Persons who participate in medical/scientific research must give prior written consent. They must be given enough time to come to an informed decision between the moments of being informed and being asked to provide consent. The period of time deemed reasonable to come to this decision depends on the type of study.
Aduls, capable subjects sign their own form of consent.
Subjects under the age of 16
Children and adolescents under the age of 16 may only take part in a study with consent from both parents/legal representatives or the guardian. The WMO states the requirement for written consent by ‘the parents who have custody’, or by the guardian (section 6, paragraph 1, d). The research may only commence after both have (co) signed.
In the case of research with minors between the ages of 12 and 16, written consent is required by both the participant and the parents/legal representative(s).
With regards to research with children the Code of conduct minors specifies the requirement that the parents’ declaration of consent must contain a passage stating that if there is resistance on the part of the minor participant, consent for further participation in the rest of the study automatically no longer applies.
Incapacitated subjects of 16 years and older
Incapacitated subjects of 16 years and older are, for example, elderly people with advanced dementia, mentally handicapped, coma patients or people with a severe psychological disorder. These are vulnerable people. They quite often have difficulty forming an idea of what the research entails, if at all. Others must do that for them.
To participate in a research, a representative must provide consent for these subjects. That person could be someone appointed by a judge, such as a curator or mentor. If there is no such person, an authorised person can give consent. And if such a person also does not exist, then the spouse, registered partner or other life partner can give consent on behalf of the participant. If these do also not exist, then adolescents who are deemed able to understand the context are allowed to give context. And lastly, if there is/are no such person(s), then brothers or sisters who are deemed able to understand the context may provide consent on behalf of the participant.