The IRB has updated its policy 15.4, titled Non English-speaking research subjects and when the short form of consent is allowed, and it is now available on the IRB’s website.
We hope the research community finds the revised version’s discussion of this potentially confusing subject a bit clearer. Some of the high points of the new policy:
When you expect to enroll subjects who don’t speak English well, the study submission should include a description of these subjects’ consent process, communication throughout the study, and a copy of the full consent form into the expected language (along with any other study materials tailored to this group).
If a non-English-speaking subject is unexpectedly encountered, you may be able use a consent process that involves the so-called short form consent document. However, you must get IRB approval for this process BEFORE actually consenting anyone with it.
The IRB is also in the process of updating the short form consent templates available on the IRB website. We expect to make a revised, full-board-approved English version available soon. This document will be able to be translated into other languages for submission to the IRB to use with participants. We also plan to initially post Spanish and Marshallese tanslations as soon as they become available. Investigators who use these forms, once posted, should use the templates exactly as they’re posted. Having these forms at the ready and using them as approved will simplify research teams’ use, and the IRB’s review, of consent processes involving short form documents.