CONSENT DOCUMENT TEMPLATES
Translation of Study Documents
Certified translations are required for studies that intend to enroll non-English-speaking individuals. The investigator is responsible for the cost of translating study materials. Please include the associated certificate(s) of translation upon submission of the translated document(s) to the IRB. To learn more about what qualifies as a certified translation please review the ATA website (Certification – American Translators Association (ATA) (atanet.org).
Translation Companies (Note: The IRB does not endorse any translation service)
The “short form” method for obtaining informed consent should only be used for the occasional and unexpected enrollment of a non-English-speaking participant. If the study design includes intent to enroll non-English-speaking individuals, or once the study team encounters one unexpected participant speaking a non-English language, the Informed Consent Form must be fully translated to that language.
Use of Sponsor Consent Forms Templates
LSUHSC prefers use of our local-approved template; however, if the study team wishes to use the Sponsor template, the LSUHSC ICF Cover Letter must be provided along with the Sponsor consent, or the required language must be embedded into the form. If the designated reviewer does not feel that the Sponsor template contains all the appropriate information or that the quality is poor, the reviewer reserves the right to request the team switch to use of the local-approved template.