LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA

LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA

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The article focuses on a complicated, no less pressing issue of conducting clinical trials in pediatrics. When vulnerable groups of patients are involved as subjects in clinical trials, specific ethical issues inevitably arise. When conducting clinical trials involving under-age subjects, it is nece...

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Main Authors: S.S. Zavidova, A.A. Tolpanova
Format: Article
Language:English
Published: Paediatrician Publishers, LLC 2010-03-01
Series:Pediatričeskaâ Farmakologiâ
Online Access:https://pf.spr-journal.ru/jour/article/view/1162
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spelling doaj-56d6a8d5cea942a4ba879da4f63d4b1d2020-11-25T02:07:42ZengPaediatrician Publishers, LLCPediatričeskaâ Farmakologiâ1727-57762500-30892010-03-017225311157LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIAS.S. Zavidova0A.A. Tolpanova1Association of clinical trial organisations, MoscowAssociation of clinical trial organisations, MoscowThe article focuses on a complicated, no less pressing issue of conducting clinical trials in pediatrics. When vulnerable groups of patients are involved as subjects in clinical trials, specific ethical issues inevitably arise. When conducting clinical trials involving under-age subjects, it is necessary to follow not only international standards, but, quite often, perform an in-depth analysis of national laws, taking into account law enforcement practice. Key words: clinical trials, Russian Federation laws, children. (Pediatric Pharmacology. – 2010; 7(2):25-31)https://pf.spr-journal.ru/jour/article/view/1162
collection DOAJ
language English
format Article
sources DOAJ
author S.S. Zavidova
A.A. Tolpanova
spellingShingle S.S. Zavidova
A.A. Tolpanova
LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA
Pediatričeskaâ Farmakologiâ
author_facet S.S. Zavidova
A.A. Tolpanova
author_sort S.S. Zavidova
title LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA
title_short LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA
title_full LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA
title_fullStr LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA
title_full_unstemmed LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA
title_sort legal aspects of clinical trials involving under-age subjects in russia
publisher Paediatrician Publishers, LLC
series Pediatričeskaâ Farmakologiâ
issn 1727-5776
2500-3089
publishDate 2010-03-01
description The article focuses on a complicated, no less pressing issue of conducting clinical trials in pediatrics. When vulnerable groups of patients are involved as subjects in clinical trials, specific ethical issues inevitably arise. When conducting clinical trials involving under-age subjects, it is necessary to follow not only international standards, but, quite often, perform an in-depth analysis of national laws, taking into account law enforcement practice. Key words: clinical trials, Russian Federation laws, children. (Pediatric Pharmacology. – 2010; 7(2):25-31)
url https://pf.spr-journal.ru/jour/article/view/1162
work_keys_str_mv AT sszavidova legalaspectsofclinicaltrialsinvolvingunderagesubjectsinrussia
AT aatolpanova legalaspectsofclinicaltrialsinvolvingunderagesubjectsinrussia
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