Published: 22 October 2022
Author(s): Rafael Dal-Ré, Arthur L Caplan, Teck Chuan Voo
Issue: January 2023
Section: Letter to the Editor

We read with interest the letter by Files et al. [1] commenting on our recently published article in which we discussed the inappropriateness of randomizing trial participants before obtaining their informed consent [2]. The I-SPY COVID Trial investigators claim that we have “fundamentally misunderstood the consent process” utilized [1].


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