Lynch Syndrome Registry Pilot Study
The Lynch Syndrome Registry Pilot Study involves patients recruited at participating hospitals in England. The study is funded by 40tude (through the St Mark’s Hospital Foundation) and Cancer Research UK. This small-scale initial study, known as a pilot study, will help to answer several important research questions about how Lynch syndrome patients are currently managed in the NHS. It will also assist with optimising the data collection process and functionality of the registry, for both users and researchers.
The study is registered with the ISRCTN registry. Its unique number is 14826039.
Our Data Protection and Privacy Notice
Privacy notice
This privacy notice explains your rights to your personal information, what you can expect us (the Cancer Screening and Prevention Research Group) to do with your personal data and our lawful basis for doing so. This notice also explains who you should contact if you have any queries or complaints about how we are processing your personal data.
Under the 2018 General Data Protection Regulation (GDPR) and accompanying Data Protection Act (2018) ‘personal data’ is any data that can be linked to an identifiable individual (for a full definition see: Information Commissioner’s Office (ICO) website: What is Personal Data?). Some types of personal data, such as health data, are additionally classified as ‘special category personal data’. The law considers special category personal data to be more sensitive and gives it more legal protection (for more information see: ICO website: Special Category Data). As the Cancer Screening and Prevention Research Group processes (processing is the term used to refer to collecting, analysing and storing data) health data, much of the personal data we hold is considered to be special category personal data.
Who is responsible for the lawful processing of your personal data?
The GDPR and Data Protection Act define roles and responsibilities for those involved in processing personal data.
The Cancer Screening and Prevention Research Group (hereafter; CSPRG) are a research group at Imperial College London. The CSPRG can be contacted via the ‘Contact Us’ page on this website. The data controller determines the purpose for which and the manner in which personal data is to be processed (see: ICO website: Controllers and Processors). For the personal data held by the CSPRG, the data controller is Imperial College London. The data controller’s representative for our data is the Director of Information Governance for Academic Health Sciences. All queries relating to the handling of personal data should be directed to the Imperial College London Data Protection Officer via email at dpo@imperial.ac.uk. Contact details can also be found at the end of this privacy notice.
Why are we processing personal data?
The research focus of the CSPRG is gastrointestinal cancers which includes bowel cancer, also known as colorectal cancer. In the UK, every year over 41,000 people are diagnosed with bowel cancer alone and 16,000 people die from this disease. Through our research we hope to reduce the number of people being diagnosed with gastrointestinal cancer and dying from this disease. Much of our work focuses on how to help make bowel cancer screening and surveillance programmes more effective and acceptable for patients, and more efficient for the NHS, and other health services internationally. To understand the effectiveness of bowel cancer screening and surveillance programmes, we conduct large scale studies on procedures conducted and the benefits to patients. Identifiable patient data are usually necessary to track long-term health outcomes for participants enrolled in our studies. The CSPRG therefore needs to collect and hold personal data – often special category personal data. Our more specific purposes for processing data for each of our studies are detailed on the ‘Studies’ pages of our website.
What personal data do we have?
The personal data we hold is special category personal data relating to individual health. For example, for several of our studies we analyse procedure and treatment information, information about cancers occurring, whether they progress and the patients’ long-term health outcomes. In addition, we also often require some basic information about patients such as age and gender to inform our analysis. The full details of the personal data processed for each of our studies can be found on the ‘Studies’ pages of our website.
To fulfil our research aims we obtain personal data from a variety of sources. Much of our data is either obtained directly from NHS Trusts, or via third parties such as NHS England, the Office for National Statistics, the Bowel Cancer Screening Programme, National Cancer Registries (including the Welsh Cancer Intelligence and Surveillance Unit) and Information Services Division Scotland, part of NHS National Services Scotland. More detailed explanations of our sources of data can be found on the ‘Patient Data’ page and ‘Studies’ pages of our website.
Where data has been obtained from third party data providers under section 251 approval, national data opt-outs have been applied by the provider since 2016.
How do we process personal data?
