Translation Library
Welcome to the University of Utah IRB Translations Library. Here you will find the University of Utah IRB Short Form Consent Document translated into multiple languages. The Short Form is a method to document informed consent and can be a a tool to help research teams conduct the consent process in a language understandable to their participants.
You will also find the University of Utah Research Participant Volunteer's Bill of Rights. The Volunteer Bill of Rights is available for researchers to disseminate or for participants to download for themselves. It is available in English, Spanish, and multiple other languages. They can be found with the Short Form Consent Documents.
Getting started
Begin by making a plan to include individuals with Limited English Proficiency (LEP) in your study.
- Equitable Selection of Participants: Equitable selection of participants requires that researchers attempt to recruit potential participants who are appropriate to answer the scientific question, but also that participants are not excluded from research for non-scientific reasons. Learn more about this topic in our Guidance Series. Individuals with LEP should not be excluded from participating in research opportunities simply because translating documents was not included in the study budget.
- Resources and Responsibilities: The top five languages spoken in Utah are English, Spanish, Chinese, German, and Navajo (ref). When conducting research that will recruit a diverse participant sample from our community, you should plan on ensuring your research has adequate resources to accommodate LEP groups. This means having sufficient resources to translate your consent documents/instruments, and having interpreters available to help with the consent process.
About Short Form Consent Process
Disclaimer: For visual reference only - no audio available.
Frequently Asked Question
- The Office of Research Participant Advocacy (RPA) has language services available to help you translate your consent documents and connect with interpreters. Please visit: https://rpa.utah.edu/researcher-resources.php for more information.
- If you choose to use the short form to document consent, please review the Short Form Consent Process Instructions for Use. The guidance summarizes the requirements for using the short form with a checklist, and includes a specific section for using the short form with participants who do not speak English.
The witness should be someone who is fluent in English and the translated language. The witness is present during the consent process and confirms that the process was conducted in full, and that the participant was given the opportunity to ask questions.
An Interpreter may serve as the witness in a short form consent process.
If you are using one of the University of Utah IRB short forms, additional translation is not needed. If you are translating your long form in its entirety and you are a native speaker of the language, you may translate your own document in some cases.
If you are translating your consent form in its entirety and you are a native speaker of the language, you may translate your own document if the IRB determines your study is exempt, or minimal risk. You also need to provide a translation certification letter with the translated documents. A template can be found below on this page, or at https://irb.utah.edu/informed-consent/forms-templates-cpt/.
If the other documents were translated specifically for the research study, you should list them all on the certification letter. If they were already translated and are publicly available, no certification is needed, but an English version of the document must be attached for reference.
It is acceptable to list multiple documents in one letter; separate certifications are not required.
Yes. Standard processes for translated documents apply to Exempt research.
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 a language (English, Spanish, Vietnamese, etc.) that the participant speaks, reads, and understands (45 CFR 46.116(a)(3), 21 CFR 50.20). The language should be based on the preference of the participant.
Yes. The interpreter signs the Short Form on the Interpreter Signature Block. If the interpreter is also serving as the witness, they also sign the Witness Signature Block on the English Consent Form.
Interpreting and translation are similar, but there are subtle differences. An interpreter facilitates an oral conversation, while a translator is trained to work with written text. In most cases, a translator's product will be verbatim from the source text, while an interpreter may be required to improvise a conversation while it is happening in real time.
If the IRB determines a second parent's signature is required in order to obtain parental permission to include a child in a research study, you should attach the "2nd Parent Signature Block" page to your IRB application. The page can be printed out and attached to the back of your short form.
Second parent signatures are only required in specific cases, and should not be attached or included in your application without specific direction from the IRB.
Second parent signature block pages must be approved by the IRB prior to use for a given study. Like any other consent document, the 2nd parent block page is required to have a current IRB approval stamp in the footer of the document to be considered valid.
Sure! Our short forms are generic and intended to be used by anyone.
Translations
American Sign Language (ASL)
Cambodian/Khmer
Haitian Creole
Hakka Chin
Kinyarwanda
Mandarin Chinese
Marshallese
Portuguese
Serbian (Cyrillic Script)
Vietnamese
Acknowledgments
Foreign Language Recordings provided by the University of Utah Office of Research Translation and Interpretation.