Thank-you for being part of our research into the causes of lung cancer.
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 future screening)
• Identify better ways to detect lung cancer earlier, leading to earlier diagnosis
• Identify ways of selecting patients for the best current and future treatment
• Contribute to improving patients’ outcome and ultimately save lives.
For any enquiries relating to participation in LLP contact: LLP@liverpool.ac.uk or
Professor John Field: 0151 794 9110
Dr Michael Davies: 0151 794 9105
As a participant you will have given us your informed consent before taking part in our study and provided information (e.g. completed a questionnaire) and /or samples (e.g. blood, sputum). You will have been provided with a patient information sheet 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 one of the individuals listed above or in writing to the address below.
It is important that as a participant you understand what data we hold about you and where it comes from:
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, if necessary, we can contact you.
The questionnaire asks questions about your medical history (e.g. if you have had any lung diseases and if anyone in your immediate 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 NHS Digital which provides us with further details of diseases that you may also have suffered from, that may have an impact on our research. We provide NHS Digital with your personal identifiable data including name, NHS number, date of birth and postcode. NHS Digital use this to link to records including your hospital admissions data, Cancer Registry data (sourced from Public Health England) and mortality data from the Office for National Statistics (ONS).
Examples of where your data comes from:
• your medical notes (e.g. if you were recruited whilst attending hospital for lung cancer diagnosis or treatment) and tell us about the results of hospital tests, the type of lung cancer you have and any treatment you receive. This hospital data supplied to us by NHS Digital is known as the Hospital Episode Statistics (HES) dataset.
• Cancer Registries, 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.
• Office of National Statistics (ONS), which provides information of dates and causes of death (mortality data) – this is important because we are very interested in what happens to you after you have been recruited into our study. Knowing when participants have died is important, as it allows us to try and determine which lung cancers are most deadly, or which treatments most effective.
You should also understand how we handle (or process) your data:
• we store the data securely and only share it anonymously with approved researchers (none of whom would be able to personally identify you from the data);
• the only data collected is that which is an important part of our research and helps us address our aims;
• how we access the 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;
• all our research is ethically approved.
• none of your data is used for automated decision making.
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
Exactly how we handle data we keep about you as part of our research at the University of Liverpool is fully explained and outlined within our Fair Processing Statement. A copy of this statement is available for your information UOL Fair Processing Statement.
The information in the statement informs you in legal language what you can expect from us when you entrust us with information about yourself. It explains to you, the participant, what our obligations are to you in order to protect your information and identity when conducting our research. We have explained some of this in simpler terms in the Frequently Asked Questions sections below.
Data protection under the EU General Data Protection Regulation (GDPR)
We take great care to abide by our legal and moral obligations when handling LLP 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.
Compliance with updated standards of consent
The information provided here is only relevant for patients who consented to enable the study team to follow up their health status via the Health and Social Care Information Centre (now called NHS Digital). Since 2008, we have applied to receive data from NHS Digital (formerly the Health and Social Care Information Centre; ‘HSCIC’). They hold the data necessary for us to complete the study of lung cancer risk and outcome.
Unfortunately the consent given by some patients at the time of enrolment prior to 2003 did not meet new standards in 2018. As such, we have obtained new approvals to access the data.
Firstly, we obtained a new favourable ethical opinion from North West – Liverpool Central Research Ethics Committee (REC) to enable data transfer under section 251 of the NHS Act 2006. We then obtained support from the Confidentiality Advisory Group (CAG) at the Health Research Authority under section 251 of the NHS Act 2006 to transfer patient information from the University of Liverpool to NHS Digital for the purpose of linkage. To find out more about section 251 and the CAG; please see the HRA website.
The patient information transferred to NHS Digital was name, date of birth and NHS number and a unique study ID to enable us to link this information regarding cancer diagnosis, health episode statistics and mortality to data collected by questionnaire, during clinic visits and from testing samples provided by subjects. No data about patients’ health condition collected during the study will be transferred to NHS Digital, and data will be transferred by a secure method. This will enable us to determine factors relating to the risk of lung cancer, to lung cancer behaviour and outcomes.
Frequently Asked Questions:
Is my information kept securely and confidential?
Yes, the information and samples you provide are treated confidentially and stored securely by the University of Liverpool. Data is held on a secure data 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. Paper records are stored in a secured room accessed only by nominated members of staff.
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.
At the end of the study, electronic data containing personal identifiers and/or sensitive data will be pseudonymised and physical data, i.e. paper records, will be retained within the University of Liverpool archives – a secured and managed records storage facility with limited and protected access. Pseudonymised data means that details that could identify individuals such as name, NHS Number and Date of Birth would be removed and replaced with a unique ID, that only allows identification by reference to the original paper copies or a securely held reference document.
The University reviews storage of data to ensure that data is only stored for as long as it is necessary (either to ensure the research is fully utilised or to meet legal or research governance requirements). Once data is no longer required, it is destroyed and disposed of in a way that maintains confidentiality (e.g. by shredding of paper records or destroying electronic records by validated means).
Do you share data 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 individualsâ€™ 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 or pseudonymised 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. We specifically ask your permission to allow your samples or data to be used as part of commercial research as part of the consent process. If you wish you can opt out and this will have no impact on your current treatment.
Collaborating with commercial organisations, including those where anonymised data may be shared, provides funded collaborative research and access to new data from techniques that would otherwise be unavailable. We only collaborate on commercial projects that fulfil mutual aims regarding the early detection and/or improved treatment of diseases such as lung cancer. For example, in order to test the ability of their new tests for lung cancer risk or diagnosis we have provided samples and anonymised information on disease status to companies. In addition, we have received funding from companies for us to test new ways diagnosing lung or to test ways of determining the best treatments for cancer patients. Examples are listed HERE.
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.
Our research is published in medical journals and at scientific meetings, for scientific audience and may not be available to you, other than in the form of a short summary (an abstract). However, you can find out about the work that the Liverpool Lung Project performs on our Liverpool Lung Project website, the University of Liverpool website, through local and national media and through our main funding body the Roy Castle Lung Cancer Foundation. If you have any questions about our research you can contact us, using the contact details above.
How do I withdraw from the study and 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 do feel you want to withdraw from the study, please complete this online form, contact us by telephone or e-mail (as above) or write to us at the address below:
Liverpool Lung Project
Institute of Systems, Molecular & Integrative Biology
University of Liverpool
William Henry Duncan Building, 3rd floor
6 West Derby Street
Liverpool, L7 8TX.