The University of Oxford is a world-leader in developing systems to ensure that information is stored safely for research studies like AMALFI. You can read the University's Data Privacy Notice on the Nuffield Department of Population Health website.
The University of Oxford is the data controller for the AMALFI information, which means that it is responsible for looking after this information and for ensuring it is used properly. Information about patients is stored securely using encryption and password protection and access is limited to only those members of staff who need to use the information.
The AMALFI study has been designed to see if using a new home ECG monitor called a Zio Patch, will increase the number of people detected early with atrial fibrillation and therefore to bring down their risk of having a stroke. To do this we hope to recruit around 2500 people, half of whom will be asked to wear a patch and half of whom won’t need to. The reason for this approach is because we need to compare different treatments to find out which one is best for patients, so we divide participants into groups and give each group a different treatment. The groups are then compared to see if one treatment is better.
To compare the two groups in AMALFI, we will count how many people are diagnosed with atrial fibrillation at 1, 2½ and 5 years after entering the study. We will then analyse if there was any difference in the number of events between those who had a patch and those who didn’t. To enable us to do this we need to collect data during the course of the study which will come from your GP or NHS Digital. This will be routinely collected data (i.e. information that is normally collected as standard practice) and will include individual, patient-level data about any deaths or significant new medical diagnoses and medication, as well as data about in-patient hospitalisations, including major events such as heart attacks and strokes.
Potential participants for AMALFI are identified by their GP Practice and sent an invitation pack including a brief questionnaire. Those who are interested in taking part, complete the questionnaire which contains personal details (such as NHS number), contact details and 8 medical questions (such as 'Have you had a heart attack?') with yes/no answers. This questionnaire is returned to the study coordinating centre in Oxford and contains the only data that the study team have about participants at the beginning of the study.
However, if you decide to take part, further information will be requested from your GP and the coordinating centre in Oxford will ask for information about your health from NHS Digital. The AMALFI team would send your name, date of birth, NHS number and postcode to NHS Digital, who can link this information to individual participants in the study. NHS Digital provides information about any admissions to hospital (called Hospital Episode Statistics) as well as information about people who may have passed away, in order that the study does not make contact and cause any distress to relatives. This information includes date and cause of death. You can contact the study team at any time to withdraw permission for the study to obtain this information from your GP or NHS Digital.
If you do choose to take part in the AMALFI study you will be free to withdraw at any stage. If you decide you no longer wish to continue, you can contact the study team, let us know you have changed your mind and we will remove your details from our contact list. You do not have to tell us the reason for your decision if you do not wish to do so.
Information about you is entered onto a computer, processed and stored securely. The study is sponsored by the University of Oxford. The University of Oxford is the data controller for the information collected about participants. This means that the University of Oxford is responsible for looking after your information and using it properly. No information that directly identifying you (such as your name, address and date of birth) will be passed to iRhythm.
Personal data that directly identifies you (such as your name, address and date of birth) can be accessed by study staff at the University of Oxford. However, the people who analyse the information contained in the patch will not be able to identify you.
Information collected about you during the study may also be looked at, in confidence, by authorised individuals from the University of Oxford and regulatory authorities, to check that the study is being carried out correctly.
The University of Oxford is required to keep the data collected about you for at least 25 years after the end of the study. The end of the study is when the last health information is collected about study participants - this may be 20 years after the end of the scheduled GP data collection and the main results are analysed.
European data protection regulations apply in this study and these laws require us to tell you about the rights you have over the personal data collected about you in the study.
The University of Oxford is using your personal data for research purposes; it will only process personal data as necessary to undertake research that is being carried out in the public interest. This is known under data protection law as our legal basis for processing your personal data.
Your rights to access, change or move your data are limited as the University of Oxford needs to manage your information in specific ways in order for the research to be reliable and accurate. You have the right to access any personal data that is held about you by the AMALFI team and the right to ask us to correct any inaccurate personal data we hold about you. You have the right to restrict or object to processing of your personal data. However, if you decide that you do not want any more information collected about you by the AMALFI team, the University of Oxford may be obliged by law to keep information already collected to ensure consistency and reproducibility of the study results. Rights to receive an electronic copy of the personal data held about you are also limited.
Further information about your rights with respect to your personal data is available at https://compliance.web.ox.ac.uk/individual-rights
We will be using information from you, your medical records and NHS Digital, and will use the minimum personally-identifiable information possible. We will keep identifiable information about you for up to 12 months after the study has finished. However, we will store the de-identified research data and any research documents with personal information, such as consent forms, securely at the University of Oxford for 25 years after the end of the study as part of the research record.
If you are not happy with the way your data has been handled by the AMALFI team you have the right to lodge a complaint with the study sponsor (01865 616480 or firstname.lastname@example.org) and/ or the Information Commissioner’s Office (0303 123 1113 or www.ico.org.uk).