Parent/guardian information

Your child is being invited to join a study about cerebral palsy. 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 your child joins in.

Part 2 gives you more details about the study.

If you are happy for your child 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. The study also wants to find out what families think about the gene 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.

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 has my child been invited to take part?

We are inviting children who have cerebral palsy who live in Cambridge, Luton and Bedfordshire, Colchester, and Newcastle to take part. We want 100 children to take part in this study.

Do we have to take part?

No. It is up to you to decide if you want your child to join the study. If your child does join the study, they can leave the study at any time without giving a reason. If you say no, or if your child joins the study and later leaves it, this will not affect the NHS care your child gets in any way.

What will the study involve if we take part?

Your child will need a blood test. We also want birth parents (mum and dad) to join the study, if possible, and have their genes read too. This is because WGS works better if a child's genes can be compared to their birth parents’ genes.

If you agree for your child to join the study, we will ask you to do these things:

Sign the form saying yes for your child

• Answer some questions
• Have your child's blood taken by a nurse or doctor
• If you agree to join the study yourself, have your blood taken too by a nurse or doctor

If your child is adopted or not living with their birth parents, they can still join. We would just need you/their guardian to sign the form saying yes for your child. Only birth parents need to give a blood sample.

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Visit 1 (day 0)

Where: Face-to-face appointment or phone call or video call.

Procedures:

• informed consent
• arrangements made for blood test(s)
• Pre-test questionnaire completion

Visit 2 (3+ months)

Where: Face-to-face appointment or phone call or video call.

Procedures:

• WGS results discussion

Visit 3 (+15 months)

Where: Phone call or video call.

Procedures:

• Post-test questionnaire completion

Visit 4 optional (+15-16 months)

Where: Phone call or video call.

Procedures: Interview (optional)

What happens at the visits?

Informed consent

• For children under the age of 16, you will sign a consent form for them.
• Children between 6 and 15 years old may sign their name on a form too to say they want to take part, if they want to and if they are able to do so.
• We will write down your child's information (name, when they were born, and their NHS number) and your contact information. We need this so we can send the samples to the NHS laboratory for testing and so that we can contact you about the study.

Blood tests

• The blood test will take some blood (about half a teaspoon to one teaspoon) from your child. Blood samples will also be collected from mum and dad if they are taking part.
• The DNA will be taken from the blood at the NHS lab (NHS East Genomics Laboratory Hub). Some of the DNA, with just a number not a name, will be sent to a commercial company called Illumina so they can read your child’s DNA code.
• Then the DNA code will be sent back to the NHS lab, where scientists will look for any changes in the code that shouldn't be there.

Result

• Your child's doctor will tell you the test results at an in-person meeting or by a phone or video call.
• We will ask your child’s doctor to tell us about your child's cerebral palsy. This will help the lab to decide if any changes in your child's DNA code are important. The lab team will write a report about the results of the genetic test and send it to your child's doctor.
• The are two different possible types of test results:
  • A useful finding - A change in the DNA code has been found that caused or helped cause your child's cerebral palsy, or
  • No useful findings - Right now, no changes in the DNA code have been found that caused or helped cause your child's cerebral palsy

A genetic counsellor who is part of the study team can answer any questions you have about the results. You can also call them anytime during the study if you have worries or need more information.

Questionnaires

• The questionnaires will collect information about you and your child, and about what you think and feel about the genetic testing before and after testing.
• The questionnaires will be online and can be done on a phone/tablet/laptop. You will be able to go back to them if you can't finish them in one go.
• If you can't do them online, a paper copy of them will be given to you to answer the questions.
• Each one will take about 20-30 minutes to finish.
• The study team is available by phone or video call if you need help to read and/or answer the questions.

Interview (optional)

One year after you are told the result, we will ask families to chat about their experience of the genetic testing, but this is optional. The chat will be on the phone or on a video call at a time you tell us. It will be recorded (just the sound) and take about 30-45 minutes. Other family members taking part in the study could also join the chat if they want to. Your child is also welcome to join the chat if they like.

Is there anything else involved?

We may need to look at some of your child's medical records to get more details about their cerebral palsy. After you are told your child’s genetic test result, we will ask the doctor for information on whether the result changed your child’s care or treatment.

We will also ask if it's ok to contact you in the future about new studies your child could join. Saying yes to being contacted does not mean your child has to join any future studies.

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. A numbing cream or spray may be used for your child to help to ease the pain.

WGS result: Your child’s genetic test result could be a surprise or it could be hard to understand what it means. It might be upsetting if you have to make decisions about your child’s medical care. If your child is found to have a genetic change, the result could also affect other family members like their mum, dad, 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 genetic test 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.

Questionnaires and Interview: Thinking about how you and your child feel about cerebral palsy and genetic testing could make you feel uncomfortable. You can say no to answering any of the questions. You can take a break at any time.

If you feel upset, please tell us. We can offer short-term support or you can contact your GP about local help and support.

What are the possible benefits of taking part?

If your child gets a result that explains their cerebral palsy, it may change and improve their care. Taking part in the study will provide information which could help other families, doctors, and the public understand cerebral palsy better.

Will my child’s participation in the study be private?

Yes. We follow best practice to keep all your child’s information and your information 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 on samples that 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 child’s DNA sample and information?

With your permission, your child's details would be kept for 10 years so we can invite them to future related studies. We would keep study data, like answers to questionnaires and related medical information, for 10 years too. DNA samples would be stored indefinitely by the NHS lab. Your child’s 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 later for other approved research studies to help more people, but only if a review board says it is ok.

At this time, we specifically ask your permission to share your child's information with the following group, but only if your child has a genetic finding that is useful for other people to see:

You can find more details about DECIPHER here:

https://www.deciphergenomics.org/files/pdfs/decipher_infofam_v7_2020.pdf (opens in a new tab)

General Data Protection Regulations

The University of Cambridge and Cambridge University Hospitals NHS Foundation Trust are in charge of this study. The study team will use some information from your child's medical records. 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 child’s information will be used?

You can find out more about how we will use your child’s 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. Interview recordings will be deleted when the study ends. Anonymous quotes and results may be shared with other researchers through reports, publications, presentations, or other media. Your child's identity and your identity will never be revealed.

What if we don’t want to carry on with the study?

You can stop your child 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 future participation in the study. Information that has already been used in the research cannot be removed.

If you or your child dies, 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 or your child have been treated during the study or if you feel you or your child suffered possible harm by taking part in the study. You can also contact the Patient Advice service at CUH by emailing cuh.pals@nhs.net or calling 01223 216756. The University of Cambridge has insurance that covers the unlikely event that you or your child suffer any harm by taking part in this study.

Will we be paid for taking part in the study?

Yes, you will get £30 for your time at the end of the study. The study ends 1 year after you are told your child’s test results and after you complete the second questionnaire.

Who is funding the study and who is responsible for 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.

Further 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

Thank you for reading this information and thinking about joining the NeuralNET Cerebral Palsy Pilot Study.

This patient information sheet - reference IRAS 319781_NeuralNER CP Pilot Study Parent / guardian PIS v2.0 has been converted to a web page.