LEGAL ASPECTS OF CLINICAL TRIALS INVOLVING UNDER-AGE SUBJECTS IN RUSSIA
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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Paediatrician Publishers, LLC
2010-03-01
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Series: | Pediatričeskaâ Farmakologiâ |
Online Access: | https://pf.spr-journal.ru/jour/article/view/1162 |
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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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