Originally Published MDDI October 2002
INTERNATIONAL AFFAIRS
General Recommendations to Carry out Effective Informed Consent for Clinical Trials in Japan-
Explain the purpose of the study clearly and simply.Return to Article:
Device Regulation in Asia: An Update - 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.
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