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.
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.
- Your first goal should be to fully translate your consent documents into the languages
you anticipate needing for your study population. At a minimum, you should plan on
having a method for obtaining consent from participants in both English and Spanish.
- If you are unsure which languages you will need, you may begin by including a short form consent process in your study plan. However, after you enroll more than one individual using a short form, you should plan on fully translating your documents and submitting them for IRB approval.
- The short forms are all based on an English version of the document that has been
pre-approved by the IRB for use with all IRB-approved research overseen by our institution.
- However, the PROCESS you will use to obtain consent from LEP participants must be approved by the IRB
on a per-study basis before including LEP individuals in your research.
- If you fully translate your documents, you must submit the translated documents along with a translation certification to the IRB for approval prior to their use.
- 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.
What is a Short Form?
How Do I Add a Short Form to My Study?
How Does a Short Form Consent Process Work?
More Frequently-Asked Questions
What is a Short Form?
A short form consent process is a method of documenting informed consent. The short form document outlines the required elements of informed consent. A short form can be used to help facilitate a 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.
How Do I Add a Short Form to My Study?
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:
- You must also describe the short form consent process in your application.
- The short form processes must be approved by the IRB prior to use for a given study.
- If you choose to use the University of Utah IRB short forms, you do not have to attach
the documents or translation certificates to your application, as the forms have already
been universally approved by the IRB.
- If an investigator wishes to use an alternative to the standard short form or translate their own version, it must be reviewed and approved by the IRB prior to use.
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:
| What You Need | Where You Add It |
|---|---|
| 1. A description of the short form consent process | 1. Consent Process Page of the ERICA application. |
| 2. If individuals with limited English proficiency will be consented using the short form process, the Interpreter Signature Block on the full, English version of your consent document should be included. | 2. At the end of your full, English consent document, which should be attached to the Consent Document section of the Documents and Attachments page of the ERICA application. |
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 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 interpreted with the use of a qualified 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 University of Utah short form. A third-party witness (who may be 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 (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. The participant or the participant’s legally authorized representative
must be provided a copy of the 1) short form and 2) written summary."
- If the research is subject to FDA regulation, "The participant or the participant’s legally authorized representative must also date the short form."
- On the Documents and Attachments page:
- Add the Interpreter Signature Block to your long consent form before attaching it.
NOTE: In October 2022, the University of Utah IRB adopted a policy which allows investigators
to use of short forms for general use after the IRB approves the short form consent
process.
How Does a Short Form Consent Process Work?
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:
| Individual | What They Do | What They Sign |
| Non-English Speaking Participant | Listens to the person obtaining consent and Interpreter and asks questions during the consent process while deciding whether to participate in the research. | Translated Short Form |
| Person Obtaining Consent | Conducts the consent process in English using the full consent document and answers the participant's questions. | English Consent Document |
| Qualified Interpreter | Repeats what the person obtaining consent says in a language understandable to the
participant. It is recommended that interpreters be cleared by the University of Utah Office of Research Translation and Interpretation before being invited to participate in a consent process for an IRB approved study.
The interpreter may serve as a witness. |
Translated Short Form & English Consent Document |
| Witness |
A witness is required to observe the oral presentation. The witness should be fluent in both the language of the participant and the language of the consent process. An interpreter may serve as a witness. | Translated Short Form & English Consent Document |
| What You Should Keep in the Research Records | What You Should Provide to the Participant |
| After the consent process is complete, you should keep the original, signed English long form and the original, signed short form. It is recommended that these documents be stored together (e.g., in a binder). An explanation of how the consent process was conducted should be kept with the consent documentation. | A copy of both signed documents should be provided to the participant. |
More Frequently-Asked Questions
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.
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.
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.
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.
Need a short form translated into another language?
Contact the Research Translations Team for help:
Blank Translation Certification Letter
Translations
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Bengali |
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Burmese (Zawgyi) |
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Cantonese |
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French |
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Greek |
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Hindi |
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Hmong |
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Igbo |
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Karen |
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Mam |
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Marshallese |
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Mandarin Chinese |
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Nepali |
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Navajo |
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Oromo |
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Pashto |
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Portuguese |
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Rohingya |
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Romanian |
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Russian |
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Swahili |
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Somali |
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Spanish |
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Thai |
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Tigrinya |
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Tongan |
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Turkish |
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Tagalog |
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Tibetan |
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Urdu |
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Ukrainian |
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Vietnamese |
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Wolof |
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| Consent Documents | ||
| Parental Permission Documents | Short Form PP Docs [PDF] Translation Certificates [PDF] |
**All translations certificates are redacted for translator privacy. For an unredacted version of the document for your records, please contact the IRB. You do NOT need to attach these certificates to your IRB application.
