CYIL vol. 11 (2020)

CYIL 11 (2020) THE BEST INTERESTS OF THE CHILD IN MEDICAL RESEARCH by national law. The aim of the research has to consist in contributing, through significant improvement in the scientific understanding of the individual’s condition, disease or disorder, to the ultimate attainment of results capable of conferring a benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition. The notion of the individual’s condition does not only encompass abnormalities peculiar to childhood, but also normal development of the child if its deeper knowledge is necessary for the understanding of a certain disease 29 . Therefore, even if the research is not directly beneficial to the particular individual, it must be capable of bringing benefit to the group of patients this person belongs to. Finally, the research without direct benefit must only entail minimal risk and minimal burden for the individual concerned. Compared with the risk/benefit proportionality test that is applied to medical research in general (in Article 16 ii), this is a much more stringent requirement. The minimal risk requirement might be seen as the last stage of protection of minors that still enables at least some research to be carried out 30 . The principle of direct benefit is in a way also reflected in Czech law. According to Section 52 (6) e) of Act on Pharmaceuticals, the clinical trial must bring direct benefits for a group of patients. Perhaps even more important is Article 32 of Regulation on Clinical Trials 31 that requires scientific grounds for expecting that participation in the clinical trial will either produce a direct benefit for the minor concerned outweighing the risks and burdens involved or some benefit for the population represented by the minor concerned. In the second case, the clinical trial is not permissible unless it poses only minimal risk to, and imposes a minimal burden on, the minor concerned in comparison with the standard treatment of the minor’s condition. 2.2 The principle of subsidiarity Simply put, the principle of subsidiarity means that involvement of children in research is only possible as a “last resort” when research cannot be carried out otherwise. This approach is a matter of a wide consensus – for example, American Belmont Report from 1979 states that “it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) (…).”  32 The Convention on Human Rights and Biomedicine in its Article 17 (1) iii sets that a minor (or another person who cannot grant consent) can be subjected to the research only if the research of comparable effectiveness cannot be carried out on individuals capable of giving consent. In a similar way, Section 52 (6) of Act on Pharmaceuticals states that the research must be essential for the verification of data obtained by the trial conducted on 29 See Explanatory Report to the Convention on Human Rights and Biomedicine, to Article 17, point 110. 30 Minimal risk is also important in some of other legal systems: for example in the USA, the permission of just one parent is sufficient for the participation in research that either involves minimal risk or prospect of direct benefit to the child. 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. 293. 31 Requirements for clinical trials involving minors are set by Article 32 of Regulation on Clinical Trials in addition to general criteria for clinical trials that are regulated in its Article 28. 32 National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. U.S. Department of Health & Human Services [online]. accessed 28 May 2020.”

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