This privacy statement may be relevant to you if:

• You are voluntarily taking part in research involving human subjects at RIVM, or;
• You are a care professional working on research involving human subjects at RIVM.

This privacy statement outlines:

• What we mean by research involving human subjects;
• Why we use personal data;
• How we use personal data for research involving human subjects;
• Whose personal data we use for this purpose, and;
• Your rights if we use your personal data.

The Minister for Health, Welfare and Sport (VWS) is responsible for RIVM’s use of personal data for research involving human subjects. The Minister commissioned RIVM to conduct research involving human subjects.

What do we mean by research involving human subjects?

Research involving human subjects in the sense of this privacy statement refers to medical scientific research in which we collect data about people. This might involve research on health, or medical care provided to all or some part of the Dutch population. Or it could be research on the health impacts of high-risk substances, environmental incidents or diet and lifestyle. The focus here is on both physical and mental human health.

Our research is conducted reliably and with all due care, in compliance with the laws and regulations of the Netherlands and the European Union. In conducting research with personal data, we also comply with the General Data Protection Regulation (GDPR) and the Dutch GDPR Implementation Act.

If you are taking part in research involving human subjects at RIVM, you received a leaflet with information specifying exactly:

• What types of personal data we collect about you;
• Who we obtained your data from;
• The purpose we use your data for, and;
• How long we retain the data.

Why do we use personal data?

RIVM is working towards a healthy population and a sustainable, safe and healthy living environment. To that end, RIVM conducts research involving human subjects. In the context of that research, we use personal data.

This makes it possible for us to, for example:

• Answer research questions;
• Invite people to take part in research;
• Contact the participant or health professional;
• Send the participant a message about the results;
• Send materials and surveys;
• Make home visits for the study;
• Offer advice on healthcare policy, and/or;
• Pay participants any travel reimbursements and/or compensation fees.

We may also use personal data for follow-up research. If that happens, we use leftover samples of bodily material (leftover materials) for other, related research. This is limited to research on a comparable topic. You can find more information about this in the information leaflet that you receive if you take part in the research. We always explicitly ask at the start of the study whether you consent to this.

What types of personal data do we use?

An item of personal data is information that is about a person or information that can be traced back to a person. Examples of personal data include a home address, a citizen service number (BSN), a telephone number or an email address.

Some personal data that we use is particularly sensitive because its use can have a significant impact on a person’s life, such as information about a person’s race, religion or health. These are considered special personal data. These special categories of personal data have stricter legal protections.

Exactly which types of personal data are used varies widely, depending on the study. The information leaflet about the study you are taking part in lists the types of personal data we use. We always check which types of personal data are necessary for the purpose of research involving human subjects. For example, it is often not necessary to collect special categories of personal data, such as information about a person’s race, ethnic origins, religion or beliefs. We always do our best to use only as much personal data as we need to achieve the purpose of the study.

For the purpose of research involving human subjects, we may use the following personal data:

General personal data, such as:

• first and last name
• date of birth, month and/or year of birth, and age
• gender
• contact details (address, phone number, e-mail address)
• participant number and/or coding number
• signature (participant >12 years, participants’ parents <18 years)
• contact details for care provider (for example the GP)
• bank details
• living situation
• profession or sector (such as agriculture, education or healthcare)
• income bracket
• work experience and educational background

Health data, such as:

• general health
• height and weight
• medical history
• medicines
• vaccination data (vaccine name, batch number, vaccination date)
• date of admission to a care institution
• first day of illness
• duration of hospital admission and ICU admission
• date of confirmed infection (diagnosis)
• data about related cases
• results of laboratory testing

In some cases, bodily material may also include personal data, such as:

• DNA from human samples of bodily material (cells)
• bacteria present in the intestinal tract (microbiome)
• human samples of bodily material (such as blood, saliva, nose and throat mucus, faeces)

Genetic data, such as:

• HLA from human samples of bodily material (this contains information about your immune system)

National identification numbers, such as:

• A-number from the Personal Records Database (BRP), only to confirm participants’ addresses
• BIG registration number of the nurses who make home visits
• Citizen service number (BSN)

Data related to race or ethnic origin, such as:

• ethnic origin
• birth country or region (indirectly also suggesting ethnicity)
• birth country or region of the parents and/or most recent partner (indirectly also suggesting ethnicity)
• date of arrival or estimated duration of stay in the Netherlands

Data about religion, beliefs, and principles, such as:

• religious or philosophical beliefs
• vaccination history and reason for not following the vaccination schedule (such as religious or philosophical beliefs)

Data about sexual conduct and/or preference, such as:

• sexual activity or sexual health

Whose personal data do we use?

For research involving human subjects, we use personal data about:

• prospective participants (people that we invited to take part in the study, or who indicated an interest in taking part)
• participants
• parents/caregivers of participants (or prospective participants)*
• people working on the research team
• care professionals

* We collect personal data about parents/caregivers of participants (or prospective participants) if the participant is under 16 years old or legally incompetent to make decisions, or if a person would like contact to be arranged through someone else.

How do we obtain the personal data?

