lexgenLex GeneticaLex Genetica3034-16393034-1647МГЮА10.17803/lexgen-2024-3-3-74-92lexgen-46Research ArticleLex Genetica: трибуна молодого ученогоLex Genetica: Tribune of the Young ScientistПравовое и этическое регулирование сообщения вторичных находокLegal and Ethical Regulation of Reporting of Secondary FindingsМосковкинаЕ. К.MoskovkinaE. K.

Елизавета К. Московкина, руководитель группы правового обеспечения

Москва

Elizaveta K. Moskovkina, the Head of the Legal Support Group

Moscow

ekmoskovkina@msal.ruООО «Биотек кампус»LLC “Biotech campus”202425102024337492Copyright © Московкина Е.К., 20242024Московкина Е.К.Moskovkina E.K.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://lexgen.msal.ru/jour/article/view/46

Вторичными находками в медицинской литературе именуются случайно обнаруженные исследователями особенности здоровья человека, влияющие на его самочувствие или развитие заболевания. Вследствие цифровизации здравоохранения, развития медицинских баз данных и их активного использования учеными большое количество вторичных находок, которые не были первоначальной целью исследования, обнаруживаются и могут подлежать сообщению пациенту. Целью настоящего исследования является определение возможности сообщения вторичных находок пациентам и участникам научных исследований, а также порядок передачи таких данных с учетом требований законодательства. В статье приводится анализ правовых норм, действующих в России, рассматриваются доктринальные и этические подходы к проблеме сообщения вторичных находок. В результате рассмотрения темы автор приходит к выводу, что законодательство не учитывает специфику вторичных находок как информации для сообщения пациенту, а также вовсе не регулирует подобные ситуации, возникающие в рамках научных исследований с условно здоровыми участниками. Автором определено, что важную роль для возможности сообщения случайных находок играет добровольное информированное согласие, при этом информирование пациентов и включение специальных разделов в данном документе остается на усмотрение медицинской или научной организации и врача. В результате исследования производится попытка сформировать комплекс мер, описанных в литературе, для дальнейшего формирования конкретных предложений реформирования законодательства России в отношении поднятой проблемы.

In medical literature the notion of secondary findings is defined as randomly discovered features of human health which may af fect their well-being. A large number of secondary findings are occasionally detected and may be disclosed to the patient as a result of the digitalization of healthcare and the development of medical databases. The aim of this paper is to determine the possibility of reporting secondary findings to patients and participants of scientific research, while also establishing a procedure for transferring such data in accordance with the legal requirements and limitations. The article provides an analysis of Russian legislation, and considers doctrinal and ethical approaches to the issue of reporting of secondary findings. The author concludes that the current legislation does not consider the special features of secondary findings, and does not address situations which could arise in the context of scientific research. The author has established that informed consent has an important role in reporting of secondary findings, while the procedure of informing patients and including special sections in the consent should remain at the discretion of the medical or scientific organization or the doctor. In conclusion, the author attempts to formulate proposals to amend the Russian legislation in relation to the issue considered.

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The authors declare that there are no conflicts of interest present.