No. Whether or not you take part is your choice. If you don’t want to take part, you don’t have to give a reason, and it won’t affect the care you receive. If you do want to take part now, but change your mind later, you can pull out of the study at any time.
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.
In the United Kingdom, the study has been funded by the National Institute for Health Research Health Technology Assessment (reference number 17/18/02). New Zealand’s involvement in the study is funded by the Starship Foundation.
The University of Oxford in the United Kingdom 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 New Zealand research team is working with Oxford Trauma in the United Kingdom.
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.
The study is running at hospitals in New Zealand, Australia as well as hospitals throughout the UK
The StarShip Hospital in Auckland led the set up for hospitals in New Zealand. Dr Nichola Wilson is the New Zealand representative on the management group of the SCIENCE study.
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, in New Zealand this study has been approved by an independent group of people called a Health and Disability Ethics Committee (HDEC), who check that studies meet established ethical standards. The HDEC has approved this study. We will provide regular reports to update them on how the study is going.
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.
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, including a copy of your signed consent form. Data will be entered into this database by study investigators and yourself, such as the questionnaires sent 6 weeks, 3, 6 and 12 months after injury. 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. All storage will comply with local data and/or international 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.
Individuals from the University of Oxford, an approved auditor appointed by the New Zealand Health and Disability Ethics Committee 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, NHI number or contact details.
During the study, your child’s information will be sent from the hospital in New Zealand to The University of Oxford (UK) and from The University of Oxford (UK) to the treating hospital in New Zealand.
We will use your name, NHI 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. If needed, information from your hospital records and your GP may also be collected. You cannot take part in this study if you do not consent to the collection of this information.
The University of Oxford and your treating hospital will collect information from you, your child and/or your child’s 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 both, such as your contact details, for 12 months after the study has finished.
De-identified research data and research documents with personal information, such as consent and assent forms, will be stored securely at the University of Oxford until the youngest participant reaches 26 years old as per the New Zealand requirements for studies that include child participants. After this time, the data will be securely destroyed.
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 (UK) and the New Zealand Privacy Act 2020. 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: daniel.perry@ndorms.ox.ac.uk
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 were injured in this study, you would be eligible to apply for compensation from ACC just as you would be if you were injured in an accident at work or at home. This does not mean that your claim will automatically be accepted. You will have to lodge a claim with ACC, which may take some time to assess. If your claim is accepted, you will receive funding to assist in your recovery.
If you have private health or life insurance, you may wish to check with your insurer that taking part in this study won’t affect your cover.
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 +441865 228929 or by email daniel.perry@ndorms.ox.ac.uk, or you may contact the UK Sponsor at the University of Oxford Clinical Trials and Research Governance (CTRG) office on +441865 616480 or the head of CTRG by email ctrg@admin.ox.ac.uk.
If you want to talk to someone who isn’t involved with the study, you can contact an independent health and disability advocate on:
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.
You will not get reports or other information about any research that is done using your information.
Your information may be used indefinitely for future research unless you withdraw your consent. However, it may be extremely difficult or impossible to access your information, or withdraw consent for its use, once your information has been shared for future research.
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 request access to your information held by the research team. You also have the right to request that any information you disagree with is corrected. This is in line with relevant New Zealand 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. Parents can download the full study details by clicking the links below. A study outline for children and young people is also available.