If you decide to take part in ACCURE-UK 2, we will need to collect information about you and some of this information will be your personal data; name, date of birth, NHS number, postal address, health information and medical history. Under data protection law, we have to provide you with very specific information about what we do with your data and about your rights. All information collected about you during the course of the study will be kept strictly confidential in the same way as all of your other medical records.
Information about your condition, treatment and follow-up will be sent by your doctors to the ACCURE-UK 2 study office at University of Birmingham, on paper and electronically, where it will be securely stored under the provisions of the Data Protection Act 2018. Your pseudo-anonymised data will be shared with the Academic Medical Centre (AMC), University of Amsterdam in the Netherlands to combine with the other ACCURE study group data. This data will not identify you but will include the trial number you are assigned on entering ACCURE-UK 2.
The University of Birmingham is the sponsor for this study based in the United Kingdom. The University will use information from you and your medical records in order to undertake this study and will act as the data controller for this study. This means that the University is responsible for looking after your information and using it properly. We consider the processing of your information to be necessary for the purpose of:
- carrying out research, which is a task performed by the University in the public interest;
- scientific or historical research purposes, statistical purposes or archiving purposes in the public interest;
- for compliance with a legal obligation to which the University is subject, for example, retention of records in accordance with good (clinical) practice, inspection or audit.
Your hospital and the University of Birmingham will keep identifiable information about you for 10 years after the study has finished.
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. The University takes great care to ensure that personal data is handled, stored and disposed of confidentially and securely. Staff receive regular data protection training and the University has put in place organisational and technical measures so that personal data is processed in accordance with the data protection principles set out in data protection law. Any physical paperwork containing identifiable data will be kept in an access-controlled and secured room inside a locked filing cabinet. In relation to this project, electronic data will be kept on secure, encrypted IT servers within the University of Birmingham. More information on how the University processes personal data can be found on the University’s website on the page ‘Data Protection – How the University Uses Your Data’ (http://www.birmingham.ac.uk/privacy/index.aspx).
Your Hospital will collect information from you and your medical records for this research study in accordance with our instructions. Your Hospital will use your name, NHS number and contact details to contact you about ACCURE-UK 2, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Your hospital will pass these details to the University of Birmingham along with the information collected from you and your medical records. Individuals from the University of Birmingham and regulatory organisations may look at your medical and research records to check the accuracy of the research study. The only people at the University of Birmingham who will have access to information that identifies you will be people who need to contact you to complete questionnaires or audit the data collection process. 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.
When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. This information will not identify you and will not be combined with other information in a way that could identify you. The information will only be used for the purpose of health and care research, and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.
With your permission, your GP and the other doctors involved in your clinical care will be notified of your participation in the ACCURE-UK 2 trial and kept informed of your progress. Also, the research staff involved in the study may, in the future, access electronic data from your central NHS records, for example through NHS Digital. This will provide researchers with information that is routinely gathered and stored during your visits to primary care and hospital, and will allow researchers to find out about your health after the trial has ended and the long-term effects of the treatments. By using routinely collected data we will be able to do this without needing to contact you further. In order to do this, we would need to send your name, gender, date of birth and NHS number with any request for information.