Ethical aspects of initiative clinical trials
- Authors: Adzhienko VL1, Adzhiyenko VL1
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Affiliations:
- Issue: Vol 4, No 4 (2007)
- Pages: 77-79
- Section: Articles
- URL: https://journals.eco-vector.com/1994-9480/article/view/140123
- ID: 140123
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Abstract
71 investigator-initiated clinical trials conducted in Russia from 2001 to 2006 were reviewed. These trials
involved 15,104 participants. In 2005 the Independent Ethics Committee of the Volgograd Research Center under Russian
Academy for Medical Sciences made 62 decisions about modifications required prior to approval of proposed investigatorinitiated clinical trials. 23 modifications concerned applicable regulatory requirement references in trials documents,
16 - reasoning for enrollment of vulnerable subjects, 19 - informed consent, 4 -adequate facilities to conduct the
trial properly and safely.
involved 15,104 participants. In 2005 the Independent Ethics Committee of the Volgograd Research Center under Russian
Academy for Medical Sciences made 62 decisions about modifications required prior to approval of proposed investigatorinitiated clinical trials. 23 modifications concerned applicable regulatory requirement references in trials documents,
16 - reasoning for enrollment of vulnerable subjects, 19 - informed consent, 4 -adequate facilities to conduct the
trial properly and safely.
Keywords
References
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