Who is a qualified translator
The process for approval of a translated version of the consent form requires that the consent be translated by a “qualified translator” and then the Principal Investigator fills out the Translator Qualifications Form and attaches both the translated consent form and the Translator Qualifications Form to the Change Request & Amendments submission.
On the Translator Qualifications Form investigators must provide the qualifications of the person doing the translation.
The form should provide enough detail about the “qualifications” for the IRB to make a determination that the translator has appropriate qualifications. The IRB review will consider what medical background, if any, would be appropriate based on the risks and complexities of study interventions, and based on whether any of the study procedures are procedures that require additional consent when performed for clinical care.