Participants who have limited or no 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 an unexpected 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.
The short form processs may be used twice for a particular langauge in a study. After the second use of the short form consent process, the informed consent document must be translated into that particular langauge as it can be anticipated you will encounter additional potential participants that understand that language.
Requirements for Use
The investigator must provide the following to the IRB:
- 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 should 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). 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
How to submit to the IRB
- If using a translated short form from the IRB website and the English language consent document as the written summary, the short form consent process may take place prior to IRB review. An RNI should be submitted to the IRB within 10 days, to report the use of the short form consent process. The RNI should contain the documents and confirmations previously described above.
- If not using a translated short form from the IRB website, the short form consent process cannot take place prior to IRB review. A modification should be submitted containing the translated short form, certificate of translation, and the documents and confirmations previously described above. The short form consent process can then be carried out once the modification has been approved.