INFORMISANI PRISTANAK NA UČEŠĆE U MEDICINSKOM ISTRAŽIVANjU: OSTVARENjE POSTAVLjENIH NORMATIVNIH ZAHTEVA U PRAKSI I PUT KA NjEGOVOM UNAPREĐENjU

Abstract

Informed consent of the participant in medical research is the expression of the recognition of the persons' autonomy and his right to physical and psychological integrity. The legal and ethical documents which regulate this form of medical activity define the qualities which this consent needs to fulfill in order to be considered valid (well informed participant, freedom and capacity to give consent), that is making the medical research legally and ethically accepted. Bearing this in mind, the subject of the author's interest in this paper is the analysis to what extent these normative requirements and theoretical ideals are met in obtaining the informed consent. The author has found out that, on the basis of the results of the studies related to this matetr, the realization of each of these qualities for the informed consent shows deviation from defined standards and the most frequent deficiency is the lack of information given to the participants in these trials, that is its subjective component - adequate understanding of offered information. The author has concluded that we cannot be satisfied with the informed consent which fulfills only the formal side of its validity, she proposes the implementation of a set of measures that, according to her opinion, could contribute to obtaining an essentially valid consent.