General Recommendations to Carry out Effective Informed Consent for Clinical Trials in Japan

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Explain the purpose of the study clearly and simply.

Distinguish investigational treatment from standard care.

Avoid overstating the potential benefit of the investigational treatment.

Focus on physical and nonphysical risks associated with the investigational treatment as a whole.

Estimate broadly the likelihood of the risks associated with the investigational treatment.

Provide supplementary documents that are easy to read and culturally sensitive, and continue to provide these materials throughout the lifetime of the study.