CYIL vol. 11 (2020)

CYIL 11 (2020) THE BEST INTERESTS OF THE CHILD IN MEDICAL RESEARCH Nowadays, a similar experiment would never be considered ethical or legal. No matter the immense potential benefits, deliberately infecting a healthy child with a deadly disease would certainly not be approved by any ethical committee (even though it is good to remember that we do not live in times when certain infectious disease kills 10 – 20 percent of the population as smallpox did in towns of Northern England in the late 18 th century 2 ). Medical research ethics, as well as its legal regulation, stand on the protection of an individual’s interests, especially when it comes to minors participating in research. Thirty years ago, in 1990, Czechoslovakia ratified the United Nations Convention on the Rights of the Child 3 . It promotes the concept of the best interests of the child which also applies to medical research. In this paper, we will analyse how the best interests of the child in research are protected by international law in the European area (primarily by the Council of Europe’s Convention on Human Rights and Biomedicine 4 ) and whether the Czech national law corresponds to this level of protection. Then, we will test whether the relevant legal rules can be ethically justified by Kantianism as a normative ethical theory that is most solidly rooted in the protection of an individual’s dignity. For the sake of brevity, we will only focus on clinical trials of medicinal products. After all, the other branches of medical research – in Czech law known as the clinical investigation of medical devices and the evaluation of new methods not yet established in the medical practice 5 – are regulated in a very similar way when it comes to the participation of minors 6 . 1. Minors as a vulnerable population As a rule, children are not able to understand research studies and their risks as profoundly as adults with normal mental capacity. Furthermore, they are significantly more vulnerable to coercion and other types of undue influence 7 . It might seem that the best policy would be restricting the research on children as much as possible. And to a certain extent, this has or RESNIK, David B. The Ethics of Research with Human Subjects. Protecting People, Advancing Science, Promoting Trust. Springer, 2018, pp. 16-17. 2 See DAVENPORT, Romola Jane, SATCHELL, Max, SHAW-TAYLOR, Leigh Matthew William. The geography of smallpox in England before vaccination: A conundrum resolved. Social Science & Medicine. (2018, Vol. 206), pp. 75-85. doi: https://doi.org/10.1016/j.socscimed.2018.04.019. 3 The Convention on the Rights of the Child was implemented into Czechoslovak law by the notification of the federal ministry of foreign affairs No. 104/1991 Coll. 4 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, also called the Oviedo Convention, was signed in 1997 and became effective in 1999. It was ratified by the Czech Republic in 2001. 5 See ŠUSTEK, Petr. Medicínský výzkum [Medical Research]. In ŠUSTEK, Petr, HOLČAPEK, Tomáš (eds.). Zdravotnické právo [Health Law]. Wolters Kluwer, Praha 2016, p. 688, or ŠOLC, Martin. Právo, etika a kmenové buňky [Law, Ethics, and Stem Cells]. Wolters Kluwer, Praha 2018, pp. 128-129. 6 An interesting difference might consist in the fact that informed consent for participation in clinical investigation of medical devices can be (under certain conditions) granted by the minor herself or himself without her or his legal representatives. 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. 7 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), pp. 291-292.

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