Interpretation and Translation: IRB Requirements
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Relevant IRB policies/procedures:
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[Translation at SCCA: contact Steve Johnson 206-288-1287 for more information]
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| Translation Certification Interpretation Certification | |
| Short Consent Forms: | |
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English (doc) | |
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:- Single Back Translation: The translator providing the back translation into English must be a person different from the person who provided the original translation. Each person providing translation service must complete and sign the Translation Certification Form.
- Double Translation: Two people translate the same document and an arbitrator reviews both translated documents to determine any differences between the two translated documents. Both translators must complete and sign the Translation Certification Form.
The IRB encourages but does not require the use of certified translator/interpreter. 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:- English and non-English versions of the documents
- Signed translation certification and/or interpretation certification form(s) from all persons providing translation or interpretation services
- A statement indicating whether single back translation or double translation was used
- A Protocol Modification Form (not required for new studies) updated August 07, 2009
Unanticipated Non-English Populations Consenting to Research - Short Form
If you encounter one research participant who does 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. 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.
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