Institutional Review Board

• 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.

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.

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.

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.

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.