Who is a qualified translator
The process for approval of a translated version of the consent requires that the consent be translated by a “qualified translator” and then the translation needs to be verified by a “qualified verifier”. (SOP for the entire process).
On the attestation form investigators must
1. For the “Translator”
- provide the printed name of the person who translated the form from English to the foreign language
- provide the qualifications of the person doing the translation
2. For the Verifier
- provide the verifier’s printed name
- provide the verifier’s qualifications
- provide the signature of the verifier
***the Verifier can NOT be the same person as the Translator (the person who provided the translation from English to the foreign language)
People frequently ask about the necessary qualifications for the translator and verifier.
Rather than limiting investigators by having very specific qualifications for translators and verifiers, when the policy was written, the term “qualified” was left wide open so that the investigators would have flexibility and the IRB could make a case by case determination as to whether the qualifications of the translator/verifier were sufficient based on the study and the specific consent forms.
For example, the IRB would not expect investigators to use someone who is a native Spanish speaker but has no medical background to translate a complicated clinical trials consent form. If this person doesn’t have a good understanding of medical terminology then he/she might not provide an adequate translation of an informed consent. On the other hand a medical student, physician, experienced nurse, etc. who is a native speaker would (usually) be appropriate for translating an informed consent.
If the study involves a survey (e.g. about how they view the services they receive, what toothpaste they use, etc. ) where the risks are minimal and the study design is very simple then a native speaker without a medical background would probably be qualified to translate/verify the translation of the consent forms. The attestation form should provide enough detail about the “qualifications” for the IRB to make a determination that the translator and verifier have appropriate qualifications.
When determining who can serve as an Interpreter when obtaining consent the IRB developed the following tool to assist investigators: