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If I’d Known You Were Coming, I’d Have Translated the Consent: Short Form Consents and the Unexpected Non-English Speaking Participant

August 30th, 2017 by Michele Russell-Einhorn, JD, VP of Human Research Protection Services and Institutional Official

For research sites in communities with large populations of non-English speakers, it may be standard operating procedure to obtain a translated version(s) of the study’s informed consent document at the beginning of a study—that way, when a non-English speaking potential study participant shows interest in the study, researchers can help the potential participant learn more about the study without missing a beat.

But what about situations where a non-English speaking potential participant shows up unexpectedly, and there isn’t enough time to obtain a translated study consent? Enter the short form consent.

The regulations require that study information be presented in a language understandable to research participants—this includes, of course, the informed consent document and process. 45 CFR 46.117(b)(2) and FDA guidance allow researchers to provide non-English speaking potential participants with an oral presentation of the informed consent information in conjunction with a written short form consent document and a written summary of the oral presentation. A witness must be at hand for the oral presentation, and the participant must receive copies of the short form and summary documents. The long form English consent may serve as the written summary.

FDA and OHRP guidance documents suggest the agencies clearly prefer that researchers use a translated version of the complete study consent for a non-English speaking participant to review, but we know this may not always be possible. For those unexpected situations, some institutions and IRBs have an approved short form consent translated into multiple languages. This way, researchers don’t have to turn away a potential study participant just because the study consent is not available in the non-English speaker’s language.

Keep in mind that the short form consent isn’t the perfect solution—an interpreter must also be present to assist with the oral consent presentation. Documentation requirements still must be followed as well:

The short form consent can be a useful tool for unexpected situations, but it should not be used when investigators expect that non-English speakers will be enrolled in the research. Remember, too, that informed consent is an ongoing process. While the short form consent can help during the initial consent discussion, researchers still need to assemble the proper communication tools to ensure the non-English speaking participant understands matters things throughout the study.

Non-English speaking study participants require additional support throughout the course of a study, but with the right tools and a little regulatory know-how, researchers can help ensure these participants are able to provide meaningful research contributions and reap potential benefits.

Want to learn more about enrolling non-English speaking participants in research? Read our blog Non-English Speaking Research Subjects: What’s in the Regs? or review Schulman’s Guidance on Using and Obtaining Translated Materials.