In order to ensure that prospective participants have sufficient information to provide informed consent to participate in research it is necessary for the Investigators to convey information regarding the research to participants through methods that will be effective for the participant population. As Investigators often wish to conduct research with participant groups who do not speak or read English fluently, the IRB has developed a policy regarding the use of translated Informed Consent Forms.
The requirements regarding obtaining IRB approval for Translated Informed Consent Forms varies depending on the level of risk of the research.
Investigators should describe in their Application for IRB Review whether translated Informed Consent Forms will be appropriate for the prospective participants. However, as the IRB often requires Investigators to revise their Informed Consent Forms, translated consent forms should not be submitted to the IRB until the IRB indicates that the English version of the consent form is satisfactory.
Regardless of the level of risk, it is recommended that English versions of consent forms be approved prior to translating, minimizing the number of iterations of translations.
Translations for Minimal Risk Research
For studies involving minimal risk to participants (“no foreseeable risks involved in participating in this research beyond those experienced in everyday life”), the qualifications of the translator should be provided (e.g., native speaker, academic degrees, certified translator, etc) to the IRB when foreign language versions of consent forms are provided. The translations should be consistent to the English versions in both content and format. Translators must sign a statement indicating that they have carried out the translation to the best of their ability.
Translations for More than Minimal Risk Research
For studies involving greater than minimal risk to participants, the Board requires that the researchers either use certified translators (with a letter of certification from the translator or translation service) or that a “back-translation” by a different translator than the one who performed the original translation be provided. The back translation (back into English) serves to ensure that the non-English version contains all of the key elements of the English version. The translated documents (forward and back), as well as documentation of the qualifications of each translator, must be submitted to the IRB for final approval.
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