No. You decide whether to take part. It’s completely up to you. You will still receive the best care if you decide not to take part. You can also change your mind at any time – and you don’t have to give us a reason.
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 study is the work of children’s bone specialists across the UK, with research support from the University of Oxford.
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).
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.
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect participants’ interests. This study has been reviewed and given a favourable opinion by Greater Manchester Central Research Ethics Committee.
Data protection regulation requires that we state the legal basis for processing information about you. In the case of research, this is ‘a task in the public interest’. The University of Oxford is the data controller and is responsible for looking after your information and using it properly.
We 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. We will keep identifiable information about you both, such as you and your child’s contact details, for 12 months after the study has finished.
We will store the de-identified research data and research documents with personal information, such as consent and assent forms, securely at the University of Oxford until the youngest participant reaches 21 years old as per the University requirements for studies that include child participants.
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. Your identifiable and de-identified information will be entered directly into an electronic database This information will be transferred to, and stored at the University of Oxford, using a confidential, secure, encrypted web-based system. All storage will comply with local data security guidelines.
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 explain in this information sheet.
We will collect the NHS number (or CHI number in Scotland or H&C number in Northern Ireland) of your child, which we will store securely for 30 years. This will enable the opportunity to collect long-term information relating to the elbow which are recorded within routine hospital records (i.e. any elbow surgery). Whilst we will collect and store this information, the future use of this information will be subject to future ethical/regulatory approvals. To achieve this, with your consent, we may share your child’s NHS/CHI/H&C number with NHS Digital and/or National Services Scotland (NSS) and/or NHS Wales Informatics Services and/or Health & Social Care (HSC) in Northern Ireland (these are official government bodies who will treat this information confidentially). The information we share will be used by NHS Digital/ NSS/ NHS Wales Informatics Services/HSC and other central UK NHS bodies in order to provide us with information about your child’s health status.
Your treating hospital will collect information from you, your child and/or your child’s medical records for this research study in accordance with our instructions. Your treating hospital will keep identifiable information about you from this study for a minimum of 12 months after the study has finished.
The University of Oxford and your treating hospital will use your name, NHS/CHI number and contact details to contact you about the research study, and to make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from the University of Oxford and regulatory organisations may look at your child’s medical and research records to check the accuracy of the research study. Your treating hospital will pass these details to the University of Oxford along with the information collected from you, your child and/or their medical records. The only people in the University of Oxford who will have access to information that identifies either of you 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 and will not be able to find out your name, NHS number (or CHI number in Scotland/H&C number in Northern Ireland) or contact details.
The lawful basis for the processing of your personal data is governed by the General Data Protection Regulation (GDPR) & Data Protection Act (DPA) 2018 Articles 6 & 9. The University of Oxford will not transfer your personal data to any third countries or international organisations.
If you are concerned about how your personal data is being used, please contact the Chief Investigator/study team at: [email protected]
If you are still not satisfied, you may wish to contact the Information Commissioner’s Office (ICO). Contact details, and details of data subject rights, are available on the ICO website at: ico.org.uk/for-organisations/data-protection-reform/overview-of-the-gdpr/individuals-rights/
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 on 01865 223114 or at [email protected], or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 616480 or the head of CTRG, email [email protected].
The University of Oxford is the Sponsor for this study and has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this trial. NHS indemnity covers any other clinical treatment with which you are provided.
For independent advice, please contact NHS Complaints. Ask your treating hospital for the contact details or visit https://www.nhs.uk/using-the-nhs/about-the-nhs/how-to-complain-to-the-nhs/. This is a confidential NHS service that can provide you with support for any complaints or queries you may have regarding the care you receive as an NHS patient. However, they cannot provide information about this research study.
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.
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.
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. Parents can download the full study details by clicking this link: Parent/Guardian Information Sheet.
A study outline for children and young people is also available at this link: Patient Information Leaflet for Children & Adolescents.