One of the most important aspects of preparing a research plan is designing your consent process.
The University of Utah provides comprehensive guidance on all aspects of the consent document and discussion preparation process.
Resources
Consent Builder
University of Utah researchers have developed an electronic consent building tool for automatically generating consent documents.
The Two-Part Consent Model
Multisite studies using a single IRB (SIRB) model require additional considerations. Balancing the need to maintain consistency of the information presented to participants and local considerations can be challenging. The University of Utah recommends you use a two-part consent model for your multisite SIRB study.
Part 1
Part 1 includes information that doesn’t change from site to site. This would likely include the Study Procedures section, Risks, Benefits, Voluntary Participation, etc.
Most of these sections are the ones required by regulation and will be the same regardless of the geographic location where the research is taking place. Instruct your sites not to alter the information in Part 1.
Static Information
- The sections of the consent that don't change from site to site
- Backgrounds, Study Procedures, Risks, Benefits, Etc.
- Inform sites that these sections should not be altered
Site-Specific Information
- The sections that change at each site
- Person to Contact, Research Related Injury, HIPAA Authorization, Costs & Compensation, language required for local laws
- Ask sites to insert their required language
Part 2
Part 2 will address the requirements of each individual site. This is where local language requirements can be included. Sections like Person to Contact, Research-Related Injury, Costs & Compensation, and HIPAA Authorization are often included in Part 2.
Sites may also have additional considerations related to genetic testing, biospecimen banking, laws related to vulnerable populations or mandatory disease reporting, etc. Work with your local study team to craft this section for each site. Encourage consultation with their local Human Research Protection Program (HRPP) to ensure site-specific requirements are met.
Local Language
If you are preparing a document for use at the University of Utah, the language we require can be found on our website.
Participants with Limited English Proficiency (LEP)
Please begin by reviewing our policy on obtaining consent from participants with Limited English Proficiency (LEP);. It is the responsibility of the reviewing IRB to review and approve the informed consent process.
HRPPs that are relying on an external SIRB for review and approval of research taking place at their institution can have guiding policies that affect how consent from non-English speaking participants is documented, and what language is included in the consent document. It is the responsibility of the study team to design a consent process that meets the requirements of both the SIRB and their HRPP.
What Does the University of Utah Require?
The University of Utah IRB requires recruitment methods, consent processes, and ongoing communication methods with research participants to include adequate provisions for non-English speaking individuals.
For consent documents, we allow researchers to utilize either a fully translated consent document, or a Short Form process when appropriate. The process must be approved by the IRB prior to use.
If you need assistance obtaining a full translation of your consent document(s), please contact the Office of Research Participant Advocacy (RPA).
FAQs
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Please review our Short Form guidance to read more about Short Forms.
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Consult with your local Human Research Protection Program (HRPP) to see if your local policies allow for the use of a Short Form process. If your HRPP allows the use of a Short Form and has a specific Short Form template they require be used, you may use it for your study.
You may also use the University of Utah IRB’s Short Forms, which are publicly available in our Translations Library. If you use the University of Utah’s Short Form, you do not need to attach it to your ERICA application for approval. You are welcome to use our Short Form as a template for non-Utah research as well, but please note that you must submit those to your local IRB or SIRB for approval per their requirements in that case.
If you choose to use any other Short Form template not published in our Translations Library, please attach it to your ERICA application for approval prior to use.
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Please review our Short Form guidance to learn more about how to include a Short Form process in your IRB application.
You may use the University of Utah IRB’s Short Forms, which are publicly available in our Translations Library. If you use the University of Utah’s Short Form, you do not need to attach it to your IRB application for approval. If you use any other Short Form template, please attach it to your IRB application for IRB approval prior to use.
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Researchers are encouraged to provide a fully translated consent form at study initiation, and it may be required by the IRB as a condition of approval. For example, it would be reasonable to expect a full consent form translation when the study population is likely to include a high number of people who speak Spanish or if the study is targeting Spanish-speaking populations. A full consent form translation would also be necessary if a consent process is self-led by the participants, e.g., an online survey study with e-consent, where there is no direct participant contact.
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If you need assistance obtaining a full translation of your consent document(s), please contact the Office of Research Participant Advocacy (RPA).
Attach full translations of documents in ERICA in the appropriate section on the Documents and Attachments page. Attach research translation certifications to the “Other Documents” section for reference.
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It depends. The SIRB is responsible for requiring that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing (45 CFR §46.116 and §46.117). When we are serving as the SIRB, we work with our participating site to ensure the method used to accomplished this is consistent with local considerations and policies.
We offer our local policy as an example if a site would like a baseline to work with. We also refer to federal guidance such as the DHHS guidance on Informed Consent of Subjects Who Do Not Speak English.
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It is helpful, but we encourage you to work with your local study team and the lead study team to ensure local consent requirements are met. If amendments are needed to your site’s approved consent process, the lead study team is responsible for communicating that to the SIRB.
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Yes. We offer short forms in many languages for our research community to use. The only pre-requisite is that the study team have a non-English consent process built into their study and approved by the IRB. After that, you may print out and use any short form available in our Translation Library as needed.
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Specific languages do not need to be specified in their protocol. Sites relying on us for SIRB review may also use our forms if they are acceptable to their local HRPP. If participating sites have their own short forms they would prefer be used at their site, the study team must submit them to the SIRB for approval prior to use.
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No. We do not stamp short forms on a study-by-study basis. However, you must have a non-English consent process built into your study and approved by the IRB. After that, you may print out and use any short form available in our Translation Library as needed.
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Yes. For all prospective research with participant interaction conducted by University of Utah researchers within the state of Utah, the University of Utah IRB requires each study to have provisions for including people who speak Spanish. The details of this local requirement our outlined in our guidance titled “Including Spanish-Speaking Individuals in Research” from the Investigator Guidance Series.
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Not specifically, but researchers are encouraged to provide a fully translated consent form at study initiation for any languages you anticipate will be used more than a few times, and a full translation may be required if deemed appropriate by the IRB as a condition of approval. For example, it would be reasonable to expect a full consent form translation when the study population is likely to include a high number of people who speak Spanish or if the study is targeting Spanish-speaking populations. A full consent form translation would also be necessary if a consent process is self-led by the participants, e.g., an online survey study with e-consent, where there is no direct participant contact.