Informed Consent of Pediatric Study Subjects
According to the Finnish Medical Research Act (section 8), informed consent is required also from minors (under 15-years old). Minors may be study subjects only when it is not a possibility to obtain the same scientific results using adult subjects and when the risk of harming or distressing effects is only very slight. It is also required that the research should be likely to be of direct benefit to the study subject’s health or the research should be likely to be of special benefit to the health of people in the same age group or with the same state of health.
Minors under 15-years of age, who are not entitled to be study subjects without the consent of their guardian or other legal representative, but capable of understanding the importance of the research procedure to be carried out on them, need to sign their own written consent to confirm their participation. If a minor opposes a research or a research measure, the minor’s opinion shall be complied with, taking account of his/her age and maturity.
When the minor has reached the age of 15 and is capable of understanding the importance of the research procedure and the research is likely to be of direct benefit to the minor’s health, it is sufficient for the minor to give his/her informed consent in writing. In such cases the guardianwill be informed of this. In other cases minors may be study subjects only when written consent for this has been given by their guardian or legal representative after having been provided with essential study information. The consent must be in accordance with the minor’s supposed will. Consent may be withdrawn on the same terms as generally for medical research. Information about the research as well as about its risks and benefits should be explained by study personnel using the language minot is able to understand.
For more information on pediatric clinical trials and informed consent forms please visit the web site of the Finnish Investigators Network for Pediatric Medicines.