All personal data we hold are processed in secure systems. For each active study we have completed a Data Protection Impact Assessment that has been approved by the Head of the CSPRG (as the Information Asset Owner) and the Imperial College London Data Protection Officer. No processing performed by the CSPRG involves automated decision-making or profiling. Unless stated otherwise on the ‘Studies’ pages of our website, all personal data are processed by the CSPRG and certain third parties (see ‘Third-party processing’ below). None of our studies process or transfer individual-level personal data outside the UK.
The Imperial College Data retention schedule mandates that data is retained for ten years after the end of a study (see the College Retention Schedule here). The expected end of these ten year retention periods for each of our studies are listed under the ‘Studies’ pages of our website under the ‘How long will we retain the data?’ sections.
Third-party processing
For the purposes referred to in this privacy notice and relying on the bases for processing as set out above, we may share your personal data with certain third parties:
- Other College employees, agents, contractors and service providers (for example, suppliers of printing and mailing services, email communication services or web services, or suppliers who help us carry out any of the activities described above). Our third-party service providers are required to enter into data processing agreements with us. We only permit them to process your personal data for specified purposes and in accordance with our policies.
What is our lawful basis for processing personal data?
Processing personal data requires justification under two legal frameworks: the GDPR/Data Protection Act 2018 and under the common law duty of confidentiality.
Article 6 of the GDPR lays out six valid bases under which personal data can be processed lawfully. We process personal data under lawful basis 6(1)(e) ‘Public task’ as: processing is necessary for the performance of a task carried out in the public interest. We are also required to have a separate lawful basis for processing the more sensitive special category personal data. Our legal basis for processing special category personal data is Article 9(2)(j) ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes […]’
In addition, health data (such as that the CSPRG hold) require a separate lawful basis under the common law duty of confidentiality. In some of our studies, patients consented to be part of the study and for the CSPRG to process their data. In other studies, consent could not be sought due to practical considerations or the nature of the study. In these studies, we have obtained lawful permission to obtain and process personal data under section 251 of the National Health Act 2006. The common law legal bases for data processing in each study are explained in the ‘Studies’ pages of our website under the ‘What approvals has the study received?’ sections.
What are your rights concerning your personal data?
The GDPR grants individuals several rights concerning their personal data:
- The right to object (to processing of the data)
- The right to correct (inaccurate or incomplete data)
- The right to erasure (also known as “the right to be forgotten”)
- The right to restrict processing (e.g. while the accuracy of the data is contested)
- The right to portability (to have a copy of any data you have provided to us)
- The right to access (to have a copy of data we hold about you)
- The right to withdraw consent (if you have previously consented to take part)
If you think that we might be processing your data and you wish to exercise any of the rights listed above, please get in touch using the details on the Contact Us page or by contacting the Imperial College London Data Protection Officer via email at dpo@imperial.ac.uk. Though it may not always be possible for us to fulfil your request, we will respond to your query within one month. For more information on your GDPR rights, please see guidance provided by the Information Commissioner’s Office.
Where can you direct queries or complaints?
Please be aware that individuals also have a right to complain to a supervisory authority- in this case the Information Commissioner’s Office (ICO) – if they feel their data is being used unlawfully. The ICO does recommend that you seek to resolve matters with the data controller – for our data that is Imperial College London – before contacting the Commissioner’s Office. If you wish to raise a complaint on how we have handled your personal data or if you want to find out more about how we use your data, please contact Imperial College London’s Data Protection Officer via email at dpo@imperial.ac.uk, via telephone on 020 7594 3502 or via post at Data Protection Officer, Faculty Building Level 4, Imperial College London, London SW7 2AZ.
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 raise your complaint with the Information Commissioner’s Office. The ICO’s address is: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF; Helpline number: 0303 123 1113; ICO website: https://www.ico.org.uk.
Privacy and data protection information relating specifically to the Lynch Syndrome Registry Pilot Study
Specific information about privacy and data protection for this study is available from the Lynch Syndrome Registry Pilot Study Website Privacy Notice.
