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Non-English Speaking Research Subjects: What’s in the Regs?

Recently, the clinical research community has been making efforts to include more diverse subject populations in clinical studies. Sec. 907 of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) directs FDA to “improve the inclusion of clinical trial data representing demographic subgroups,” and in 2016 the agency declared it The Year of Diversity in Clinical Trials.

What the Regulations Say

Enrolling non-English speaking participants is a common way researchers include diversity in clinical studies. FDA and OHRP regulations encourage this as a way to ensure subject selection is equitable (45 CFR Part 46.111[3] and 21 CFR Part 56.111).

Unfortunately, federal guidance on non-English speakers participating in research is limited, focusing mainly on informed consent requirements. Information must be presented “in language understandable to the subject” (45 CFR Part 46.116), and in most cases “informed consent should be documented in writing” (45 CFR Part 46.117). FDA’s Guide to Informed Consent – Information Sheet provides a bit more detail:


When the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate.

[…A] copy of the consent document must be given to each subject. In the case of non-English speaking subjects, this would be the translated document. While a translator may be helpful in facilitating conversation with a non-English speaking subject, routine ad hoc translation of the consent document should not be substituted for a written translation.

If a non-English speaking subject is unexpectedly encountered, investigators will not have a written translation of the consent document and must rely on oral translation. Investigators should carefully consider the ethical/legal ramifications of enrolling subjects when a language barrier exists. If the subject does not clearly understand the information presented, the subject’s consent will not truly be informed and may not be legally effective.


The Information Sheet also discusses the use of a short form written consent, which can be used when a non-English speaking potential subject unexpectedly arrives at the research site. FDA and OHRP guidances clearly express a preference that the long form be translated, and that the short form is used only in unexpected situations. We’ll talk more about short form consents in a forthcoming blog.

What the Regulations Do Not Say

When it comes to non-English speaking research participants, the federal regulations and guidances remain silent on many details. The informed consent document is only one piece of the ongoing consent conversation, and researchers must prepare for the many other instances when non-English speaking subjects need to be provided with new and/or updated study information and ongoing education about their study participation.

This is where individual organizations and IRBs must rely on best practices, learning from researchers, the local community and the research community at large to develop meaningful policies and procedures. We’ve outlined a few common considerations below; check with your IRB for specific policies and requirements.

Enrolling non-English speaking subjects can pose additional challenges for researchers and IRBs, but this doesn’t mean non-English speaking subjects should be excluded entirely from research. Including a diverse subject population can help confirm that investigational products are safe and effective for the actual populations and subgroups who will use the products. It can also help ensure the risks and benefits of research are equitably shared across all populations who may potentially benefit from the research.

Want to learn more about enrolling non-English speaking subjects in research? View our webinar Enrolling Non-English Speaking Participants in Clinical Research: Regulatory and Practical Considerations.

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