CYIL vol. 11 (2020)

CYIL 11 (2020) THE BEST INTERESTS OF THE CHILD IN MEDICAL RESEARCH is still the need for justification of research that cannot be effectively carried out without the participation of minors. The principle of direct benefit seems to be crucial in this regard. Shifting the moral significance of participation in research much closer to therapy, it undoubtedly aims at treating minors as ends in themselves. The maxim we can extract from this principle might be formulated as: “you can put a minor in risk if this minor directly benefits from it and, at the same time, the risks are not disproportionate to the foreseeable direct benefits”. Even though this duty requires the careful balancing of risks and benefits, we believe it can be justified under Kantianism. The problem with Kantian justification might arise in connection with the possibility to carry out non-beneficial research. If such a research study aims at results that could ultimately lead to the benefit of the person concerned (even if not directly), it could arguably still correspond to the formula of humanity. However, non-beneficial research is also legal if it might lead to the benefit of other persons in the same age category or having the same condition. In this case, the minor is definitely used as a means to help others. Informed consent or the minor’s own assent are not relevant here. Another rule that aims at protecting children is the requirement that non-beneficial research can only be carried out if it entails minimal risk and minimal burden for the minor concerned. The Explanatory Report to the Convention on Biomedicine seems to echo Kantian ethics when it stresses that the minimal risk requirement is essential for carrying out research “without constituting an instrumentalisation of these persons contrary to their dignity” . 96 The definition of minimal risk might be important for the assessment from deontological perspective. It can be argued that minimal risk should not exceed the risk that minors of the same age face in normal daily life, the risk of routine physical or psychological tests, 97 or the risk of typical community services carried out by children of certain age 98 . This approach is not flawless and might become especially problematic in multinational studies where children in different countries typically encounter different levels of risk 99 . Nevertheless, it makes it possible to argue that minimal risk research is morally equivalent to involving children in normal activities of daily life. The maxim could then be defined as: “you can involve a child in medical research even if she does not benefit from it if the risks do not exceed her or his normal daily life”. The concordance of this maxim with the formula of humanity is still disputable but arguably no longer impossible. It might be argued that Kant himself opposed smallpox vaccination, even considering it a partial suicide since it entailed a voluntary self-endangerment. However, it seems reasonable to assume that Kant’s disagreement with the newly arising practice of inoculation was rather motivated by the lack of scientific knowledge at the time and by the overestimation of risks. Kant was especially afraid of “familiarising” between mankind and animals since the vaccines contained materials derived from cows. In Kant’s eyes, this might have made humans susceptible to bovine diseases. Furthermore, he doubted the actual protection against

96 Explanatory Report to the Convention on Human Rights and Biomedicine, to Article 17, point 111. 97 See RESNIK, David B. The Ethics of Research with Human Subjects. Protecting People, Advancing Science, Promoting Trust. Springer, 2018, p. 172.

98 See ibid., pp. 222-223. 99 See ibid., pp. 174-175.

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