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Predicting AF after Cardiac Surgery - the PARADISE Score. A Clinical Prediction Rule for Post-operative Atrial Fibrillation in Patients Undergoing Cardiac Surgery – Privacy Notice

Who is responsible for your data?

The data controller for this study is the Sponsoring organisation, University of Oxford.

Under Section 251 of the NHS Act 2006, we have permission to conduct this study without consent.

The study relies on accessing a large number of historical patient records. The study requires access to these health records without individual patient consent, on the basis that the scale data needed to address its aims would otherwise be reasonably unobtainable. 

PARADISE has support from the Health Research Authority following advice by the Confidentiality Advisory Group (England and Wales) under Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 to conduct the study without study-specific consent (i.e., link, transfer, process and analyse the data) – CAG reference number: 20/CAG/0097.

Personal data we collect about you

The study will use routinely collected data to construct a research database of patients who have undergone cardiac surgery. 

Data providers will use a service provided by NHS Digital to identify potential participants who have indicated that they do not wish their data used for research purposes (https://www.nhs.uk/your-nhs-data-matters/). The data providers will remove these patients, and then anonymise participants’ data before transferring it securely to the study office at the University of Oxford. No direct identifiers will be communicated to the study office at any time and will not be retained in the study database. The study office will only hold the pseudonymous study ID linked to anonymised data. The study database will store information on your local area, which has been derived from your postcode. 

The pseudonymous data will be imported into a database held securely by the University of Oxford and used solely for academic research purposes. Importantly, while the information received is specific to each study participant, no individual person will be identifiable in any publication arising from this work. Your personal data will not be shared with any third parties and will not be used for any automated decision making or profiling. If you would like to have this data withdrawn, please contact the study team using the details given below.

How we use your personal data

Research is a task that we perform in the public interest. The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after your information and using it properly. We will use the minimum personally-identifiable information possible.

The legal basis for the processing and storage of personal data for the PARADISE Study is that it is ‘a task in the public interest’ (article 6(1)(e)) and, that sensitive personal data is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes (article 9 (2) (j), based on Article 89(1)).

How long we keep your data

The study hospitals will keep a record of your direct identifiers (e.g. data of birth, NHS number) until the end of the study. Your other (anonymised) personal data will be retained for at least five years, in line with the MRC Retention Framework for Research Data and Records and relevant legislation.

Further information on how long research information is retained by the University can be found in the University’s Policy on the Management of Research Data and Records, available via http://researchdata.ox.ac.uk/university-of-oxford-policy-on-the-management-of-data-supporting-research-outputs/.

How we protect your data

The Sponsor has security policies in place to protect your personal data against unauthorised access, unlawful use, accidental loss, corruption or destruction. These policies are reviewed regularly to ensure best practice.

The study will use secure computer systems, secure networking, NHS standard encryption and electronic records, secure disposal of confidential waste and computer storage media, and staff with a contracted obligation to ensure data protection.

Sharing data

The deidentified personal data collected and managed by the Sponsor will only be used for research purposes. The deidentified data will not be combined with any data sources that could identify you.   

Your rights

For more information, please see: https://compliance.admin.ox.ac.uk/individual-rights. If you wish to exercise any of these rights, please contact the study at ccrg.research@ndcn.ox.ac.uk.

Complaints and withdrawing from the study

If you decide you do not want your data to be used for this study you can withdraw at any time, without affecting your medical care. There are several ways to do this. You can register with the NHS Opt-out scheme (https://digital.nhs.uk/services/national-data-opt-out) to ensure your data are not used for research. Data providers will use a service provided by NHS Digital to identify potential participants who have indicated that they do not wish their data used for research purposes (https://www.nhs.uk/your-nhs-data-matters/). The data providers will remove these patients before anonymising participants’ data and transferring it securely to the study office at the University of Oxford.

You can also contact the study team (ccrg.research@ndcn.ox.ac.uk) or Chief investigator, Peter Watkinson (peter.watkinson@ndcn.ox.ac.uk) directly to inform us that you do not wish your data to be used. We will ask the individual data providers to contact you. They will ask for your identifiers (e.g., name, NHS number) and your data will be removed from the data set before the anonymised version is transferred to the University of Oxford.

Data protection regulation provides you with control over your personal data and how it is used. When your health care information is being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate. Further information about your rights with respect to your personal data is available at https://compliance.admin.ox.ac.uk/individual-rights or by contacting the study team using the details below.

If you have further questions or are not happy with the way your data has been handled, please contact the study team using the contact details below.  Alternatively, you can contact the study sponsor on 01865 616480 or ctrg@admin.ox.ac.uk.  You have the right to lodge a complaint with the Information Commissioner’s Office (0303 123 1113) or www.ico.org.uk.

Further information

If you require any further information on the use of your data or any aspect of the study, please email ccrg.research@ndcn.ox.ac.uk