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2011•The Quality Assurance JournalOpen access

Framework for Activity of Ethics Committees in Ukraine

V. M. Kornatsky, Tatyana Talaieva, Olga Silantieva

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Abstract

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.

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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.

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Available abstract

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.

Key concepts: Directive, Good clinical practice, Declaration of Helsinki, Clinical trial, Ethics committee, Helsinki declaration, Parliament, Political science

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