20.    How can I assure informed consent from non-English speaking participants? Department of Health and Human Services regulations for the protection of human participants require that informed consent information be presented "in language understandable to the participant" and, in most situations, that informed consent be documented in writing. The written consent document should embody, in language understandable to the participant, all the elements necessary for legally effective informed consent. Participants who do not speak English should be presented with a consent document written in a language understandable to them. In addition, someone who speaks the language of the participant must be present to answer any questions that the participant might have. This person could be the researcher, a certified translator, etc.

If informed consent information is present entirely orally, then a consent document written in the language of the participant (stating that the elements of consent have been presented orally) must be signed by both the participant and the individual who did the oral presentation. The participant must be given copies of the consent document.

 At the time of consent, the consent document should be signed by the participant (or the participant's legally authorized representative). The IRB must receive all foreign language versions of the consent document as a condition of approval. It is important to have the translated documents independently back-translated into English to assure that the translation has not distorted the intention of the English version.

Example: The approved consent form is in English and needs to be translated into Spanish.

1.  The approved English version (document 1) is converted to a Spanish version (document 2) by translator 1.

2.  The Spanish version (document 2) is converted back to an English version (document 3) by translator 2.

3.  The original approved English version (document 1) is compared to the re-converted English version (document 3) for content and language. If it compares sufficiently to ensure to the IRB that the translated version (document 2) is comparable to the original approved version (document 1), the translation is then approved.

  Some web sites seem to do a pretty good job of translating English into various languages (cf., http://babelfish.altavista.com).