Participant Facing Materials

Lay-Friendly Participant Materials

Participant-facing study materials should be understandable to the general population of the study. 

The Emory IRB uses the Flesch-Kincaid formula to assess the readability of participant-facing materials. In most cases, these materials should be written at no greater than a 9th grade reading-level.

Note: This requirement only applies to items that will be seen by study participants (e.g., consent forms, educational materials, etc.). IRB-required consent template language should not be edited for readability (e.g., HIPAA Authorization, Cost and Injury language).

Review the IRB training materials on developing lay-friendly consents (.pptx).

Materials for Non-English-Speaking Participants

For more information, review the IRB Policies and Procedures Chapter 44: Informed Consent of Non-English-Speaking Subjects and Chapter 16: Local Research Context; Research Conducted at Non-Emory Sites

Short Form Consents

A short form consent is used to enroll subjects with limited English proficiency into a research study when a version of the consent form translated into the subject's language is not available.

Review the IRB Short Form page for more information.

Translating Documents

Documents used with research subjects will need to be reviewed in English by Emory’s IRB and any translated versions of the documents will need to be submitted to Emory’s IRB, after initial IRB approval. Translations must be done through either a qualified translator or back translation.

Qualified translations must be assured with a translation certification. The certification must be provided with the translated documents in the eIRB submission.

Back translations require two individuals who are familiar with English and the language for translation. The first translator "forward-translates" the English document into the required language; the second translator then "back-translates" the initial document back to English. The two translators must confirm that no important details are lost through the translation process.

When back-translating documents, the eIRB submission should include the "forward-translated" document and attestation statements from both of the translators. Translator attestations should demonstrate their proficiency in English and the other language (e.g., they are a native-born speaker of the language and have completed X years of education in English, have an interpretation certificate, etc.).

Working with Interpreters

Please note that Emory has a strict policy about using family members and study staff as interpreters. For more information, review the IRB Guidance on Using Family Members and Study Staff as Interpreters (.docx).

Review the IRB Webinar presentation on Interpretation and Translation Services under Section 1557 of the ACA (.pdf).

Advertising and Recruitment Materials

Review the IRB Study Submission Guidance page. More information is available in the section titled "Advertisement, Recruitment, and Compensation."