It is your choice whether or not your child takes part in the research project. You do not have to agree if you do not want to. If you decide you do not want your child to take part, it will not affect the treatment and care your child will receive.
Doctors are not sure if it is best to treat your child with a cast or splint, or with an operation. We are doing this study to find out which is better.
No. The way we compare the treatments fairly is to create two groups of children who are the same, by a process called randomisation. You can’t choose the treatment, and neither can the doctors, otherwise the groups would not be the same. When we have groups of patients who are as identical as possible, we can then compare them fairly in terms of outcomes.
The study has been funded by the National Institute for Health Research Health Technology Assessment (reference number 17/18/02).
The University of Oxford is the sponsor for the study, and the day to day running of the study is being completed by Oxford Trauma, a research group of the Nuffield Department of Rheumatology, Orthopaedics and Musculoskeletal Sciences (NDORMS), at the same University.
The study is running at hospitals in Australia, New Zealand, as well as hospitals throughout the UK.
The Royal Children’s Hospital (RCH) in Melbourne led the setup for hospitals in Australia.
The research team is qualified to do this study because they have all the specialties and skills needed. The team has a lot of experience in caring for children and young people with injuries and is active in health research. Parents and children have been involved in the development of this study, and are involved in the management.
In the UK, this study has been reviewed and approved by an independent group of people, called a Research Ethics Committee. The study was approved on 25th March 2019 under reference number 19/NW/0158.
In addition, we have full approval from the Human Research Ethics Committee at The Royal Children’s Hospital Melbourne, Australia to conduct this study (HREC 68948). We will provide regular reports to update them on how the study is going.
The University of Oxford is the data controller and is responsible for looking after your information and using it properly.
Your child will be given a unique study identification number which will be used for all of the information we collect from you about your child. Identifiable data is information with personal identifiers attached to it, including name, date of birth, UR number and email address. De-identified data is where we remove all personal identifiers from your child’s information, including name, date of birth and email address and replace your child’s name with a code.
Your identifiable and de-identified information will be entered directly into an electronic database,including a copy of your signed consent form. Data will be entered into this database by study investigators and yourself, including the questionnaires. This information will be transferred to, and stored at the University of Oxford, using a confidential, secure, encrypted web-based system. This means that it is protected as it moves between your computer and the secure data cloud at The University of Oxford.
De-identified X-rays taken as part of your child’s normal routine care will be sent to The University Oxford for central review. If your child requires CT or MRI as part of their regular care, these images may also be sent in a similar fashion.
De-identified research data and your consent forms containing personal information, will be stored securely at the University of Oxford and your child’s treating hospital until the youngest participant in the study reaches 25 years of age. After this time, the consent forms will be securely destroyed.
Your data from the questionnaires will also be sent to your study team at the site where you will have consented for the study, in this way your doctor will have full oversight of the data in relation to your study participation. Your personal data will only be used as we explained in this information sheet.
We will use your name and contact details to contact you and/or child about the research study, to make sure that relevant information about the study is recorded for your child’s care and to oversee the quality of the study.
The University of Oxford and your child’s treating hospital will be using information from you, your child and their medical records in order to undertake this study and will use the minimum personally-identifiable information possible (the University of Oxford will not be able to access your child’s medical records). We will keep identifiable information about you, such as your contact details, from this study for 12 months after the study has finished.
Individuals from the University of Oxford, an approved auditor appointed by the RCH Human Research Ethics Committee and regulatory organisations to check the accuracy of the research study. The only people in the University of Oxford who will have access to identifiable information will be people who need to contact you to enable your follow-up in this study, or audit the data collection process. The people who analyse the information will not be able to identify you.
If you wish to discuss any aspect of the way in which you have been approached or treated during the course of this study, you should contact Professor Daniel Perry who is the overall study lead by email daniel.perry@ndorms.ox.ac.uk, or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office by email ctrg@admin.ox.ac.uk.
You can contact the Director of Research Ethics & Governance at The Royal Children’s Hospital, Melbourne if you:
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 at the University of Oxford 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.
Your child’s data will not be protected by Australian Regulations.
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.
Data protection regulation provides you with control over your personal data and how it is used. When you agree to your information being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate.
You have the right to access and correct the information we collect and store about your
child. This is in line with relevant Australian and/or Victorian privacy and other relevant
laws. Please contact us if you would like to access this information.
Further information about your rights with respect to your personal data is available at http://www.admin.ox.ac.uk/councilsec/compliance/gdpr/individualrights/
Yes. You can download the full study details by clicking either of theselinks: Parent/Guardian Information Sheet. Participant Information Sheet