Суб’єкти, які мають право давати інформовану згоду на участь у клінічних випробуваннях лікарських засобів

Abstract

У статті досліджені положення щодо осіб, які уповноважуються надавати інформовану згоду на участь іншої особи у клінічному випробуванні лікарських засобів у разі недосягнення нею повноліття, обмеження її дієздатності або визнання недієздатною, а також коли пацієнт з огляду на свій клінічний стан неспроможний особисто дати інформовану згоду. Сформульовані пропозиції стосовно приведення переліку цих осіб у відповідність до положень щодо дієздатності та законного представництва.

The author of the article, based on the analysis of the norms of national legislation and international regulatory acts, as well as the positions of the European Court of Human Rights, has studied the provisions concerning persons who are authorized to provide informed consent to participate in clinical trials of other person’s medicinal products. This refers to the involvement of patients into clinical trials, who are minors, whose dispositive legal capacity is limited, or who are admitted legally incapable, and those who due to their clinical condition can not personally give informed consent. The author has formulated propositions to bring the list of these persons in accordance with the provisions of the current legislation on dispositive legal capacity of an individual and legal representation. In particular, the author has substantiated the necessity of normative consolidation for obtaining informed consent from both a person whose dispositive legal capacity is limited, and from his tutor to be involved into clinical trials of medicinal products. It has been proved that it is appropriate to exclude close relatives from the range of persons, who have the right to give consent for the involvement of legally incapable patients to participate in clinical trials of medicinal products, since such consent is solely provided by a trustee of legally incapable person. The author has suggested to exclude adoptive parents and parents-educators from the range of legal representatives of a patient, who may give consent to his involvement for clinical trials, since children deprived of parental care, adopted children or orphans are not allowed to be involved in such trials. The author has proved the expediency of replacing the term «close relatives», which does not cover a husband or a wife of a patient with the term «family members and close relatives» within the Procedure of conducting clinical trials of medicinal products and examinations of the materials of clinical trials. It has been suggested to include adoptive parents into this list. The range of such persons does not include people who live together with one family without registration of a marriage. Involvement of patients to clinical trials of medicinal products on the basis of informed consent of an unauthorized person is the violation of inherent rights of patients to health and personal integrity.