For Minimal Risk Studies(approved via expedited review):
All translations of IRB-approved documents must be certified by a qualified translator who is acceptable to the IRB (an "Acceptable Translator"). The IRB will use its discretion in determining whether the credentials of the translator are acceptable, based on the nature and level of risk involved in the research study.
Acceptable translators for minimal risk studies include the following:
A commercial entity that provides translations as a service to the public.
An individual who is bilingual and fluent in both English and the language of the Non-English-Speaking subject. For this option, the IRB office requires that the study materials undergo back-translation, meaning that one person will translate the consent form and another will back-translate the translated version into English. The back translation will need to be submitted along with the translation for IRB review.
For each translation, the IRB must receive a letter or other written documentation certifying that the translation is consistent in content, style, and level of readability with the IRB approved document, and for non-commercial translators, and explanation of the tranlatro's qualifications. The letter or other documentation should reference the IRB approval and expiration dates of the study as well as a document identifier (Consent Form version number, document title, etc.) that is unique to each IRB approved item that is being translated.
For More than Minimal Risk studies (research that receives Full Board Review):
Once the English material has been approved by the IRB, the investigator will be required to have it translated by an IRB-approved translator (listed below). The translated document should be written at no more than an eighth grade reading level, as per IRB policy for all consent forms.
The translator must certify that the translated document is an accurate and complete translation of the approved English document by either stamping each page of the translated document or providing a written certification that the translation is consistent in content, style and level of readability with the IRB-approved document. The translated documents, with the certification, should then be submitted to the IRB, along with a copy of the stamped English consent form and/or additional material submitted for translation. The translated forms may not be used until they have also been stamped and approved by the IRB.
In addition, to ensure that there is adequate communication between the research team and research participants during the course of the study, investigators must agree that there will be at least one person on the research team who will be able to communicate with non-English speaking participants in their own language.
Following are translation services that we know to be acceptable:
(Contact: Magaly Garcia, MD)
30¢ per word (Spanish only)
Contact GLS for a free quote: may be between 25¢ - 30¢ per word, depending on the language