TRANSLATED CONSENT DOCUMENTS
| FORMS | Translation Certificate | Document Version Date | Translated from English Version Date |
| Arabic Short Form Consent Document Template |
Translation Certificate Short Form Translation Certificate (Arabic) [PDF] ARCHIVED: Version K1310 [PDF] |
L2815 |
G2012
|
| Bosnian Short Form Consent Document Template |
122010 |
12.20.2010 |
|
| Burmese Short Form Consent Document Template** |
Translation CertificateTranslation Certificate Short Form Translation Certificate (Burmese) [PDF] - Redacted (for unredacted version, please contact the IRB) |
12.14.2016 |
G2012 (072012) |
| Chinese-Cantonese Short Form Consent Document Template |
Translation CertificateTranslation Certificate Short Form Translation Certificate (Chinese-Cantonese) [PDF] |
122010 |
12.20.2010 |
| English Short Form Consent Document Template | N/A |
07.20.2012 (G2012) |
N/A |
| ARCHIVED: English Short Form Consent Document Template | N/A |
04.27.2007, K1310, L2010 |
N/A |
| ARCHIVED: English Short Form Parental Permission Document Template | N/A |
11.20.2013 (K2013) |
N/A |
| ARCHIVED: English Short Form Parental Permission Document Template | N/A |
07202012, 122010, K1310 |
N/A |
| French Short Form Consent Document Template |
Translation Certificate |
C2012 |
12.20.2010 |
| Korean Short Form Consent Document Template |
Translation Certificate |
11.19.2015 (K1915) |
11.10.2015 |
| Mandarin Chinese Short Form Consent Document Template |
Translation Certificate Mandarin Chinese Translation Certification [PDF] - Redacted (for unredacted version, please contact the IRB) |
04.08.2016 (D0816) |
07.20.2012 (G2012) |
| Nepali Short Form Consent Document Template |
Translation Certificate |
122010 |
12.20.2010 |
| Russian Short Form Consent Document Template |
Translation Certificate Russian Short Form Translation Certificate [PDF] ARCHIVED: Version 04.27.2007 [PDF] |
04.25.2016 (D2516) |
07.20.2012 (G2012) |
| Spanish Short Form Consent Document Template |
Short Form Translation Certificate (Spanish) [PDF] ARCHIVED: Version 03.04.2015 [PDF] ARCHIVED: Version 072012 [PDF] ARCHIVED: Version 04.27.2007 [PDF] |
C0415 |
07.20.2012 (G2012) |
| Spanish Short Form Parental Permission Document Template | Translation Certificate Translation Certificate Short Form Translation Certificate (Spanish) [PDF] |
K2013 | K2013 |
| Swahili Short Form Consent Document Template |
Translation Certificate Short Form Translation Certificate (Swahili) [PDF] (send request via email) |
072012 |
07.20.2012 |
| Thai Short Form Consent Document Template |
Translation Certificate |
072012 |
07.20.2012 |
| Thai Short Form Parental Permission Document Template | Short Form Translation Certificate (Thai) [PDF] | 072012 | 07.20.2012 |
| Tongan Short Form Consent Document Template |
Translation CertificateTranslation Certificate |
122010 |
12.20.2010 |
| Vietnamese Short Form Consent Document Template |
072012 |
07.20.2012 |
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| Vietnamese Short Form Parental Permission Document | Translation Certificate Translation Certificate Short Form Parental Permission Translation Certificate (Vietnamese) [PDF] |
072012 | 07.20.2012 |
| Spanish Translations of IRB Consent Template Boilerplate | 03.08.2011 | ||
| Translation Certification Letter Template | 09.30.2015 | ||
| Witness Signature Block for Long Form | 06.12.2012 | ||
| IRB Guidance: Consent Process Models | N/A |
**MS Word may not display this document correctly. If you have the required translation software, you can correct this issue by going to "Review > Language" and selecting the desired language. If you have difficulty working with this document, please contact a member of the IRB Staff to assist you.