![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-734x1024.jpg\")
<\/figure>\n\n\n\nTheory and practice of intellectual property
\u2116 6 \/ 2021<\/p>\n\n\n\n
ISSN (Print) 2308-0361
ISSN (Online) 2519-2744<\/p>\n\n\n\n
![\"\"](\"https:\/\/test.inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153.png\"){kind=icon}
PDF (Ukrainian)<\/a><\/div>\n<\/div>\n\n\n\nDOI: https:\/\/doi.org\/10.33731\/62021.249467<\/a><\/p>\n\n\n\n Published \u00a0\u00a0\u00a0\u00a0\u00a02021-12-27<\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n<\/div>\n\n\n\n Ensuring the confidentiality of patient information obtained during a clinical trial of a medicinal product<\/strong><\/p>\n\n\n\n Olena Ponomarova<\/strong> <\/p>\n\n\n\n Abstract Therefore, it is important to note that the right of a patient not to disclose confidential information about him is guaranteed by the Constitution of Ukraine. The right to medical secrecy is enshrined in the Law of Ukraine “Fundamentals of Health Legislation”. In cases where the rights of the patient (subject) have been violated, the legislator provides for criminal liability for intentional disclosure of medical secrets to a person who became known in connection with the performance of professional or official duties, if such an act caused serious consequences and for illegal collection, storage, use, destruction, dissemination of confidential information about a person or illegal change of such information comes criminal liability.<\/p>\n\n\n\n Keywords: <\/strong>clinical trial, confidential information, personal data, patient<\/p>\n\n\n\n References<\/strong><\/p>\n\n\n\n \u0423\u0433\u043e\u0434\u0430 \u043f\u0440\u043e \u0442\u043e\u0440\u0433\u043e\u0432\u0435\u043b\u044c\u043d\u0456 \u0430\u0441\u043f\u0435\u043a\u0442\u0438 \u043f\u0440\u0430\u0432 \u0456\u043d\u0442\u0435\u043b\u0435\u043a\u0442\u0443\u0430\u043b\u044c\u043d\u043e\u0457 \u0432\u043b\u0430\u0441\u043d\u043e\u0441\u0442\u0456. \u041f\u043e\u043d\u043e\u043c\u0430\u0440\u044c\u043e\u0432\u0430 \u041e. \u041e. \u041a\u043b\u0456\u043d\u0456\u0447\u043d\u0456 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u043d\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u043e\u0433\u043e \u0437\u0430\u0441\u043e\u0431\u0443 \u043f\u0456\u0434 \u0447\u0430\u0441 COVID-19: \u0456\u043d\u0444\u043e\u0440\u043c\u043e\u0432\u0430\u043d\u0430 \u0437\u0433\u043e\u0434\u0430. \u0428\u043e\u0441\u0442\u0430 \u043d\u0430\u0443\u043a\u043e\u0432\u043e-\u043f\u0440\u0430\u043a\u0442\u0438\u0447\u043d\u0430 \u043a\u043e\u043d\u0444\u0435\u0440\u0435\u043d\u0446\u0456\u044f \u0437 \u043c\u0456\u0436\u043d\u0430\u0440\u043e\u0434\u043d\u043e\u044e \u0443\u0447\u0430\u0441\u0442\u044e \u00ab\u041a\u043b\u0456\u043d\u0456\u0447\u043d\u0456 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u043d\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456: \u043d\u043e\u0432\u0456 \u0432\u0438\u043a\u043b\u0438\u043a\u0438 \u0442\u0430 \u0432\u0456\u0434\u043f\u043e\u0432\u0456\u0434\u0456 \u043d\u0430 \u043d\u0438\u0445\u00bb. \u041a\u0438\u0457\u0432, 8\u22129 \u0436\u043e\u0432\u0442\u043d\u044f 2020 \u0440. \u0421. 95\u221297.<\/p>\n\n\n\n \u041f\u0440\u043e \u0456\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0456\u044e : \u0417\u0430\u043a\u043e\u043d \u0423\u043a\u0440\u0430\u0457\u043d\u0438. \u041a\u043e\u0445\u0430\u043d\u043e\u0432\u0441\u044c\u043a\u0430 \u041e. \u0412. \u0422\u0435\u043e\u0440\u0435\u0442\u0438\u0447\u043d\u0456 \u043f\u0440\u043e\u0431\u043b\u0435\u043c\u0438 \u0456\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0456\u0439\u043d\u0438\u0445 \u0432\u0456\u0434\u043d\u043e\u0441\u0438\u043d \u0443 \u0446\u0438\u0432\u0456\u043b\u044c\u043d\u043e\u043c\u0443 \u043f\u0440\u0430\u0432\u0456 : \u043c\u043e\u043d\u043e\u0433\u0440\u0430\u0444\u0456\u044f. \u041a\u0438\u0457\u0432 : \u0412\u0438\u0434\u0430\u0432\u043d\u0438\u0447\u043e-\u043f\u043e\u043b\u0456\u0433\u0440\u0430\u0444\u0456\u0447\u043d\u0438\u0439 \u0446\u0435\u043d\u0442\u0440 \u00ab\u041a\u0438\u0457\u0432\u0441\u044c\u043a\u0438\u0439 \u0443\u043d\u0456\u0432\u0435\u0440\u0441\u0438\u0442\u0435\u0442\u00bb, 2006. 463 \u0441.