The following information is provided for participants who consented to long-term follow up using information provided by Cancer Registries and the Office of National Statistics (ONS) as part of these studies:
The Melanoma Follow-Up and Case-Control Family Study. Ethics Committee number: MREC 01/3/057
A Genetic Epidemiological Study of Melanoma to Investigate The Protective Role Of Vitamin D For Relapse. Ethics Committee number: MREC 07/H1010/66
Why are we providing this information?
Participants in the two studies listed above were asked to consent to the use of information from the cancer registries and the Office of National Statistics about their health.
The way in which this information is supplied to researchers has changed and this information is intended to update participants so they know exactly what is entailed.
Why is this important to know?
The changes include ensuring greater transparency about how personal data (information such as cause of death or a new diagnosis of cancer) is handled. In other words, it is now crucial that participants in research studies know where researchers get data about them from, why they want it and what they do with those data. The organisation handling these data in the UK is now known as NHS Digital.
The information below is designed to make it clearer to melanoma patients taking part in the above studies (and/or their relatives) just how their data will be managed by NHS Digital and the University of Leeds in the future.
What data do we get from NHS Digital?
NHS Digital collect data about NHS patients and their illnesses. Research groups like ours can apply to NHS Digital to have some of those data for our research. The research studies, listed above, managed by the University of Leeds, were designed to look at a number of lifestyle factors in melanoma patients and how those factors might affect their health. We get most of this information directly from each patient but we also need to collect data from NHS Digital about two important aspects: Firstly; whether participants have had new cancers, and if so what type(s) and when were they diagnosed, and secondly; if they die, what was their cause of death and when did their death occur.
Why do we want this data?
Knowing these facts allows the research group to determine whether people who have had melanoma live for different period of time after diagnosis according to their lifestyle. Melanoma specialists can subsequently better advise melanoma patients on what lifestyle factors to adopt or avoid. Using NHS Digital is the best way of obtaining accurate data without accessing medical records held by GPs or hospitals and without repeatedly contacting the study participants.
What do we do with this data and how do we look after it?
Any data obtained can only be used for the purpose described in the participant information leaflet for that study. The data which are identifiable, including name and NHS number, will be seen only by a University of Leeds employee who will link the data provided by NHS Digital to the data collected directly from each participant by the research group. The staff analysing the research data cannot see that personal information. For both melanoma studies, we will seek information from NHS Digital until 2018 only. We will retain the research data but delete identifying information such as names, date of birth (we will use age at diagnosis in our analyses), addresses and NHS numbers.
What actually happens?
- The research group in Leeds (led by Professor Newton-Bishop) will request information about cancers registered or death (as mentioned above).
- The name, date of birth, and where possible the NHS number of each participant is given securely to NHS Digital.
- NHS Digital then supply any information they hold, such as registration of another cancer diagnosis, to the Senior Data Manager (currently May Chan).
- That Senior Data Manager will add the new information to an existing master research record of the relevant patient. This research record is stored in a restricted database in a restricted area of the University of Leeds computer system. Only the Data Manager and a Research Nurse can access this database.
- The data analysts and scientists working on the project will then ask for these data to enable their analysis. They make a formal request (via an application form) to a data access team comprised of; the Senior Data Manager and the Head of the Institute, who will review the application and if satisfied prepare and release only the necessary sections of the data. For example, the data will be labelled with a study number only.
- In 2018, we will remove all names, dates of birth, addresses and other contact information from the master records so that the resource can be used in the future without risk to the confidentiality of participants.
What to do if you have concerns about asking NHS Digital for information
If you have any concerns then contact research nurse Christy Walker or Professor Newton-Bishop by email, or telephone 01132064575. Withdrawal from the study is possible at any stage. You may decide to withdraw only from further data collection via NHS Digital but stay in the study or you may in fact choose to withdraw all your data. If you chose to have your data destroyed, we will destroy all the data we hold, although we would not always be able to remove data already analysed.