The objective of this guidance is to "provide a unified standard for the European Union, Japan and the Unites States to facilitate the acceptance of clinical data by the regulatory authorities in these jurisdictions". In practice these guidelines have far-reaching effect, as it is recommended that they are followed whenever the resulting clinical data is to be submitted to regulatory authorities. 

The guideline is intended to provide "international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involved the participation of human subjects". Topics covered include the composition of ethics committees / review boards, the responsibilities of investigators and sponsors, and provisions regarding trial protocols and protocol amendments.

While much of the guidance relates to various regulatory and administrative procedures, there is some specific consideration of ethical issues, including the informed consent of participants.

The guidance is also available in Spanish.


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