ORIGINAL RESEARCH

Legal and ethical issues of establishing the boundaries of informed consent

Ruda MG
About authors

Kutafin Moscow State Law University, Moscow, Russia

Correspondence should be addressed: Maria G. Ruda
ul. Sadovaya-Kudrinskaya, 9, Moscow, 125993, Russia; ur.liam@aduryram

About paper

Acknowledgements: Maria V. Zakharova, Doctor of Law, Associate Prof., Kutafin Moscow State Law University, for assistance in selection of research directions and provision of a valuable critical feedback while working on the article; Alexander A. Mokhov, Doctor of Law, Prof., Kutafin Moscow State Law University, for assistance in formulation and presentation of ambiguous legal aspects related to the research topic and provision of priceless support in selection of literature sources.

Received: 2022-04-20 Accepted: 2022-05-25 Published online: 2022-06-30
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The article deals with legal and ethical issues of establishing the boundaries of informed consent as a basic procedure being an integral part of medical practice, biomedical and clinical human research, and a broad list of medical procedures. A comparative analysis was based on examination of the best global models of informed consent. In the future, their implementation into the Russian legislative and regulatory compliance practices is suggested. The research uses the following methods: analysis and synthesis, analogy, method of legal modelling, and method of comparative legal research. Some conclusions were made about the reception of certain legal issues considering such factors as legal mental structure, level of legal culture, etc. In this article, the following aspects are highlighted: requirement for information disclosure, requirement to understand the relationship, a researcher’s liability to enhance qualifications, a patient’s responsibility, and the issue about an informed consent form.

Keywords: voluntary informed consent, legislation, boundaries, legal and ethical issues

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