UK Biobank: a large scale prospective epidemiological resource
Research type
Research Tissue Bank
IRAS ID
200778
Contact name
Nicola Doherty
Contact email
Research summary
UK Biobank: a large scale prospective epidemiological resource of 500,000 people aged 40-69 from around the UK.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0274
Date of REC Opinion
13 May 2016
REC opinion
Favourable Opinion
Data collection arrangements
During 2006-2010, UK Biobank recruited 500,000 men and women from the UK population, aged 40-69 at the date of their baseline assessment visit. Participation in the study was entirely voluntary.\n\nEach participant provided their written consent to confirm their willingness to take part and agreed to the following:\n\n•\tThat they may be re-contacted by UK Biobank (e.g. to answer some more questions and/or attend another assessment visit), but this would be optional.\n•\tTo give permission for access to their medical and other health-related records, and for long-term storage and use of this and other information about them, for health-related research purposes (even after incapacity or death).\n•\tTo give permission for long-term storage and use of biological samples for health-related research purposes (even after incapacity or death).\n•\tThat they understood that none of their results would be given to them (except for some measurements during the visit) and that they would not benefit financially from taking part.\n\nExtensive data was collected at baseline from all participants on their lifestyle, environment, personal and family medical history. Participants also underwent a wide range of physical measures, and provided samples of blood, urine and saliva.\n\nIn addition to information collected at baseline (which has also been repeated) participants have been invited to wear a wrist-worn activity monitor (to record 7-day physical activity); and complete detailed web-based questionnaires on their diet, cognitive function and work history.\n\nParticipants are currently being invited to attend an imaging assessment centre and undergo magnetic resonance (MR) scans of the brain, heart and body, DXA scan of the bones, joints and body composition, and ultrasound scan of the carotid arteries.\n\nSamples are stored at UK Biobank (in Stockport)and the NIHR National Biosample Centres (in Milton Keynes and Oxfordshire).\n
Research programme
UK Biobank is a major national health resource, 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\n\nUK Biobank is open to bona fide researchers anywhere in the world, whether funded by academia or industry, for health-related research that is in the public good.[COVID-19 amendment – 23/04/2020] Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It was first identified in Wuhan, China in December 2019 and has since spread globally,reaching the UK at the end of January 2020. Coronavirus testing is based on detecting the genetic signature (RNA) of SARS-CoV-2 from a nasal swab in patients\nwith an active infection. In the UK, such testing has so far been limited chiefly to patients admitted to hospital with severe COVID-19 symptoms, although these antigen tests are now being scaled up to test essential healthcare workers and other high-risk groups. A large proportion of infections are asymptomatic or produce mild symptoms, so\nthere is an urgent need for nationally representative data about past infection across the UK population to provide key data needed for epidemiological modelling to help manage the response to the pandemic. The purpose of this amendment is to seek approval to collect samples and data from UK Biobank participants (who were aged 40 -69 when recruited during 2006-10) to determine the extent of previous infection with SARS-CoV-2 (by measuring blood antibodies) in different regions across the UK. In order to extend the age range for which the prevalence data would be generated, we propose also inviting younger adult children and grandchildren (i.e. aged over 18) of UK Biobank participants to provide samples and data for COVID-19 research purposes only. Combined with the existing genetic and lifestyle data and regular updates of health outcomes that we receive for UK Biobank\nparticipants with their consent, these seroprevalence data will also help scientists to understand why some people develop severe COVID-19 disease and others do not. The proposed study is part of the UK Government’s “five pillars” strategy to help strengthen our scientific understanding of the extent of infection and immunity across the UK (and how long it lasts), and so help inform the strategies implemented for dealing with the pandemic:\nhttps://assets.publishing.service.gov.uk/government/uploads/syste\nm/uploads/attachment_data/file/878121/coronavirus-covid-19-testin g-strategy.pdf. The intention is to recruit 20,000 individuals, of whom 10,000 would be existing UK Biobank participants and 10,000\nwould be adult children or grandchildren of existing participants in order to obtain information about the extent of infection across a nationally representative sample (e.g. in terms of location, age, sex and socio-economic deprivation) of the UK population. We will send a blood sampling kit to participants each month for at least six months to provide a finger-prick amount of blood (approximately 10 drops, which is about 0.5ml or one tenth of a teaspoon) and to complete a questionnaire asking about COVID-19 symptoms. The sample and questionnaire will be returned in the mail to the UK Biobank laboratory on the same day of collection for processing prior to antibody testing. Further details of the study design and process are included in the coronavirus study protocol v1.0 20th April\n2020.docx.