Informed consent process in the I-SPY COVID trial is questionable

Rafael Dal-Ré,Arthur L Caplan,Teck Chuan Voo

European Journal of Internal Medicine（2023）

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摘要

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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关键词

COVID-19,Ethics,Informed consent,Deferred consent,Post-randomization consent

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