CYIL vol. 14 (2023)

HELENA VAN BEERSEL KREJČÍKOVÁ CYIL 14 (2023) was adopted, the Czech Ministry of Health published its Regulation No. 463/2021 Coll., setting up additional conditions for conducting clinical trials, without any provisions on conflicts of interest. The national authority for authorizing and supervising clinical trials in the Czech Republic, the State Institute for Drug Control (further referred to as the Institute), requires a disclosure form from participating investigators, in which the investigators shall specify what interests, e.g., economic interest, affiliation to institutions or personal interests, could influence the investigators’ impartiality. 98 No policy of further management of conflicts of interest, i.e., following the disclosure, was found in public accessible sources, nor was provided by the Institute on request. 99 Research on stem embryonal cells is regulated by a special legislation, namely Act No. 227/2006 Coll. Conflict of interest is briefly mentioned in internal regulations of the Bioethical Committee of the Council for Research, Development and Innovation 100 , in the very specific context of prohibiting a member of the Committee who has a conflict of interest, to participate in decisions regarding the permit to conduct research on stem embryonal cells. However, due to the way in which the internal regulations define conflict of interest, 101 the main concern seems to be narrowed to a potential link between the researchers, the researchers’ institution or the research itself, and members of the body who granting a permit to conduct the research, whilst completely overlooking other potentially influential external relationships of the researchers or their institution (e.g., payments from industry with an interest in the research). If medical research is conducted by a physician who is a member of the Czech Medical Chamber, 102 the researcher is subject to the Binding statement No. 1/2008 of the Czech Medical Chamber (further referred to as the Statement ) on the rules for cooperation between doctors and pharma companies. In its Art. 3, the Statement regulates, albeit quite vaguely, the role of a clinician in clinical trials and research. According to Art 3 Para b) of the Statement , a physician may be rewarded for his/her work within a clinical trial. This reward must be in accordance with the attempt and time invested in the work. a physician may be rewarded for presenting the results of a clinical study, and the sponsor of the study must be disclosed. 103 98 Declaration of Investigator’s Interests Template. Accessed August 15, 2023. https://www.sukl.cz/leciva/klh ctis-01. This declaration though hardly complements nor specifies the required disclosure under the Clinical Trials Regulation. 99 I contacted the State Institute for Drug Control via an email on August 1, 2023, with a request to obtain information whether there are internal documents on management of investigators’ conflict of interest and whether the Institute considers the Czech terminology (e.g., “investigator” translated as “zkoušející”, i.e., “examinator”, or “site” translated as “studijní centrum”, i.e., “study center”) accurate. 100 Statut Bioetické komise Rady pro výzkum, vývoj a inovace . [Statute of the Bioethical Commission of the Council for Research, Development and Innovation]. Accessed August 15, 2023. https://www.vyzkum.cz/FrontClanek. aspx?idsekce=675. 101 A member of the committee has a conflict of interest if they have any relationship towards the applicant of the permit or towards the institution where the research will be conducted, or are in any way involved in conducting the research themselves. 102 Every physician who conducts a medical practice in the Czech Republic is required to be a member of the Czech Medical Chamber which possesses a disciplinary authority to exclude a physician (and thus to restrain the physician from conduct of their profession, up to 5 years in the most severe cases of professional misconduct). 103 Závazné stanovisko České lékařské komory č. 1/2008 , Pravidla spolupráce mezi lékaři a farmaceutickými firmami. [ Binding opinion of the Czech Medical Chamber No. 1/2008 , Rules of cooperation between doctors and pharmaceutical companies]. Accessed August 15, 2023. https://www.lkcr.cz/zavazna-stanoviska-clk.

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