Enrolling Non-English-Speaking Subjects

Overview

Research with Non-English-Speaking Participants

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:

  • Are funded by a federal agency or department following the “Common Rule” regulation
  • Were approved after January 21, 2019
  • Were transitioned to the Revised Common Rule regulation by the IRB of Record

Ensuring Correct Documentation

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.

“Short Form” Consent Forms

Enrolling Non-English-Speaking Patients Quickly

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.

Contact the RSPP/IRB Office

We’re here to answer your research documentation questions.

IRB Approval of Research

Find out the steps you need to take to get IRB approval of research.

Resources & Forms

Download templates for IRB application, informed consent and more.

Policies & Procedures

Want to know about our research policies and procedures?