Participant Information Sheet (PIS) for Parents/Carers/Guardians
The Parent and Baby Project
Preventing food allergy in infants with early tastes of common food allergens: feasibility and cluster randomised controlled trial
Chief Investigator: Professor Graham Roberts
IRAS number: 351201
You are being invited to take part in a research project. Before you decide if you would like to take part, it is important that you understand why the research is being done and what it will involve for you. Please read this information carefully and ask questions if would like more information. You may like to talk to family or friends, but it is up to you whether you take part.
If you have any questions, you are welcome to contact the research team by emailing parentandbabyproject@soton.ac.uk or telephoning us on 02380 598173.
What is the project about?
The number of children with food allergy is increasing. Some allergies can be life-long. Although most allergic reactions are mild. However, they often have a significant impact on a person's daily life and with those they interact with, and in some cases are life threatening. We are a team of researchers that are working on how to prevent food allergy. We have developed a new approach with the help of many parents, carers and health care professionals. This project involves lots of experts who are trying to see if new resources offering support to parents/carers can help prevent children developing food allergy. These resources will support parents/carers with early introduction of small amounts of particular foods in addition to breast milk or usual milk feeds. Lots of previous studies have already shown that this is safe for your baby.
This project is funded by the National Institute of Health Research (NIHR), which is part of the National Health System (NHS). It is being led by University Hospital Southampton NHS Foundation Trust and the University of Southampton. Many hospitals from the North-East and South Coast are involved in the project.
Why have I been invited to take part?
You have been asked to take part because you are a parent or carer of a child who is in the age range for this project (aged 0-3 months) and you live in an area that we are running the project in (North-East, South-Coast or Thames Valley). You may have been invited by a health care professional, or via a community group that you have attended.
What would taking part involve?
The project will last for 12 months. There are two groups in this project. You will be allocated to one of the groups. This will be decided by the area you live in, which have an equal chance of being allocated to one group or the other.
- Group 1 – parents/carers will have access to new resources (online and paper) which will support them to introduce small amounts of particular foods in addition to breast milk or formula feeding to their baby from 4-months of age
- Group 2 – parents/carers will have access to current NHS resources which will support them to introduce complementary feeding from around 6-months of age
Both groups are really important to help us better understand how best to prevent food allergy. Both groups will be able to access support from allergy experts throughout the project. Your general practitioner and the other community healthcare professionals will be informed about your baby’s participation; this will include the details about the support and advice being given.
If you decide to take part, you will be asked to sign a paper or electronic consent form to let us know you are happy to take part in the project. In both groups, you will be asked to answer some questions online at different time points:
- When you enrol - about yourself, your child and their medical history
- When your child is 3 months of age
- When your child is 4-7 months old - short (5 minute) online weekly feeding questionnaire
- When your child is 9 and 10 months old
- When your child is 12 months old
Your child’s medical records will be reviewed when your child is 52-70 weeks to see which NHS services they have used.
Throughout the whole project, if any of your answers at any point suggest your child may have a food allergy, you will be offered the chance to have further tests for your child at hospital within the project. This will use the usual NHS approach (e.g. allergy skin or blood tests).
When everyone has completed the project, we will compare the number of children with food allergy in both groups.
Regular newsletters will be sent to all participants about the project.
Optional interview
You may also be invited to take part in a short chat (by phone or videocall) with the research team about your experiences of the project, which would last up to 60 minutes. This will also be optional. If you are selected, we will contact you with full information and ask for your consent.
Do I have to take part in the project?
No, it is entirely up to you to decide whether to take part. This information sheet can help you decide. If you have any questions, you may wish to contact the research team by emailing parentandbabyproject@soton.ac.uk or telephoning us via 02380 598173. Your child’s current or future care will not be affected by whether you choose to take part or not. It does not cost you anything to take part in the project.
What are the possible benefits of taking part?
A benefit for everyone taking part in the project is that if your child is suspected to have food allergy, you will have the opportunity to have a food allergy assessment as part of the project. Occasionally (1-2% children) these allergy tests don’t give us the answer and we offer a food challenge. This is usually to prove that a child is okay with a food. These have a separate information sheet to help you decide whether or not you want to consent to your child to have one.
