Many research studies involve participants who do not speak or write in English. Our Research Subject Protection Program’s (RSPP) guidance document [PDF] has instructions for enrolling and getting informed consent from non-English-speaking participants.
Before enrolling a non-English-speaking participant, you must provide a concise summary of your study in the subject’s native language. Researchers must provide the summary to the participant using an approved interpreter.
Studies that need to provide summaries to non-English-speaking participants include those that:
We advise all researchers to document all steps taken to provide a summary of the research study to non-English-speaking participants. Our IRB or another study sponsor may seek written confirmation of the steps taken to provide subjects with summaries in their native language as part of ARI quality audits.
If you have an unexpected encounter with a patient who does not speak English, a “short form” helps you obtain informed consent quickly. Please submit the Request for Use of Short Form Consent Form to the Aurora RSPP office along with a copy of the short form consent document (translated and in English) you wish to use. A copy of the certificate of translations should also be included.
To get the short form consent template you need, contact the Aurora RSPP office.