Ensuring the confidentiality of patient information obtained during a clinical trial of a medicinal product

Abstract

Keywords: clinical trial, confidential information, personal data, patient Clinical trials are conductedin accordance with legal norms, subject to human rights and in accordance with internationalethical principles. Each clinical trial for the patient (subject) begins on a voluntarybasis and with acquaintance of the patient (subject) about the features of the study, itspurpose and purpose, explanation of possible risks, in addition, the patient is informedabout innovative drugs and access to free treatment during research. The patient participatesin 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 themedicinal product to privacy and the protection of personal data, which is confidential informationabout the person who is the subject of the study, are respected. During clinicaltrials, researchers and all persons involved in the research process should treat responsiblythe 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 legalentities 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 commercialpractice, if such information is confidential in the sense that it is as a whole or in theexact configuration and combination of its components, commonly known or available topersons in the circles normally involved with the information in question. It is importantto note that any information that becomes known about the patient (subject) during theclinical trial of the drug should be carefully protected by the party conducting the study.Therefore, it is important to note that the right of a patient not to disclose confidentialinformation about him is guaranteed by the Constitution of Ukraine. The right to medicalsecrecy is enshrined in the Law of Ukraine "Fundamentals of Health Legislation". Incases where the rights of the patient (subject) have been violated, the legislator providesfor criminal liability for intentional disclosure of medical secrets to a person who becameknown in connection with the performance of professional or official duties, if such an actcaused serious consequences and for illegal collection, storage, use, destruction, disseminationof confidential information about a person or illegal change of such informationcomes criminal liability.