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Peer-reviewedCC BYРепродуктивная эндокринология

Medical and legal support for patient autonomy in reproductive medicine: a balance between rights, governmental restrictions, and clinical practice

  1. 1Institute of Jurisprudence, Psychology and Innovative Education of Lviv Polytechnic National University, Lviv
  2. 2Lviv State University of Internal Affairs, Lviv
  3. 3Ivan Franko National University of Lviv, Lviv

Abstract

Background. Patient autonomy in reproductive medicine should be understood not merely as a formal right to sign or withdraw consent, but as an ongoing process of informed clinical decision-making that includes understandable information about diagnosis, prognosis, alternatives, risks, expected outcomes, and the legal consequences of assisted reproductive technologies (ART). Objective of the review: to provide an integrated medico-legal analysis of mechanisms safeguarding patient autonomy in ART, to define the limits of permissible State interference, and to formulate practical criteria for valid informed consent. Materials and methods. This study is a narrative interdisciplinary medico-legal review. The source corpus included current Ukrainian legislation directly relevant to medical intervention, ART, and legal parentage; international human-rights instruments; selected European Court of Human Rights (ECtHR) case law; and clinical-ethical guidance issued by World Health Organization (WHO), European Society of Human Reproduction and Embryology (ESHRE), and American Society for Reproductive Medicine (ASRM) concerning informed decision-making in reproductive medicine. Ukraine, Germany, France, Italy, and the United Kingdom were compared descriptively using the following parameters: regulatory model, procedural safeguards for informed consent, access to selected ART procedures, regulation of gametes and embryos, and mechanisms of legal protection; no quantitative ranking of autonomy was used. Analysis of the literature. In Ukraine, the basic safeguards of autonomy derive from the Fundamentals of Ukrainian Health Legislation, the Civil Code, the Family Code, and the Procedure for the Application of Assisted Reproductive Technologies approved by Ministry of Health Order No. 787; however, the regulatory framework remains dispersed across instruments of different legal force. WHO, ESHRE, and ASRM guidance supports a process-based understanding of informed consent that includes discussion of alternatives, risks, expected outcomes, patient values, opportunities for questions, and the possibility of withdrawing consent. European Court of Human Rights (ECtHR) jurisprudence shows that reproductive autonomy is protected primarily through Article 8 of the Convention, while coercive reproductive interventions may, in sufficiently serious circumstances, engage Article 3. Conclusions. The article proposes a minimum structured model of informed consent for ART comprising clinical information, alternatives, medical and legal consequences, disposition of cryopreserved material, rules for modification or withdrawal of consent, verification of patient understanding, and documentation of shared decision-making. This model links legal safeguards of autonomy to the realities of clinical reproductive care.

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BibTeX
@article{blikhar2026medical,
  title = {{Medical and legal support for patient autonomy in reproductive medicine: a balance between rights, governmental restrictions, and clinical practice}},
  author = {M.M. Blikhar and I.O. Lychenko and O.V. Avramenko and M.I. Holynska and K.Т. Sliusarchuk},
  journal = {Репродуктивная эндокринология},
  year = {2026},
  month = sep,
  doi = {10.18370/2309-4117.2026.85.80-89},
  url = {https://doi.org/10.18370/2309-4117.2026.85.80-89},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Medical and legal support for patient autonomy in reproductive medicine: a balance between rights, governmental restrictions, and clinical practice
AU  - M.M. Blikhar
AU  - I.O. Lychenko
AU  - O.V. Avramenko
AU  - M.I. Holynska
AU  - K.Т. Sliusarchuk
PY  - 2026
DA  - 2026/09/01
JO  - Репродуктивная эндокринология
DO  - 10.18370/2309-4117.2026.85.80-89
UR  - https://doi.org/10.18370/2309-4117.2026.85.80-89
AB  - Background. Patient autonomy in reproductive medicine should be understood not merely as a formal right to sign or withdraw consent, but as an ongoing process of informed clinical decision-making that includes understandable information about diagnosis, prognosis, alternatives, risks, expected outcomes, and the legal consequences of assisted reproductive technologies (ART). Objective of the review: to provide an integrated medico-legal analysis of mechanisms safeguarding patient autonomy in ART, to define the limits of permissible State interference, and to formulate practical criteria for valid informed consent. Materials and methods. This study is a narrative interdisciplinary medico-legal review. The source corpus included current Ukrainian legislation directly relevant to medical intervention, ART, and legal parentage; international human-rights instruments; selected European Court of Human Rights (ECtHR) case law; and clinical-ethical guidance issued by World Health Organization (WHO), European Society of Human Reproduction and Embryology (ESHRE), and American Society for Reproductive Medicine (ASRM) concerning informed decision-making in reproductive medicine. Ukraine, Germany, France, Italy, and the United Kingdom were compared descriptively using the following parameters: regulatory model, procedural safeguards for informed consent, access to selected ART procedures, regulation of gametes and embryos, and mechanisms of legal protection; no quantitative ranking of autonomy was used. Analysis of the literature. In Ukraine, the basic safeguards of autonomy derive from the Fundamentals of Ukrainian Health Legislation, the Civil Code, the Family Code, and the Procedure for the Application of Assisted Reproductive Technologies approved by Ministry of Health Order No. 787; however, the regulatory framework remains dispersed across instruments of different legal force. WHO, ESHRE, and ASRM guidance supports a process-based understanding of informed consent that includes discussion of alternatives, risks, expected outcomes, patient values, opportunities for questions, and the possibility of withdrawing consent. European Court of Human Rights (ECtHR) jurisprudence shows that reproductive autonomy is protected primarily through Article 8 of the Convention, while coercive reproductive interventions may, in sufficiently serious circumstances, engage Article 3. Conclusions. The article proposes a minimum structured model of informed consent for ART comprising clinical information, alternatives, medical and legal consequences, disposition of cryopreserved material, rules for modification or withdrawal of consent, verification of patient understanding, and documentation of shared decision-making. This model links legal safeguards of autonomy to the realities of clinical reproductive care.
SN  - 2309-4117
SN  - 2411-1295
ER  -