The personal data we use for the research involving human subjects is given to us by:

• participants
• parents/caregivers of participants
• the Personal Records Database (BRP)
• other studies (if participants have granted consent for sharing data)
• Municipal Public Health Service (GGD)
• hospitals
• doctors
• other care professionals (if prospective participants have given their consent), and/or
• other government databases

What does the law say about the use of personal data?

The GDPR says that organisations can only use personal data if they have a valid ‘ground’ for doing so. The GDPR lists six legal bases for processing personal data:

1. consent from the person concerned
2. performance of a contract
3. legal obligation
4. vital interest of the person concerned or other people
5. public interest (exercise of official authority)
6. legitimate interest

In order to conduct research involving human subjects, RIVM often uses personal data. Scientific research is one of RIVM’s legally mandated tasks. This means that the use of personal data is necessary for reasons of public interest. RIVM is also permitted to use special categories of personal data that are necessary for its research tasks.

RIVM does not use personal data or health data for profiling. Profiling is a method for categorising people into different groups based on their data.

Our use of research data is as anonymous as possible. This means that data cannot be linked to participants. When it is not possible to anonymise the data, we take other measures to protect your privacy. One example is by coding your data. We call this method pseudonymisation.

Consent for participation in research involving human subjects
If you voluntarily take part in research involving human subjects, we ask for your ‘informed consent’. This means that we may only collect your personal data if:

• we have given you enough information about the study, and;
• you give your consent to take part in the study.

How long do we retain the personal data?

The personal data we use for research involving human subjects is retained for a specific time period. The data retention period is stated in the information leaflet that you received from RIVM. We do not retain your personal data longer than necessary.

After the end of the data retention period, the government is required to destroy the information.

Whom do we share the personal data with?

In some cases, RIVM may want or need to share personal data with others. When sharing personal data with other organisations, RIVM exercises all due care and is compliant with the rules of the GDPR.

If we share data with others, we reach agreements in which RIVM protects your privacy rights. Data that we collected for research involving human subjects may, for example, be shared with:

• hospitals
• research institutes
• government ministries
• laboratories
• members of the committee that reviews research safety
• an auditor working for the commissioning clients or the researcher, and/or
• national and international supervisory authorities

If we share data with recipients outside RIVM, we anonymise the data wherever possible, or make use of pseudonyms. That means we replace personal data with a meaningless code, so the recipients cannot know who the data is from – not even if they contact one of our collaborating partners. Before sharing research data with others, we request advice from a multidisciplinary review committee.

Even if RIVM shares personal data with a recipient outside the European Economic Area (EEA), we are still compliant with the GDPR. When needed, we will take extra measures – together with the receiving party – so that your personal data is as well protected as it is under the GDPR.

What are my rights?

Under the GDPR, you have a number of rights. This privacy statement outlines your rights when your personal data is used for research involving human subjects. It also explains how you can submit a GDPR request to exercise your rights.

You can use the e-mail address in the information leaflet from the study to contact us and exercise the following rights:

• Stopping participation in the study
  You gave your consent to take part in research involving human subjects. If you no longer want to take part in the study, you can stop by withdrawing your consent. After you withdraw your consent, we will not collect any more data about you for scientific research purposes.
• Deleting data
  You can also ask us to completely delete your data, but this is not always possible, since deleting data could harm the study. It may also be possible that your data can no longer be identified and traced back to you. In considering such requests, we always weigh your privacy rights against the research integrity of the study.
• Viewing data
  At any time, you may ask to view your own personal data that RIVM is using for research involving human subjects.
• Changing or adding data
  If your personal data is incorrect or incomplete, you can ask for your data to be changed or supplemented.

If you do not have an e-mail address to contact the researchers, you can send an e-mail to avg-rivm@rivm.nl to exercise your rights. You can also contact avg-rivm@rivm.nl to exercise the following rights:

• Submitting an objection
  You can object to the use of your personal data due to your specific situation.
• Restricting use of personal data
  You can ask RIVM to temporarily stop using your data. This is possible if your data in our records is incorrect, no longer needed, or not used in accordance with the law, or if you object to the use of your personal data.
• Sending personal data to another organisation
  You can ask to receive a copy of the data RIVM has about you. You can also ask RIVM to send your data to another organisation.

You may also have other rights in the context of the study you are taking part in. Always read the information leaflet so you are aware of the privacy rights applicable to your study.

The general privacy statement of RIVM explains how to submit a general GDPR request to RIVM.

Any questions?

After reading the privacy statement, do you still have questions about how personal data is used at RIVM? You may find the answer in the general privacy statement of RIVM.

If you have any questions about this privacy statement, or think that RIVM is not respecting this statement, please send an email to: avg-rivm@rivm.nl.

Would you like to file a complaint?

The RIVM website offers more information about the complaints procedure and how to file a written complaint. You can also send your complaint to the Data Protection Officer (DPO) of the Ministry of Health, Welfare and Sport (VWS): FG-VWS@minvws.nl.

Under the GDPR, you may also send a complaint to the Autoriteit Persoonsgegevens (AP), the Dutch data protection authority.

Our privacy statements may be subject to change

Laws and regulations about privacy change regularly. For that reason, this privacy statement about research involving human subjects and the general privacy statement may be subject to change. We recommend that you read these privacy statements again from time to time. This means that you will always know how we are using your personal data.