CYIL vol. 11 (2020)

CYIL 11 (2020) THE BEST INTERESTS OF THE CHILD IN MEDICAL RESEARCH elements, for example 1) ability to express a choice, 2) ability to understand the information, 3) reasoning ability, and 4) ability to appreciate the consequences of the decision 53 . Each of these elements needs to be assessed separately and specifically for the individual minor 54 . Moreover, the exact development of understanding and decision-making capacity has not yet been unambiguously described. Some studies suggest that seven to eight-year-old children generally understand concepts like the freedom to ask questions and to withdraw or the potential benefits of the research 55 . Seven-year-old children are often accepted as capable of providing assent 56 . Children’s comprehension of the research goals, procedures, and their risks is even less understood 57 . Nevertheless, adolescents older than thirteen years seem to achieve similar understanding of medical decisions as adults 58 . Results regarding the development of decision-making capacity are similar. According to a 1982 study, nine-year-old children seem to be capable of expressing their preferences regarding health care based on an informed decision, being able to participate meaningfully in personal health care decision-making. Fourteen-year-olds did not seem to differ from adults in their decision-making capacity. 59 The competency of adolescents aged thirteen- to fifteen has also been confirmed by several other studies 60 . A recent study from 2014 suggests cited in 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. 296. 53 See DOLEŽAL, Tomáš. Způsobilost nezletilých udělit souhlas s poskytováním zdravotních služeb [Informed Consent to the Medical Treatment of Minors]. Časopis zdravotnického práva a bioetiky [Journal of Medical Law and Bioethics]. (2018, Vol. 8, No. 1), p. 50. 54 The necessity of individualised assessment of minor’s capacity has also been endorsed by Act No. 89/2012 Coll., the Civil Code, for the general context of health care provision. Unlike the previous Civil Code of 1964, the Civil Code of 2012 understands the intellectual and volitional maturity subjectively, requiring an individualised assessment of capacity of the particular minor (see Section 31). See DOLEŽAL, Tomáš. Způsobilost nezletilých udělit souhlas s poskytováním zdravotních služeb [Informed Consent to the Medical Treatment of Minors]. Časopis zdravotnického práva a bioetiky [Journal of Medical Law and Bioethics]. (2018, Vol. 8, No. 1), p. 55. 55 See HURLEY, Jennifer C., UNDERWOOD, Marion K. Children’s understanding of their research rights before and after debriefing: informed assent, confidentiality, and stopping participation. Child Development. (2002, Vol. 73, No. 1), pp. 132-143, or SUSMAN, E. J., DORN, L. D., FLETCHER, J. C. Participation in biomedical research: the consent process as viewed by children, adolescents, young adults, and physicians. The Journal of Pediatrics. (1992, Vol. 121, No. 4), pp. 547-552. As cited in 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. 296. 56 RESNIK, David B. The Ethics of Research with Human Subjects. Protecting People, Advancing Science, Promoting Trust. Springer, 2018, p. 136. 57 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. 296. 58 See ibid., s. 298. 59 See WEITHORN, Lois A., CAMPBELL, Susan B. The Competency of Children and Adolescents to Make Informed Treatment Decisions. Child Development. (1982, Vol. 53, No. 6), pp. 1589-1598. doi: https://doi. org/10.2307/1130087. 60 See STEINBERG, Laurence. Does Recent Research on Adolescent Brain Development Inform the Mature Minor Doctrine? The Journal of Medicine & Philosophy. (2013, Vol. 38, No. 3), pp. 256-267. doi: https:// doi.org/10.1093/jmp/jht017, or GROOTENS-WIEGERS, Petronella, HEIN, Irma M., VAN DEN 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. See also an overview of these studies in DOLEŽAL, Tomáš. Způsobilost nezletilých udělit souhlas s poskytováním zdravotních služeb [Informed Consent to the Medical Treatment of Minors]. Časopis zdravotnického práva a bioetiky [Journal of Medical Law and Bioethics]. (2018, Vol. 8, No. 1), pp. 50-51.

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