HOW WE USE YOUR DATA

Confidentiality

In this study, most of the research team will not need to know your name. In these cases, someone will remove your name from the research data and replace it with a code number. This is called coded data, or the technical term is pseudonymised data. For example, your blood test might be labelled with your code number instead of your name. It can be matched up with the rest of the data relating to you by the code number. In the FINESSE study, this code number is called a Patient Identification Number (PIN).

Your PIN will be used on all your study records and samples instead of your name to ensure information is kept confidential. Your medical records may be looked at by people who are authorised to check that the study is being carried out properly, and the quality of the research. Representatives of health regulatory authorities and the hospital NHS Trust, and auditors from the Trials Unit and Sponsor may have access to your medical records, and these people will be required to keep your information confidential. A responsible representative from King’s College London will also require access to records for the purpose of monitoring and auditing. By signing the consent form you are giving your permission for this to happen.

Your contact details and information collected about you will be securely stored on the trial database and restricted access to this data will only be given to authorised and trained members of the trial team, other members of King’s College London who may wish to monitor the study, and a third party based outside of the UK who will send text messages on our behalf. These details will also be required to send you study related information questionnaires, and to allow the study team to collect registry data during passive follow-up.

Any identifiable personal information will be stored on a secure, restricted access server data haven maintained by AIMES, a contracted GDPR compliant third-party storage provider based within the UK.   

Data protection statement 

 Your data will be processed under the terms of UK data protection law [including the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018]. The sponsor, Sheffield Teaching Hospitals NHS Foundations Trust, is the Data Controller and is responsible for looking after your information and using it properly. The KCL Data Protection Officer provides oversight of KCL activities involving the processing of personal data, and can be contacted at info-compliance@kcl.ac.uk.

Data protection regulation requires that we state the legal basis for processing information about you. In the case of research, this is ‘a task in the public interest.’ Special category personal data is personal data that reveals racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, health (the physical or mental), sex life or sexual orientation, genetic or biometric data. The lawful basis used to process special category personal data will be for scientific and historical research or statistical purposes.

If you would like more information about how your data will be processed in accordance with UK GDPR, please visit the link click here. 

This notice is in addition to the Sponsor’s privacy policy STH NHS Privacy Policy, and applies specifically to personal information held for research purposes in the FINESSE trial.