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MARTIN ŠOLC CYIL 11 (2020) adapted to her or his age and mental maturity. The explicit wish of a minor who is capable of forming an opinion and assessing the above-mentioned information to refuse participation in, or to withdraw from, the clinical trial at any time, must be respected. No incentives or financial inducements for the minor or her or his legal representative are allowed except for compensation for expenses and loss of earnings directly related to the participation in the clinical trial. If during a clinical trial the minor reaches the age of legal competence to give informed consent as under the law of the respective Member State, her or his express informed consent needs to be obtained before her or his participation in the trial can continue. Act on Pharmaceuticals as amended by Act No. 66/2017 Coll. in Section 52 adds one more criterion. Apart from the informed consent of the legal representative, there must also be given a signed written informed consent of the minor (if it is appropriate with regard to her or his intellectual and volitional maturity). 2.3.1 Assessing the minor’s capacity Even though the minor cannot grant consent on her or his own (with the exception of clinical investigation of medical devices 47 ), her or his opinion is important. We might need to note that unlike the Czech language, legal English distinguishes between consent and assent, the former authorising the participation in a study 48 while the latter “merely” expressing a willingness to participate 49 . Soliciting the child’s assent does not “only” respect her or his emerging decision-making capacity but also protects her or him from moral (and perhaps also physical) harm resulting from being coerced to participate in research against her or his will 50 . However, the minor’s autonomy always needs to be balanced against the protection of the minor as a vulnerable person. Furthermore, the minor’s actual capacity is heavily influenced by various situational aspects (such as the influence of illness, stress, etc.) which need to be taken into account when assessing her or his assent. 51 It is not surprising that the assessment of the child’s capacity represents one of the crucial legal and ethical problems related to research on minors. Essential elements of minor’s opinion might be categorised in several ways. William Bartholome distinguishes the following elements: 1) the understanding of the nature of the condition that is appropriate to the child’s developmental stage, 2) disclosure of the proposed intervention regarding its nature and what it will involve, 3) an assessment of the child’s understanding of the information provided as well as the influences that impact the child’s evaluation of the situation, and 4) a solicitation of the child’s expression of willingness to accept the intervention 52 . The minor’s capacity itself can also be divided into several 47 See Section 18 (6) of Act No. 268/2014 Coll., on Medical Devices. 48 Under Czech law, the term informed consent denotes just this: the legal reason for the interference with physical and/or mental integrity of a person. See HOLČAPEK, Tomáš. Informovaný souhlas. Základní principy [Informed Consent. Basic Principles]. In ŠUSTEK, Petr, HOLČAPEK, Tomáš (eds.). Zdravotnické právo [Health Law]. Wolters Kluwer, Praha 2016, pp. 232-234, or SALAČ, Josef. Souhlas [Consent]. In ŠUSTEK, Petr, HOLČAPEK, Tomáš (eds.). Zdravotnické právo [Health Law]. Wolters Kluwer, Praha 2016, p. 250. 49 See for example RESNIK, David B. The Ethics of Research with Human Subjects. Protecting People, Advancing Science, Promoting Trust. Springer, 2018, p. 135. 50 See ibid., p. 136. 51 See DOLEŽAL, Tomáš. Způsobilost nezletilých udělit souhlas s poskytováním zdravotních služeb [Informed Consent to the Medical Treatment of Minors]. Časopis zdravotnického práva a bioetiky [Journal of Medical Law and Bioethics]. (2018, Vol. 8, No. 1), p. 50. 52 BARTHOLOME, William G. Hearing children’s voices. Bioethics Forum. (1995, Vol. 11, No. 4), pp. 3-6. As

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