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CONSENT OF THE LEGAL REPRESENTATIVE AND ASSENT OF PERSONS INCAPABLE OF GIVING INFORMED CONSENT TO PARTICIPATE IN MEDICAL RESEARCH
Abstract
Nowadays, in principle, medical research in a human is not possible without its consent. Since duly valid consent to participate in a research can be given only by individual capable of giving informed consent, subject of authors' considerations is an issue: based on whose consent will persons incapable of giving independent consent participate in researches? This category includes: children, incapacitated adults and persons capable of giving informed consent who are temporarily disabled in reasoning due to specific psychological and physical state of theirs. Authors search for an answer to the raised question, among other, by analyzing and comparing solutions contained in the Declaration of Helsinki, Directive 2001/20/ЕС and individual national regulations. In the first part of the paper, authors conclude that research involving persons incapable of independently giving their consent is possible only on the basis of the consent of their legal representatives, and authors identify who can have role of legal representative in respect of each category of subject persons. In the second part, they deal with analysis of criteria to follow when deciding to give consent to participation in the research on behalf of subject persons. Within the third part, authors elaborate role and importance of the assent of a person incapable of independently giving it for the participation in a research which was already accepted by its legal representative. Concluding part of the paper suggests a model of regulations for elaborated issues which, in the opinion of authors, is in the best interest of subject persons.
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