Definitions

Interpretation is the spoken exchange of communication between two languages.

• A certified interpreter is an individual who has passed a certification exam given by an accredited entity to verify his/her professional interpretation skills in a certain language.
• A qualified interpreter is a person who speaks English and Spanish and facilitates communication either through virtual, in-person or over the phone. NOTE: for the purposes of this guidance, the interpreter would be a Spanish interpreter.

A native speaker is an individual who acquired a language as their first language and has an intuitive understanding of the language including nuances and cultural context. They must have also maintained fluency through continued use in personal, educational, and professional contexts. For the purposes of this guidance, a native speaker who has proficiency in English may act as a translator or interpreter only in acceptable circumstances detailed below.

Translation is the change of written materials from one language into another.

• A certified translator is an individual who has passed a certification exam given by an accredited entity to verify his/her professional translation skills in a certain language.
• A qualified translator is person who speaks and writes in both languages, English and Spanish, and converts a document into the target language. NOTE: for the purposes of this guidance, the translator would be a Spanish translator.

Guidance

Spanish is the second-most common language spoken in the state of Utah. The principles of justice and equitable selection of participants compel the University of Utah IRB and research community to make adequate provisions for including Utahns who speak Spanish in research. This policy is effective July 1, 2023.

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 non-exempt study to have provisions for including people who speak Spanish. In this policy, a person who speaks Spanish is a person for whom a) Spanish is their native or only language spoken, and/or b) Spanish is their preferred language for communication.

Provisions must include the following:

1. Recruitment methods for people who speak Spanish, including translated recruitment materials and interpretation services if individuals would like to discuss the study.
2. Consent processes for people who speak Spanish, including translated consent documents and interpretation services during the consent process and discussion.
3. Methods for ongoing communication with and data collection from participants who speak Spanish, including translated study materials and interpretation services for ongoing communication.

It may be reasonable to modify study procedures for Spanish-speaking participants to facilitate efficient, effective communication and data collection. For example, English-speaking participants may be asked to record side effects they experience in writing, where Spanish-speaking participants may be asked to provide answers orally through an interpreter so that their responses can be recorded by the study team in English.

Spanish Consent Methods

Studies may utilize either a full Spanish translation of the consent document or the Spanish Short Form consent process, depending on what is most reasonable for the study.

Researchers are encouraged to provide a full consent form translation at study initiation, and it may be required by the IRB as a condition of approval. 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.

If the likelihood of enrolling a person who speaks Spanish is considered low at study initiation, the use of a Spanish Short Form is recommended by the IRB to conserve study and translation resources. Limits on continued use of the Spanish Short Form are considered according to the following guidelines:

1. For studies that are greater than minimal risk, a Spanish Short Form may generally be used up to two (2) times at which point the IRB expects the full consent form to be translated and used for all subsequent Spanish-speaking participants who enroll.
2. For studies that are minimal risk, a Spanish Short Form may be used to enroll all Spanish-speaking participants, at the discretion of the IRB. Limits may be set by the IRB on a study-specific basis, based on the following factors:
   1. The complexity of the study procedures.
   2. The complexity of the consent process.
   3. The length of time participants are expected to be in the study.
   4. The number of Spanish-speaking participants expected to enroll or are observed to have been enrolled via ongoing reporting to the IRB.

Refer to the IRB’s Short Form Instructions for Use for details on how to document informed consent using a Short Form.

Who can Perform Translation and Interpretation?

To ensure that high-quality communication occurs between the study team and Spanish-speaking participants, the following standards must be met for those performing document translation and interpretation.

Translation of written materials

Who can serve as a qualified translator? This individual must read, speak, and write the native language (in this guidance, Spanish) and English. A translation certification must be submitted. For a sample translation certification letter, see the IRB website. See specific restrictions based on study risk in the following table.

For written recruitment materials and written study materials that involve complex explanation of study concepts, study procedures, risks, etc., translation must be performed by someone who is qualified as outlined above.

For direct written communication through email or text that does not require complex delivery of information, translation may be performed by a study team member who is proficient in speaking both the native language (in this guidance, Spanish) and English. Examples include study visit scheduling; study reminders; simple study instructions that do not involve substantial risk; and collecting data that would not expect a report of substantial risks experienced by the study participant.

Interpretation of Spoken Conversation

Who can serve as the qualified interpreter for the consent process and any re-consent processes? This individual must read and speak the native language (in this guidance, Spanish) and English. See specific restrictions based on study risk in the following table.

