Series 705 Translations and Language-Based Exclusions

I. Language-Based Exclusion

The Belmont Principle of Justice often requires that non-English speaking populations be permitted the same opportunities as English speakers in research involving human participants. The principle of Justice requires that those who stand to benefit from the research have equivalent opportunities to participate. It also demands that participants be equitably selected into the research, rather than relying on considerations such as ease of access or underresourced research projects. Thus, prospective participants cannot be excluded from research on the basis of language alone when there is a meaningful chance that those same participants stand to receive direct benefits from the research.

Another application of the Belmont Principle of Justice includes that the opportunity to participate in research must be equitable, regardless of the benefits offered. This issue arises most often when broad recruitment strategies are utilized in areas where prospective participants are likely to be non-English speaking.

In all such cases, translations, translators, or bilingual research team members may be considered by the IRB to be a necessary tool for the ethical conduct of research.

II. Written Translation Requirements

Human Subjects Research materials often require the translation of written material from English into another language. There are many ways to ensure that the translated version of materials are as easily understandable as the English version. The USU IRB will approve translations obtained or conducted by the research team using the following methods:

1. Translation by members of the research team or their colleagues who have personal proficiency in the language. In this case, a back translation to English should be provided in the protocol, which back translation must be completed by a different person than the person who completed the initial translation.
2. Translation by a member of Utah State University (or another institution’s) Languages faculty.
3. Certified translation from a reputable service. Utah State University’s IRB encourages the use of inlingua Utah, which has provided translations for many USU-based studies and has demonstrated strong understanding of the research context and the need for carefully considered word choices.
4. Translation of uncertain or other origin that has been reviewed and approved by a language consultant for the IRB. This option requires additional time for completion of the protocol review, as the USU IRB will need to locate a consultant and give them time to complete the review. Consultant reviewers for the IRB do not make edits. They simply inform the USU IRB as to whether the translation is acceptable.
5. Translation by an individual that the IRB has worked with over the course of several projects, and who is known to provide high-quality translations of research materials into the target language.

III. Verbal/Spoken Translations

A translator, or interpreter, may be used to translate, in real-time, the information pertinent to study participation. Translators who only translate information in real-time, and who are not otherwise engaged with the study, are not “investigators” and do not need to be listed on the protocol where they are providing commercial or other services for the researchers, and all of the following are true:

• The services performed do not merit professional recognition or publication privileges;
• The services performed are typically performed by interpreters or translators for non-research purposes; and
• The interpreters or translators do not administer any study intervention being tested or evaluated under the protocol.

Otherwise, the translator or interpreter is a member of the research team and must be listed as study personnel, and be appropriately trained. This also requires that they be appropriately qualified to perform the tasks assigned to them, including having sufficient knowledge of the research and target language to perform that research-related task.