Participants who have limited English proficiency may be enrolled in your research provided that you have the resources to communicate effectively during the recruitment process, while obtaining consent, and for the duration of the study. The short form consent is typically used when the potential participant does not speak English and there is not enough time to translate the English version of the approved consent document into a language the potential participant understands.
A short form consent document attests that the elements of informed consent, as required by DHHS and the FDA, have been presented orally to either the participant or the participant's legally authorized representative. A short form consent may be used as described in HRP-317: WORKSHEET: Short Form of Consent Documentation. The IRB Office has Short Form Consent Templates available in English and other languages. If the language you need is not available on the IRB's website, you must have the English short form translated into the appropriate language prior to submitting your request to the IRB.
If you expect to enroll more than one participant with limited English proficiency or if your study is being conducted internationally, you are expected to translate all study documents provided to participants into the appropriate language(s). If you are using a commercial translation service and wish to reduce costs, it is recommended that you first obtain IRB approval for the English version of the document(s) and then have your document(s) translated. Translated document(s) require IRB approval. This is accomplished by submitting a Modification in eIRB+ that includes a completed certification of the translation. You may use this blank Certificate of Translation if the person or service providing the translation does not have a certificate of their own.
Requirements for Use
The investigator must provide the following to the IRB for review:
- A written summary of what is to be said to the participant or the participant's legally authorized representative. The summary must include all of the required and appropriate elements in Section 7: Elements of Consent Disclosure in the WORKSHEET: Criteria for Approval (HRP-314). The PI may use the English version of the IRB-approved informed consent document.
- The short form document that will be signed by the potential participant.
- Confirmation that:
- The oral presentation will be conducted in a language understandable to the participant.
- The person obtaining consent is authorized by the IRB.
- There will be a witness to the oral presentation (this cannot be the same person who is obtaining consent). If the participant does not speak English, the witness should be fluent in both English and the language of the participant. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.
- The short form will be signed by the participant and the witness.
- The written summary will be signed by the witness and the person actually obtaining consent.
- A copy of the oral summary and the short form will be given to the participant.
The request to use the short form consent process is typically made because time is of the essence. As such, the IRB prioritizes the review of these requests in order to avoid denying a patient an opportunity to participate in research. However, once the participant is enrolled, the investigator is expected to adhere to the IRB's standard requirements for non-English speaking participants. This includes providing the IRB the following in a timely fashion:
- certified translations of all documents the participant will be required to complete (such as surveys and questionnaires);
- certified translations of the modified consent document in a language understandable to the non-English speaking participant if the English version of the approved consent document undergoes subsequent modification;
- the plan for ensuring that ongoing communication with the participant is in a language understandable to the participant.