What will happen to your information collected about you during the study?
We will be using information from you and your medical records in order to undertake this study.
Keele University is the sponsor for this study and will act as the data controller. This means that Keele University is responsible for looking after your information and using it properly. They 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. This is because 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. You can find out more about how we use your information.
Your GP and physiotherapy service will collect information from you and your medical records for this research study in accordance with our instructions. Your local hospital and Keele CTU will use your name and contact details to contact you about the research study. They will make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Authorised individuals from Keele University and regulatory organisations may look at your medical and research records to check the accuracy of the research study.
On joining the study, your information will be securely stored under a unique study number. Your questionnaire answers (data) will only be associated with this number, not your personal details. Your consent form, containing your personal identifiable details, will also be stored securely at Keele University but separately to your data. Our procedures for handling, processing, storage of and destruction of data are in line with relevant regulatory requirements. To ensure data are stored securely, it will be held on networks approved by a government-backed cyber-security scheme.
If you give permission, the research team will link information that you provide us within the study with information routinely collected by the National Joint Registry for England, Wales, Northern Ireland and the Isle of Man, and by the Hospital Episodes and Statistics Registry. To do this we would use an NHS identifier such as your NHS number (or equivalent), name and date of birth to link and pull your data from these registries. This linking information will be stored securely for 10 years after the end of the study. Any information received in this way remains confidential and is used only for the purposes of this particular study.
If you agree to take part in an interview, the audio-recording will be typed out to make a paper copy of the discussion (called an interview transcript). This will be carried out by a professional transcription company who operate under strict terms of confidentiality. The transcript will then be anonymised. Both the audio-recording and the paper transcript will be stored securely and will be kept for 10 years after the study has finished.
The only people in Keele University who will have access to information that identifies you will be people who need to contact you about the study or audit the data collection process. The people who analyse the information will not be able to identify you or find out your name or contact details. Your identifiable data will be securely stored by Keele CTU at Keele University and will not be used beyond these purposes. To ensure continuing care, we will inform your GP of your participation in this study.
Your local hospital will keep identifiable information about you from this study in line with local procedures, which may be for 10 years after the study has finished.
When you agree to take part in a research study, anonymous information about your health and care (i.e. information that will not identify you) 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 anonymous information will only be used for research that is conducted in accordance with the UK Policy Framework for Health and Social Care Research.
This anonymised 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.