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116.3 Organization Policy on Translation of Consent Documentation

April 2016

The Organization requires consent materials to be written in language that is understandable to the participant population(s). 

For research conducted in the United States, the JHM IRBs will require Principal Investigators  who plan to recruit known populations of non-English speakers to have informed consent documents translated into the languages most commonly used by the target study populations. 

For research conducted in countries where English is not the primary language, the investigator will be required to submit both the English version and local language versions of the informed consent document.

When informed consent documents will be translated into another language, the investigator is advised to submit only the English version of the informed consent document to the JHM IRB for initial review.  After the JHM IRB has approved the English version, the translation into the local language(s) should be completed and submitted with a Certificate of Translation to the JHM IRB.  This allows any changes required by the JHM IRB to be included in the translated version.

The JHM IRBs will accept translated documents from consultants or other individuals who provide certification of their fluency in both English and in the language to which they have translated the documents.

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