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The specifics of the informed consent of the donors of biomaterials


E.V. Bryzgalyna – Ph.D. (Philos.), Associate Professor, Head of the Department of Philosophy of Education, Faculty of Philosophy, Lomonosov Moscow State University
S. M. Gavrilenko – Ph.D. (Philos.), Associate Professor, Department of Ontology and Epistemology, Faculty of Philosophy, Lomonosov Moscow State University
T.A. Varkhotov – Ph.D. (Philos.), Associate Professor, Department of Philosophy and Methodology of Science, Faculty of Philosophy, Lomonosov Moscow State University
K.Yu. Alasania – Ph.D. (Polit.), Associate Professor, Department of Philosophy of Politics and Law, Faculty of Philosophy, Lomonosov Moscow State University
E.M. Shkomova – Ph.D. (Philos.), Lecturer, Department of Ethics, Faculty of Philosophy, Lomonosov Moscow State University
A.L. Ryzhov – Ph.D. (Psychol.), Senior Research Scientist, Department of Neuro- and Pathopsychology, Fa-culty of Psychology, Lomonosov Moscow State University

The article considers ethical and legal status of the informed consent of the donors of human biomaterials, being an obli-gatory condition of establishing and functioning of biobanks. Basing on the analysis of normative and law acts regulating biobanks’ activities in different countries, the article states that forms of the informed consent can differ significantly from each other. In this context, the article pays special attention to Russian peculiarities in interpreting and normative and le-gal regulating of the voluntary informed consent.
Assuming that normative and legal acts are extremely important regulators of biobanks’ activities, the article proves there is a need to take into consideration a humanitarian aspect of problems connected to biobanking and, accordingly, to have social and humanitarian support of biobanking. The article emphasizes the activities of subjects involved into biobanking depends on solving the problems going beyond strictly medical, technological or natural and scientific problematics and belonging to humanitarian and social sphere. It obviously depends on the choice of a conceptual model of the informed consent including particular mechanisms of obtaining it.
Taking into consideration that the need of special adaptation of models and general principles for implementing tools of the voluntary informed consent for applying in biobanking is explained by high specificity of this institution, the article analyzes a range of biobanking peculiarities that demand to be included when elaborating a model of the informed consent. The article state the informed consent in biobanking has a few functions. One part of these functions corresponds to functions of informed consents used in other biomedical practices and institutions. The other part is specific for biobanks and connected to their specifics.
In connection to considering the specifics of the informed consent in biobanking, the article pays special attention to the procedures of anonymization of the donor’s individual data guaranteeing confidentiality and privacy protection. In this context, the article examines the shifts in functions of anonymization in biobanks.
The article analyzes peculiarities of modeling the voluntary informed consent of the biobanks’ donors. The basis for the modeling are the key aims of the informed consent use in biomedicine. These are: providing the respect towards the patient as to the autonomous personality, that can make a free choice and control all the procedures and actions performed with their body in therapy or scientific; research; minimizing moral or material damage that can be made in the process of unfair treatment or experiment; establishing conditions contributing to increasing a sense of responsibility of medical personnel and researchers for moral and physical well-being of their patients and test persons.
The article pays special attention to the notion of “donor-candidate”. This term is used for identifying a subject – a potential donor of the biomaterial being at the stage of getting the informed consent to biomaterial sampling. In this regard, the article considers the peculiarities of communication between the “donor-candidate” and researchers.

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May 29, 2020

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