The consent of minors in clinical trials combines the legally required consent of the legal representative with the age- and maturity-appropriate involvement of the child. It serves the protection of the child and ensures that participation takes place only after comprehensible information, free decision and under the special conditions for minors. The details are based on Regulation (EU) No 536/2014 and the respectively applicable national law.
Legal basis and protective requirements
For minors, consent is given by the legally designated representative after being informed. The regulation furthermore requires that the minor receives information from suitably trained or experienced persons that is adapted to his or her age and mental maturity. The information should in particular explain the object, risks, benefits as well as possible burdens of the trial. The minor must have the opportunity to ask questions and express his or her opinion.
A clinical trial with minors is only permissible if the relevant additional conditions are met. These include a trial aimed at the pediatric population, a justified ratio of benefit and risk as well as the limitation of burden and risks. The interests of the individual minor participant take priority over the interests of science and society. Consent is an ongoing process: new safety-relevant information or substantial modifications may require a re-information of the parties involved.
Assent and age-appropriate involvement
Assent is the affirmative, developmentally appropriate agreement of the child to participate. It is not to be equated with the legal consent of the legal representative. ICH E11(R1) describes that the absence of an objection is not consent. Whether and in what form assent is to be obtained depends on the child’s maturity, the requirements of the ethics committee and local requirements. A child-friendly information and assent document therefore supplements the documents for the legal representative, but does not replace them.
The wish of a child capable of understanding not to participate or to refuse further measures is to be taken seriously and evaluated in the legal and clinical context. The trial site documents what information was conveyed, who conducted the conversation and what signatures or other proofs are planned. Materials, language and conversation must be comprehensible; a formal signature alone does not prove understanding involvement.
Differentiation from informed consent and the age of majority
Informed consent is the generic term for the voluntary consent based on adequate information of a person capable of giving consent or the legally provided consent for a person incapable of giving consent. For minors, it regularly consists of two separate components: the legally effective consent of the legal representative and the assent of the child, provided the latter is capable of it. The terms must therefore neither be equated nor interchanged.
If a participant reaches the legal age of consent during an ongoing trial, appropriate consent must be obtained from him or her for the continuation of his or her participation. ICH E11(R1) explicitly highlights this obligation. Further participation must not rely solely on the previously granted consent of the legal representative. The trial site must plan this transition proactively, document the new information and observe the national regulation on reaching the age of majority.
Relevance for clinical trials
The consent of minors influences the protocol, ethics application, recruitment, visit procedures and training of trial personnel. Frequent quality risks are unclear roles of the legal representatives, unsuitable information materials, missing documentation of the assent or a delayed re-consent upon reaching the age of majority. Trial sites therefore need a comprehensible procedure for conversations, document versions and the re-evaluation of involvement over the trial period.
Full-service CROs such as Mediconomics support the development of child-friendly information and assent documents, the regulatory and ethical submission, the training of trial sites and the monitoring of consent documentation. Clinical operations, regulatory affairs and quality management can thereby coordinate deadlines for re-consent upon reaching the age of majority and the implementation of national requirements in the trial procedures.
Frequently Asked Questions (FAQ)
Does assent replace the consent of the legal representative?
No. Assent is the developmentally appropriate agreement of the child. The legal basis of participation is fundamentally the consent of the legal representative granted under applicable law.
Must every child sign an assent form?
The necessity and form depend on maturity, ethics vote and national requirements. Decisive is information comprehensible to the child and traceable involvement, not solely the existence of a signature.
What happens upon reaching the age of majority?
For further participation, the consent of the then adult participant must be obtained. The transition is documented at the trial site and must not be skipped without the participant’s own decision.
Regulatory references
- Regulation (EU) No 536/2014, Articles 29 and 32 – regulates information, consent and additional conditions for minors.
- ICH E11(R1) Clinical Investigation of Medicinal Products in the Pediatric Population, Section 2.6.3 – explains consent of the legal representative and assent of the child.
- ICH E6(R3) Good Clinical Practice – anchors the informed, voluntary participation and the continuous protection of participants.
- Declaration of Helsinki of the World Medical Association – formulates ethical principles for research involving individuals incapable of giving informed consent.