CYIL vol. 11 (2020)

CYIL 11 (2020) THE BEST INTERESTS OF THE CHILD IN MEDICAL RESEARCH inclusion of minors must be justified in the clinical trial protocol (Annex I to Regulation on Clinical Trials, D (x)). 3. Ethical considerations: is the research on children ethically justifiable? There might be identified three or four main normative ethical theories that can be used to evaluate actions and policies in health care. The oldest of them is virtue ethics, asking what would a virtuous person – “the good doctor” in this context – do in a specific situation. While virtue ethics is a very interesting branch of moral philosophy, it is nowadays usually not robustly represented in discussions on applied ethics. 69 For this reason, we will not use this normative theory for our analysis. Principlism – an ethical theory specially created for the area of health care – is a very popular approach in contemporary medical ethics 70 . It was defined by Tom Beauchamp and James Childress as a combination of four principles: respect for autonomy, beneficence, nonmaleficence, and justice. Their theory combines various ethical approaches in an attempt to create the new ethics of biomedicine. 71 Beauchamp and Childress question the strong ethical distinction between clinical practice and medical research from both factual and moral perspective. They nevertheless acknowledge the possible ethical problems related to research on persons and define seven relatively specific conditions under which a randomize clinical trial is ethical. 72 We can assume that if certain conditions are met, principlism does not oppose medical research on minors 73 . Probably the most influential approach in today’s ethics is utilitarianism 74 . In a very simplifying manner, its basis can be described as the moral necessity to choose an action that will bring the greatest amount of happiness to the greatest number of persons 75 . Even though there is more than one type of utilitarianism, it always entails the principle of consequentialism, meaning it evaluates actions based on their consequences 76 . Even though further analysis would be enriching, it can be assumed that utilitarianism will as a rule endorse medical research on minors as long as its foreseeable benefits to humanity will be greater than risks. In the context of medical research ethics, however, the mainstream approach significantly deviates from consequentialism approach. Based on the horrific experiences of cruel non- voluntary experiments of humans (not only) during the second world war, the ethics of 70 See for example PAGE, Katie. The four principles: Can they be measured and do they predict ethical decision making? BMC Medical Ethics. (20 May 2012) accessed 12 June 2020. doi: https://doi.org/10.1186/1472-6939- 13-10. 71 See BEAUCHAMP, Tom L., CHILDRESS, James F. Principles of Biomedical Ethics. 7 th ed. Oxford University Press, Oxford 2013. 72 See ibid., pp. 331-340. 73 See ibid., p. 91. 74 See for example ŠOLC, Martin. Právo, etika a kmenové buňky [Law, Ethics, and Stem Cells]. Wolters Kluwer, Praha 2018, p. 40. 75 See The History of Utilitarianism. Stanford Encyclopedia of Philosophy. (22 September 2014.) accessed 9 June 2020. 76 See Consequentialism. Stanford Encyclopedia of Philosophy. (3 June 2019.) accessed 9 June 2020. 69 See Virtue Ethics. Stanford Encyclopedia of Philosophy. (8 December 2016.) accessed 9 June 2020.

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