Legal aspects of informed consent in paediatric clinical trials of medicinal products

Daugelio gyvybiškai svarbių vaistų vaikams gydyti indikacijos nėra patvirtintos reikiamais klinikiniais tyrimais, todėl juos vartojant padidėja nepageidaujamų reakcijų, įskaitant mirtį, rizika. Siekiant sudaryti palankias sąlygas pediatrinių vaistų kūrimui, 2006 m. sausio 26 d. buvo priimtas Europos Palamento ir Tarybos Reglamentas (EB) Nr. 1901/2006 dėl pediatrijoje vartojamų vaistinių preparatų. Šiame straipsnyje analizuojami Europos Tarybos, Europos Sąjungos ir Lietuvos Respublikos teisės aktai, siekiant išnagrinėti svarbiausius asmens sutikimo dalyvauti pediatriniame tyrime teisinius aspektus: vaiko atstovavimas, tėvų, vaiko teisių apsaugos tarnybos vaidmuo; vaiko pritarimas dalyvauti tyrime. Taip pat straipsnyje siekiama įvertinti, ar Lietuvoje teisės normomis nustatant sutikimo įtraukti vaiką į tyrimą tvarką yra numatyta pakankama jo teisių apsauga, ar nėra sudaromos nepagrįstos kliūtys pediatrinių vaistų kūrimui, bei pateikiami siūlymai, kaip spręsti nustatytas problemas.A lot of medicinal products currently administered to the pediatric 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 Pediatric Use (the Pediatric Regulation) was approved in response to the need to have medicinal products properly adapted for the pediatric population. A system of incentives set out by the Pediatric Regulation is focused on the promotion and development of pediatric research as its purpose is to generate data on the safety and efficacy of medicinal products for pediatric 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 pediatric 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 emphasizes 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 pediatric 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