How Should We Apply the Wisdom of the Crowd to Clinical Trials With Exception From Informed Consent?

How Should We Apply the Wisdom of the Crowd to Clinical Trials With Exception From Informed Consent?
Invited Commentary 
Michael J. Lanspa, Eddy Fan, Alan H. Morris
JAMA Network Open, 24 July 2019; 2(7)
Open Access
Excerpt
In emergency trials applying for an exception from informed consent (EFIC), the US Food and Drug Administration (FDA) requires transparency, achieved through consultation with community members, before clinical investigators can enroll patients without informed consent. Feldman et al1 provide a review of surveys intended to achieve these consultations. Their results contribute to the literature by indicating the persistent gap between our goals and the imperfect surveys that have been reported…

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