\nSubject to Ethics Committee approval, recruitment will include the following steps:\n1. UK Biobank will select a sub-sample of participants based on:\na. Geographical location\nb. Age and sex\nc. Socio-economic status 2. Eligible participants (selected at random within the strata outlined above but restricted to one invitation per\nhousehold) will be sent an invitation email (1_coronavirus study UKB ppt email invite v1.0 20th April 2020.docx). This email provides brief information about the study, weblinks to the study information sheet (2a_coronavirus study information sheet_UKBppt v1.0 20th April 2020.docx) and a list of frequently asked questions (Coronavirus study FAQs version 1.0 20th April 2020.docx), and details of how to contact UK Biobank if participants have further\nquestions. 3. If interested, participants will visit the UK Biobank participant website (3a_coronavirus study UKB ppt landing page\nv1.0 20th April 2020.docx). They will be asked to check their contact details, provide consent to take a blood sample\n(with no feedback of results) in their own home and answer a brief questionnaire about potential symptoms\n(11_coronavirus study questionnaire version 1.0 15th April 2020). They will also be asked to indicate if they would be\nwilling to forward an email invite from UK Biobank to their children and/or grandchildren (if applicable). 4. Consented participants will be sent an acknowledgement email to thank them for registering their interest and to\nlet them know they will be notified if they are selected to take part (based on the selection criteria for obtaining a\nnationally representative sample; 4a_coronavirus study UKB ppt acknowledgement email v1.0 15th April 2020.docx). 5. If a participant has adult children and grandchildren who they think may agree to participate, UK Biobank will send\nthe participant a similar acknowledgement email, which will also contain an invitation from UK Biobank that they can\nforward to these relatives (4b_coronavirus study UKB ppt acknowledgement and invite email v1.0 20th April\n2020.docx). This invitation email will provide brief information about UK Biobank and the specific purpose for inviting\nthem to join the present study. It will provide weblinks to the study information sheet (2b_coronavirus study\ninformation sheet_relatives v1.0 20th April 2020.docx) and the list of frequently asked questions (Coronavirus study\nFAQs version 1.0 20th April 2020.docx), and details of how to contact UK Biobank if they have further questions. 6. If adult children and grandchildren are interested in participating, they will be asked to click on the hyperlink in the\ninvitation email. This will take them to a webpage where they will be asked to provide personal details (i.e. name,\nDoB, address, phone number, email address, sex at birth, ethnicity) and to give consent to join the study. This\nconsent includes linkage to their medical and other health-related records and for their data and samples to be\ndonated to UK Biobank to be used for the purposes of COVID-19 research (3b_coronavirus study relatives landing page v1.0 20th April 2020.docx). 7. Relatives who have signed up will be sent an email asking them to confirm their contact details in order to complete the consent process (4d_coronavirus study confirmation of details email for relatives v1.0 16th April 2020).\n8. Once contact details have been confirmed, an acknowledgement email will be sent thanking the relatives for signing up, and telling they will be notified if they are required to take part (4c_coronavirus study relatives acknowledgement email v1.0 15th April 2020.docx).\nConsented UK Biobank participants and their children/grandchildren will comprise a pool of individuals from which UK Biobank can select individuals that are as nationally representative as possible.\nCohorts of 5,000 individuals will be selected on a weekly basis for 4 weeks, with each cohort asked to provide samples every month for at least 6 months.\nCohorts will be stratified with respect to:\na. Geographic location\nb. Age and sex\nc. Socio-economic status\nd. Only one person per household (as co-infection rate is 80-100%) 9. Individuals who are not selected to take part (for example, because we have sufficient numbers in that region) will\nbe sent an appropriate acknowledgement email thanking them for their offer of help (5_coronavirus study not selected v1.0 15th April 2020.docx). \n10. Individuals who are selected will be sent an email notifying them that they will receive their first blood sampling pack within the next week (7_coronavirus study first sample due email v1.0 15th April 2020.docx). Prior to the despatch of each subsequent sampling kit, a similar email will be sent (8_coronavirus study new test (2-5) due email version 1.0 15th April.docx and 9_coronavirus study final sample due email v 1.0 15th April 2020.docx).