Effectiveness of the Protection of Biomedical Research Subjects in International and National Laws

Abstract

The article analyses the relationship of international and national law regulating and ensuring the protection of biomedical research subjects as well as factors determining the actual effectiveness of this protection. For this purpose the article reveals reasons affecting legislation initiatives at international and European level; shows circumstances of adopting specific legal acts, their wording and compatibility. Analysing whether harmonized standards in this area ensure the actual protection of the research subjects the authors assessed the role of national legal norms and the level of legal consciousness and legal culture. Authors pursued the objectives of the article by analysing the main areas of biomedical research directly determining the protection of the research subjects’ rights and the effectiveness of their protection such as operation of Research Ethics Committees, biomedical research liability and liability insurance. The analysis was carried out on the basis of national examples of the Baltic countries (Lithuania, Latvia, and Estonia) which were also compared to the situation in Western European countries. The article also assesses issues of the scope and effectiveness of biomedical research regulation related to the ratio of legal, ethical, and deontological norms in biomedical research.