The University of Oxford is a world-leader in developing systems to make sure that information is stored securely for research studies like AMALFI. You can read the University's Data Privacy Notice on the Nuffield Department of Population Health website. This explains how we use, collect and store information we collected about you (which we refer to as data).
The University of Oxford is the data controller for the AMALFI information. This means it is legally responsible for looking after your data and making sure it is used properly. Information about you is entered onto a computer, processed and stored securely. It is stored securely using encryption and password protection. Only members of staff who need to use this information are able to access it.
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. This could bring down their risk of having a stroke. To do this we have recruited just over 5,000 people. Half these people wore the Zio Patch and half did not. The reason for this approach is because we need to compare different approaches to find out which one is best for patients. To compare the two groups in AMALFI, we will count how many people are diagnosed with atrial fibrillation two and a half years, and five years after entering the study. We will then analyse if there was any difference in the number of atrial fibrillation events between those who had a patch and those who did not.
To enable us to do this, we need to collect information (data) over the course of the study, which will come either from your GP or NHS Digital. This will be information that is collected as standard practice (known as routinely collected data), not specifically for AMALFI. The data will let us know if you have been diagnosed with any significant new medical condition, or prescribed medication, or if you pass away during the study. It will also include data about any hospital stays, or major events such as a heart attack or stroke.
- Potential participants for AMALFI were identified by their GP Practice and sent an invitation pack, which included a brief questionnaire.
- Those who were interested in taking part, completed the questionnaire, which contained personal details, such as their NHS number, contact details and eight medical questions, such as, ‘Have you had a heart attack?’, with yes/no answers. This questionnaire was returned to the study coordinating centre in Oxford. It contained the only data that the study team had about participants at the beginning of the study.
- After you decided to take part, the co-ordinating centre in Oxford requested further information from your GP. It will also request information from NHS Digital. NHS Digital is a branch of the NHS that uses the nation's health data to drive research and transform services to help people get the best care. To get this information, the AMALFI team will 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 then provides us with information about any admissions to hospital, outpatient and A&E visits, as well as information from primary care records and medications, and 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. Please note, that you can contact the study team at any time to withdraw your permission for the study to get this information from your GP or NHS Digital.
- We will also ask you to complete a questionnaire (EQ5D) which aims to collect information about quality of life. We will do this either via the post or online at two time points: when recruitment to the study is completed, and approximately two and a half years after that.
You are free to withdraw from taking part in the AMALFI study at any stage. If you decide you no longer wish to continue, you can contact the study team, let us know that you have changed your mind, and we will remove your details from our contact list. You do not have to tell us the reason why.
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.
Staff at iRhythm (the company of produces and provides the Zio Patch) who analyse the information contained in the patch will not be able to identify you. However, other members of staff working on the AMALFI study at Oxford can access personal data that directly identifies you, such as your name, address and date of birth.
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.
In addition, AMALFI has been invited to take part in an international collaboration that aims to better understand the impact of the patch on clinical events, such as strokes. The collaboration will pull together and analyse data from all similar atrial fibrillation screening trials that have taken place in different countries. The University of Copenhagen, in Denmark has created a secure database specifically for this purpose. AMALFI plans to provide the collaboration with a limited subset of the data that has been collected as part of the study. This will not include any information that might identify you. You can opt out of having your data shared by calling us on 0808 164 50 80, or via email on firstname.lastname@example.org.
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 up to 20 years after the last planned data collection from GP practices (5 years after your inclusion in the study) and the main results are analysed.
Even though the UK has left the European Union, European data protection regulations apply in this study. 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. But 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 that the study results we publish are correct and robust. Rights to receive an electronic copy of the personal data held about you are also limited.
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 Information Commissioner’s Office (0303 123 1113 or www.ico.org.uk).