Assuring Accurate Document Translation
When an investigator plans to enroll a non–English-speaking subject in research, the relevant documents should be prepared in the subject’s native language. These documents—including informed consent forms, advertisements, patient education material, contact letters, and questionnaires—must be approved by the Institutional Review Board (IRB). The Tufts–New England Medical Center/Tufts University Health Sciences IRB has revised the process for ensuring that documents are intelligible to a research subject and sensitive to that subject’s culture.
The process: The investigator should submit English versions of all relevant documents to the IRB for review. The material may be considered through an expedited review process or through a full-committee review, depending on the nature of the documents and in accordance with federal guidance and regulations. All documents must satisfy IRB standards for reading level and required elements of consent. English documents approved and validated by the IRB may then be translated into the subject’s primary language. To confirm that the meaning has not been changed, the translated material needs to be back-translated into English by an independent translator.
All translated documents, copies of the approved English versions, and each translator’s qualifications should be forwarded to the IRB for review. If approved, validated copies of the translated documents will be sent to the principal investigator for use. An investigator may not use translated documents until they have been approved and validated by the IRB.
A member of the research team may translate approved documents from English into another language; however, the back-translation must be performed by someone independent of the research team. The IRB recommends that when the budget for a study is developed, fees for document translation services be included as part of the cost of the study.
Qualifications of translators: Certifications should be submitted when available. If no certification is available, a cover letter should be provided outlining the translator’s qualifications and relation to the study.
For more information, please contact the IRB office at (617) 636-7512.