Welcome to the University of Utah IRB Translations Library. Here you will find the
UU IRB Short Form Consent Document, translated into multiple languages. The Short
Form is a tool to help research studies ensure they have the necessary tools to 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.
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?
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.
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:
- 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:
| 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. The English version of the short form |
2. The Consent Document section of the Documents and Attachments Page of the ERICA application. NOTE: The English version of the document will not be used for your consent process, but is required as part of the submission process. |
| 3. The translated version of the short form. | 3. The Consent Document section of the Documents and Attachments Page of the ERICA application. |
| 4. The Interpreter Signature Block on the full, English version of your consent document. | 4. 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. |
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.
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 |
| Interpreter/Witness | 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. | 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.
The Interpreter may serve as the witness in a short form consent process.
If you are using one of the IRB's short forms, additional translation shouldn't be 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 the IRB determines your study is exempt, or minimal risk, it may be acceptable to translate your own document. This is determined on a case-by-case basis. However, the IRB may require you to obtain independent verification of the accuracy of the translation.
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 in some cases.
If the IRB determines your study is exempt, or minimal risk, it may be acceptable to translate your own document. This is determined on a case-by-case basis. However, the IRB may require you to obtain independent verification of the accuracy of the translation.
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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American Sign Language (ASL) |
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Albanian |
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Arabic |
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Armenian |
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Amharic |
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Bosnian |
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Burmese (Unicode) |
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Burmese (Zawgyi) |
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Cantonese |
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Cambodian/Khmer |
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Czech |
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French |
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Farsi |
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Greek |
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German |
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Hindi |
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Hmong |
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Korean |
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Kirundi |
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Marshallese |
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Mongolian |
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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 |
R
Russian |
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Romanian |
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Swahili |
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Samoan |
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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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| 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.