Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 59

The development of the and other standards by the ICH has moved the needle, so to speak, for furthering ethical and scientific best practices in the conduct of clinical trials throughout the world. A primary example is the country of Japan. When the ICH was founded circa 1990, Japan did not require that informed consent be given to trial subjects. This was a cultural matter however it did impact the usability/acceptability of clinical trial results by the regulatory authorities of other countries and regions because subjects had not been given informed consent. As an original founder of the ICH organization, Japan eventually fully adopted the ethical principle of informed consent. This adoption of the ethical principles inherent in the ICH E6(R2) is probably as important an outcome as any associated with the promulgation of the Standard.