CYIL vol. 10 (2019)

MARTIN ŠOLC CYIL 10 ȍ2019Ȏ The philosophical basis of these regulations lies in a belief which was very aptly outlined by Dr. Beecher: a clinical study is ethical or unethical from its start regardless of the value of its scientific contributions 102 . A research that is unethical can never be justified by any benefits it could possibly bring. In medical research ethics, categorical (also known as deontological) moral reasoning still prevails. It means that the moral quality of the research (i.e. whether the research is ethically permissible or not) does not depend on the consequences of the research, but solely on its inner quality. It is an interesting phenomenon, taking into account that contemporary ethics in general, including most of medical ethics, is permeated by utilitarianism with its consequentialist approach which consists in judging the moral value of an act by its consequences. 103 This uniqueness of the research ethics approach only outlines the value that modern medicine puts on the protection of research subjects. If Harvard geneticist George Church says that the justification of criticism of Jiankui’s work will depend on whether his experiment will turn out to be “a Jesse Gelsinger or a Louise Brown event ”, 104, 105 he might be right regarding the media image of He Jiankui. However, this notion is inconsistent with the mainstream development of medical research ethics in at least the last fifty years. The ethical permissibility of the experiment is not informed by its outcomes. In this context, it needs to be emphasised that both international law and mainstream medical ethics strongly promote the principle of the primacy of the human being. It is famously guaranteed in Article 2 of the Convention on Biomedicine which states that “[t]he interests and welfare of the human being shall prevail over the sole interest of society or science” . The Explanatory Report stresses that all articles of the Convention on Biomedicine must be interpreted in light of this principle 106 . The same guiding principle is expressed in several research ethics declarations 107 . It represents a very important confirmation of categorical moral reasoning in medical research ethics. The ethical assessment of any research study involving human subject must, therefore, be based on the evaluation of proportionality between potential benefits and harm to the subjects. The assessment must be carried out by independent and competent ethical committees. 102 As cited (after translation to the Czech language) in MUNZAROVÁ, Marta. Lékařský výzkum a etika. [Medical Research and Ethics.] Grada Publishing, Praha 2005, p. 48. 103 For a brief outline of consequentialism and categorical moral reasoning, see ŠOLC, Martin. Reflections of Ethical Debate in the International Law Regulation of Stem Cell Research. In Czech Yearbook of Public & Private International Law. Česká ročenka mezinárodního práva veřejného a soukromého. Vol. 8. Česká společnost pro mezinárodní právo, Praha 2017, pp. 430-432. Also available at accessed 1 June 2019. For a more detail analysis, see Stanford Encyclopedia of Philosophy. Consequentialism. (22 October 2015.) accessed 1 June 2019, HERRING, Jonathan. Medical Law and Ethics. 5 th ed. Oxford University Press, Oxford 2014, pp. 12-16, VÁCHA, Marek. Základní etické teorie. [Fundamental Ethical Theories.] In VÁCHA, Marek, KÖNIGOVÁ, Radana, MAURER, Miloš. Základy moderní lékařské etiky. [Fundamentals of Modern Medical Ethics.] Portál, Praha 2012, pp. 29-39. 104 As cited in an interview: COHEN, Jon. “I feel an obligation to be balanced.” Noted biologist comes to defense of gene editing babies. Science. (28 November 2018.) accessed 27 May 2019. 105 As mentioned above, Jesse Gelsinger was the first patient to have died in a gene therapy clinical trial. Louise Brown was the first baby born from IVF who is still healthy today. 106 Explanatory Report to the Convention on Biomedicine, to Article 2, point 22. 107 See Article 8 of the World Medical Association Declaration of Helsinki (1964, the newest revision from 2013), Article 3 (2) of the Universal Declaration on Bioethics and Human Rights (2005), or the Preamble of the International Declaration on Human Genetic Data (2003).

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