retina
  • Optical coherence tomography scan of retina
  • Electrocardiogram during exercise
  • Collection of saliva sample
  • Dietary assessment

Ethics and governance

The UK Biobank project operates within the terms of an Ethics and Governance Framework.[8][9][10] The Framework describes a series of standards to which UK Biobank will operate during the creation, maintenance and use of the resource and it elaborates on the commitments that are involved to those participating in the project, researchers and the public more broadly. The independent UK Biobank Ethics and Governance Council provides advice to the project and monitors its conformity with the Framework.[11] The Council also advises more generally on the interests of research participants and the general public in relation to the project.

Recruitment

Following the initial pilot stage in 2006 2005 period, the main study began in April 2007 and by the end of that year 50,000 people had taken part. Recruitment reached 100,000 in April 2008, 200,000 in October 2008, 300,000 in May 2009, 400,000 in November 2009 and passed the 500,000 target in July 2010. Participant enrolment was declared complete in August 2010.[12]

Usage

The UK Biobank dataset was opened to applications from researchers in March 2012. The resource is available to scientists from the UK and outside, whether they work in the public or private sector, for industry, academia or a charity, subject to verification that the research is health-related and in the public interest.

Further developments

Since the completion of recruitment several new types of data have been added:

  • During 2011-12 participants who supplied an email address were asked to assist by completing web-based dietary questionnaires, with the aim of combining a series of daily 'snapshots' to form a picture of overall nutrition. Over 200,000 of the participants responded.
  • During 2012-13 25,000 participants were asked to attend an assessment centre to repeat the initial measurements.
  • In 2013 information from UK death and cancer registries was linked to the main dataset.

Future plans

There are several plans, either provisional or underway, for enhancing the resource:

  • In 2013 Activity Monitors will be distributed to interested participants. These will create a one-week long snapshot of the levels of actual physical activity.
  • Data from NHS hospital records (inpatient and outpatient) and GP visits will be linked to the main dataset.
  • A new type of assessment centre will be opened to collect imaging data, including MRI scans of brain and chest regions, whole body DXA and ultrasound measurements of the carotid arteries. It is hoped that 6,000 participants will take part in the pilot.
  • A set of additional assays on the blood samples will be conducted.
  • A genomic assay is being developed.
  • Several web-based questionnaires are under development, including cognitive function and occupational history.

Opinion

The Biobank project has been generally praised for its ambitious scope and unique potential. A scientific review panel concluded, the "UK Biobank has the potential, in ways that are not currently available elsewhere, to support a wide range of research".[12] Colin Blakemore, chief executive of the MRC, predicted it "will provide scientists with extraordinary information" [7] and "grow into a unique resource for future generations." [12]

There was some early criticism, however. GeneWatch UK, a pressure group that claims to promote the responsible use of genetic information, asserted that the complexity of the programme could result in the finding of "false links between genes and disease",[12] and expressed concern that the genetic information from patients could be patented for commercial purposes. Biobank's chief executive described such a risk as "extremely low, if it exists at all." [7]

The method of recruiting participants was also initially controversial. Participants were sent letters of invitation based on names, addresses, and dates of birth provided by the NHS to the UK Biobank organisers. Although compliant with UK data protection law,[13] some people objected to the NHS passing on such data to third parties without explicit consent, and also had concerns about the data security in such a large project.[citation needed]

Funding

The UK Biobank is funded by the UK Department of Health, the Medical Research Council, the Scottish Executive, and the Wellcome Trust medical research charity. The cost of the initial participant recruitment and assessment phase was 62 million GBP.[14]

Related projects

EPIC (European Prospective Investigation into Cancer and Nutrition) is a similar study that involves 370,000 participants from nine European countries; it is specifically designed to study the respective roles of diet and genes in the development of cancer.[4]

As of 2006, a similar project by the U.S. National Human Genome Research Institute is in the planning stages.[6]

Sources

  1. ↑ Registration number 4978912
  2. ↑ UK Biobank, Registered Charity no. 1101332 at the Charity Commission
  3. ↑ UK Biobank, Registered Charity no. SC039230 at the Office of the Scottish Charity Regulator
  4. ↑ 4.0 4.1 Draft protocol for the UK Biobank, 14 February 2002
  5. ↑ Reviewers' comments on Draft protocol, and responses
  6. ↑ 6.0 6.1 Andy Coghlan: One million people, one medical gamble. New Scientist, 20 January 2006
  7. ↑ 7.0 7.1 7.2 Sarah Hall: £61m medical experiment begins The Guardian, 22 August 2006
  8. ↑ UK Biobank Ethics and Governance Framework. UK Biobank, October 2007
  9. ↑ Ethics and Governance Framework for UK Biobank published for comment. Wellcome Trust, 22 September 2003
  10. ↑ Rules for UK Biobank revealed. BBC News, 24 September 2003
  11. ↑ Ethics and Governance Council formed to oversee UK Biobank Wellcome Trust, 1 November 2004
  12. ↑ 12.0 12.1 12.2 12.3 Biobank set for national roll out. BBC News, 21 August 2006
  13. ↑ Why have you contacted me?
  14. ↑ Daily Telegraph 2004

External links

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