\n11. An SMS will also be sent to notify them that their sampling kit has been despatched (6_coronavirus study SMS reminder v1.0 15th April 2020.docx). If samples are despatched within 24 hours of the 7-day email notification, this SMS may be redundant.\n12. An email and SMS will be sent on the day that they should ideally take their blood sample asking them to take the sample and post it back that same day (13_coronavirus study please take sample email v1.0 16th April 2020.docx) and (12_coronavirus study please take sample SMS v1.0 16th April 2020.docx). They will be advised only to take samples on Monday to Thursday to ensure that they arrive at the central laboratory when it is operational. Taking part in this study is voluntary. In accordance with UK Biobank’s consent procedure, participants and their children/grandchildren who agree to take part will be asked to confirm that that they will do so on the understanding that there will be no feedback of results. A hyperlink contained in the sample kit dispatch email will direct participants to a webpage where they can opt out of receiving further sampling kits, should they wish to do so (10_coronavirus study change of contact prefs form v1.0 15th April 2020). UK Biobank policies and procedures for withdrawal will apply (https://www.ukbiobank.ac.uk/withdrawal/).\nHyperlinks contained in the sample kit dispatch email enable participants to change their contact details via the\nparticipant website (https://biobank.ctsu.ox.ac.uk/members/members.cgi); children/grandchildren of UK Biobank participants will be directed to a new webpage in order to do this (coronavirus study change of contact details form v1.0 15th April 2020.docx). Sample collection\nA capillary blood collection kit for taking up to 500 μL of blood (a tenth of a teaspoon) will be sent to households on a monthly basis. Each kit will contain two contact-activated safety lancet devices, a K2EDTA microtube, an alcohol wipe, a sterile gauze, a cleansing wipe, a plaster, freepost return packaging for the tube (compliant with UN3373\nstandards for shipping biological samples) along with clear instructions for how to collect the sample and a short symptom questionnaire which should be completed on the day that the sample is provided.\nThe instruction leaflet on how to take the sample and a related video are being finalized, but will be based on a\nmodified version of RM0203 SAVING LIVES Mini Tube Blood Sample Instructions V3.pdf and videos produced by LiveSmart\n(https://www.getlivesmart.com/pages/home-kit) and Thriva\n(https://intercom.help/thrivahelpcenter/en/articles/2245306-how-d o-i-collect-my-sample), which are included in this submission, in the interest of time.\nSample transportation\nThe return packaging comprises of a rigid plastic clam pack which contains an absorbent lining and space to insert the blood sample tube. The clam pack folds over the sample and clips shut to ensure if any spillage occurs it is contained (compliant with UN3373 standards). The lancets are also to be returned using packaging provided in the kit. The rigid plastic packaging is to be placed inside a return envelope which is appropriately labelled to notify anyone coming into contact with the sample that it contains a biological substance. The envelope is to be mailed freepost to the UK Biobank laboratory in Cheadle on the day of collection. Clear instructions will be provided only to mail them on Monday-Thursday (to ensure receipt when the laboratory is open), and to adhere to social isolation guidelines and social distancing measures that may be in place when mailing them.\nSample Processing Samples will be fractioned and stored pending the ELISA test at the UK Biobank coordinating centre laboratory in Cheadle which is accredited to IS9001 and IS027001. Samples will be inactivated using the WHO protocol and the plasma pipetted to a storage tube and/or plate linking the newly created tube to the source tube in a tracking system.\nResidual sample will be disposed of in accordance with the laboratory’s standard procedures.\nSample storage\nBlood samples will be stored at –80°C in monitored freezers at the UK Biobank coordinating centre laboratory in Cheadle. Samples will be fully traceable in storage.\nSample Analysis\nSamples will be shipped in accordance with UN3373 regulations to an external laboratory for antibody ELISA assays.\nOn completion of the assay any residual material will be destroyed in accordance with local waste disposal\nprotocols.
Storage license
12002
RTBTitle
UK Biobank: a large scale prospective epidemiological resource of 500,000 people aged 40-69 from around the UK.
Establishment organisation
UK Biobank Limited
Establishment organisation address
1-4 Spectrum Way
Adswood
Stockport
SK3 0SA