Effective date: February 21, 2014
Investigators are strongly encouraged to obtain written translation of consent forms subjects who are non-English speaking (NES) or have limited English-speaking (LES) skills will be enrolled in the research study. If NES or LES subjects will be targeted for enrollment into a research study, written translation of consent, assent, and HIPAA authorization forms or scripts are required. Copies of the English version of the consent and assent documents or consent and assent scripts should be submitted to the IRB for review with the Initial Review Application or translation of these forms. The translated forms based on the approved English version can then be submitted to the IRB for review. The translated forms should be accompanied by a letter from the translator attesting that the translated forms or scripts are accurate representations of the English versions approved by the IRB. In addition, the translator should document his or her qualifications.
In the case of clinical research, if translation of the consent form is not possible due to emergent circumstances (e.g., waiting translation of the consent documents would result in unacceptable delay in subjects treatment), the IRB recommends the investigator use an interpreter to present the IRB-approved English version of the consent form to the potential subject (or potential subject's representative, if applicable) and the presentation of this document, as well as the consent process, can be audio taped. A copy of the tape or disc can then be provided to the potential subject for review and reference. In parallel with the UWHC policy for discussion of clinical care, family members should not be the individuals involved in providing the oral translation during the consent process. In the case of protocols that have a therapeutic intent, the consent documents should be translated by an individual with the same level of qualifications required by the UWHC for clinical care. A short form can then be used to document the oral presentation of the consent form to the subject.
If the investigator does not have explicit IRB approval for the enrollment of NES or LES subjects, then full change of protocol should be submitted to the IRB office that revises the Initial Review Application to include this possibility and to obtain approval of the proposed consent process. Should a written translation of the consent form be obtained for later reference, this document can be submitted to the IRB for review under expedited procedures. The translated consent forms should be accompanied by a letter from the translator attesting that the translated forms or scripts are accurate representations of the English versions approved by the IRB. In addition, the translator should document his or her qualifications. Investigators should consider whether enrollment of NES or LES subjects in a clinical trial under emergent circumstances is possible at the time of initial submission of a protocol for IRB review and describe this and the proposed consent process in the Initial Review Application.
Short Form to document an oral consent process