FAQ

The study is funded by the Department of Health (NIHR127817) and is the work of Orthopaedic surgeons across the UK, with research support from The University of Oxford.

The University of Oxford is the lead centre and sponsor for the study, with Mr Steve Gwilym being the Lead Investigator. 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.

The research team is qualified to do this study because they have all the relevant training and skills required. The team has a lot of experience in caring for patients with fracture injuries and are active in health research. Members of the public have been involved in the development of this study and are involved in its 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 favourable opinion by the East of England – Cambridge Central Research Ethics Committee.

We value the patient perspective which has been key in the development of this research. Our patient representative has reviewed this Patient Information Sheet and all HUSH patient facing documents. Participants’ views will continue to be represented throughout the study. Additionally, the oversight committees, that will regularly review the study progress, include at least one patient representative who will be involved in discussion and decision making throughout the duration of the study.

If you would like to know more about getting involved in research as a patient or member of the public, please see this link: https://www.nihr.ac.uk/patients-and-public/

Sometimes during the course of a research study, new information becomes available about the treatment that is being studied. If this happens, the research team will tell you about it and discuss with you whether you want to continue in the study. If you decide to withdraw, we will encourage you to discuss your continued care with your doctor. If you decide to continue in the study you will be asked to sign an updated electronic consent form.

The University of Oxford, as Sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study. NHS indemnity operates in respect of the clinical treatment which is provided.

If you wish to complain about any aspect of the way in which you have been approached or treated during the course of this study, you should contact Steve Gwilym who is the overall lead of this trial on [email protected] or 01865 223115; or you may contact the University of Oxford Research Governance, Ethics & Assurance Team (REGA) office on 01865 616480 or email [email protected].

Your personal details will be held by the research team at the University of Oxford. We will remove any details that would identify you personally (such as your name, date of birth, etc.) from your answers to our questions and no individual patient results will be published.

All information that is collected during the course of the research will be used and stored in accordance with the most up to date data protection legislation.

Your data from the questionnaires will be sent to your trial team at the site where you were consented for the trial, in this way your doctor will have full oversight of the data in relation to your participation in the trial. Your personal data will only be used as we explained it in this information sheet, and research is a task that we perform in the public interest.  If you are concerned about how your personal data is being used, please contact the study team using the contact details at the end of this information sheet.

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 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, as sponsor, is the data controller and is responsible for looking after your information and using it properly. We will use the minimum personally identifiable information possible. We will keep identifiable information about you for 12 months after the study has finished. This excludes any research documents with personal information, such as consent forms, which will be held securely at the University of Oxford for 5 years after the publication of the results of the study.

Responsible members of the University of Oxford [and the relevant NHS Trust(s)] may be given access to data for monitoring and/or audit of the study to ensure that the research is complying with applicable regulations.

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 https://compliance.admin.ox.ac.uk/research-data.

The lawful basis for the processing of your personal data is governed by the General Data Protection Regulation (GDPR) Articles 6 & 9. The University of Oxford will not transfer your personal data to any third countries or international organisations.

You will be given a unique study identification number which will be used for all of the information we collect from you. This information will be transferred to, and stored at, The University of Oxford, using a secure, encrypted web-based system, which will only be accessed by limited members of the trial team.