It is the policy of Fred Hutch that all documents that are translated or interpreted from English to another language must receive Institutional Review Board review and approval before use.
For additional details about interpretation and translation, refer to the Use of Interpreter Services and Translated Documents policy.
Studies Intended for Non-English Speaking/Reading Populations
When a study targets a particular group that does not speak or read English, the recruitment materials must be translated into the language understood by the targeted group (Office for Human Research Protections at 45CFR46.116-117; U.S. Food and Drug Administration at 21CFR50.20). The IRB may invite a consultant to review the translated materials to determine cultural appropriateness.
General requirements for translators and interpreters include the following:
- The IRB requires the use of qualified translators. Unless certified as a translator, written documentation of qualification for each translator must be submitted to Fred Hutch.
- Every person providing translation services must complete and sign the Translation Certification Form.
- For consent that takes place at Seattle Cancer Care Alliance, the SCCA policy regarding use of interpreters must be followed and no additional documentation is required to be submitted to the IRB.
- For consent that takes place at locations other than SCCA, the interpreter must complete and submit an Interpreter Certification Form after the interpretation service is completed.
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 one who provided the original translation.
- Double translation: Two people translate the same document and an arbitrator reviews both translated documents to determine any differences between the two.
- English and non-English versions of the documents.
- Signed Translation Certification Form from all persons providing translation services.
- A statement indicating whether single-back translation or double translation was used
- A Research Modification Form (if adding translated documents to an ongoing study)
Unanticipated Non-English Populations Consenting to Research: Short Form
For research participants who do not speak and/or read English, a short form consent should be used (Office for Human Research Protections 45CFR46.117(b}(2]); U.S. Food and Drug Administration 21CFR50.25 and 50.27 (b)(2)]). The short form is used to document that the elements of informed consent were orally presented to the research participant by a qualified interpreter. Both the short form and a written summary, which may also be the IRB-approved English-language informed consent document, must be submitted to the IRB.
General guidelines for use of the short form include the following:
- Copies of the summary and the short form must be given to the participant or participant's legally authorized representative.
- The short form is signed by the research 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 interpreter may also serve as the witness.
- Witnesses must be proficient both in English and in the language of the participant.