Commentary Ethical and Legal Framework for the Inclusion of Critically Ill Patients in Clinical Research
International Standards and the Georgian Regulatory Perspective
DOI:
https://doi.org/10.5281/zenodo.18079164Keywords:
Ethical review, Informed consent, Vulnerable populations, Good clinical practice, Regulatory framework, GeorgiaAbstract
This article provides a comprehensive ethical and legal analysis of the inclusion of critically ill patients in clinical research. It examines the heightened vulnerability associated with severe illness, including impaired decision-making capacity and increased risk of therapeutic misconception. Drawing on internationally recognized bioethical standards and good clinical practice guidelines, the article outlines the fundamental requirements for independent ethical review, informed consent, and proportional risk–benefit assessment. The analysis further contextualizes these principles within the Georgian legal and regulatory framework, demonstrating that national legislation fully aligns with international norms. The article concludes that enrolling critically ill patients in clinical research without prior ethical approval and legally valid informed consent is impermissible, emphasizing ethical oversight as an essential safeguard for patient rights, scientific integrity, and public trust.
References
1. World Medical Association. Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191–2194.
2. Council for International Organizations of Medical Sciences. International Ethical Guidelines for Health-related Research Involving Humans. 4th ed. Geneva; 2016.
3. Emanuel EJ, Wendler D, Grady C. What Makes Clinical Research Ethical? JAMA. 2000;283(20):2701–2711.
4. International Council for Harmonisation. ICH E6(R2) Guideline for Good Clinical Practice. 2016.
5. საქართველოს კანონი პაციენტის უფლებების შესახებ. საქართველოს პარლამენტი; 2000.
6. საქართველოს კანონი ჯანმრთელობის დაცვის შესახებ. საქართველოს პარლამენტი; 1997.
7. საქართველოს მთავრობის დადგენილება №335 — ფარმაკოლოგიური საშუალებების კლინიკური კვლევის ნებართვის წესისა და პირობების დამტკიცების შესახებ. 16 ივლისი 2019.
8. საქართველოს მთავრობის დადგენილება №386 — სამედიცინო მოწყობილობების კლინიკური კვლევის ტექნიკური რეგლამენტის დამტკიცების შესახებ. 3 ოქტომბერი 2023.
9. საქართველოს კანონი პერსონალურ მონაცემთა დაცვის შესახებ. საქართველოს პარლამენტი; 2011.
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