Legal support for the participation of volunteers (volunteers) in clinical trials of the efficacy and safety of immunobiological drugs-Reference-Cited by-同舟云学术

Legal support for the participation of volunteers (volunteers) in clinical trials of the efficacy and safety of immunobiological drugs

Published:2021-06-15 Issue:2 Volume:16 Page:81-91
ISSN:2500-2562
Container-title:Genes & Cells
language:
Short-container-title:Genes & Cells

Author:

Kholopova E. N,Goncharov A. G,Pestrikova A. A,Litvinova L. S

Abstract

In modern realities, medicine is an object of close attention, both from regulatory organizations and from social media. In such conditions of constant monitoring and pressure, clinical trials of newly developed immunobiological drugs (IBD) require effective legal support for all stages of the trials, as well as proper legal protection of volunteers in clinical trials of the effectiveness and safety of IBD, taking into account all possible risks. In the presented review, the Russian and foreign experience of legal support of this sphere of public relations is studied using the example of a vaccine against coronavirus infection, as well as proposals for its improvement.

Publisher

ECO-Vector LLC

Subject

Transplantation,Cell Biology,Molecular Biology,Biomedical Engineering,Surgery,Biotechnology

Reference49 articles.

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