Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP)

Abstract

Informed consent means approval of the legal representative of the child and/or of the competent child for medical interventions following appropriate information. National legal regulations differ in regard to the question when a child has the full right to give his or her autonomous consent. Informed assent means a child's agreement to medical procedures in circumstances where he or she is not legally authorised or lacks sufficient understanding for giving consent competently. Doctors should carefully listen to the opinion and wishes of children who are not able to give full consent and should strive to obtain their assent. Doctors have the responsibility to determine the ability and competence of the child for giving his or her consent or assent. All children, even those not judged as competent, have a right to receive information given in a way that they can understand and give their assent or dissent. This consent/assent process must promote and protect the dignity, privacy and confidentiality of the child and his or her family. Consent or assent is required for all aspects of medical care, for preventive, diagnostic or therapeutic measures and research. Children may effectively refuse treatment or procedures which are not necessary to save their lives or prevent serious harm. Where treatment is necessary to save a life or prevent serious harm, the doctor has the duty to act in the best interest of the child. However, parents may also refuse to consent and in this case national laws and legal mechanisms for resolving disputes may be used.

Informed Consent in Decision-Making in Pediatric Practice

“…5, 76 -80 A recent statement from the Confederation of European Specialists in Pediatrics clearly states that pediatric patients may not refuse life-saving treatment. 35 Although the Confederation of European Specialists in Pediatrics references the United Nations Convention of the Rights of the Child, citing article 12, which provides for "the view of the child being given due weight in accordance with the age and maturity of the child, " and finds that this clearly applies to medical treatment, they state that the physician has a duty to act in the best interest of the child.…”

Mit Kindern und Jugendlichen reden

“…Besondere Bedeutung hat die Einschätzung der Kompetenz und das Recht auf Teilhabe in der Arbeit mit behinderten Kindern und Jugendlichen [27]. Sie ist eng mit ethischen Fragestellungen verknüpft, weshalb man sich auf europäischer Ebene bereits auf verbindliche Richtlinien geeinigt hat [10].…”

Parental perceptions of the informed consent process in pediatric oncology clinical trials

“…Joint decision-making between a child/adolescent and their parents to participate in a research trial is the optimal recommendation for obtaining assent [17,19] . This process however, also requires that the child or adolescent is considered competent to assent to treatment [20,21] .…”