Will my taking part in the study be kept confidential?
Yes, your taking part in the study will be kept confidential.
- With your consent, your details will be sent to the central research team in Oxford so that they can organise sending you the questionnaires. Your personal information will be stored by the central research team at the University of Oxford.
- If you consent to take part in this study, the records obtained while you are in this study as well as related health records will remain strictly confidential at all times. The information will be held securely on paper and/or electronically at your treating hospital under the provisions of the General Data Protection Regulation (EU) 2016/679. Your name and personal information will not be passed to anyone else outside your treating hospital and the research teams in Oxford and Bath.
- Your CT scans and X-ray imaging will be securely sent to the Trials Office at University of Oxford, who will send them on to the manufacturer who will make your personalised plate. The scans will be sent with your unique study number, your NHS number and the dates the scans were taken. Researchers at the Universities of Oxford and Bath will use the imaging information for all study participants, further to improve the design of surgical plates used in HTO in the future.
- Your anonymised X-ray imaging will be securely sent by the Trials Office to an independent panel of reviewers from the University of Oxford.
- Your VVA data will be stored on encrypted and password protected computers. University of Bath staff will be informed of your name and address and date of surgery, so they can arrange the VVA appointments. Results of the VVA will be recorded using a unique study number for identification only (rather than your name and date of birth).
- You will be allocated a trial number, which will be used as a code to identify you on all trial forms.
- The central research team at the University of Oxford will keep identifiable information about you for 12 months after the study has finished.
- If you withdraw consent from further study involvement, with your consent, we will continue to use the information related to your treatment. This will be included in the final study analysis.
- In line with Good Clinical Practice guidelines, at the end of the study, your data will be securely archived for a minimum of 10 years. Arrangements for confidential destruction will then be made.
- The information collected about you may also be shown to authorised people from the UK Regulatory Authority and Ethics Committee; this is to ensure that the study is carried out to the highest possible scientific standards. All will have a duty of confidentiality to you as a research participant.
- 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.
- Hospitals participating in the study (known as ‘data processors’) will be under instruction of the sponsor (known as the ‘data controller’).
How will we use information about you?
We will need to use information from you and from your medical records for this research project.
This information will include your NHS number, name, date of birth and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly.
We will keep all information about you safe and secure.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
What are your choices about how your information is used?
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
Where can you find out more about how your information is used?
You can find out more about how we use your information:
- at www.hra.nhs.uk/information-about-patients/
- at https://www.bath.ac.uk/corporate-information/university-of-bath-privacy-notice-for-research-participants/
- by asking one of the research team
- by sending an email to the Data Protection Officer at the University of Bath: firstname.lastname@example.org