Ethical and legal principles of biomedical research.

Abstract

Objective: Aim: To analyze the regulatory and legal foundations of biomedical research by examining key ethical principles, including respect for individual autonomy, human dignity, voluntary informed consent, and benefit, with a particular focus on their implementation in both global and Northern European contexts, while identifying challenges to their practical application in modern healthcare systems.

Patients and methods: Materials and Methods: This research employed a comprehensive analytical approach utilizing comparative legal analysis and systematic review of international and national regulatory frameworks governing biomedical research. The methodology included examination of constitutional provisions, specialized legislation, and bioethical guidelines from European jurisdictions, with particular attention to Northern European regulatory models established since the late 1980s. The study incorporated analysis of scholarly literature addressing theoretical foundations and practical implementation of key bioethical principles, focusing on works by established authorities in the field such as J. Hans, O. Pasternak, and S. Shevchuk.

Conclusion: Conclusions: Ethical regulation of biomedical research requires strict adherence to the fundamental principles of respect for autonomy, human dignity, voluntary informed consent, and benefit, which collectively provide a comprehensive framework for protecting research participants while enabling scientific progress.