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Compliance In Focus
Posted by John Lehmann on Thu, Jun 7, 2012

21 CFR 50.20 & Non-English Speaking Subjects

Informed consent must be obtained from research subjects prior to having any study-related testingConsenting Patients or procedures completed for clinical trials.  For the requirements of informed consent, we refer to the Code of Federal Regulations (CFR), Title 21, Part 50: Protection of Human Subjects.   21 CFR 50.20 states, “The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.”  And 21 CFR 50.25 describes elements which have to be included in the Informed Consent.   But what does this mean exactly?

Some IRBs (Institutional Review Boards), which oversee investigations at the site level) require Informed Consents to be written at a specific reading level; a  6th or 7th grade reading level is commonly required.    The Western Institutional Review Board (WIRB), a national IRB, goes into detail in their policies regarding the language of consents.  Their policy states, “Consent forms should be written in simple, non-technical language for readers of a seventh-grade reading level who may not have taken science courses in school.”

Things get complicated when a consent form is translated into another language.  And, we should think about the increase in the Spanish speaking population in the US.  When an Informed Consent is translated into Spanish, is it European spoken Spanish?  The Spanish spoken in Mexico, Central, and South America can be quite different and it is possible the subject may have some questions upon reading it.

WIRB deals with this by requiring that, “If the subject is not fluent in English……Was there also a bilingual translator present to assist with the informed consent process?”  This is an important step in the process and helps ensure the subject really understands what they are signing.  I think this is something other IRB’s should consider, if it is not already required.

As a monitor, a non-English consent is something I cannot verify the content of.  Site staff and monitors must rely heavily on the translators and the IRB to ensure the site’s compliance with 21 CFR 50.20. Other aspects of the informed consent process a monitor should be aware of include:

  • The consent was signed and dated by the subject
  • Study related procedures were not performed before informed consent was obtained
  • The site is in compliance with their IRB’s consenting SOPs

The consenting process of a subject is such an important part of conducting research, and whether the consent is in English, or any other language, the same rule applies:  “The information that is given to the subject or the representative shall be in language understandable to the subject or the representative.”

How do you ensure proper informed consent of non-English speaking subjects?  Please share your experiences with us!

Photo Credit: Alex E. Promios

Topics: Informed Consent, 21 CFR 50.20, Non-English Speaking Subjects


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