Interpretation and Translation: IRB Requirements

Relevant IRB policies/procedures:

  • Use of Interpreter Services and Translated Documents (Policy 2.13) [pdf]

[all IRB policies/procedures]

[Translation at SCCA: contact Steve Johnson 206-288-1287 for more information]

Download Forms:Ukrainian
Translation Certification
Interpretation Certification 
Short Consent Forms:

English (pdf)
Amharic (Ethiopian) (pdf)
Arabic (pdf)
Cambodian (pdf)
Chinese (Traditional) (pdf)
Chinese(Simplified) (pdf)  Chinese (Cantonese) (pdf)   Croatian (pdf)
Farsi (pdf)                        Filipino Bisaya (pdf)        Filipino lokano (pdf)             French (pdf)                     Italian (pdf)                             Korean (pdf)                            Lao (pdf)                        Marshallese(pdf)                Polish (pdf)             Portuguese (pdf)             Punjabi Eastern (pdf)       Punjabi Western (pdf)
Russian (pdf)
Samoan (pdf)                Somali (pdf)
Spanish (pdf)
Tagalog (pdf)
Thai (pdf)
Ukranian (pdf)                    Uzbek (pdf)
Vietnamese (pdf)

   

Studies Intended for Non-English Speaking/Reading Populations

If your study population targets a particular group that does not speak and/or read English, the recruitment materials (e.g. approach letters, informed consent document) must be translated into the language understood by the targeted group (OHRP at 45CFR46.116-117; FDA at 21CFR50.20).

The IRB recommends that documents be translated in one of two ways:

The IRB requires the use of a qualified translator.  Written documentation of qualification of each translator must be submitted if they are not certified. The IRB may invite a consultant to review the translated materials to determine cultural appropriateness.

Submit the following documents to the IRB:    

Unanticipated Non-English Populations Consenting to Research - Short Form

If you encounter occasional research participants who do not speak and/or read English, the short form should be used (OHRP 45CFR46.117(b)(2); FDA 21CFR50.25 and 50.27(b)(2)).

The short form documents that the elements of informed consent were orally presented to the research participant by a qualified interpreter. The short form used, and a written summary which may also be the IRB-approved English-language informed consent document, must be submitted to the IRB.

The short form is signed by the research participant or participant's legally authorized representative. Copies of the summary and the short form must be given to the participant or participant's legally authorized representative.

A witness must be present during the entire consent process, and must attest to the adequacy of the consent process and to the participant's voluntary consent. The witness must be proficient both in English and in the language of the participant. The interpreter may also serve as the witness.

If consent is occurring at SCCA, the SCCA policy on use of interpreters must be followed and no additional documentation is required to be submitted to the IRB.  If consent is occurring at locations other than SCCA, the interpreter must complete and submit an Interpreter Certification Form after the interpretation service is completed.

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