CYIL vol. 11 (2020)

MARTIN ŠOLC CYIL 11 (2020) that in children older than 11.2 years, the competence to consent to participation in medical research is probable 61 . Other sources state that the competence for clinical treatment decisions starts around the age of twelve 62 . However, research also suggests that in spite of adolescents’ relatively high level of understanding, their judgment might be distorted more easily than that of adults because of lower levels of responsibility, perspective, and temperance 63 . In other words, while cognitive contributors to decision-making are very similar between adolescents and adults, psychosocial contributors relevantly differ 64 . The competence can be diminished in emotional situations as a result of adolescence-related brain changes 65 . In situations without emotional context, adolescents take risks in a similar way as adults. Their risk-taking in emotionally loaded situations, however, is significantly increased 66 . For this reason, adolescents need to be provided with specific environmental support such as a time to ponder on the decision or the absence of peer pressure 67 . 2.4 Other conditions It needs to be noted that every research on persons, be they minors or adults, needs to fulfil the general criteria set in Article 16 of the Convention on Human Rights and Biomedicine. These include the principle of subsidiarity in a wider sense (there is no alternative of comparable effectiveness to research on humans), the proportionality between the risks and the potential benefits for the person concerned, the approval of the scientific project by the competent body, informing the persons concerned about their rights and safeguards, and an expressly and specifically granted consent which was documented. There are also several other rules aiming at the protection of minors under European and Czech law. According to Section 52 (6) of Act on Pharmaceuticals as valid in autumn 2020, the clinical trial must be carried out in accordance with the instructions issued by the European Commission and the European Medicines Agency 68 . Article 10 (1) of Regulation on Clinical Trials sets that the assessment of the application for authorisation of a clinical trial involving minors requires specific consideration on the basis of paediatric expertise or taking advice on clinical, ethical, and psychosocial problems in the field of paediatrics. The 61 See HEIN, Irma M., TROOST, Pieter W., LINDEBOOM, Robert et al. Accuracy of the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) for Measuring Children’s Competence to Consent to Clinical Research. JAMA Pediatrics. (2014, Vol. 168. No. 12), pp. 1147-1153. doi: https://doi. org/10.1001/jamapediatrics.2014.1694. 62 See GROOTENS-WIEGERS, Petronella, HEIN, Irma M., VANDEN BROEK, Jos M., DE VRIES, Martine C. Medical decision-making in children and adolescents: developmental and neuroscientific aspects. BMC Pediatrics. (2017, Vol. 17, No. 120.) doi: https://doi.org/10.1186/s12887-017-0869-x. 63 See CAUFFMAN, Elizabeth, STEINBERG, Laurence. (Im)maturity of Judgment in Adolescence: Why Adolescents May Be Less Culpable Than Adults. Behavioral Sciences and the Law. (2000, Vol. 18, No. 6), pp. 741-760. See also 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. 298. 64 See CAUFFMAN, Elizabeth, STEINBERG, Laurence. (Im)maturity of Judgment in Adolescence: Why Adolescents May Be Less Culpable Than Adults. Behavioral Sciences and the Law. (2000, Vol. 18, No. 6), p. 757. 65 See GROOTENS-WIEGERS, Petronella, HEIN, Irma M., VANDEN BROEK, Jos M., DE VRIES, Martine C. Medical decision-making in children and adolescents: developmental and neuroscientific aspects. BMC Pediatrics. (2017, Vol. 17, No. 120.) doi: https://doi.org/10.1186/s12887-017-0869-x. 66 See an overview of relevant research in ibid. 67 See ibid. 68 Section 52 (6) f) of Act on Pharmaceuticals.

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