1PURPOSE
1.1This document describes the policies and procedures associated with translation and interpretation in human subjects research.
2POLICY
2.1For research intended, or likely, to involve subjects who are not fluent inEnglish,any consent, assent, and parental permission formsmust be translated or interpreted into a language understood by the subjects.
2.2The UW IRB expects that translated documents will meet the following requirements. Researchers are required to inform the IRB how they will ensure that these translation requirements will be met. A qualified translator/interpreter should be able to ensure that the tone, meaning, and content of the translated documents remain consistent with the IRB-approved English version.
2.2.1Linguistically accurate;
2.2.2At an appropriate reading level for the subject population; and
2.2.3Culturally sensitive for the locale in which they will be used.
2.3Translated or interpreted materials may not be used until they have been approved by the IRB.
3DEFINITIONS
3.1Interpreter: refers to a person who reads aloud (in another language) materials written in English, or who conveys (in another language) information that is spoken in English.
3.2Translate: refers to converting materials written in English into materials written in another language
3.3Back translation:refers to the practice of translating materials from one language to another language and then (in a separate action) translating the materials back into the original language. The purpose is to evaluate the quality and integrity of the translation.
4RESPONSIBILITIES
4.1The researcher is responsible for ensuring that all materials and information will be provided to subjects in a language understandable to them, and for ensuring that any translations and interpretations will accurately convey the information.
4.2The researcher is responsible forthe cost of translating written documents, including consent forms. These costs may be quite high, particularly for studies requiring multiple translations (i.e., multiple languages, multiple consent versions) or involving complex consent information that may require additional time by a skilled professional. Researchers should include the costs of written translations as well as interpreter services in contracts and in grant applications.
4.3The IRB is responsible for requiring translations and interpretations, when appropriate. The IRB uses its judgment to evaluate the researcher’s proposed method for obtaining translations and interpretations.
5PROCEDURES
5.1Obtaining translation or interpretation.
5.1.1The researcher’s IRB materials should describe the translation or interpretation process, including any criteria that will be used to identify the translator or interpreter. This may, for example, involve the use of a certified translation service.
5.1.2The translated materials must meet the requirements described above in section 2.2.
5.1.3The following issues should be considered when selecting a translator or interpreter:
5.1.3.1The vocabulary of the materials (e.g., how complex and specialized)
5.1.3.2The background, experience, and language proficiency of the translator or interpreter
5.1.3.3The risks to subjects that might reasonably be expected with poor translation or interpretation
5.1.3.4Local cultural context and issues
5.1.4Sources of translation. The UW IRB does not require researchers to use a specific translation service. Possibilities include but are not limited to:
5.1.4.1The American Translators Association maintains two online directories, at:
5.1.4.1.1Directory of Translation and Interpreting Services (by individuals)
5.1.4.1.2Directory of Translation and Interpretation companies
5.1.4.1.3UW Medicine uses and recommends the following local translation service, which is experienced in working with UW researchers (including biomedical research) and with invoicing to UW budgets: Dynamic Language.
5.1.4.2Native speakers who have demonstrated proficiency in English, including knowledgeable members of the research team, academics at other institutions, bi-lingual tribal leaders, etc.
5.1.4.3Graduate students or instructors in foreign language programs.
5.2IRB review and approval of translated materials. It is unlikely that an IRB member will be proficient in the translated language. Therefore, the IRB’s review focuses on whether the translation method is appropriate, based on consideration of the factors described in section 5.1.3 (above).
5.3IRB review and approval of interpretation. The IRB evaluates the researcher’s selection (or criteria for selection) of an interpreter. The IRB considers the factors described in section 5.1.3 (above).
5.3.1It is almost never appropriate to use children as interpreters. Exceptions may be rarely allowed when the children are considered adults in the local setting, the risks are low, there are no alternatives, and there are no potential conflicts of interest.
5.3.2Privacy, confidentiality, and accuracy of translation/interpretation should be considered if family members or friends will be asked to interpret.
5.3.3Working effectively with interpreters. Researchers should consider discussing some or all of the following topics with a possible interpreter:
5.3.3.1If the English version of the consent is presented orally for the alternative “1-2-3” consent documentation method, how will the interpreter incorporate cultural considerations into the consent information?
5.3.3.2How will the researcher and interpreter determine whether the subject truly understands the consent information?
5.4The IRB has the authority to require revisions or additions to the consent process to ensure that non-English speaking subjects are adequately informed and are providing truly voluntary consent.
5.5Stamping translated materials. The current default practice of the UW IRB is to return any approved consent form (whether in English or translation) with the IRB approval stamp, although this is not a federal regulatory requirement. The IRB may decide that stamping is not necessary or appropriate for a specific study.
6MATERIALS
6.1None
7REFERENCES
7.145 CFR 46.116
7.221 CFR 50.20
7.3OHRP, “Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English”, memorandum; November 9, 1995.
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