Informed Consent (and Assent) is needed for trial participation
Participation in a clinical trial is based on voluntary willingness and awareness of what participation means in practice. All subjects participating in clinical trials must give informed consent before study start.
The consent requirement is based on respect for human rights and for study subject’s opinions and rights. When participating in a trial, the child / adolescent and his/her legal reprensentatives / guardian (i.e.parents) has the right to withdraw his/her consent, or after consenting discontinue the trial participation at any time before the end of the trial with no impact on his/her future medical care.
Children and adolescents below 18 years of age, can participate to clinical trial only, if the informed consent (legal permission) of their legally designated representative has been obtained after receiving the trial specific information in a way adapted to their age and mental maturity. If a child or adolescent can understand the significance of the trial and has capacity to assess the given information, he/she must also provide own written consent (it is non-legal alone and equivalent to assent, but the legal term is “consent” in Finland).
In Finland, an adolescent between 15-17 years of age can give his/her independent written legal consent if he/she can understand the significance of the trial and that there are scientific grounds for expecting that participation in the clinical trial will produce a direct benefit for the minor concerned outweighing the risks and burdens involved. In such a case, the child’s guardian must be notified (by written notification) about the child’s participation in the trial.
Children and adolescents should be able take part in the informed consent discussion (interview) and it should be also encouraged, but the discussion must be adapted to the age and mental maturity of a child / adolescent. The informed consent discussion (interview) must be performed by an investigators or members of the investigating team who are trained or experienced in working with children. The discussion must be documented.
No incentives or financial inducements are given to the children / adolescents or his or her legally designated representative except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial.
The explicit wish of a minor who is capable of forming an opinion and assessing the information to refuse participation (dissent) must be respected by the investigator. Children or adolescents should not be forced, persuaded, or induced in any way to participate in clinical trials.
The consent (and the assent, which is Finland is called also consent) is based on the information that the patient has received well beforehand. The information must be provided both orally and in written format.
The guardian’s information form includes all the information about the trial as regulated by law.
The child patient’s information form is written taking into account the child’s age and stage of development so that he or she is capable of understanding, to a sufficient degree, the nature of the trial in question, and capable to express whether or not he or she wants to take part in the trial. The information should be fairly short and easy to understand.
Patient information for children may be explained in a short format, which includes only the most important aspects of the planned trial. The information can be presented by using pictures, photographs, or videos. See more: Resources; FINPEDMED Picture Cards.