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

Autor:	E. N Kholopova, A. G Goncharov, A. A Pestrikova, L. S Litvinova
Rok vydání:	2021
Předmět:	Transplantation Biomedical Engineering Surgery Cell Biology Molecular Biology Biotechnology
Zdroj:	Genes & Cells. 16:81-91
ISSN:	2500-2562 2313-1829
DOI:	10.23868/202107011
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::d9324a943de8a738d03ac65d0751a88b https://doi.org/10.23868/202107011 Zobrazit plný text záznamu