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03/03/2025 11:42 pm
Topic starter
Hi All, seeking guidance with regard to translated consent. Please see questions below:
- When does the IRB require fully translated consent? For example, after the Short Form is used?
- Does any IRB require certification of the translation or permit translations only from certain qualified organizations?
- Does any IRB require/recommend the witness be impartial? What kind of guidance do they provide for this?
Thank you!
1 Answer
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14/04/2025 7:42 pm
- When does the IRB require fully translated consent? For example, after the Short Form is used? Translation is required when they plan to enroll >3 patients who speak that language.
- Does any IRB require certification of the translation or permit translations only from certain qualified organizations? We require written documents to be translated by a certified translator with a copy of the certification attached. If the sponsor or investigator does not have a certified translation, HRPP staff can facilitate sending the documents to an approved translator and the investigator will be billed for the translation. Verbal translations must be done by an institutionally approved interpreter or service.
- Does any IRB require/recommend the witness be impartial? Yes What kind of guidance do they provide for this? This is written in the policy.