What are the aims of the Lynch Syndrome Registry Pilot Study?
This small-scale pilot study will allow us to evaluate the feasibility of our plans for a national registry and to optimise the data collection process and functionality of the registry database. Data collected will enable us to answer some key initial questions and aid in the development of a national registry.
What type of study is the Lynch Syndrome Registry Pilot Study?
This is an observational, questionnaire-based pilot study. A pilot study is a small-scale test of the methods and procedures to be used on a larger scale, in this case in a national Lynch syndrome registry.
What is Lynch syndrome?
Lynch syndrome is an inherited disorder that is associated with an increased risk of several cancers, particularly bowel cancer, as well as cancer of the womb. In the UK, there are only 6,000 known Lynch syndrome patients. However, it is estimated that there are about 176,000 undiagnosed cases. Given their high risk for bowel cancer, these patients require close monitoring, also known as ‘surveillance’, by colonoscopy – a thin tube with a camera on one end which is used to examine the bowel lining.
When and where does the study take place?
Recruitment is due to begin in 2022 at participating hospitals in England – St. Mark’s (London), Newcastle, Birmingham and Manchester.
Who is included in the study?
English participants with a confirmed genetic Lynch syndrome diagnosis, who have previously taken part in the CaPP3 trial and consented to be contacted about participation in a national Lynch syndrome registry.
What type of information will we hold for the purposes of the Lynch Syndrome Registry Pilot Study?
The patient information we collect and hold for this study includes name, date of birth, NHS number, contact details (email or postal address), details of GP, hospital and/or genetic centre, as well as some medical information, such as Lynch syndrome related medical history (including MMR gene information) and details from colonoscopy examinations, including dates and results.
What approvals has this study received?
Several national experts reviewed the scientific plan before funding was awarded and the study has undergone review with the sponsor, Imperial College London. The registry pilot study will be overseen by an independent Steering Committee. All research in the NHS is overseen by the Health Research Authority (HRA) and looked at by an independent group of people, called an NHS Research Ethics Committee, to protect your safety, rights, wellbeing, and dignity. The registry has been reviewed and given a favourable opinion by an NHS Research Ethics Committee.
Why do we need to hold identifiable data for this study?
We would also like to know whether participants have been diagnosed with a condition, such as cancer, in the future. We can do this by collecting information from NHS systems. In order to collect this information, we will need to provide NHS Digital with date of birth and NHS number, which are already held by them; these details will be treated in confidence and in accordance with the Data Protection legislation. Registry information will not be released to any other organisations such as insurance companies.
The information held in the Lynch syndrome Registry Pilot Study will be accessible to a limited number of local and central study team members, including a very small number of authorised experienced staff at the Cancer Screening and Prevention Research Group as well as local hospital research staff who would already have access to your medical data. Local research staff will only have access to information for their own patients and they will not have access to information collected from other sites. Data sharing agreements will be in place with all relevant organisations and personal data will not be shared outside of the direct research team and sponsor representatives.
All the data we collect will be kept strictly confidential and in accordance with the General Data Protection Regulation (GDPR), and Data Protection legislation.
How long will we retain the data?
We will retain data for 10 years following end of study.
What are the expected results of the study and what impact are they expected to have?
Any research results from the registry will be displayed on the ‘Research’ page at www.lynchregistry.org.uk. Research results will be presented to the research community and service providers in scientific literature and presented at national and international scientific conferences, clinical meetings and patient conferences. Our findings will also be disseminated to patient communities and the public with the help of our Patient and Public Representatives, collaborators, patient advocacy and support groups such as Lynch Syndrome UK, and through our social media channels. Individual registry participants will not be identifiable from any reports or publications placed in the public domain.
In the future, anonymised information from the Lynch Syndrome Registry Pilot Study may also be used to support other studies in the UK, Europe and outside of the European Economic Area, that aim to conduct further research to improve care for Lynch syndrome patients, but only if participants give specific consent for this. Further information about data sharing and international transfers can be found at https://lynchregistry.org.uk/Privacy.html.