Getting consent from non-English speakers

Don’t avoid this population in your research

According to the U.S. Census Bureau, in 2000, just under 18% of the population — that’s more than 46 million people — spoke a language other than English at home. For researchers doing work that can apply across populations, that has one big implication: Minority groups need to be actively recruited for clinical studies; and since many don’t speak English, informed consent documents should be translated into a language they can read and understand.

Presenting the subject with a form written in his or her primary language is not just beneficence; it’s the law. Federal regulations require that informed consent documents be in a language understandable to the subject and in the same language in which the consent interview is conducted. And before even recruiting patients, institutional review boards must ensure that the translation is accurate.

How to do that? "We ask for an English original, a translation into the language in question, and then a translation of that document back into English," says Helen McGough, MA, CIP, director of the human subjects division at the University of Washington in Seattle. "Then we ask the researcher to compare the two and make any changes necessary until the two English versions have the same meaning and intent. They don’t have to be the same word for word, but the intent must be equivalent."

Even though providing for the needs of non-English-speaking subjects requires additional effort, that’s not reason enough to exclude them, McGough says. "There is a long history here going back to the Belmont Report. Recruitment should be equitable. You have to enroll a representative sample of the people who will be affected by the outcome of a study. If a disease has an impact across various groups, you have to recruit from a wide range of those groups. That would be easy if everyone spoke English, and in many areas that really isn’t an issue. But in many areas — and increasingly so in some — it is an issue."

In states such as Texas, where the number of Spanish speakers is large, there is no tendency to avoid non-English speakers, says Diana L. Anderson, PhD, CEO of D. Anderson & Co., a patient recruitment services firm based in Dallas. "But I could see people wondering in smaller sites and with some languages whether you can take on the responsibility involved in recruiting non-English speakers."

Still, the idea that whole communities of people would be left out of research because recruiting them is troublesome or adds additional costs is worrisome to McGough. "The only good enough response for not enrolling people from different groups is that there is no difference in outcomes. You have to understand the science and determine if it is relevant. If it is, then you have an obligation to recruit appropriately. Only if you have science that says race, ethnicity, age, or gender doesn’t matter can you just recruit who it’s easiest to recruit."

That said, McGough says there are some other reasonable arguments for not recruiting certain groups who don’t speak the language. If a data collection instrument hasn’t been validated in the language you need, then you can’t do it. "For instance, if you are using the Beck Depression Index, it is done in English and scored on the assumption that it is done in English. If it hasn’t been tested in another language, then you don’t know if a given translation will give the same results. Many such tools and tests have been validated in other languages, but you have to know."

Ongoing communication

Translating consent documents only is the first step, says McGough. "What are you going to do for the rest of the study? If you are doing a study that includes Hmong people, do your nurses speak Hmong? If there is an adverse event, do you have someone available 24 hours a day who can speak the language?"

In high-risk studies that are in first or second phase, McGough says she would consider the need to keep participants to English speakers or those who speak languages where good translation services are immediately, readily, and constantly available.

Consider, too, a global perspective, McGough says. "If you are one of multiple sites in a study, and one site is heavily Asian, and another is heavily Hispanic, and another is heavily Caucasian, then no one site has to meet all the criteria. The study as a whole can meet the need for adequate representation."

Finding resources

The process for getting informed consent from patients who don’t speak English is the same as for English speakers with one caveat: regulations allow for a short form in cases where a subject is recruited and no translated long form is available. The short form must be presented in conjunction with an oral presentation in the language that the participant understands. What was stated orally must be documented. While the FDA regulations seem to grudgingly accept the notion of short forms, the regulations clearly state that the "ramifications" and "ethics" of recruiting someone without complete informed consent should be considered. On the other hand, the OHRP seems much more willing to accept the notion of the short form. Full regulations for the FDA are available at and for the OHRP at

Don’t rely on family

Finding good translators is pretty easy in big cities, places with diverse populations, and university towns. It is best to make use of outside translation services and not rely on relatives or caregivers. There isn’t any federal rule stating you can’t use them as translators, but McGough sees several problems.

First, it might not be appropriate for a bilingual child to act as translator to a parent involved in the study. Second, there are privacy issues that have to be dealt with. There also may be cultural issues that preclude using someone close to the subject as a translator. "In some places, older people, younger people, and women may be sheltered from bad news," McGough points out. You could conceivably run into a situation where the translator may not reveal all the important information to the subject, or where something could be revealed to the translator that might cause a problem within the family.

Anderson says another issue with caregivers doing the translating is that they may not be familiar with medical terminology. "It is best to have someone who is familiar with clinical trials doing the translating for you," she says.

If you find yourself stuck on a particular medical word, there is a web site with a medical terminology dictionary in several languages available at

In the end, the money spent on good translations is worth it, McGough explains. "Translation may be expensive, but it pays off. In a clinical research setting, the quality of the data must be better if you have good translation services."


1. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects in Research. DHEW Publication No. (OS) 780012; 1978. This can be seen in its entirety at

Language translation