CYIL vol. 14 (2023)

MARTIN ŠOLC CYIL 14 (2023) notion of risk. In other cases, the law may provide for a collective system of compensation irrespective of individual liability. 40 Enforcing individual fault-based is undoubtedly among the options for fulfilling the obligation under Article 31. In a similar manner, nothing in this provision suggests that it would require a specific compensation scheme, given that the more general compensation mechanisms under national law can be deemed as enabling fair compensation. 4.2 The Lack of a Robust and Enforced Approval System Despite the formal framework for the evaluation of new methods, the practice in Czech hospitals largely goes its own way. As we have described above, new methods are most often carried out and tested based on local ethics committees’ approvals. According to Article 16 of the Convention on Human Rights and Biomedicine, any research project must be “ approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research, and multidisciplinary review of its ethical acceptability. ” The Explanatory Report explains that the examination must concern “ the scientific merit as well as (…) the ethical, including legal, social and economic acceptability of the research project ”, and that it has “ to be carried out by independent multidisciplinary ethics committees. ” 41 Furthermore, Article 7 of the Additional Protocol concerning Biomedical Research states that “ [r]esearch may only be undertaken if the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of research, and multidisciplinary review of its ethical acceptability. ” According to Article 9(1) of the Additional Protocol, “ [e]very research project shall be submitted for independent examination of its ethical acceptability to an ethics committee. Such projects shall be submitted to independent examination in each State in which any research activity is to take place. ” The purpose of the ethical examination is “ to protect the dignity, rights, safety and well-being of research participants ” (Article 9(2) of the Additional Protocol), including the non-existence of undue influence, such as financial motivation, on research participants (Article 12). The opinion issued by the ethics committee must contain reasons for the conclusion (Article 9(3) of the Additional Protocol). The committee must have a multidisciplinary nature, which, however, is only specified as “ an appropriate range of expertise and experience adequately reflecting professional and lay views ” (Article 9(2) of the Additional Protocol). Furthermore, the Additional Protocol sets very broad rules to secure the committees’ independence (Articles 10 and 12) as well as the provision of all relevant information to the committee (Article 11). The Explanatory Report to the Additional Protocol explicitly acknowledges “ that in some countries, the ethics committee could also act as the competent body while in other cases or in other countries, the competent body might be a Ministry or a regulatory agency (for pharmaceuticals, for instance), which would take the opinion of the ethics committee into account. ” 42 While the Additional Protocol requires that “ [r]esearch must comply with the relevant legal requirements ” 40 Explanatory Report to the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, points 145 and 146. 41 Explanatory Report to the Convention on Human Rights and Biomedicine, point 100. 42 Explanatory Report to the Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, point 28.

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