How we protect your information

We are committed to protecting your privacy. We will not share any personal information you provide with advertising or marketing companies, or insurance companies.

The United Kingdom Aneurysm Growth Study (UKAGS) is bound by the terms of the approvals given for the Study by the University of Leicester and the Health Research Authority.

Information you need to know

The United Kingdom Aneurysm Growth Study (UKAGS) is bound by the terms of the UKAGS Ethics approvals in place and is committed to protecting the privacy of participants samples and personal details.

UKAGS is a project sponsored by the University of Leicester. Further information on the institution can be found here.The University of Leicester is the Data Controller for your information. You can contact the University of Leicester regarding data protection as follows:

University of Leicester Data Protection Officer: Parmjit Gill, Information Assurance Services Manager, Information Assurance Services, University of Leicester, University Road, Leicester, LE1 7RH. 0116 229 7945. pg170@le.ac.uk.
The University of Leicester is the responsible organization that collects and controls the data that we obtain from men participating in UKAGS.

This privacy notice explains how we use your personal information and your rights regarding that information.

When you supply any personal information and samples to this study we have legal obligations towards you in the way we deal with your data as follows:

• We will securely hold your samples and personal information on our systems for as long as needed to complete our academic research into the study of aortic aneurysm growth in men, and remove it at the end of the research, or at your request. We will ensure that all personal information supplied is held securely, in accordance with the Data Protection Act 1998 and from May 2018 the General Data Protection Regulation.
• We will ensure that the information you submit to us remains private, and is only used for the purposes of research.
• Your personal information is only processed with your knowledge. Only information that we actually need is collected and processed. Your personal information is only seen by those who need it to do their jobs, and is only identifiable by your unique study ID number and not by your personal information (name/address/etc.).
• Your information is securely stored and is protected from unauthorised access or accidental loss, damage or destruction.
• Your information and biological (blood/urine/saliva) samples are securely stored in locked cupboards/freezers in locked rooms within a lockable building. Access to these materials is strictly limited to personnel who need access in order to carry out research or manage participant data.

All information requested is used solely for the purpose of academic research and is collected, stored and processed in accordance with the Data Protection Act 1998. We will treat your personal information as confidential and we will not disclose it to any third party except for purposes of academic research and only then in accordance with the Data Protection Act 1998.

What personal information do we collect?

To understand more about the causes and natural history of abdominal aortic aneurysm the UKAGS is collecting a large amount of information and biological samples from men both with, and without abdominal aortic aneurysms. We collect personal information to be able to manage the day-to-day activities of the project and also to study abdominal aortic aneurysms.

To be able to run the practical aspects of the study we have to be able to contact you and we therefore keep the following personal data; name, address, email address (if supplied) on file. In addition, for research analysis purposes we collect your date of birth and NHS/CHI number.

As part of the overall data collection process for research we obtain information about your medical history and on-going medical condition by asking you to complete questionnaires. As part of this process we also ask you to tell us about your ethnic origin and this is recorded in your study records as confidential sensitive personal data. No other sensitive personal information is collected.

In addition to the data we collect directly from you, we obtain information about your medical history and health from electronic health records held by the NHS for research purposes. This collaboration ensures that, in the event of your death, we are notified and can avoid sending any study materials to your family. To enable these processes we have to share your personal identifiable details with the NHS to indicate your involvement in the study.

All personal information that can be used to identify or contact you (name, address, date of birth, NHS/CHI number) is securely stored in a separate database from the database containing research data for analysis. From this research data your personal details cannot be identified as they are given a pseudonymised study ID.

Why are we collecting your data? 

Abdominal aortic aneurysms (AAA) affect 5% of males over 65 years, and are the 8th most common cause of death in England and Wales.

Most deaths occur because of aneurysm rupture, which causes 10,000 deaths per annum in the UK. The natural history of small aneurysms (<5.5cm) is progressive expansion and eventual rupture at much larger sizes. This long latent period when an AAA is small and at low risk of rupture provides a window of opportunity for diagnosis by screening and pharmacotherapeutic intervention aimed at preventing growth.

At present there are 2 principle obstacles to the development of such a treatment: firstly, the dearth of knowledge regarding the biochemical pathways involved in aneurysm growth;  and secondly, the phenotypic variation and nature of aneurysm growth is poorly defined.

This project aims to address both of these areas in a national cohort study of patients with small aneurysms and a screened control group. Through detailed and comprehensive laboratory investigation of DNA, RNA and protein samples utilizing state of the art genomic, transcriptomic and proteomic approaches (omics) the biochemical markers of AAA and AAA growth will be investigated. In addition to these basic science aims the project will also examine the effect of aneurysm screening and surveillance on the psychological wellbeing of the participants recruited into the study.

Patients are invited to participate in this study, and explicit documented consent is obtained.

How do we access your electronic health records?

The NHS and your General Practitioner records information about your health in electronic databases for the purposes of organizing and delivering healthcare. The UK Government records information about all deaths in the UK in electronic format for statistical purposes. Information about hospital admissions, civil registration data (deaths) and some general practice data is accessible from central NHS organizations (NHS Digital (England and Wales)) or the NHS Central Register (Scotland)). In addition, a few general practices contribute data to regional or national general practice research databases (if your practice does this you will have been informed). By accessing this information in this research study we can find out about what happens to you in the future without having to contact you directly.

