Information for participants in medical research

ROVI study

You are reading this information because your child went to the Accident and Emergency Department or was admitted to hospital with stomach flu symptoms (such as diarrhoea and/or vomiting). We would like to ask you to allow your child to take part in a medical research study. Participation is voluntary. The information below tells you what kind of study it is, what it means for you and your child, and what we will do with your child’s data.

Please read the information and decide if you want to take part. If you do, you can click on the I give consent button on the consent form.

1. About the study

Thousands of children are admitted to hospital every year in the Netherlands with serious stomach flu. Rotavirus is the main cause of stomach flu in children. Vaccination against rotavirus infection was introduced in the Netherlands in 2024. The aim of this study is to find out how this vaccination affects the number of hospital admissions and visits to the Accident and Emergency Department. Children that are admitted to hospital or go to the Accident and Emergency Department with stomach flu symptoms are checked for rotavirus. Then we look at how many of those children are vaccinated against rotavirus. We also want to see if there are factors that can influence the effectiveness of the rotavirus vaccination (such as an underlying health condition or pre-term birth).

2. How does the study work?

Children born after 1 January 2024 who go to the Accident and Emergency Department or are admitted to hospital for stomach flu symptoms are eligible for the study. It does not matter whether or not your child was vaccinated against rotavirus. We are looking for children who were vaccinated and children who were not.

All those who want to take part can follow these steps:

Register through the website. When you sign up, we will ask you to tick the box indicating your agreement on the consent form. We also ask for your consent to request your child’s data about rotavirus vaccination from the national vaccination registry (Praeventis).
Complete the questionnaire. It includes questions about your child’s health and your child’s stomach flu episode.
Collect your child's stool (poop) sample in the tube. Using the contents of the study package that you received in the hospital, collect a bit of stool (poop) from your child and send it to RIVM. RIVM will test your child’s stool sample to determine what caused the stomach flu symptoms.
Complete the second questionnaire. About two weeks after completing the first questionnaire, you will receive another short questionnaire about your child’s stomach flu episode.

3. When does the study end?

It is up to you to decide whether your child will take part in the study. Your contribution to the study ends once you have completed the twee questionnaires and sent in your child’s stool sample.

You can also decide to stop taking part in the study at any time. If you decide to stop, you do not have to explain why your child is leaving the study. As soon as you stop taking part, no more data will be collected about you or your child. The researchers will use the data and stool samples collected up to the time that you stopped. If you want, the collected samples can be destroyed. Let the principal investigator know.

Children can take part in the study from January 2025 to June 2026. The study may be ended before then by RIVM if there is a reason to do so.

4. What do we do with your data?

Would you like to take part in the study? Then you give your consent for your child to take part in this study. If you consent, RIVM is allowed to collect, use and retain your child’s data for the purposes of this study. This is established by the General Data Protection Regulation (GDPR).We process your personal data to benefit the general interest, and to fulfil our legal obligations.

What data do we collect?

We collect the following data:

Your email address
Your mobile phone number
Your postal code
Your child's date of birth
Your child's gender
Your child's birth weight and gestational age at birth
Household composition
Information about daycare attendance
Information about your child's health (diseases/health conditions, medicine use)
Information about your child's stomach flu episode (symptoms, treatment, etc.)
Data about your child's vaccination
Data about the test result from the stool sample, including the sample material

Why do we collect, use and retain your data?

We collect, use and retain your personal data in order to answer the questions being researched in the study, and to publish the results.

We only use your e-mail address and phone number to contact you during the study, for example to remind you to complete the second questionnaire or to share the test result from the lab with you.

How do we protect your privacy?

We only process data about your child that is necessary for the study. The data is stored securely and can only be accessed by authorised employees.

To protect your privacy, and the privacy of your child, you have received a study number. The research data and your child’s stool sample are only linked to this study number. When we process the data and the sample, we only use this study number.

Identifying details such as your child’s date of birth and your postcode will only be used to request data about your child’s rotavirus vaccination status from Praeventis, the vaccination registry. The data from the vaccination registry, linked to your study number, will then be processed with the other research data. Identifying data is stored separately and will not be processed with the other research data.

Your e-mail address cannot be linked to the research data. Your phone number can be linked to the research data, but will be stored separately, so your phone number cannot be traced directly to the research data.

Who can view your data?

Your e-mail address can only be accessed by the technical administrators of the website. They cannot see your answers to the questionnaires or any other research data. The researchers have access to all research data and your child’s stool sample. They do not have any access to the account information, such as your e-mail address. The principal investigator is the only person who can view the identifiable personal data to request records about rotavirus vaccination from the vaccination registry. Data contained in reports or publications about the study cannot be traced back to your child.

How long will your data be retained?

We retain your data for 10 years after the end of the study. Your child’s sample will not be destroyed immediately after use. It will be stored in order to be analysed for new findings related to this study during the course of the study. Once it is no longer necessary, we will destroy your sample.

5. Any questions?

Would you like to know more about your rights in the context of processing personal data? Go to www.autoriteitpersoonsgegevens.nl.
If you have any questions about your rights, or a complaint about processing of your personal data, contact the researchers at: ROVIstudie@rivm.nl
If you have complaints about processing of your personal data, we advise you to start by talking to the researchers. You can also contact the data protection officer for RIVM at: FG-VWS@minvws.nl. Or you can file a complaint with the Dutch data protection authority, Autoriteit Persoonsgegevens. · The general privacy statement of RIVM is available online: RIVM privacyverklaring
If you have other questions about the study, please contact the researchers at: ROVIstudie@rivm.nl

First, you can take your time to think about this study. Then you can consent to take part in the study. Would you like to take part? If you do, you can click on the 'I give consent' button on the consent form.

Thank you for your time.