UKLS Participants – Your data and how we handle it
The United Kingdom Lung Cancer Screening (UKLS) trial is a study of lung cancer screening in the UK.
Information for UKLS participants can be found here: www.ukls.org/participants-information.html
Thank-you for being part of our clinical trial on the early detection of lung cancer utilising Low Dose CT Screening
Without the continued support of our participants, we would not be able to perform studies that aim to:
• determine factors associated with the risk of lung cancer (to help identify ways to select people for screening).
• identify better ways to detect lung cancer earlier, leading to earlier diagnosis, selecting patients for the best current and future treatments; all of which will contribute to improving patients’ outcome and ultimately save lives.
For any enquiries relating to participation in UKLS
Professor John Field – J.K.Field@Liverpool.ac.uk (0151 794 9110)
It is important that as a participant you understand:
• What data we hold about you and where it comes from.
• That we store that data securely and only share it anonymously with approved researchers (none of whom would be able to identify you from the data)
• That the only data collected is that which is an important part of our research and helps us address our aims.
• That how we access data is governed by strict guidance – part of which is to make sure you are aware of your right to withdraw from the research at any time.
• That all of our research is ethically approved
• None of your datais used for automated decision making.
As a participant you will have given us your consent before taking part in our study and providing information (e.g. completed a questionnaire) and /or samples (e.g. blood, sputum). You will have been provided with a patient information booklet specific to your consent form at the time of recruitment.
Should you at any time have any questions about the study, or wish to view any of the information or documents in relation to your own recruitment/agreement to take part, please do so either by contacting the individual listed above or in writing to the address below. Additional information in relation to the UoL UKLS Trial and the research is available freely to individuals across various internet websites, e.g. University of Liverpool website, UKLS website, as well as via links within cancer research websites such as NIHR etc., all of which are openly accessible to the public. Some of these links are listed below:
This information does not include any personal details of participants, or identifiable clinical or research outcomes that can be traced to individuals, other than where individuals have volunteered to speak freely about their experience (e.g. when interviewed).
Frequently Asked Questions:
What data do you collect about me, where from and why do you need it?
Some of the data we collect is provided by you in the form of a questionnaire, including your name, address and contact details – these are important so that we can keep in contact with you and so that we can be sure data relates specifically to you.
The questionnaire also asks questions about your medical history (e.g. if you have had any lung diseases or if anyone in your family has had cancer) and environmental factors (including smoking) – these are important because they may be risk factors for lung cancer.
If you have specifically consented to us having access to your medical records, we also collect data about you that specifically relates to our research goals. This data may come from:
• Your medical notes (GP and hospital records) and tell us about the results of hospital tests, the type of lung cancer you have and any treatment you receive.
• In addition, we obtain information from NHS Digital in relation to:
o Cancer Registries, run by Public Health England, which provide us with details of any cancer you might suffer after joining our study. This is important information because it allows us to help find new ways of predicting lung cancer – using the data and samples you have provided.
o The Office for National Statistics, which provides information of dates and causes of death. This is important because we are very interested in what happens to you after you have been recruited into our study.
o Hospital Episode Statistics (HES) data which will give details of any hospital admissions you may undergo after you have joined our study, that might have an impact on our research.
It will be necessary to send participants’ NHS number, date of birth, first name, surname and postcode to NHS Digital so that records related to the above information can be retrieved and sent to the UKLS IT manager in order that the UKLS database can be updated. No identifiable participant information will be shared with researchers or third parties. Any linkage to other datasets for research purposes will be on an anonymised basis only – it will not be possible to identify individual participants.
Is my information kept securely?
Yes, the information and samples you provide are treated confidentially and stored securely by the University of Liverpool. Data is held on a secure server at the University of Liverpool, is password protected and only available to approved, trained staff who are aware of all the rules (and laws) about confidentiality and data protection. By keeping it safe in this way, we not only protect our participants, but also ensure our research is of the highest scientific and ethical standards. We have ethical approval and patient consent to retain the data for 20 years, which is important for us to understand the full impact of our study.
