To translate or not to translate?

When it comes to the integrity of clinical studies conducted in the United States, the importance of translating informed consent forms into Spanish cannot be overstated. And these are our top three reasons why.

Equity and Access

Selecting subjects for a clinical study should be an equitable process. People should not be excluded from US studies simply because of a lack of English skills. But if a US subject doesn’t speak English, they are most likely to be a native speaker of Spanish.

Spanish is the second most spoken language in the United States and it is spoken at home by more than 41 million people. While 57% of these Spanish speakers also speak English very well, 43% of them don’t.

Translating informed consent forms into Spanish provides clinical subjects with equitable treatment, as well as clinical studies with increased access to an important population.

Ethical and Legal Standards

For most clinical studies, it’s required to obtain informed consent from subjects for both ethical and legal reasons. It’s fundamental that subjects understand the purpose and duration of the study, the procedures the study will include, foreseeable risks, expected benefits, etc. before they can voluntarily provide their consent. Even for native language speakers, informed consent forms should be written in plain language for maximum comprehension.

In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) mandate that informed consent forms be translated for subjects who have limited English proficiency. Due to the prevalence of Spanish in the United States, enrolling Spanish-speaking subjects is to be reasonably expected.

Translating your informed consent forms into Spanish is not only legally and ethically necessary; the sooner you translate, the sooner your study may proceed.

Study Integrity

Even if you think it may be easier to effectively keep your clinical study “English only,” please remember that there is value in including different populations. Spanish-speaking participants may provide insights that wouldn’t otherwise be available with English-only participants. Also, depending on your particular study, you may only need to translate your short form into Spanish, but either way, Responsive Translation would like to help make things run as smoothly as possible for you.

We know that compliance with your Institutional Review Board is essential. We offer certificates of translation accuracy free of charge. We can also provide back translation or any other steps as required by your Institutional Review Board, including making oral language interpreters available. Just let us know what you need.

Responsive Translation has decades of experience translating informed consent forms into Spanish and other languages. Please get in touch with us at 646-847-3309 or [email protected].