Being involved in research can be a rewarding experience. You will have the chance to influence how we provide support and information to parents/carers in the future to help prevent food allergy. Additionally, once you have completed the 52-week questionnaire we will send you a £10 voucher to thank you for your time.
What are the possible disadvantages and risks of taking part?
Completing the questionnaires will take a few minutes of your time but there are not any risks involved with this. Some babies are expected to develop food allergy during the project, but previous studies tell us that earlier introduction of food does not result in more babies developing food allergy. The project questionnaire will help us identify babies who are at higher risk of having an allergic reaction (including anaphylaxis) and we will contact their parents. When introducing foods into a baby’s diet, there are always concerns about choking, impact on breast feeding and obesity. Previous studies that have looked at this have not seen any issues though with any of these concerns. NHS staff (including honorary contract holders) undertaking research as part of their job role are covered by NHS Resolution indemnity schemes if working for a member of those schemes, subject to the usual scheme terms and conditions.
What happens if I change my mind?
If you change your mind, you can stop taking part in the project at any time. This will not affect the care that you or your child receives. If you do decide to stop, the information collected up to that point may still be used to complete the objectives of the project.
What data will be collected?
Personal data including your child’s gender and ethnicity will be collected. This information will help us to make sure we involve a wide range of people in the project. Project data (information collected in the questionnaires you complete) and personal data (e.g. your child’s name and date of birth) will be stored on separate parts of a secure database. When you join the study, you will be assigned a study number which will be used on paperwork instead of your name and will be linked to all your project data. This is called ‘pseudonymised data’ and you cannot be directly identified from this. Only relevant people from the project team will have access to these databases.
If you agree, we would also like to collect information from your child’s doctor’s surgery for any information about food allergy and other allergic including asthma up to their 16th birthday. This will allow us to compare the NHS costs associated with food allergies in each group and see how feeding in early life affects food and other allergic conditions.
Will my information be kept private?
Yes, your taking part in the project and all of your information will be kept strictly confidential. We only tell people that need to know, which includes your doctor’s surgery. Information would only be shared outside of the project if it seemed someone was in danger. It will not be possible to recognise you or your child from looking at your project information. Once the project has finished, we will keep your information for up to 15 years.
Pseudonymised data, managed by the Southampton Clinical Trials Unit (SCTU), will be held on servers located in the UK, EU and USA and access will be strictly controlled. Access to data managed by Southampton Clinical Trials Unit (SCTU) will be strictly controlled and applicable Data Protection Legislation will be abided by.
We would like to collect your child’s NHS number to allow linkage with national data registries.
What will happen to the results of the project?
We will use information from the project to write reports, to share with interested organisations and at scientific meetings. This will not include any information that makes it possible for you or your child to be identified. We will also send you a summary of the results if you would like to see them.
We now try to ensure that the valuable data collected in projects is fully utilised. We would plan to remove any information that could identify you or your child. These data may be used for future research, clinical purposes, study materials or for teaching by other universities or National Health Service organisations in this country or abroad. None of these organisations would know that you or your child were involved in the project.
Future plans
Food allergy changes over a childhood and other allergic conditions such as eczema, hayfever and asthma can develop. There may be an opportunity to assess the children involved in this project when they are older. As part of this we may contact you again to ask if you can help with these further studies.
Who has reviewed the project?
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee. This project has been reviewed and approved by 25/EE/0067 Ethics Committee. The project is also supported by University Hospital Southampton NHS Foundation Trust. Parents, carers and health care professionals from diverse backgrounds have been involved throughout all parts of the project and have helped to create the project documents, questionnaires and the new approach being tested.
The University Hospital Southampton NHS Foundation Trust is the research sponsor for this project. If you wish to complain or have any concerns about the way you have been approached or treated during this project, please contact the R&D Governance, QA and Sponsorship Manager on 023 8120 3598 or by email to sponsor@uhs.nhs.uk.
Data protection privacy notice
How will we use information about you and your child?
We will need to use information from you for this research project. This information will include:
- Your child’s age, gender, ethnicity, historical socioeconomic status and contact details.
- Information you give directly to the research team or on the study website.
- Sound recordings and written transcripts (the words you say written down) if you choose to do a telephone, online or face-to-face interview with the research team.