For recruitment conversations and study visits that involve complex discussion of study concepts, study procedures, risks, etc., interpretation must be performed by someone who is qualified to conduct the consent process as outlined above.

For recruitment conversations and study visits that do not require complex delivery of information, interpretation may be performed by a study team member who is proficient in speaking both the native language (in this guidance, Spanish) and English. Examples include study visit scheduling; study reminders; simple study instructions that do not involve substantial risk; and collecting data that would not expect a report of substantial risks experienced by the study participant.

Exceptions to this Requirement

Not all prospective studies will be well-suited to include people who speak Spanish. The investigator may request a study-specific exception to this requirement by providing adequate justification in the IRB application. Reasons for exception may include the following:

1. The study population does not reasonably include people who speak Spanish. Examples include, but are not limited to:
   1. University students who are expected to communicate in English as requirement of their admission are the target study population.
   2. The study population speaks a language other than English or Spanish.
2. The study methodology cannot be reasonably modified to accommodate people who speak Spanish without a large expenditure of resources. Examples include:
   1. The study uses validated surveys and questionnaires that are not available in Spanish.
   2. The study requires a large amount of self-reported, written data collection from participants and the options for translating responses back into English are not feasible.

Additional Considerations

Language Services for Research

The Office of Research Participant Advocacy (OPRA) provides certified translation and interpretation services specifically for research. Contact them to discuss services for your study.

Studies For You Recruitment Listings in Spanish

The Office of Research Participant Advocacy provides no-cost Spanish translation of all recruitment listings on the University of Utah Studies For You website. To add a recruitment listing to Studies For You, select this option in the IRB application in the recruitment methods section. The listing will be posted in both English and Spanish automatically upon receipt of IRB approval for the listing text.

Veterans

If the primary study population involves veterans, an exception may be requested since veterans are expected to communicate in English as a requirement of their admission to the United States military.

Exempt Research

Studies that are determined to be exempt need not adhere to this policy but are encouraged to make provisions to include Spanish-speaking individuals.

Documents and References

Studies For You FAQ

Studies For You Website

Office of Research Participant Advocacy

University of Utah IRB Short Form Instructions for Use

University of Utah IRB Translation Library

Points to Consider

Appendices

Appendix A: Frequently asked questions (FAQs) regarding the University of Utah IRB’s policy of the including Spanish speaking individuals 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. 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
3. Who can act as an interpreter? The answer will vary depending upon the type of study and the type of conversations requiring interpretation. Please see the chart above for the details.
4. If a study coordinator is fluent in Spanish, can they speak directly to the participant in Spanish during the consent process, or must they speak in English with an interpreter translating? A fluent Spanish-speaking coordinator may speak directly to the participant in Spanish during the consent process. However, a certified interpreter must still be present. The interpreter ensures that the information conveyed is accurate and consistent. The interpreter may intervene if any discrepancies arise during the conversation.
5. Can I use contracted hospital interpreters? Yes
6. Can study personnel certify as interpreters? Study personnel who wish to serve as certified interpreters must demonstrate fluency in Spanish and English and complete a certification exam given by an accredited entity to verify his/her professional interpretation skills. University Health employees may be approved to serve as interpreters for patient care by completing the evaluation and training by the Interpreter Services Department (Policy: Interpreter Services/Language Assistance). Questions may be directed to the Interpreter Services Department.
7. 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 for your study.
8. What if I have not budgeted for translation of study materials? Contact the Office of Research Participant Advocacy to discuss.
9. Can I use the Short Form to document consent if I’ve requested a Waiver of Documentation of Consent (no signature)? A short form is used to document the consent process, including obtaining a signature. A Waiver of Documentation of Consent means that a signature is not required to document consent. Study teams should consider translation of the consent cover letter. If an oral consent process is used with the assistance of an interpreter, detailed notes about the consent process should be recorded. Study teams may use the Consent Process Documentation Note found in the Office of Quality Compliance Toolkit.
10. 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? While the IRB does not require all studies to make provisions to include other-language speakers, the IRB may set study-specific requirements and limits based on the context of the study.

Footnotes

[1] Based on the Interpretation Code of Ethics a family member or friend should not be used as an interpreter.

https://uoflhealth.org/articles/why-medical-interpreting-should-not-be-left-to-family-members/

https://minorityhealth.hhs.gov/omh/Content.aspx?ID=9119&lvl=2&lvlid=8