Theory and practice of intellectual property
№ 2 / 2026
ISSN (Print) 2308-0361
ISSN (Online) 2519-2744
PDF (Ukrainian)DOI: https://doi.org/10.33731/tpip.2026.2.11
Submitted 2026-04-29
Accepted 2026-05-20
Published 2026-05-28
Subjects of biomedical research on human embryos created in vitro: general characteristics and legal requirements in the international context
Ihor Shyshko
PhD (Law),
Junior Researcher at the Sector of Legal Research in the Field of Bioethics and Biosafety, Science Department for Research on Intellectual Property Rights and Human Rights in Healthcare,
Intellectual Property Scientific Research Institute
of the National Academy of Legal Sciences of Ukraine
Kyiv, Ukraine
https://orcid.org/0009-0002-2112-7759
Abstract
The article examines the subjects of biomedical research on human embryos created in vitro, their general characteristics, and legal requirements applicable to them. The subject of the research comprises national legal acts of foreign countries governing social relations connected with the conduct of such research. The article identifies five groups of subjects: the researcher; gamete donors; persons holding rights over the human embryo; an independent bioethics committee; and a specially authorised public authority. It is established that professional competence is a mandatory legal requirement for the researcher, guaranteeing the legitimacy and ethical acceptability of the research process and its outcomes. Gamete donors and persons holding rights over the human embryo are obligatory subjects, without whose consent, conducting such research is unlawful. The government agency with specific authorisation, in conjunction with the autonomous bioethics committee, constitutes the pivotal entity responsible for guaranteeing the legality and ethical conduct of such research. These entities are vested with the authority to supervise and approve biomedical research that involves human embryos created in vitro.
Keywords: biomedical research; human embryo; research subjects; gamete donor; bioethics committee
References
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http://www.ndiiv.org.ua/index.php/ua/spetsializovani-vcheni-rady-phd/579-shyshko-ihor-mykolaiovych