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To ensure that the burdens and benefits of research are fairly distributed, Federal regulations for the protection of human research subjects require that Institutional Review Boards (IRBs) consider whether selection of subjects is equitable (45CFR 46.111).
A related ethical principle is that the target sample for a study should be representative of the population that has the potential to benefit from participation in the research. For this reason, the IRB requires the inclusion of non-English-speaking persons in research studies that have the prospect of direct benefit to subjects unless there is a compelling justification for their exclusion. Examples of acceptable justifications include:
- Study requires use of data collection instruments that have not been validated scientifically in languages other than English.
- Study will include participants already known to the PI and who all speak English (this often is the case for “follow-up” studies in which only a known group of current subjects will be eligible to participate in the second phase of study).
- Study is of a disease or disorder so rare that local enrollment is expected to be five or less.
Federal regulations also require 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). Where informed consent is documented in accordance with 46.117(b)(1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent.
When a potential research subject expresses interest in participating in a study and is unable to speak or read English, they must be presented with a translated informed consent document unless the IRB has approved the use of a short form. Investigators should plan ahead for expected subject populations who are unable to speak or read English and should arrange for translation of the IRB-approved English informed consent/assent form prior to beginning study recruitment. The informed consent process is the same for non-English-speaking subjects; however, a qualified interpreter must be present to facilitate the consent conversation between the investigator and the potential subject prior to enrollment.
When non-English speakers will be enrolled, a professional translation of the complete consent/assent form(s) is required unless the IRB has granted a waiver of documentation of informed consent or has approved the use of a short form. The translated forms must be stamped as approved by the IRB prior to use.
The following documents should be translated before enrolling non-English-speaking subjects on a study:
- The IRB-approved English informed consent/assent document(s), and
- The Authorization for the Use of Personal Health Information for Research (when applicable).
Note: Templates are available in Spanish on the IRB forms page.
- All translated consent/assent forms must have an IRB approval stamp on each page prior to their use. Copies of the original-stamped document should be made for consenting subjects.
- If any of the English IRB-approved documents are modified, new translated documents containing the changes must be submitted to the IRB for approval. Translated consent/assent forms that no longer match the most recent IRB-approved English version may NOT be used to consent/assent subjects. When the IRB requires re-consent of enrolled subjects, non-English-speaking subjects must be re-consented with new translated documents.
- Once the English version of each document is approved by the IRB, investigators may forward them for translation as described below.
- Once the documents have been translated, investigators should submit them to the IRB.
For purposes of research:
- An interpretation is a verbal exchange between the subject (or their representative) and an investigator (or other member of the study team authorized to obtain consent), which is facilitated by an interpreter who is fluent (can speak, read, and write) in English and the language of the subject.
- Translation is the process of translating a written document (e.g., consent form) from one language into another, assuring the language of the translated document has the same meaning as the written document in the first language.
Language And Translation Services are provided for your convenience. Although investigators are free to use the services of outside companies for translation and interpretation, please note that the William P. Clements Jr. University Hospital language service is staffed by UT employees and is located on site.
Federal regulations for the protection of human subjects at 46.117(b)(2) permit oral presentation of informed consent information in conjunction with an IRB-approved short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary. (IRB forms page, including Short Forms)
When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.
At the time of consent, (i) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by an interpreter, the interpreter may serve as the witness.
The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of 46.117(b)(2). Expedited review of these versions is acceptable if the protocol, the full English-language informed-consent document, and the English version of the short-form document already have been approved by the convened IRB.
It is the responsibility of the IRB to determine which of the procedures at 46.117b is appropriate for documenting informed consent in protocols that it reviews.
IRB approval is required prior to the use of the short form. Investigators may request the use of the short form for studies with relatively low risks, or for cooperative group trials with very low subject accruals. However, the IRB may require the full translation of the consent/assent form for higher risk studies.