IRB policies are inconsistent for obtaining informed consent from non-English speaking research participants, according to a comparison of guidelines of the top 21 recipients of National Institutes of Health funding in 2018.1

“I thought I would find well thought-out documents that were consistent, logical, and tied to sound ethical reasoning. Most of all, I expected similarity across the board,” says Gianna McMillan, DBe, the study’s author and program administrator at the Bioethics Institute at Loyola Marymount University.

Instead, the results showed much disparity. “Just over 25% of them had what I would call sound policies. Another 25% did not do a good job at all. Those in the middle were all over the place,” McMillan reports.

The criteria for “sound policies” were based on identifying actions that directly affected the consent process in a positive way. Best practices included reference to federal regulations, minimal use of short form consent, definitions of key terms, standards for interpretation and translation, no use of family members as interpreters, and ethical discussion about language use. Some institutions used all of these; some used only a few.

“Every potential subject deserves a full explanation of the study before they make a decision, and ethical practice demands that a consent form be understandable to the potential subject,” McMillan says.

Translations, interpretation services, and other necessary accommodations for non-English speakers need to be built into study budgets, McMillan argues. “Those 21 institutions received $3 billion that year. That seems like enough money to come up with sound and consistent policy that supports a full explanation of a study in the language the subject actually speaks,” McMillan says.


  1. McMillan G. IRB policies for obtaining informed consent from non-English-speaking people. Ethics Hum Res 2020;42:21-29.