Life Sciences

FDA rules (21 CFR 50.20) and the Common Rule (45 CFR 46.116(a)(2)) both require that consent information be given “in language understandable to the subject.” For participants with limited English proficiency, that means an IRB-approved translated consent form, or an IRB-approved translated short form with a written summary, a witness and qualified interpreters.

Linguistic validation of a clinical outcome assessment (COA) usually follows the 10-step ISPOR process (Wild et al., 2005). The steps are preparation, two forward translations, reconciliation, back translation, back translation review, harmonization, cognitive debriefing with 5 to 8 respondents, finalization, proofreading and a final report. FDA reviews this process when COA data support labeling claims.