Open AccessFramework for Activity of Ethics Committees in Ukraine
Author(s) -
Kornatsky Vasil,
Talaieva Tatyana,
Silantieva Olga
Publication year - 2011
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.483
Subject(s) - directive , good clinical practice , declaration of helsinki , clinical trial , ethics committee , helsinki declaration , parliament , political science , compliance (psychology) , informed consent , medicine , research ethics , engineering ethics , alternative medicine , law , public administration , psychology , engineering , pathology , social psychology , politics , computer science , programming language
Summary Ethics committee supervision is an essential part of conducting clinical trials and is required to ensure compliance with the international recommendations including the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice (ICH GCP), Directive 2001/20/EC of the European Parliament and Council and WHO recommendations etc. No clinical trial can be initiated without prior review and approval from an ethics committee. In addition to expert evaluation of planned clinical trials, ethics committees are responsible for providing regular monitoring of clinical trial compliance with the international and national ethic, moral and legal aspects throughout the whole process of the trial conduct. Copyright © 2011 John Wiley & Sons, Ltd.