Recruiting Non-English-Speaking Participants
The approach for obtaining informed consent from participants who do not understand English but are literate in another language is :
- To provide an NTU-IRB-approved consent form translated into a language they understand, or
- To provide an NTU-IRB-approved English informed consent form with an appended translated short consent form.
Participants must not be excluded solely due to limited English proficiency.
When enrolment of non-English-speaking participants is anticipated, the Principal Investigator (PI) should plan for translation-related costs and ensure adequate resources for the consent process where needed. The PI should also ensure that all translations are accurate and consistent with the IRB-approved English version. Translation performed by a service provider or a qualified bilingual individual must be accompanied by certification or a declaration of the translator’s qualifications or language competence and translation accuracy, which must be submitted to the NTU-IRB and retained in the study file.
When a translated short consent form is used, the following conditions must be met:
- The consent discussion and the translated short consent form must be conducted in a language understandable to the participant.
- Where required, a witness (another adult not administering the consent), fluent in both English and the participant’s language, should be present throughout the consent process.
- The participant (or legally authorised representative), the person obtaining consent, and the witness (where required) must all sign and date both:
- the English full informed consent form, and
- the translated short informed consent form.
- the English full informed consent form, and
- The participant should be provided with copies of both signed consent forms. The translated short informed consent form should be appended to the English full informed consent form as a single document set, with signature and date clearly indicated.
- All translated and signed consent forms must be retained in the study file.