Spanish is the second-most common language spoken in the state of Utah. Approximately 10 percent of people in the state of Utah and 14 percent of people in Salt Lake County speak Spanish at home. Currently, the University of Utah IRB requires the inclusion of Spanish-speaking individuals in research on a case-by-case basis.

At the beginning of 2022, the IRB began the process of developing a policy to require all University of Utah researchers to make provisions to include individuals who speak Spanish in research. Two of the guiding principles of research ethics, 1) justice, and 2) equitable selection of participants, compel the University of Utah IRB and research community to make adequate provisions to include Spanish speakers in research.

Prior to implementation of a policy requiring researchers to make adequate provisions for the inclusion of individuals who speak Spanish, the University of Utah IRB has:

• Engaged the research community in sharing plans to develop this policy.
• Sought feedback from the research community.
• Provided a translator-verified, IRB-approved version of the Spanish Short Form.
• Approved a change to the IRB’s short form policy, which no longer requires translated short forms to be attached to the IRB application, making it a simplified process with fewer documents to submit to the IRB.

This new policy, Investigator Guidance Series: Inclusion of People Who Speak Spanish in Research will be effective July 1, 2023. In anticipation of the effective date, the policy is being released with this announcement for review. Please see the timeline below for implementation of the policy.

July 1, 2023:  All new, prospective studies with participant interaction conducted by University of Utah investigators within the state of Utah submitted after July 1, 2023, must adhere to this new policy to receive IRB approval.

April 1, 2024: All previously approved, prospective studies with participant interaction conducted by University of Utah investigators within the state of Utah that are open to enrollment and submit for continuing review after April 1, 2024, must adhere to this new policy to receive renewed IRB approval.

Frequently Asked Questions (FAQs) regarding the University of Utah IRB’s policy of inclusion of people who speak Spanish in research

1. If my study was approved before July 1, 2023, and does not expire because IRB does not require continuing review, will my study have to adhere to this new policy? No, but investigators are encouraged to make provision for the inclusion of Spanish-speakers and submit an amendment.
2. My study was approved before April 1, 2024. What do I need to do?While it is true that as of April 1, 2024, we are requiring the inclusion of Spanish speaking individuals in studies that are still open to enrollment, we are enforcing this via each study’s continuing review application.  If your next continuing review isn’t due until after April 1, 2024, we would not enforce this policy for your study until you submit that continuing review application, provided you are still open to enrollment.
3. If my study is currently approved to use a Short Form consent process, do I need to continue to attach the translated versions in ERICA? No.
4. Who can act as an interpreter? Please see the IGS: Inclusion of People who Speak Spanish in Research for the details.
5. Can I use contracted hospital interpreters? Yes.
6. How much should I budget for the translation of study materials? The Office of Research Participant Advocacy provides certified translation and interpretation services specifically for research.  Contact them to discuss services and fees for your study.
7. What if I have not budgeted for translation of study materials? Contact the Office of Research Participant Advocacy to discuss.
8. Are there exceptions to this policy? Yes, see details in the IGS: Inclusion of People who Speak Spanish in Research.
9. How do I get my Study Locator listing translated into Spanish? The Office of Research Participant Advocacy provides no-cost Spanish translation of all recruitment listings on the University of Utah Study Locator website (studylocator.utah.edu). To add a recruitment listing to Study Locator, select this option in the IRB application in the recruitment methods section.
10. When will my study locator listing be translated into Spanish and posted to the Spanish Study Locator website (https://studylocator.utah.edu/es/index.php )? The Study Locator study summary is translated into Spanish once the IRB approves the English Study Locator summary via a new study application, amendment, or continuing review with amendment. The translation turnaround time varies but is generally available within 5 to 7 business days. The Spanish translation will be posted to the site once the PI/study team amends the study to include it and it has been IRB approved via an expedited amendment.
11. Do the same requirements and limits placed on use of the short form for people who speak Spanish apply to people who speak other languages? Generally, yes. The IRB can set study-specific requirements and limits based on the context of the study.