Short form consent translations library 

Information that is given to a potential research subject must be in a language understandable to the subject. This means that you must conduct the consent process in a language that the participant understands. You should use the language (English, Spanish, Vietnamese, etc.) that the participant speaks, reads, and understands (45 CFR 46.116(a)(3), 21 CFR 50.20).

Short forms are translated documents that describe the required elements of informed consent.  A short form can be used to help facilitate the consent process for non-English speaking participants when a fully-translated version of the full consent document is not available in the participant's language. 

The short form should not be used to obtain consent alone. A complete "short form process" includes several elements, discussed in detail in the "How Does a Short Form Consent Process Work?" section on this page.

You may either include a short form process in your study initially, or you may add it later via an Amendment.  Important things to remember:

• In addition to attaching the short form document(s) you would like included in your study application, you must also describe the short form process in your application.  
• Short form documents/processes must be approved by the IRB prior to use for a given study.  Like any other consent document, the short forms are required to have a current IRB approval stamp in the footer of the document to be considered valid.
• If you use one of the IRB's short forms, you do not have to attach translation certificates to your application, as the forms have already been verified by the IRB.  You should download copies of the certificates and save them in your research records. 

Before adding a short form process to your IRB application, please review the IRB's guidance on the topic: "Short Form - Instructions for Use".  In order to include a short form process in your study, you need to include the following in your IRB application:

REMINDER: You DO NOT need to attach the translation certificates to your IRB application if the certificate is provided by the IRB.  

More Information

To add a short form process to your application, begin by selecting the translated documents you need for your participant population.

In your ERICA application:

• On the Consent Process Page, indicate that you will use a translated short form and describe the process you will use.  
  • For example, “In the event that a participant does not speak English, the oral presentation will be translated with the use of an interpreter.  The written summary of the oral presentation will be the IRB approved long consent document.  Hospital-based, professional translation services will be provided to all non-English speaking study participants.  Consent will be documented using a short form.  A third-party witness (e.g. the interpreter) will be present during the oral presentation and will sign both the long form and the short form.  The witness will be fluent in both English and <<add translated language>>.  The person obtaining consent will sign the long form.  The participant will sign the short form.  The participant will receive a copy of the consent form in English and the translated short form.”
  • For example, "The oral presentation and the short form must be in a language understandable to the subject.  The witness should be fluent in both the language of the participant and the language of the consent (i.e. English).  The short form document and the written summary should be signed by the witness. When the person obtaining consent is assisted by an interpreter, the interpreter may serve as the witness.  The written summary must be signed by the 1) witness and 2) person obtaining consent. A signature block for each individual should be included at the end of the summary.  The short form must be signed by the 1) witness and 2) participant or the participant’s legally authorized representative.  If the research is subject to FDA regulation, the participant or the participant’s legally authorized representative must also date the short form.  The participant or the participant’s legally authorized representative must be provided a copy of the 1) short form and 2) written summary."
    
• On the Documents and Attachments page:
  • Attach the translated short form documents to your study under "Consent Documents".  
  • Attach the English version of the short form.  NOTE: The English version of the document will not be used for your consent process, but will be the version of the document English-speaking IRB reviewers will use to review your process.
  • Add the Interpreter Signature Block to your long consent form before attaching it. 

 NOTE: As of 2017, the short forms no longer require specific PI contact information be added, so all of the documents are in PDF format and do not require editing on a per-study basis.  There is a blank section at the end of the document reserved so ERICA can stamp the document with a watermark footer.  Short forms are still required to be attached to each study and submitted for re-approval via continuing review before they expire.  

Careful preparation and coordination is required to conduct a compliant consent process using a short form.  You should be prepared to include the following individuals in every consent process where a short form is utilized: