You are being invited to join a study about cerebral palsy because your child is taking part. Before you say yes or no, please read this information carefully. Talk to others if you want. Please ask us questions if anything is not clear or you want more information.
Part 1 tells you what the study is about and what will happen if you join in.
Part 2 gives you more details about the study.
If you are happy to be part of the study, you will need to sign your name on a form. A person from the study will also sign this form.
Part 1
What is the study about?
Doctors can now do a special test called Whole Genome Sequencing (WGS) to help find if some illnesses like cancer or problems with the brain can be caused by a change in your genes. Cerebral palsy can have different causes and for most children we don't know why it happens. Some research has already shown that for some children it is because of a change in their genes.
Right now, WGS testing is not offered by the NHS for cerebral palsy. This study wants to do WGS testing on children with cerebral palsy to learn more about possible genetic causes of cerebral palsy in the UK. It also wants to find out what families think about the testing and results. All this will help the NHS decide if they should offer WGS testing for cerebral palsy. In this study, only genetic findings clearly related to your child's cerebral palsy will be shared with you and your doctor. In rare cases, other important genetic findings that are not related to cerebral palsy may be shared with you.
As well as children with cerebral palsy taking part in this study, we also want their birth parents to take part. By comparing the genes in a child to those of the birth parents, it helps us to find changes in the genes that might be linked to cerebral palsy.
Why is this study important?
Cerebral palsy cannot be cured now but some children who get a genetic result could be helped in these ways:
- Become able to join clinical trials
- Have their treatment tailored to them by adding or changing medication
- Doctors adjusting their care
All these things could improve care and outcomes. Knowing how you feel about this testing will also help make sure the NHS WGS service meets the needs of patients, families and doctors.
Why have I been asked to take part?
We are inviting the birth parents of children who have cerebral palsy and who are taking part in this study to also take part in the study.
Do I/we have to take part?
No. It is up to you to decide if you want to join the study. If you do join the study, you can leave at any time without giving a reason. If you say no, or if you join the study and later leave, it will not affect the NHS care you or your child gets in any way.
What will I have to do if I take part?
If you would like to take part, you will need to attend an appointment where we will explain the study and answer your questions. If you are happy to take part, you will need to sign a consent form. The appointment can be at the same time as your child’s, and it could be in-person or by phone/video call.
You will need to have a blood test and give 1 teaspoon of blood. The blood test will be done by a doctor, nurse or member of the study team at the time of the appointment. If it is not possible to have your blood test at the appointment, or if the appointment was by phone/video call, you will be given a form to take to your local hospital or GP practice who will do the blood test. The DNA will be taken from the blood at the NHS lab (NHS East Genomics Laboratory Hub). Some of the DNA, labelled with just a number not your name, will be sent to a commercial company called Illumina so they can read your DNA code.
The DNA code will be sent back to the NHS lab, where scientists will compare your DNA with your child’s DNA to look for any changes in your child’s code that shouldn't be there. We will record your personal details (name, date of birth, NHS number) and your contact details. We need this information so that we can send your blood sample to NHS EGLH for testing.
Part 2
Are there any risks of taking part?
Collecting a blood sample: Trained staff will be very careful when they collect the blood sample, but it may hurt a little bit, bleed, leave a bruise, or cause fainting.
WGS result: If your child is found to have a genetic change, the results could also affect you and/or other family members like their other parent and/or brothers/sisters since they all share some of the same genes. It's best to talk to wider family about whether they would want to know about the result before joining the study. There is a small chance of learning about non-paternity (that someone is not the birth father) or other family relationships that may be private (like adoption). The study team can talk to you about any concerns you may have about the risks of taking part.
What are the possible benefits of taking part?
By taking part, you improve the chance that your child gets a result that explains their cerebral palsy, which could lead to changes and improvements to their care. Taking part in the study will provide information which could help other families, doctors, and the public understand cerebral palsy better.
Will our participation in the study be private?
Yes. We follow best practice to keep all information is kept safe and private.
Everyone in the study gets a special study number instead of using names. Only certain study team members can see personal details linked to these study numbers. This information is stored securely.
None of the answers or results will be used or shared with others for anything else other than research or to improve healthcare. Responsible people from the University or NHS Trusts may check our work to make sure the rules are being followed, but we will not share private information.
Names, dates of birth and NHS numbers are used when samples go to the NHS lab so they know who the samples belong to. All samples are kept private and secure by the NHS. When the DNA is sent to the commercial lab for testing, only the study number is used.
What will happen to my DNA sample and information?
Your details would be kept for 10 years so we can invite you to future related studies. Your DNA samples will be stored indefinitely by the NHS lab. Your doctors may access the stored DNA sample for NHS genetic testing with proper consent if other genetic testing is needed in the future. The genetic code information will be stored at the University of Cambridge Secure Research Computing Platform (SRCP) until the end of the study and not for longer than 5 years, and only the study ID number will be used.
Samples and information may also be used anonymously in the future for other approved research studies to help more people, but only if a review board says it is ok.
General Data Protection Regulations
The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are in charge of this study. They are responsible for looking after the information properly. Identifiable information will be kept for 10 years after the study ends. You can stop being part of the study at any time but information already used cannot be removed. The study needs to keep records a certain way for it to be reliable. Your rights to change information are limited. Responsible people may check records to make sure the study is done properly. Only people who need to contact you will see identifiable information.
Where can I find out more about how my information will be used?
You can find out more about how we will use your information by asking one of the study team directly, or via email (cuh.neuralnetstudy@nhs.net) or telephone (01223 768614), or by going to www.hra.nhs.uk/information-about-patients/ (opens in a new tab) or to https://www.information-compliance.admin.cam.ac.uk/data-protection/research-participant-data (opens in a new tab)
What will happen to the study results?
Study data will be kept securely in the Department of Paediatrics for 10 years. Anonymized results may be shared with other researchers through reports, publications, presentations, or other media. Your identity will never be revealed.
What if I don't want to continue with the study?
You can stop being part of all or part of the study at any time without giving a reason. You can withdraw the DNA sample and information that have already been collected, or simply stop any involvement in the future. Information that has already been used in the research cannot be removed.
If you die, the data and samples that have been provided would continue to be available for use in the study in perpetuity.
What if there is a problem?
Please contact Professor David Rowitch 01223 769386 or pahodpaeds@medschl.cam.ac.uk if you are unhappy about the way you have been treated during the study or if you feel you suffered possible harm by taking part in the study. You can also contact the Patient Advice service at CUH by emailing cuh.pals@nhs.netor calling 01223 216756. The University of Cambridge has insurance that covers the unlikely event that you suffer any harm by taking part in this study.
Who is funding the study and who is in charge of the study?
The study is funded by Rosetrees Trust, Isaac Newton Trust and NIHR Cambridge BRC. Illumina, a commercial company, provides the WGS testing. The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust both sponsor the study and are jointly responsible for it. The study has been approved by Wales Research Ethics Committee 5 Bangor (23/WA/0012) and by the Health Research Authority to run in the NHS.
More information
The study is managed by Professor David Rowitch at the University of Cambridge. Please contact the Study Team on cuh.neuralnetstudy@nhs.net or telephone 01223 768614 for more details.
Department of Paediatrics, University of Cambridge, Box 116, Level 8, Cambridge Biomedical Campus, Cambridge CB2 0QQ