- If you consent, we may collect data from your child’s medical records so we can see which children in the project have food allergy and other allergic diseases including asthma up to their 16th birthday.
People will use this information to do the research or to check your records to make sure that the research is being done properly.
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a Study ID number. We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data for up to 15 years so we can check the results. We will write our reports in a way that no-one can work out that you or your child took part in the study.
We will use the email address and/or phone number you provide to send you emails or text messages from time to time to remind you about questionnaires. You can stop or change how often you receive these emails or text messages by changing your settings on the study website. Our team may also occasionally call you while you are taking part in the study. Your contact details will only be kept for the duration of your participation in the trial and to be able to inform you of the results of the study. Sometimes we find that our contact details for you are not up to date. In those cases, we will use NHS systems to locate your updated contact details.
University Hospital Southampton NHS Foundation Trust is the sponsor of this research, and the University of Southampton Clinical Trials Unit (SCTU) are managing this research on their behalf. SCTU is responsible for looking after your information. We will keep all information about you safe and secure by:
- Securely storing personally identifiable data about you and your child within an encrypted database hosted on UK based University of Southampton servers. All personally identifiable data about you and your child will be kept strictly confidential and in accordance with applicable data protection legislation. Information would only be shared outside the study if it seemed someone was in danger.
- All research data collected during the study about you and your child will be held on both UK based and international servers (US and Europe) that meet the highest data protection and security standards, but access to this data will be strictly controlled by SCTU and all applicable Data Protection legislation will be abided by.
- Only members of the research team and responsible and delegated members of the SCTU may be given access to data about you for monitoring purposes and/or to carry out an audit of the trial to ensure that the research is complying with applicable regulations. Individuals from regulatory authorities (people who check that we are carrying out the trial correctly) may require access to your data. All of these people have a duty to keep your information, as a research participant, strictly confidential.
- With your permission, a copy of your consent will be sent to the SCTU (where it will be kept securely), to allow confirmation of your consent.
International transfers
We may share data about you outside the UK for research related purposes to:
- Share data with a USA-based researcher who is providing their expertise on this study.
- Store data within the study databases which has servers that are based outside of the UK (US and Europe).
- No identifiable information will be sent to the US.
- Inform future research.
If this happens, we will only share the data that is needed. We will also make sure you can’t be identified from the data that is shared. Access to data managed by Southampton Clinical Trials Unit (SCTU) will be strictly controlled and applicable Data Protection Legislation will be abided by. If your data is shared outside the UK, it will be with the following sorts of organisations:
- Our research partners who analyse your data.
- Database organisations who store your data.
We will make sure your data is protected. Anyone who accesses your data outside the UK must do what we tell them so that your data has a similar level of protection as it does under UK law. We will make sure your data is safe outside the UK by doing the following:
- We use specific contracts approved for use in the UK which give personal data the same level of protection it has in the UK. For further details visit the Information Commissioner’s Office (ICO) website.
- We do not allow those who access your data outside the UK to use it for anything other than what our written contract with them says.
- We need other organisations to have appropriate security measures to protect your data which are consistent with the data security and confidentiality obligations we have. This includes having appropriate measures to protect your data against accidental loss and unauthorised access, use, changes or sharing.
- We have procedures in place to deal with any suspected personal data breach. We will tell you and applicable regulators when there has been a breach of your personal data when we legally have to. For further details about UK breach reporting rules visit the Information Commissioner's Office (ICO) website.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
We will keep your study data for a maximum of 15 years. The study data will then be fully anonymized and securely archived or destroyed.
What are your choices about how your information is used?
- You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
- If you choose to stop taking part in the study, we would like to continue collecting information about your health from your GP and central NHS records. If you do not want this to happen, tell us and we will stop.
- You have the right to ask us to remove, change or delete data we hold about you for the purposes of the study. We might not always be able to do this if it means we cannot use your data to do the research. If so, we will tell you why we cannot do this.
- If you agree to take part in this study, you will have the option to take part in future research using your data saved in the University of Southampton from this study.
Where can you find out more about how your information is used?
You can find out more about how we use your information, including the specific mechanism used by us when transferring your personal data out of the UK.
Document reference: Parent and Baby Project PIS v3.0 02JUL2025
IRAS: 351201
Thank you for reading this information sheet.