The informed consent document must be in a language understandable to the participant. When the prospective participant is fluent in English, and the informed consent discussion is conducted in English, then the consent document should be in English. However, when and if the study population is to include non-English-speaking participants, so that the principal investigator or the IRB anticipates that the consent discussion is likely to be conducted in a language other than English, the investigator should address the following criteria in the description of the informed consent process:
- research and other personnel (e.g., PI, staff, translator) who will conduct the consent procedures/discussion, communicate other information, and be available to answer questions in a language understandable to the participant;
- Submit translations and back translations of the informed consent documents for targeted populations for review and approval. (The IRB strongly encourages the use of a full translation of the entire informed consent document.);
- For international research with local IEC/IRB review this requirement applies to locally approved documents;
- For the UAB IRB to grant approval, informed consent documents must include, at a minimum, the required elements of informed consent and the signatures of the participant, or legally authorized representative if applicable, and the person obtaining consent;
- Provide certification that verifies that the informed consent document has been properly translated into the non-English language;
- Provide the qualifications of the individual or the service that was used to translate the informed consent documents (e.g., credentials, certifications, education, or native language fluency);
- Provide participants with the IRB-approved non-English-language informed consent document as part of the informed consent discussion and gives them an opportunity to read and discuss the document with a fluent translator present.
Translation services for international patients are available through UAB Medical Center. For more information, contact:
Service for International Patients
1523 4th Avenue South, ABC Building
Birmingham, AL 35294, US
Tel (205) 934-2096, Fax (205) 975-5940