First of all, thank you (again) for being part of UK Biobank. Your involvement (and the involvement of 500,000 others like you) means UK Biobank is now one of the leading health research resources in the world.
As you would expect, a research resource with the size and scope of UK Biobank has guidelines in place to ensure that we do what we told you we would do when you kindly agreed to participate. This Ethics & Governance Framework (EGF) was designed to capture the overall objectives and remit for UK Biobank, in particular its relationship with the participants, the researcher community and the general public. It provided guidance to protect your interests, and to ensure the long-term stability and utility of the project. This included ongoing engagement with participants, a participant’s right to withdraw, and the principles governing access to the resource by scientists.
It is now almost 10 years since the first participants joined UK Biobank. We thought this would be a good time to remind you of those key assurances. In particular, we should like to show you how they have guided decisions made during the project’s first decade, and how they might sustain the project over the next.
To do this, we have provided you with a summary of UK Biobank’s activities since you joined the project, which we hope you find of interest. We have also provided you with an annotated explanation of how the Ethics & Governance Framework has helped guide our decisions on these matters. We highlight certain instances where we have felt the need to interpret the EGF as the situation in question was not specifically covered.
The EGF did envisage that things change over time – amongst other factors, the legal and technological backdrop – and that the provisions of the EGF might need to be updated to reflect these changes. Our approach is that we would like to retain the original wording of the EGF, as this provides the basis for our governance framework when you were recruited, but from time to time we would like to provide you with further information and detail about how it meets our needs.
Incidentally, you will see that there are sections of the EGF which are not directly commented upon: this is because the provisions either deal with events which are solely of historical relevance or still accurately reflect the current situation. Our own view is that the EGF has proven to be a robust and pragmatic document. It covers the majority of situations we have encountered and although it doesn’t cover every eventuality, it has given us the facility to use it constructively and interpret it in a way which we believe is consistent with participant (your) intentions.
In any event we hope you enjoy reading through it and we would welcome your feedback [ ].
Summary of UK Biobank’s activities over the past 10 years
The recruitment of 500,000 participants began in 2006 and ended in late 2010. Recruitment involved taking blood, urine and saliva samples from you – which we store in a secure, purpose-built facility on the outskirts of Stockport – and asking you detailed questions about your health, wellbeing and lifestyle.
Since 2010, there have been some major enhancements to the resource, to provide additional information for health research. We have:
- used a small portion of the blood sample you donated to undertake analysis of your DNA (genetic information);
- measured about 40 of the most common biomarkers in your blood, such as cholesterol, hormones & glucose;
- generated activity data on 100,000 participants, through wrist-worn activity monitors;
- asked you extensive questions about your diet, cognitive health and work history through web-based questionnaires;
- established links to your health information held by your GP, hospital or other health records, such as cancer registries;
- completed a successful imaging pilot and begun the full study to image 100,000 participants.
During the next 10 years or so, we intend to:
- generate information about common infections you may have had or been exposed to;
- complete the main phase of the imaging project, creating the largest imaging research study in the world (by some distance);
- complete links to primary care and other health-related information for all 500,000 participants;
- validate the health information provided to us (i.e. if the source of information indicates that a participant has had a stroke, then we will use various records to determine precisely what kind of stroke it was).
In terms of researchers using the UK Biobank resource, in early 2012 we granted bona fide researchers access to the resource for health related research, which is in the public interest. As of October 2016, more than 3,100 researchers have registered, 236 applications have been approved and more than 100 papers have been published.
Researchers from over 40 countries are currently using UK Biobank. You can find out who is using the resource by visiting the Approved Research pages of the website. You can read their publications by visiting the Publications pages of our website.
This is just the start for UK Biobank. UK Biobank is a prospective resource, which means that its usefulness to researchers increases year-on-year, as our participants get older. A wide range of diseases are already being studied, and the expectation is that this will increase signficantly over the coming years.
UK Biobank is a unique health resource. It is both very large (over 500,000 participants) and very broad (because you have provided us with lots of information about yourself). In this vein, in 2015 a leading article in the Lancet acknowledged that UK Biobank had effectively come of age.
- Purpose and Overview, and Organisations and Funding
- Recruitment and consent
- Collection of data
- Provision of health information
- Ongoing engagement with participants
- Right to withdraw/ incapacitated/ expectation of personal financial gain
- Confidentiality & security