This page provides background information on participating in medical research. It is supplementary to the page General information on taking part in research (IRP). That page sets out, in plain English, all the essential information that research participants need to know before signing a consent form.
Every year, hundreds of studies with human participants are initiated in the Netherlands. Participation in this type of research is always voluntary. Participants may be patients, but they may also be healthy volunteers.
Research usually takes place in hospitals, but it can also occur elsewhere. For example, at the general practitioner, the child health clinic, in the care home, at a university or at another research institution.
Research participants primarily interact with the researcher conducting the study, for example a doctor, a scientific researcher, a physiotherapist, or a psychologist. Ultimate responsibility lies with the sponsor. This may be a company, a hospital, or a non-commercial institution.
When someone visits a doctor with health complaints, they undergo a diagnostic examination. The aim of this is to cure the patient. Medical research is not primarily aimed at curing the participants. However, if the participants are patients, they may benefit from it.
There are three types of medical research:
- Research to find better treatment methods. For example, a better remedy for headaches, a new heart valve, or better treatment for depression.
- Research to gain a better understanding of medical issues. For example, whether eating a lot of licorice leads to high blood pressure. Or what causes ADHD. Or what happens in the case of a herniated disc.
- Research to detect diseases. For example: how can bowel cancer be detected at an early stage? How can Parkinson’s disease be recognized early on?
Sometimes a new treatment or operation is tested, or a new medicine or food product. Usually, the researcher compares the new treatment with an existing one. A draw then determines who receives which treatment. This is called randomisation. The participants are not told which group they have been assigned to. This is called a blind study. Often, the researcher does not know either who is receiving the new treatment and who is receiving the existing one. This is called a double-blind study.
It may also be the case that a new treatment is compared with a sham treatment. The sham treatment (or placebo treatment) resembles the new treatment. In this case, for example, some participants receive the medicine being studied, whilst others receive a medicine without active ingredients.
Often, research primarily involves collecting data. For example, body temperature, blood values, or information about the participants’ mental state. Treatment is not the aim in such cases. Sometimes participants are asked to keep their own notes (a diary) or to complete a questionnaire.
Research with a medicinal product is often divided into four phases:
- Is the medicinal product safe?
The researchers observe how participants (usually healthy volunteers) react to the medicinal product. - Does the medicinal product work?
If the medicinal product is safe enough, the researchers check whether it actually works in a small number of patients. - Does the medicinal product work better than existing medicinal products?
If the results of Phase 2 are good, the researchers ask more patients to participate. They then often compare the new medicinal product with an existing treatment. If the results are good, this phase is often followed by registration of the product as an official medicinal product. Doctors are then allowed to prescribe it. - What are the long-term effects?
Medicinal products prescribed by doctors are also still being studied. Usually the research focuses on long-term adverse reactions. Sometimes research is carried out to see if a medicinal product also helps against other diseases.
Healthy volunteers usually participate in Phase 1 research. During that phase, the researcher assesses how well the medicinal product is tolerated. Patients can sometimes participate in Phase 2, 3, or 4 of research with a medicinal product. People suffering from cancer can sometimes participate in Phase 1 research. Phase 1 and 2 research usually do not result in any improvement for the patient.
Sometimes volunteers participate in multiple studies. Dutch research centres that investigate medicinal products calculate when a volunteer can participate in a next study. To calculate this, they look back four studies. Research centers that carry out a lot of research with medicinal products using healthy volunteers check this using the Verified Clinical Trials (VCT) system. This system records who participated in which study and when.
It is usually not prohibited to participate in multiple studies at the same time, but it is not recommended. It can be detrimental to the participant’s safety and to the reliability of the study. Participation in one study must not affect participation in another study.
In research with a medicinal product, it is usually not permitted to participate in multiple studies at the same time. There is a risk of cross-reactions: one medicinal product may interfere with the effect of another.
Sometimes a break between studies is mandatory. This is certainly necessary if the studies could influence one another. The length of this break depends on the type of study.
The Netherlands has strict rules for conducting research with human participants. The Medical Research Involving Human Subjects Act (WMO) is designed to protect research participants.
If you are asked to participate in a study, ask whether it is a WMO study. The researcher will know. All the information on this website is intended for research participants taking part in WMO studies. Even if your study is not covered by the WMO, your consent is still required.
Participating in research is always voluntary. Healthy volunteers are often compensated. The amount depends on the duration and burden of the study. The CCMO has issued a memorandum on Compensation for research participants and researchers (in Dutch).
The burden is related to the number of measurements and any potential discomfort. For example, volunteers must set aside time to participate. This can range from a number of short visits to a hospital stay of a few days.
The compensation is based on the minimum wage. The Medical Research Ethics Committee (MREC) that assesses the study checks the amount of the compensation. The compensation is usually a gross amount. You may be required to declare this to the tax authorities.
Patients are usually only reimbursed for travel expenses. They do not have to pay for the medicines they receive during the study. This does not apply to registered medicines. These are usually reimbursed by the health insurer.
Consent Form
Only after signing a consent form does a person officially become a research participant. The researcher must provide this consent form (also known as ‘informed consent’). Prior to this, the researcher is required to have a conversation with the prospective research participant.
The consent form states what the research involves and what the research participant is consenting to. The declaration is valid once the name, date, and signature have been provided.
Participants aged 16 and older sign the consent form themselves. Adolescents between the ages of 12 and 16 sign themselves, together with both parents who have parental authority or their guardian. For children under the age of 12, both parents who have parental authority—or their guardian—must give consent. The website ‘Kind en onderzoek’ (Children and Research) provides further information on children and medical research, for children, parents, and professionals alike.
Adults lacking legal capacity
For adults lacking legal capacity—for example, elderly people with severe dementia, people with intellectual disabilities, or patients in a coma—a representative may give consent. Research involving these vulnerable people may only take place if it complies with special rules. A representative may be a guardian or a mentor, appointed as such by the court. If there is no such person, the following are eligible to give consent in the following order:
- A person authorised in writing.
- The spouse, partner, or other life partner.
- The parents.
- Adult children who can reasonably be contacted.
- Adult siblings who can reasonably be contacted.
If you want to know whether there is a study in which you can participate as a patient, you can ask your general practioner or specialist. Information about studies seeking participants can also often be found on the websites of patient organisations. Researchers usually recruit participants through healthcare institutions and doctors. This is often done through advertisements or leaflets. The CCMO does not act as an intermediary between researchers and participants. It is an independent body. On the website Onderzoekmetmensen.nl, you can search for studies that are still looking for participants.
If you have any complaints about the study, it is best to discuss them with the researcher first.
If you would prefer not to do so, you can find out who you should contact by reading the information for research participants. The researcher is obliged to provide you with this written information before you participate in the study.
If you feel that things are seriously amiss during the study, you can report this to the Health and Youth Care Inspectorate.
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Information about medical research on Rijksoverheid.nl (in Dutch).
- Government leaflet: Medical research: information for research participants (in Dutch).
- Search for a study on Onderzoekmetmensen.nl.
- Website Children and research (in Dutch).
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CCMO memorandum: Compensation for research participants and researchers (in Dutch).