As legitimate medical researchers, we can access all of this information providing we have your permission to use your personal details to do so.

We do this in the following way:  Using an NHS approved secure data transfer system we send your personal information (NHS or CHI number, name, address and date of birth) to NHS Digital (England) or the NHS Central Register (Scotland) together with a unique study identification number relating to the UKAGS Study. These organisations then look up your records in their databases and return information about your health to us using just your unique study identification number. All information is transferred electronically as encrypted (scrambled) data. None of your information is sent by post or placed on removable electronic media such as CD-ROMs or memory sticks.

How we hold your information and samples

We will securely hold your samples and personal information on our systems for as long as needed to complete our academic research into the study of aortic aneurysm growth in men, and remove it at the end of the research, or at your request. The Study is due to finish recruiting new participants by the end of 2018 and we plan to find out what happens to all the men in the study for the foreseeable future. We will continue to contact you by post for up to 5 years after you join the study to obtain information about your health. After this we plan to use electronic health and death records to monitor men involved in the study for between another 5 to 10 years.

Your information and biological samples are securely stored in locked cupboards/freezers in locked rooms within a secure building. Access to these materials is strictly limited to personnel who need access in order to carry out the Study.

All information requested is used solely for the purpose of academic research and is collected, stored and processed in accordance with the Data Protection Act 1998. We will treat your personal information as confidential and we will not disclose it to any third party.

How will we use this data?

The blood, urine and saliva samples collected for this study will be processed and stored as purified DNA, RNA, plasma, serum, and urine at the University of Leicester NIHR Biomedical Research Centre. The separate samples will be used in a range of experiments, all aimed at determining the biochemical pathways involved in the initiation, growth and rupture of abdominal aortic aneurysms. The DNA samples will be used to determine which genetic variations are associated with AAA. RNA samples will be used to determine whether peripheral blood cell expression profiles are associated with either the presence or size of AAA. Plasma, serum and urine samples will be used for protein profiling and subsequent individual protein assays. Standard statistical techniques will be applied to collected and acquired research data to determine associations with aneurysm growth.

Samples and/or data may be transferred and analysed in laboratories and by researchers outside of the University of Leicester, including overseas. Where this occurs samples will be anonymized prior to dispatch. All sample and data transfers will be subject to approval by the project steering committee and formal transfer agreements will be established prior to transfer.

What is the legal basis for processing the data?

The purpose of collection is supported under the following sections of the GDPR:

• “Article 6(1)(e) processing is necessary for the performance of a task carried out in the public interest…”
• Article 9(1) processing of personal data revealing racial or ethnic origin, political opinions, religious or psychological beliefs … and the processing of genetic data, biometric data for the purpose of uniquely identifying a natural person, data concerning health or data concerning a natural person’s sex life or sexual life or sexual orientation shall be prohibited.
• Article 9 (1) (j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

If we are sharing your data with others who are we sharing it with?

One of the main benefits of this study is that we will generate a large amount of information about men who have been screened for aneurysms. To get the most benefit from this information it is important that legitimate medical research teams from outside of the University of Leicester can also use this information. Data and/or samples from the study will only be shared with others for medical research purposes. If this happens all personal information will be removed from any information that is shared so that your identity will be protected.

Other than with the NHS organisations listed in Section 4 of this notice your personal data will not be shared with any other organisation or researchers for the purpose of this study.

How long we will process your data for?

We will securely hold your samples and personal information on our systems for as long as needed to complete our academic research into the study of aortic aneurysm growth in men, and remove it at the end of the research, or at your request. We will ensure that all personal information supplied is held securely, in accordance with the Data Protection Act 1998 and, from May 2018, the General Data Protection Regulation.

In accordance with the University Research Code of Conduct:

“Data must be retained intact for a period of at least six years, or any longer period required by an approving body, the research funder or under legislation.”

“Confidential information (including personal data) must be destroyed and disposed of securely once it is no longer required, after agreed periods of retention have expired, or in cases where destruction is required for legal or ethical reasons, in accordance with the University’s Information Handling Policy”

Further information on this can be found on the University website.

What are your rights and how to enforce them?

Right to withdraw consent or restrict processing

When we send you questionnaires to fill in each year you will be given the option to leave the study. You can request to either stop taking part in the study, or stop taking part and have all your information deleted from our records. We provide you with a postage paid envelope to return your response to us. After we stop sending you questionnaires, or at any other time, you can request to opt out of the study, or any part of it by contacting us by post, email or telephone (see contact details on the website).

Right of access, rectification or erasure of personal information

In accordance with the Freedom of Information Act 2000, you have the right to request access to, rectification or erasure of your personal data. If you require access to your stored data, visit our FOI page.

How to complain to the Information Commissioner’s Office

You have the right to complain to the Information Commissioner’s Office. If you wish to complain the Information Commissioner can be contacted via:

Information Commissioners Office, Wycliffe House, Water Lane, Wilmslow, Cheshire, SK9 5AF
0303 123 1113
Email contact can be made by accessing www.ico.org.uk