Do you share it with anyone?
Sharing results and data is an important part of scientific research, ensuring that the best minds have access to the best resources to tackle the important questions and that our research can be judged fairly and used confidently to change the way that we detect and treat cancer. This involves sharing data with research collaborators in other countries and with international organisations. However, in sharing data we never identify individuals. All data used in research by us and our international collaborators, or published in scientific journals, is pseudonymised or anonymous.
When publishing research data all personal identifiers are removed. Data is only published in aggregate form, e.g. giving number of cases of a specific cancer type, or ethnicity or by giving age ranges. We do not publish individual case studies.
Before releasing data for sharing in the UK or internationally, our designated staff remove any identifier that might be used to identify our participants, i.e. all names and addresses are removed apart from high level post code areas in epidemiological studies, no dates of birth are given (but ages may be). Combinations of data for rare or unusual cases (that might be recognisable to individuals) are avoided; as lung cancer is a common disease, the population base is large enough to mitigate the risk of re-identification. In this way, although collaborators hold individuals’ data, it cannot be related back to a specific individual by them and is therefore no longer considered personal data.
We never release data to third parties who might try to contact you and those researchers who we do release anonymous or pseudonymised data are required to sign a legal contract that ensures they abide by the same high standards.
When we do share data with other researchers we ensure that legally binding agreements are in place to limit the use of the data to ethically approved research and to make sure that the same high standards of confidentiality are applied (even though we do not share data that would allow individuals to be identified).
It may be beneficial to work with a commercial company to develop new medical tests or treatments. We may therefore wish to share some of the samples or some of the information with other researchers working for such a company. If we do so the sample will be anonymous and no personal information about you will be disclosed. If, eventually, this research leads to any new treatment or medical test you will not benefit financially. If you wish, you can opt out of use of your data and samples by commercial companies.
How can I find out about the research that has been performed using my samples and data?
Because of the way we use your data anonymously and because this is purely research data, we are unable to share with you exactly what the results are relating specifically to you, or which studies your samples and data have been used in. However, you can find out about the work that the UKLS researchers carry out on the News page of this website, through local and national media and through our funding body, the National Institute for Health Research Health Technology Assessment Programme (NIHR HTA).
How do I withdraw from the study & what will happened to my samples and data?
We very much hope that you will continue to participate in our research and let us use your samples and data. However, as explained to you when you were recruited, you have the right to withdraw at any time and we will do our best to make sure that it is easy to do so.
If at any stage you feel you want to withdraw from the study, please contact us by telephone or e-mail (as above) and we will be happy to explain the simple procedure and provide a form that allows you to clearly state your wishes.
Professor John Field
Chief Investigator, UK Lung Cancer Screening Trial
University of Liverpool,
William Henry Duncan Building, 3rd floor,
6 West Derby Street,
Liverpool, L7 8TX.
The University of Liverpool are the Data Controller for this linked data and have policies and procedures in place to ensure that it kept securely and processed in keeping with your wishes and with the necessary regulation (such as the Data Protection Act). Contact details: Professor John Field (firstname.lastname@example.org).
As a University we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.
If you wish to raise a complaint on how we have handled your personal data, you can contact our Data Protection Officer who will investigate the matter. If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO).
To contact our Data Protection Officer you can e-mail LegalServices@liverpool.ac.uk or write to:
The Data Protection Manager
University of Liverpool
2nd Floor – The Foundation Building
EU General Data Protection Regulation (GDPR)
We take great care to abide by our legal and moral obligations when handling UKLS Project participants’ personal and healthcare data (this includes data classed as “sensitive data” because it includes details about you that you would expect us to treat with extra care, for example, ethnic origin, genetic or biometric data and data concerning health). Due to changes introduced in the EU General Data Protection Regulation (GDPR) and the UK Data Protection Act, the legal (or lawful) basis for processing of personal data for our research (from 25 May 2018) is as a “task in the public interest”. Informed consent is still important to meet our common law duty of confidentiality and is still needed to access and use confidential patient information for research.