Rights and obligations of human subjects
The rights of human subjects are laid down in the Medical Research (Human Subjects) Act . The most important rights are described below.
Right to decide for oneself
People decide for themselves whether or not to participate in medical research.
Right of information and right to ask questions
The researcher talks to the subject before their participation in the research project begins. The researcher must also provide information in writing about the research. The researcher must answer any and all questions the subject may have before, during and after the research project.
Research subjects will also have contact details of an independent expert. This expert knows a lot about the topic, but is not involved in the research project. The subject can ask this expert any questions they may have too.
Right to quit the research project
Subjects can decide not to take part in a medical research project at any time, even if the project has already begun. They don’t have to give a reason for their decision. Quitting a project will have no effect on the treatment a subject received before the research project
Right to protection of personal data
During the course of the research project the researcher collects data about the subjects. This data is treated confidentially and is given a code. The codes are used in research reports instead of people's names.
For more information about your data protection rights, visit the website of the Dutch Data Protection Authority
Samples may be taken of blood, saliva or other bodily material. These samples may be used only for the research for which the subject has given consent. If the researcher wants to use the samples again for a different research project, they must ask the subject to give specific consent for this.
The subject's obligations
Human subjects must follow the rules of the research projects. Every research project has its own rules. For example, you might be asked not to eat or drink anything before giving a sample or doing a test. You might have to take a pill at a certain time every day. Or you might be expected to write down how you feel every day.
It is important for you to follow these rules. If you don't, the researcher will not be able to carry out the research properly and the results will not be accurate. In that case the researcher may decide to remove a subject from the research project.