Parents and Carers

We would like to invite your child to take part in a study of a medical device for children with asthma, run by Great Ormond Street Hospital.

Before you decide whether you would like your child to participate, we would like you to understand why the research is being done and what it would involve for you and your child. A member of the team at the hospital involved in this study will go through this information sheet with you and answer any questions that you may have.

Please ask if there is anything that is not clear.
If you agree for your child to take part, you will be asked to sign a consent form.

You are free to withdraw your child at any time, without giving a reason. This will not affect the standard of care that your child will receive.

What is the purpose of this study?

This study aims to use a new breath testing device called ExhaleDx to measure chemicals in the breath that appear to be increased in adults with asthma. The device has been made by a company called Applied Nanodetectors, and we have worked with them to secure funding from UK Research and Innovation to see if the device works. We would like to see if this device is able to measure these chemicals in children’s breath, and if they are also raised in children with asthma.

Why has my child been invited to participate?

Your child has been invited to take part because they have asthma (or they are healthy and we can use them as a comparison) and:

  • are between 12 years and 15 years 364 days, inclusive

Does my child have to take part?

No. It is up to you and your child to decide whether to join the study. Taking part in this trial is voluntary and will not affect the standard of care your child receives.
A member of the research team will describe the study and go through this information sheet with you. If you agree for your child to take part, you will be asked to sign a consent form. You are free to withdraw your child at any time, without giving a reason. This would not affect the standard of care your child will receive.

What will happen to my child if they participate?

If your does participate in the study, you will be asked to ensure that they :

  • Keep all appointments with their doctor
  • Try to record if they have asthma attacks between the beginning of the study and their next clinic

What will happen to the samples taken in this study?

The information from the breathing test will be recorded by your doctor or nurse. The information is transmitted to an app, but it does not know any of your child’s personal data.

During the study we will also use information that we have previously collected about your child (e.g. age, gender), their medical history including details of their medical condition and treatment, in order to compare how well the test works.

Will any genetic tests be done?

No, we will only sample your child’s breath and we will not be doing any genetic tests.

What will happen to the information at the end of the study?

Any information remaining at the end of the study will be stored for three years in the secure computers at Great Ormond Street Hospital. Any future research carried out using this data will need to have appropriate research ethics approvals in place.

What will happen if I don’t want my child to carry on with the study?

You are free to withdraw your child from the study at any time without giving a reason and this will not affect their standard of care.

Following withdrawal from the study, we will discard any information already collected.

What are the possible benefits of taking part?

There may be no direct benefit to your child from taking part in this study.

What are the possible risks of taking part?

We do not anticipate and risks to taking part. We will not make any medical decisions on the basis of the results from the device.

What to do if there are problems

If you have a concern about any aspect of this study, you should ask to speak to your child’s study doctor or research nurse who will do their best to answer your questions.


If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure. Details can be obtained from your hospital. Additionally, the contact information for your local Patient Advice and Liaison Service (PALS) or equivalent is at the end of this information sheet.

If your child is harmed

If your child is harmed by taking part in this study there are no special compensation arrangements. If your child is harmed due to someone’s negligence, then you may have grounds for a legal action for compensation but you may have to pay your legal costs. The NHS have a duty of care to participants whether or not the participant is taking part in a study and normal NHS complaints mechanisms will still be available to you.

What if relevant new information becomes available?

If we get new information concerning the study that is applicable to your child, your child’s study doctor will discuss this with you both. If you and your child decide to continue in the study the study doctor may ask you to sign an updated Informed Consent Form.

Will my child’s taking part in the study be kept confidential?

All information collected about your child for this study will be subject to the General Data Protection Regulation and the Data Protection Act 2018 and will be kept strictly confidential.  Great Ormond Street Hospital is the Sponsor for this study. We will be using information from your child’s medical records in order to undertake this study and will act as the data controller. This means that we are responsible for looking after your child’s information and using it properly. The the NHS will keep identifiable information about your child for at least 10 years after the study has finished, to allow the results of the study to be verified if needed.

All information collected about your child by the Sponsor will be securely stored in Great Ormond Street Hospital and will only be accessible by authorised personnel associated with the study. The only people in Great Ormond Street Hospital who will have access to information that identifies your child will be people who manage or audit the study.

NHS staff may use your child’s name and contact details to contact you about the research study, and make sure that relevant information about the study is recorded for their care, and to oversee the quality of the study.

By taking part in the study, you will be agreeing to allow research staff from Great Ormond Street Hospital to look at the study records, including your child’s medical records. It may be necessary to allow authorised personnel from government regulatory agencies e.g. the Medicines and Healthcare products Regulatory Agency (MHRA), the Sponsor and/or NHS bodies to have access to your child’s medical and research records. This is to ensure that the study is being conducted to the highest possible standards.

From time to time we may be asked to share the study information (data) and research samples we have collected with researchers running other studies in this organisation and in other organisations. These organisations may be universities, NHS and Public Health England or companies involved in health research and may be in this country or abroad. Any such request is carefully considered by the study researchers and will only be granted if the necessary procedures and approvals are in place. This information will not identify you or your child and will not be combined with other information in a way that could identify your child. The information will only be used for the purpose of health research, and cannot be used to contact you or to affect your child’s care. It will not be used to make decisions about future services available to your child, such as insurance.

All individuals who have access to your child’s information have a duty of confidentiality to your child.

You and your child can withdraw consent to our processing of your child’s data at any time. Your rights to access, change, or move your child’s information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If your child is withdrawn from the study, we will not keep the information about them that we have already obtained. To safeguard their rights, we will use the minimum personally identifiable information possible. Under the provisions of the Data Protection Act they and you have the right to know what information the study has recorded about them. If you wish to view this information or find out more about how we use this information, please contact Great Ormond Street Hospital via the address below.

Patient Experience and Engagement

Great Ormond Street Hospital for Children

Great Ormond Street



Involvement of the General Practitioner/family doctor (GP)

Your GP will not be informed that your child is taking part in the study; you can choose to do so.

What will happen to the results of the study?

When the study is complete the results may be published in a medical journal. Your child will not be identified in any report or publication arising from the study. We will also make a lay summary of the result available and publicise the results via patient groups.

Who is organising and funding the study?

This study is a collaborative project between Great Ormond Street Hospital and Applied Nanodetectors Ltd. This research is funded by UK Research and Innovation Small Business Research Initiative. The study is being run by the Great Ormond Street Hospital.

Who has reviewed the study?

This research study has been reviewed by an independent Research Ethics Committee. Research Ethics Committees review all research to protect the safety, rights, wellbeing, and dignity of participants. This study was reviewed and received XX opinion by XX Research Ethics Committee.

Further information and contact details

If you or your child have any questions or concerns about your disease or this research study, please discuss them with your child’s study doctor. You may also find it helpful to contact your local Patient Advice and Liaison Service (PALs) or equivalent who provide advice and support to patients, their families and their carers, website:

Hospital Contact Details

Principal Investigator: <<insert name and contact telephone number of Principal Investigator >>

Research Nurse: << insert name and contact telephone number of Research Nurse >>

Please take as much time as you need to make a decision and then let your child’s study doctor or research nurse know what you have decided.