PARROT Patient Information
Want to find out more? Take a look at our FAQs below…
What if there is a problem?
If you have a concern about any aspect of this trial, you should ask to speak with one of your research team who will do their best to answer your questions.
If you are unhappy and wish to complain formally, you can do this by contacting local NHS Patient Advice and Liaison Service (PALS) in the UK, or Children’s Health Queensland Human Research Ethics Committee in Australia. Members of your local hospital team should be able to provide this information to you.
Every care will be taken in the course of this clinical trial. However, in the unlikely event that you or your child are harmed by taking part in this research trial, Sponsor (the University of Liverpool) compensation may be available but you may have to pay your related legal costs.
Your hospital where your child received treatment has a duty of care to you and your child whether or not you agree to participate in the trial. The trial Sponsor accepts no liability for negligence on the part of your hospital’s employees. However, if you or your child are harmed and this is due to someone’s negligence at the hospital, then you may have grounds for a legal action for compensation against the NHS Trust / public health service where your child is being treated but you may have to pay for your legal costs.
How will yours and your child’s information be collected and handled?
Your child’s hospital will collect information from you, your child and your child’s medical records for PARROT in accordance with our trial instructions and all ethical and legal requirements.
Your child’s hospital will use your name and contact details to contact you about PARROT as needed. They will also make sure that relevant information about the trial is recorded for your child’s care and ensure the quality for the trial. The hospital will pass these details to the University of Liverpool along with the information collected from your child’s medical records.
PARROT is sponsored by the University of Liverpool (UK) and Menzies School of Health Research (Australia), which means they are in charge of the study and responsible for its management. Individuals from the UK Sponsor, the Liverpool Clinical Trials Centre (LCTC, part of the University of Liverpool) and regulatory organisations may look at your child’s medical and research records to check the accuracy of the research trial.
The only people in the University of Liverpool and the LCTC who will have access to information that identifies you will be people who need to audit the consent and data collection process.
The people who analyse the information will not be able to identify you or your child and will not be able to find out your name, your child’s name or your contact details.
In addition, if your child is cared for at an NHS hospital in England, the trial team will retrieve electronic hospitalisation records held by NHS Digital. NHS Digital collect information about inpatient, outpatient and A&E hospital care. These are known as Hospital Episode Statistics (HES). HES data will be collected from 3 months preceding your child’s enrolment to the PARROT trial, and for the duration of the trial. To retrieve your child’s HES records, information to identify them, including their name, postcode, date of birth, NHS number and PARROT trial number, will be securely transferred by the University of Liverpool to NHS Digital, towards the end of the trial. After linking the data, NHS Digital will remove your child’s identifying details (name, postcode date of birth, NHS number) before sending the HES data securely to Bangor University using an encrypted electronic transfer system. In addition, University of Liverpool will send research data to Bangor University. The HES data and research data will be stored on Bangor University computer servers that meet NHS data security standards in order to conduct the economic analysis. Researchers at Bangor University will not be able to access your child’s identifying details and will not keep the HES and research data longer than 15 years.
Your hospital will keep identifiable information about you and your child from PARROT for 25 years after the trial has finished. Trial information will also be kept by the Sponsor for 25 years after the trial has finished.
We will notify your child’s GP that they will be taking part in the trial for their information.
Will your Information be used for other research?
When you agree to take part in a research trial, the information about your child’s health and care may be provided to researchers running other research studies within the 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. This 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 information could be used for research in any aspect of health or care, and could be combined with information about your child from other sources held by researchers, the NHS or government.
Where this information could identify you or your child, the information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research, or to contact you about future opportunities to participate in research. It will not be used to make decisions about future services available to you, such as insurance.
Where there is a risk that you or your child can be identified your data will only be used in research that has been independently reviewed by an ethics committee.
Where can you find out more about how your child’s information is used?
You can find out more about how we use your child’s information:
- at www.hra.nhs.uk/information-about-patients/
- at www.hra.nhs.uk/patientdataandresearch
- our leaflet available from www.parrot-trial.org.uk
- by asking one of the research team
The contact details for the UK Sponsor’s Data Protection Officer are as follows:
University of Liverpool Legal Services
Tel: 0151 794 2110
Who are the data controllers?
The University of Liverpool, Menzies School of Health Research and Bangor University will be using information from you and your child’s medical records in order to undertake this trial and will act as the data controllers for this trial. This means that they are responsible for looking after yours and your child’s information and using it properly. The University of Liverpool will keep identifiable information about you and your child for 25 years after the trial has finished.
Your rights to access, change or move yours or your child’s information are limited, as they need to manage this information in specific ways in order for the research to be reliable and accurate. If you withdraw from the trial, we will keep the information about you and your child that we have already obtained. To safeguard yours and your child’s rights, we will use the minimum personally-identifiable information possible.
You can find out more about how we use your information at www.parrot-trial.org.uk.
Who has reviewed the trial?
The trial has been reviewed by the Medicines and Healthcare Products Regulatory Agency, the Health Research Authority and the National Research Ethics Service Committee (in the UK) and Children’s Health Queensland Human Research Ethics Committee (in Australia) to make sure that the trial is scientifically and ethically acceptable.
Who is sponsoring the trial?
The University of Liverpool is the Sponsor of this trial and are responsible for managing it in the UK. They have asked that the day to day running of the trial is carried out by a team based at the Liverpool Clinical Trials Centre (LCTC, part of the University of Liverpool), and health economics researchers based at Bangor University. Together these bodies are the central trial team.
This trial is also taking place in Australia. In Australia PARROT is Sponsored by Menzies School of Health Research. Collaborators from Australian trial team will input into the running of this trial but will not be provided with any information to identify you or your child.
Who is funding the trial?
In the UK, this trial is funded by the National Institute for Health Research’s HTA Programme (Ref: 16/17/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
In Australia, the trial is funded by the National Health and Medical Research Council (GNT1149332)
Why take part in the PARROT trial?
Despite the impact chest infections have on children with NI, their families and health services, there is very little information on how best to prevent them. Some doctors prescribe long-term antibiotics but we don’t really know whether this makes any difference to the numbers of chest infections children suffer from, or whether these antibiotics can cause harm in the longer term. We hope that the results from the PARROT trial will help doctors and patients in the future when making decisions about treatment.