Applicability of a Function-Based Approach to Informed Consent in International Settings

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FUNDING

This work was supported by award R25TW007090-10, Fogarty International Center at the National Institutes of Health.

Notes

1. One could argue that the Vietnam study presented net risks equal to zero, as both arms of the trial were conceivably in equipoise with alternatives in clinical care, but further analysis is beyond the scope of this commentary.

2. There was a concern, however, that maybe some refusals resulted from physician directives.