What is personal data?
Your personal details including your name, address, contact details, date of birth, NHS number (i.e. anything that could identify you) are called “personal data”. You can find out more about how your personal data is used by visiting:
https://www.information-compliance.admin.cam.ac.uk/data-protection/research-participant-data
https://www.cuh.nhs.uk/patient-privacy/
How we use your provided personal details and health history
The information you provide on your health and lifestyle is known only to the EMBED study and will be used only for medical research. Your name and address are used by the study investigators, so that we can contact you personally.
In addition, identifiable data including your date of birth and NHS number are supplied by us to NHS Digital to enable EMBED to obtain data from your medical records, but we do not send them information on your health. We will receive details from the NHS Digital on a periodic basis regarding any cancer diagnoses that study participants may have had. NHS Digital will also provide us with information from the Office of National Statistics (ONS – https://www.ons.gov.uk/aboutus) about those who may have passed away since the start of our study, including date and cause of death, which also helps us avoid attempting to make further contact. The reasons for obtaining data from NHS digital and the ONS are to make sure that we have up to date and correct information and to ensure that the results of the study are as accurate as possible.
All data is handled and held under appropriate secure conditions by the study team. Your information undergoes pseudoanonymisation for all data analysis. This means your data is pooled with thousands of others and each person is only identified by an artificial identifier rather than by their personal details, such as their name. All publications and presentations are based on these large datasets and do not use individual records, instead they display results of our analyses using tables and graphs.
The EMBED study is based at the Department of Public Health and Primary Care within the University of Cambridge. The University of Cambridge is therefore the ‘Data Controller’ and as such has legal responsibilities for keeping your personal data safe. Please refer to the following link for more information concerning the use of your data and your rights – [data protection](https://www.information-compliance.admin.cam.ac.uk/data-protection/research-participant-data)
Will the use of my personal data meet GDPR Rules?
GDPR stands for the General Data Protection Regulation. In the UK we follow the GDPR rules and have a law called the Data Protection Act. All research using patient data must follow UK laws and rules.
This study is part of the university of Cambridge and as such the legal basis to hold and use personal data is covered under the General Data Protection Regulation “Article 6 (1)(e) processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller”. This research is in public interest given the large proportion of people who suffer from breast and ovarian cancer, and Cambridge are permitted to conduct research. To hold special categories of personal data our lawful basis is for pursuing scientific research under “Article 9 (2)(j) processing is necessary for achieving 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 interests of the data subject”. University of Cambridge has a track record of excellent health research and have staff and the necessary expertise to undertake this role in the public interest.
Under the GDPR, there are six principles. Personal data must be processed following these principles so that the data are:
- Processed fairly, lawfully and transparently – and only if there is a valid ‘legal basis’ for doing so.
- Processed only for specified, explicit and legitimate purposes.
- Adequate, relevant and limited.
- Accurate (and rectified if inaccurate).
- Not kept for longer than necessary.
- Processed securely – to preserve the confidentiality, integrity and availability of the personal data.
Research studies have to go through a rigorous approval process before researchers can start recruiting patients. A study application has to show it meets all of these principles before given the go ahead to proceed. This study has been approved by the East of England – Cambridge South Research Ethics Committee on 13/04/2020, Reference number: 20/EE/0052 and the Health Research Authority.
You can find out more by visiting:
https://www.information-compliance.admin.cam.ac.uk/data-protection
Or click
to download a GDPR leaflet.
Withdrawing from the study
Participants are free to withdraw from the EMBED study at any time. If you would like to do so please tell us by writing, telephone or e-mail using the contact details below.
Louise Lucraft
Centre for Cancer Genetic Epidemiology
Strangeways Research Laboratories
2 Worts Causeway
Cambridge CB1 8RN
Tel: 01223 748670
You don’t have to give a reason. Your decision will have no effect on your care or treatment in the future.
When withdrawing from the study, please also let us know if we can continue to use your data already provided, or if you would prefer for it to be destroyed. The following four examples show how you may wish to withdraw:
- I wish to contribute again in future, but would rather not do so at present: This can occur when a questionnaire and/or a request for a blood sample arrives during a difficult time, for example whilst you are undergoing treatment. In this case we can skip a questionnaire and contact you again in future when you would be due for the next one. This would allow us to continue using the data we have collected so far, and to continue obtaining data from your medical records.
- I no longer wish to be contacted: in this case we would no longer contact you, but you give us permission to keep and continue to use information (and any blood samples) you have already provided, and to continue to obtain and use information from NHS Digital, as before.
- No further contact or access to your health records: we will not contact you again and we will not collect any more information through your health records; but you give us permission to keep and use the information (and any samples) already provided.
- Complete withdrawal (no further use of data): in addition to no longer contacting you or obtaining information through medical records, we will destroy your information and of samples already provided. Your information may have been used in pseudoanonymised analysis datasets carried out in the past, but we will ensure that your information is not used in future.
An Important Notification
Following the disbandment of Public Health England (PHE) last year we are currently in the process of applying to NHS Digital for cancer related data. The consent form you signed however made reference to PHE as the source for this data. You don’t need to do anything; everything we said we would do is still the same. This notification is to make you aware of this change however if you would like to speak to a study team member our contact details are overleaf.
If you have questions
You are very welcome to contact the study coordinator Louise Lucraft (EMBED@medschl.cam.ac.uk) at any time before or during the study. If she is unable to help she will direct you to the person/services that can.