Consent
Persons who participate in medical scientific research must give prior written consent.
Persons being asked to participate in medical scientific research (the research subject) should be given enough time to consider their willingness to participate. An adequate amount of time needs to be given from the moment the person is informed about the research until the moment this person is asked to provide consent. The amount of time given for reflection is not strictly defined. It also depends on the type of study. A period of at least two days (48 hours) is a good benchmark. Another requirement is that the person participating should have an opportunity to ask questions in order to reach an informed decision.
Capable research subjects > 16 years of age
Capable research subjects aged 16 years and over (adults) sign their own form of consent.
Research subjects < 16 years of age (children)
Children and adolescents under the age of 16 years may only take part in a study with written consent from both (authoritative) parents/legal representatives or the guardian. This is laid down in section 6, paragraph 1, under d of the WMO.
For research involving children under 12 years of age, consent from both parents/legal representatives or the guardian is required to participate in the study. Adolescents 12 to 16 years of age give consent independently in addition to their parents/legal representatives or guardian. Adolescents 16 years and older give their own consent.
If a child reaches the age of 12 while participating in the study, then the child must also give explicit consent before he/she can continue participation in the study. In that case, the parents/legal representatives or guardian have already given consent earlier. If a child reaches the age of 16 while participating in the study, no further action is needed as the child has already given consent.
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
Incapacitated subjects 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.
Deferred consent for medical research in emergency situations
Under strict conditions subjects may participate in medical research in emergency situations without their (or their legal representative’s) prior written consent. In order to clarify this situation, CCMO has drawn up a memorandum with two flowcharts. The first flowchart describes in which situations deferred consent is allowed regarding medical research in emergency situations. The second flowchart describes the steps that must be taken to obtain deferred consent and the use of data already collected.