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Participate in research

Meedoen aan onderzoek
Before a doctor/researcher can conduct clinical research, he/she needs to write a research protocol. In the protocol is stated exactly what he/she wants to investigate and how they are going to perform the study. In the protocol is also described what the patient or volunteer will endure and how he/she will be affected by the research. The protocol must meet all kinds of rules and regulations for conducting research in human beings.

Specific law in the protection of study subjects

Meedoen aan onderzoekIn The Netherlands there is a special law for the protection of subjects (humans) contributing to medical research: this is called in Dutch: Wet medisch-wetenschappelijk onderzoek met mensen (WMO). In research that is conducted within the WMO-regulations the researcher will submit the protocol to the Medical Ethics Review Committee. The Commission shall review research protocols to the rules and regulations of the WMO. Without a positive advise of the Commission and permission of the Board of Directors it is legally prohibited to conduct the study.

Consent and patient information

If you and your child are asked to participate in clinical research you will get information about the study first. Only then you can assess thoroughly whether you want your child to participate. You will be given written information about the study presented and an verbal explanation by the researcher involved.

In the written patient information you will find information about the goals and the practical implementation of the study/treatment. The advantages and disadvantages and the possible risks of treatment are pointed out to you and any additional examinations are indicated and explained. The patient information also describes the rights and obligations of patients contributing to the research and provides information about expenses and the insurance of the research. In addition to all this in the written patient information is described how the protection of privacy of the patient is ensured. The name and contact details of the researcher can be also found in the documents.

The research data are encoded during the study period so that names of patients can be only traced by the researcher and by no one else. All research data will be treated confidentially.

Meedoen aan onderzoekIf you decide to let your child participate in the study you must give your permission. You do this by signing a consent form (informed consent). It is of course also possible that you prefer not to let your child participate in the study. Your child will then be given the treatment which until then is prevalent for his/her condition.

Your child and you can decide at any given moment during the study to stop participation. The doctor will then discuss with you and your child how the treatment is continued in the most optimal manner.

Closing of the study and publications

If the study is completed, the doctor will inform you and your child. The data collected during the study will be used to write a report or an article. Often results will be published in a medical journal so that other physicians can use this new information in the treatment of their patients.

Medical scientific research leads to valuable and indispensable information that helps health care professionals to improve healthcare. More information about how to participate in research and your rights and obligations you can read in the Dutch brochure of medical-scientific research (Medisch-wetenschappelijk onderzoek ) of the Ministry of Health, Welfare and Sports (in Dutch called VWS). If at any time you have additional questions, please do not hesitate to contact your attending physician.