CYIL vol. 11 (2020)

MARTIN ŠOLC CYIL 11 (2020) persons capable of giving informed consent or by other research methods. Furthermore, the research should be directly focused on the minor’s health condition or it should not be possible to carry out the research only on adults. 33 The principle of subsidiarity can also be implicitly found in the requirement that the trial must be designed in a way that minimizes the pain, discomfort, fear, and all other foreseeable risks. The threshold of permissible risk and stress must be defined by the clinical trial protocol and constantly controlled. 34 Also under Article 32 of Regulation on Clinical Trials, the research study must relate directly to a medical condition from which the minor suffers or be of such a nature that it can only be carried out on minors. It must be intended to investigate treatments for a medical condition that only occurs in minors or, alternatively, it must be essential with respect to minors to validate data obtained in clinical trials on persons able to give informed consent or by other research methods. 2.3 The principle of autonomy In the last decades, the patient’s autonomy has been understood as the cornerstone of medical law and ethics 35 . The Convention on Human Rights and Biomedicine in its Article 6 (2) states that any medical intervention can only be carried out on a minor who is not capable of granting consent if there is given the authorisation of her or his representative or an authority or a person or body provided for by law. It is left for domestic law in each country to determine whether and under what conditions persons are capable of consenting to an intervention 36 . The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to her or his age and degree of maturity. The authorisation can be withdrawn at any time but only if the withdrawal is in the best interests of the person concerned 37 . The representative must be provided with the same information as if she or he was granting consent to an intervention in her or his own integrity 38 . That is only logical given the fact that the consent of the legal representatives clearly aims at the protection of the child’s best interests by the closest adult persons (under Czech law, this is explicitly expressed in Section 457 of Act No. 89/2012 Coll., the Civil Code 39 ). It would not be reasonable to burden the child with the same standard of information. The level of detail of the information provided to the child, most importantly regarding the nature of the study, depends on the child’s age and actual capacity. In the context of parental protection, it makes sense that the child’s assent consists in a simple preference to participate (or not) in the research. 40 35 For an interesting overview of the shift of health care paradigm to the respect to autonomy in the post-communist Czech Republic, see ŠUSTEK, Petr. Two Decades of the Convention on Biomedicine: Has It Been Any Good? In ŠTURMA, Pavel (ed.). Czech Yearbook of Public & Private International Law. Česká ročenka mezinárodního práva veřejného a soukromého. Vol. 9. Česká společnost pro mezinárodní právo, Praha 2018, pp. 257-269. 36 See Explanatory Report to the Convention on Human Rights and Biomedicine, to Article 6, point 42. 37 Article 6 (5) of the Convention on Human Rights and Biomedicine. 38 Section 6 (4) in connection with Section 5 of the Convention on Human Rights and Biomedicine. 39 Section 457 of Czech Civil Code: Legal representation and guardianship aim to protect the interests of the person represented and the fulfilment of his rights. 40 See ROTH-CLINE, Michelle, NELSON, Robert M. Parental Permission and Child Assent in Research on Children. Yale Journal of Biology and Medicine. (2013, Vol. 86, No. 3), p. 292. 33 Section 52 (6) e) of Act on Pharmaceuticals. 34 Section 52 (6) g) of Act on Pharmaceuticals.

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