The University of York is the sponsor for this study based in the United Kingdom. We will be using information from you and your medical records (if you gave us permission to access your medical records on the E-SEE Trial consent form) in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The day-to-day management for the trial is delegated and split across the Department of Health Sciences at the University of York, the Clinical Trials Research Unit (CTRU) at the University of Sheffield and the University of Exeter Medical School. Together these organisations will be using information from you in order to undertake this study. The University of York will keep identifiable information about you for 10 years after the study has finished.
The University of York uses personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.
The Research teams at the University of York and the University of Exeter will collect information from you for this research study (and from your medical records, if you gave us permission to access these on the E-SEE Trial consent form) in accordance with our instructions.
The University of York and the University of Exeter will use your name, and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for your participation. The only people from the University of York or the University of Exeter who will have access to information that identifies you will be people who need to contact you about the research. Individuals from the University of York or Sheffield University and regulatory organisations may look at your research records to audit the data collection process, oversee quality and check the accuracy of the research study. The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.
Where you gave consent to do so on the E-SEE trial consent form, The University of York will collect information about you for this research study from NHS Digital. This information will include the number of times you or your child have required access to services including admissions to hospital, visits to the doctors or with nurses, health visitors and other health workers as well as records of general health checks. We will be looking at number of times you or your child have required access to services rather than the reasons why services were accessed. Access to this data will enable us to look in a bit more detail at any benefits for health and wellbeing by participating in this trial. Where you gave consent to do so on the E-SEE trial consent form, we may access these medical records again in the future. The reason we would like to look at these records is because it will tell us about whether there are any longer-term benefits to health and quality of life. This information can only be accessed if you gave your permission on the E-SEE trial consent form. Your name, postcode, date of birth, NHS number and those of your baby will be used to access this data.