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When the short form process must be used, the limitations of this process can be mitigated in part by translating the consent promptly after enrollment and providing it to the individual that was consented using the short form.  FDA guidance on informed consent indicates that this is an expectation of the FDA any time a short form consent process is used. 

In the guidance document and summary documents below are the step-by-step instructions for enrolling non-English speaking persons onto studies in the NIH Intramural Program. 

HRPP Policies#300Series-InvestigatorResponsibilities

Summary of the NIH Guideline for Consenting Non-English Speakers 

Both HHS and FDA regulations allow for consent to be documented using a process referred to as the “short form” process. (45 CFR 46.117(b)(2)) (21 CFR 50.27)(b)(2)).  In brief, the short form process allows for an oral presentation of the information that is contained within the full written English consent document, and for written documentation of consent to be obtained by having the participant sign a form that lacks any study specific information (the short form).  Typically, the short form has only generic headers that correspond to each of the required elements of consent, with no information about the actual study in which the person is enrolling. 

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