Ethical and Legal Framework for the Inclusion of Critically Ill Patients in Clinical Research
A new scientific commentary has been published in the Georgian Medical Journal addressing the ethical and legal framework for the inclusion of critically ill patients in clinical research. The publication reviews internationally accepted bioethical principles and legal approaches that aim to protect patient rights, human dignity, and the integrity of scientific research.
The article provides an in-depth analysis of informed consent in situations where patients are unable to make autonomous decisions. Particular attention is given to surrogate consent mechanisms, the role of research ethics committees, and the necessity of independent oversight throughout the research process. The author emphasizes that the inclusion of critically ill patients in research is permissible only under clearly defined ethical conditions, sound legal justification, and continuous monitoring.
The commentary also examines international practices and their relevance to the Georgian regulatory environment, offering valuable guidance for clinical researchers, ethics committees, and policy makers. The article is intended to contribute to professional discussion in a highly sensitive and high-responsibility area of clinical research.
The article is published in English and represents an official, citable scientific publication.
For citation:
Pkhakadze G. Ethical and Legal Framework for the Inclusion of Critically Ill Patients in Clinical Research: International Standards and the Georgian Regulatory Perspective. Georgian Medical Journal. 2025; 2025(1).
DOI: https://doi.org/10.5281/zenodo.18079164
Full text available at:
https://gmj.ge/index.php/pub/article/view/5
This announcement is provided for informational purposes only and does not constitute a separate scientific publication.
A new scientific commentary published in the Georgian Medical Journal examines the ethical and legal foundations for including critically ill patients in clinical research. The article is based on international standards and the Georgian regulatory context and is available in English with a DOI.
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