<\/p>\n\n\n\n \u0414\u0456\u0434\u0443\u043a \u0410. \u0413. \u041f\u0440\u0430\u0432\u043e\u0432\u0438\u0439 \u0440\u0435\u0436\u0438\u043c \u043a\u043e\u043d\u0444\u0456\u0434\u0435\u043d\u0446\u0456\u0439\u043d\u043e\u0457 \u0456\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0456\u0457: \u0446\u0438\u0432\u0456\u043b\u044c\u043d\u043e- \u043f\u0440\u0430\u0432\u043e\u0432\u0438\u0439 \u0430\u0441\u043f\u0435\u043a\u0442 : \u0434\u0438\u0441. … \u043a\u0430\u043d\u0434. \u044e\u0440\u0438\u0434. \u043d\u0430\u0443\u043a. \u0425\u0430\u0440\u043a\u0456\u0432, 2008. 243 \u0441.<\/p>\n\n\n\n \u0427\u0430\u0431\u0430\u043d \u041e. \u0410. \u041f\u0440\u0430\u0432\u043e \u0444\u0456\u0437\u0438\u0447\u043d\u043e\u0457 \u043e\u0441\u043e\u0431\u0438 \u043d\u0430 \u0442\u0430\u0454\u043c\u043d\u0438\u0446\u044e \u043f\u0440\u043e \u0441\u0442\u0430\u043d \u0437\u0434\u043e\u0440\u043e\u0432\u2019\u044f \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456 : \u0434\u0438\u0441. \u2026 \u043a\u0430\u043d\u0434. \u044e\u0440\u0438\u0434. \u043d\u0430\u0443\u043a. \u041a\u0438\u0457\u0432, 2018. 222 \u0441.<\/p>\n\n\n\n \u0415\u0442\u0438\u0447\u043d\u0438\u0439 \u043a\u043e\u0434\u0435\u043a\u0441 \u043b\u0456\u043a\u0430\u0440\u044f \u0423\u043a\u0440\u0430\u0457\u043d\u0438. \u0406\u043d\u0444\u043e\u0440\u043c\u0430\u0446\u0456\u044f \u0449\u043e\u0434\u043e \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0438\u0445 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u044c \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456. \u0417\u0430\u0433\u0430\u043b\u044c\u043d\u0456 \u043f\u0440\u0438\u043d\u0446\u0438\u043f\u0438 \u043e\u0440\u0433\u0430\u043d\u0456\u0437\u0430\u0446\u0456\u0457 \u0434\u0456\u044f\u043b\u044c\u043d\u043e\u0441\u0442\u0456 \u043a\u043e\u043c\u0456\u0441\u0456\u0439 \u0437 \u043f\u0438\u0442\u0430\u043d\u044c \u0435\u0442\u0438\u043a\u0438 \u043f\u0440\u0438 \u043b\u0456\u043a\u0443\u0432\u0430\u043b\u044c\u043d\u043e-\u043f\u0440\u043e\u0444\u0456\u043b\u0430\u043a\u0442\u0438\u0447\u043d\u0438\u0445 \u0437\u0430\u043a\u043b\u0430\u0434\u0430\u0445, \u0432 \u044f\u043a\u0438\u0445 \u043f\u0440\u043e\u0432\u043e\u0434\u044f\u0442\u044c\u0441\u044f \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0456 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u043d\u044f \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 (\u0440\u0435\u043a\u043e\u043c\u0435\u043d\u0434\u0430\u0446\u0456\u0457 \u0434\u043b\u044f \u0435\u043a\u0441\u043f\u0435\u0440\u0442\u0456\u0432) : \u043f\u043e\u0441\u0456\u0431\u043d\u0438\u043a. \u041f\u0440\u043e \u0437\u0430\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043d\u044f \u041f\u043e\u0440\u044f\u0434\u043a\u0443 \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0438\u0445 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u044c \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0442\u0430 \u0435\u043a\u0441\u043f\u0435\u0440\u0442\u0438\u0437\u0438 \u043c\u0430\u0442\u0435\u0440\u0456\u0430\u043b\u0456\u0432 \u043a\u043b\u0456\u043d\u0456\u0447\u043d\u0438\u0445 \u0432\u0438\u043f\u0440\u043e\u0431\u0443\u0432\u0430\u043d\u044c \u0456 \u0422\u0438\u043f\u043e\u0432\u043e\u0433\u043e \u043f\u043e\u043b\u043e\u0436\u0435\u043d\u043d\u044f \u043f\u0440\u043e \u043a\u043e\u043c\u0456\u0441\u0456\u0457 \u0437 \u043f\u0438\u0442\u0430\u043d\u044c \u0435\u0442\u0438\u043a\u0438 : \u043d\u0430\u043a\u0430\u0437 \u041c\u041e\u0417 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u2116 690 \u0432\u0456\u0434 23.09.2009 \u0440\u043e\u043a\u0443. What are the major ethical issues in conducting research? is there a conflict between the research ethics and the nature of nursing? Confidentiality of personal health information used for research. \u0420\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u043e\u0433\u043e \u041f\u0430\u0440\u043b\u0430\u043c\u0435\u043d\u0442\u0443 \u0456 \u0420\u0430\u0434\u0438 (\u0404\u0421) 2016\/679 \u0432\u0456\u0434 27 \u043a\u0432\u0456\u0442\u043d\u044f 2016 \u0440\u043e\u043a\u0443 \u043f\u0440\u043e \u0437\u0430\u0445\u0438\u0441\u0442 \u0444\u0456\u0437\u0438\u0447\u043d\u0438\u0445 \u043e\u0441\u0456\u0431 \u0443 \u0437\u0432\u02bc\u044f\u0437\u043a\u0443 \u0437 \u043e\u043f\u0440\u0430\u0446\u044e\u0432\u0430\u043d\u043d\u044f\u043c \u043f\u0435\u0440\u0441\u043e\u043d\u0430\u043b\u044c\u043d\u0438\u0445 \u0434\u0430\u043d\u0438\u0445 \u0456 \u043f\u0440\u043e \u0432\u0456\u043b\u044c\u043d\u0438\u0439 \u0440\u0443\u0445 \u0442\u0430\u043a\u0438\u0445 \u0434\u0430\u043d\u0438\u0445, \u0442\u0430 \u043f\u0440\u043e \u0441\u043a\u0430\u0441\u0443\u0432\u0430\u043d\u043d\u044f \u0414\u0438\u0440\u0435\u043a\u0442\u0438\u0432\u0438 95\/46\/\u0404\u0421 (\u0417\u0430\u0433\u0430\u043b\u044c\u043d\u0438\u0439 \u0440\u0435\u0433\u043b\u0430\u043c\u0435\u043d\u0442 \u043f\u0440\u043e \u0437\u0430\u0445\u0438\u0441\u0442 \u0434\u0430\u043d\u0438\u0445). <\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":" Theory and practice of intellectual property\u2116 6 \/ 2021 ISSN (Print) 2308-0361ISSN (Online) 2519-2744 DOI: https:\/\/doi.org\/10.33731\/62021.249467 Published \u00a0\u00a0\u00a0\u00a0\u00a02021-12-27 Ensuring the confidentiality of patient information obtained during a clinical trial of a medicinal product Olena PonomarovaUkrainehttps:\/\/orcid.org\/0000-0002-8232-3748 AbstractClinical trials are conducted in accordance with legal norms, subject to human rights and in accordance with international ethical principles. […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-9415","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/9415","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/comments?post=9415"}],"version-history":[{"count":3,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/9415\/revisions"}],"predecessor-version":[{"id":9418,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/9415\/revisions\/9418"}],"wp:attachment":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/media?parent=9415"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2025\/11\/CC-2.png\")
<\/figure>\n\n\n\n
Ukraine
https:\/\/orcid.org\/0000-0002-8232-3748<\/a><\/p>\n\n\n\n
<\/strong>Clinical trials are conducted in accordance with legal norms, subject to human rights and in accordance with international ethical principles. Each clinical trial for the patient (subject) begins on a voluntary basis and with acquaintance of the patient (subject) about the features of the study, its purpose and purpose, explanation of possible risks, in addition, the patient is informed about innovative drugs and access to free treatment during research. The patient participates in the study of the drug of his own volition, signing a voluntary informed consent. It is important to ensure that the rights of the patient (subject) in the clinical trial of the medicinal product to privacy and the protection of personal data, which is confidential information about the person who is the subject of the study, are respected. During clinical trials, researchers and all persons involved in the research process should treat responsibly the person participating in the study of the medicinal product as the object of study, namely with respect for the human right to privacy and its secrecy. Individuals and legal entities should be able to protect information legally under their control from disclosure, acquisition or use by others without their consent in a manner contrary to fair commercial practice, if such information is confidential in the sense that it is as a whole or in the exact configuration and combination of its components, commonly known or available to persons in the circles normally involved with the information in question. It is important to note that any information that becomes known about the patient (subject) during the clinical trial of the drug should be carefully protected by the party conducting the study.<\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/981_018#Text<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/2657-12#Text<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/rada\/show\/n0001748-09#Text<\/a><\/p>\n\n\n\n
https:\/\/www.clinicaltrials.dec.gov.ua<\/a><\/p>\n\n\n\n
https:\/\/www.dec.gov.ua\/\/wp-content\/uploads\/2019\/08\/posibnykn.pdf<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/z1010-09#Text<\/a><\/p>\n\n\n\n
https:\/\/www.hsj.gr\/medicine\/what-are-the-major-ethical-issues-in-conducting-research-is-there-a-conflict-between-the-research-ethics-and-the-nature-of-nursing.php?aid=3485<\/a><\/p>\n\n\n\n
https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC1513443\/<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/984_008-16#Text<\/a><\/p>\n\n\n\n