LEGAL NATURE OF INFORMED CONSENT FOR PARTICIPATION IN CLINICAL TRIAL
Journal Title: Часопис цивілістики - Year 2018, Vol 29, Issue
Abstract
This article is devoted to the analysis of the characteristic signs and features of the informed consent for participation of the person as a subject in a clinical trial, determination of its legal nature and place in the system of civil transactions. It is determined that the main characteristics of informed consent are the following: compulsory, voluntary, written form, advance information disclosure and legal competence. The author has researched existing national and foreign approaches to determining the legal nature of informed consent in a clinical study. It is shown that prevailing the majority of scientists consider this issue from the point of view of the general medicine informed consent or focus on highlighting the specific procedural and substantive requirements to informed consent in the area of clinical trials. Therefore, the traditional approaches to the definition of the legal nature of informed consent are the non-property right or acceptation by the patient the offer of the contract be the provider of medical services (as a preliminary contract). The main differences between the informed consent in the clinical trial and the consent for general medical interventions are established, such as different spheres of activity (scientific-experimental and medical), mandatory written form in Ukraine, the difference in their volume and the corresponding legal consequences, certain additionality or affiliation of the general medical informed consent to the medical service contract. On this ground, the author has offered to consider informed consent in a clinical trial as a contractual obligation. The author has determined that such a contract is a consensual, payable or free of charge, term and bilateral. The main consequences of the consideration of informed consent in a clinical trial as an agreement are outlined.
Authors and Affiliations
Дмитро Андрійович Лур’є
Keywords
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