Legal Aspects of Informed Consent in Paediatric Clinical Trials of Medicinal Products

Kristina Zamarytė-Sakavičienė


A lot of medicinal products currently administered to the paediatric population have not been specifically studied or authorized for their use. This leads to problems such as, for example, increase in adverse (and sometimes lethal) reactions risks. EC Regulation 1901/2006 on Medicinal Products for Paediatric Use (the Paediatric Regulation) was approved in response to the need to have medicinal products properly adapted for the paediatric population. A system of incentives set out by the Paediatric Regulation is focused on the promotion and development of paediatric research as its purpose is to generate data on the safety and efficacy of medicinal products for paediatric use.
This article analyses international, EU, and Lithuanian legal acts, judicial practice and the doctrine of law in order to assess whether Lithuanian regulations of giving the informed consent to participate in clinical trials provide sufficient protection of rights and interests of minors and does not place unfounded obstacles to the stimulation of development of paediatric medicinal products.
The first part of the article explains legal concepts of minor, child in the context of biomedical research and fundamentals of the representation of a minor by parents or legal guardians in giving the informed consent to participate in research. The author of the article analyses the legal notion “separated parents” and gives two recommendations: identified problems could be solved by regulation providing the right to parents to give each other power of attorney for the custody of the child that expressly states that consent to participate in trial is given; the law could also provide an exception to the joint decision-making of both parents when on the basis of objective reason, delay in reaching the decision may cause harm to the child. The third part of the article emphasises problems of the legal requirement to obtain the consent of children’s rights protection agencies. The article concludes that this requirement does not provide any additional protection of minors’ interests and contradicts EU law. Therefore, this requirement is inapplicable in cases where parents are giving the consent for paediatric research. The article also explores the peculiarities of regulation of minors’ assent to participate in research in Lithuania. This analysis shows that in the case of consenting to biomedical research, a minor over sixteen years old must always consent to participate in a clinical trial (additionally, apart from the parents or guardians). The legal regulation should impose fixed age or competence (i.e. capability to form an opinion and assess the information that was given) criteria for minors under sixteen assent. The right to determine the minor’s age of assent or competence criteria, which are needed for a particular clinical trial, can be left for the determination of ethics committees.


clinical trials of medicinal products; biomedical research; paediatric clinical trials; Paediatric Regulation; Clinical Trials Directive

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"Societal studies" ISSN online 2029-2244 / ISSN print 2029-2236