Participating in clinical trials
From the point of view of clinical trials, children under 18 are considered minors and a pediatric population that can be divided into several age groups providing a basis for pediatric study design. As an example, the following is one possible categorization;
preterm newborn infants (born before 37 weeks of gestation)
term newborn infants (0 to 27 days)
infants and toddlers (28 days to 23 months)
children (2-11 years)
adolescents (12-17 years)
In practice, this judgment is more flexible and accurate age classification cannot be done due to considerable overlap in developmental issues across the various age categories. Notably, in longer term studies, pediatric patients may move from one age category to another.
Informed Consent is needed for 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 and his/her guardian has the right to withdraw his/her consent at any time before the end of the trial with no impact on his/her future medical care.
According to the Medical Research Act, children under 15 years of age must give a written consent signed by a guardian (parent or legal representative). The child must also give his/her consent taking in to account his/her age and developmental stage. A child who is over 15 years of age and who is capable of understanding the significance of the trial can give his/her own consent if the trial is likely to be of direct benefit to his/her health. In such a case, the child's guardian must be notified about the child's participation in the trial.
The consent is based on the information that the patient has received well beforehand. 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. Patient information for children may be explained using pictures, photographs, or videos. See; FINPEDMED Picture Cards.
Children or adolescents should not be forced, persuaded, or induced in any way to participate in clinical trials; child's own willingness, opinion, and possible objection must always be taken into account and honored.
According to law, no fees must be paid for participation, nor must other inducements be used. In some special cases minimal items of low value may be given to participants, for example, to help the child identify the end of the trial or to motivate him/her to continue participation. In such a case the items in question must also be approved by the Ethics Committee as part of the trial protocol.