CYIL vol. 11 (2020)

CYIL 11 (2020) THE BEST INTERESTS OF THE CHILD IN MEDICAL RESEARCH For the purpose of research, the consent must be given specifically and in writing 41 . Furthermore, the research cannot be carried out if the person concerned objects 42 . As the Explanatory Report to the Convention on Human Rights and Biomedicine explains, the aim of this rule is to respect the child’s autonomy and dignity as well as to ensure that the burden of the research is acceptable to her or him. In the case of very young children, it is necessary to evaluate their attitude taking account of their age and maturity. 43 This is in accordance with Article 12 of the Convention on the Rights of the Child that imposes on the State Parties the duty to assure to the child who is capable of forming her or his own views the right to express those views freely in all matters affecting the child, the views of the child being given due weight in accordance with the age and maturity of the child. It also corresponds with Article 29 of the World Medical Association’s non-binding Declaration of Helsinki, 44 according to which “[w]hen a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative. The potential subject’s dissent should be respected” . Of course, the informed consent of the minor’s parents or other legal representatives (i.e. a tutor) is also required by Act on Pharmaceuticals. If it is possible with regard to the minor’s age and intellectual capacity, the consent must express the presumed will of the minor. The investigator or a person who has experience with the work with minors and who was appointed by the investigator is obliged to inform the minor of the clinical trial, its risks and benefits. This information must be provided in a way the minor can understand. If the minor is capable of assessing the information and form her or his own opinion, her or his express wish to refuse the participation in the trial or to withdraw from the trial must be respected. No financial or other incentives can be offered to the minor or her or his representatives. However, the compensation of costs that arose in connection with the participation in the trial is permitted. Informing the minor and soliciting her or his assent should take place in the frame of cooperation between investigators (or competent appointed persons), the minor, and her or his parents 45 . Even if the minor’s assent was formally granted, the investigator cannot continue with the participation of this minor in research if her or his cooperation is apparently not voluntary 46 . The respect to autonomy is protected in practically the same way in Article 32 of Regulation on Clinical Trials. Informed consent of the minor’s legally designated representative must be obtained. Additionally, the minor must be provided with the relevant information in a way adapted to her or his age and mental maturity. The information must be provided by investigators or members of the investigating team who are trained or experienced in working with children. The minor shall take part in the informed consent procedure in a way 41 Article 17 (1) iv of the Convention on Human Rights and Biomedicine. 42 Article 17 (1) v of the Convention on Human Rights and Biomedicine. 43 See Explanatory Report to the Convention on Human Rights and Biomedicine, to Article 17, point 106. 44 Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 45 See DIVOKÝ, Jaroslav. Specifika informovaného souhlasu u dětí a osob s omezenou svéprávností [Specific Aspects of Informed Consent in Children and Persons With Limited Capacity]. In KŘEPELKA, Filip, KOŠČÍK, Michal, LANČOVÁ, Petra, JANOVEC, Michal (eds.). COFOLA 2018. Část IX. – Právní otázky medicínského výzkumu [COFOLA 2018. Part IX – Legal Issues of Medical Research]. Masarykova univerzita, Brno 2018, p. 15. 46 See ibid., p. 18.

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