Abstract
The aim of this paper is to establish the categories of adult persons which could be considered as the subjects incapable of giving consent for the participation in clinical trials – which is the expression used by the legislator that the author considers to be vague. In the first part of the paper, the author analyzes the issue whether the adult persons with restricted or terminated legal capacity belong to this category. The second and the third part of the paper represent a response to the question whether an adult subject with full legal capacity can be classified in this category for a particular reason. In the conclusion, the author states that the category of adult persons which could be considered incapable of giving consent for the participation in clinical trials includes only the individuals without full legal capacity and explains why such categorization is not adequate, suggesting the corrective solutions.
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