Federal regulations require that informed consent information be presented "in language understandable to the subject." Please note that obtaining informed consent in the subject's language is only the beginning of the research. In order to involve non-English speaking subjects, investigators must ensure that all aspects of the study can be conducted in the subject's language. For example, instructions about drug dosing, interviews about symptoms, quality of life surveys, assessments of adverse events and all other communications must be presented to the subject in a way that would provide for their comprehension and safety as well as supplying the study with valid data.
If an investigator expects to enroll non-English speaking subjects, the IRB requires the use of a foreign-language translation of the informed consent document. However, there may be times when a non-English speaking subject is unexpectedly found to be eligible for enrollment. In this case, investigators will not have an IRB-approved written translation of the consent form in the subject's native language.
When such circumstances arise, the investigator may use a written "short form" in the subject's native language as written documentation of the consent process, along with an oral translation of the complete English version of the informed consent document. The translator may be a qualified hospital/clinic staff member or a professional translator. Family members are not allowed to serve as translators for research consent. The family member may or may not understand medical terminology and may have a biased viewpoint about the potential subject's participation in the study. The written "short form" states that the elements of informed consent required by the regulations have been presented verbally to the subject. The IRB must have approved the content of what is to be verbally presented to the subject; therefore, the IRB-approved consent form becomes the basis of the oral translation. A member of the study team must be present during the consent process with the translator. The presence of a study team member ensures that any questions about the study can be answered by a knowledgeable individual. When this method of obtaining consent is used, there must be a witness to the oral presentation. The witness must be fluent in both English and the subject's language. The translator may serve as the witness. In summary, the individuals involved in a "short form" consent process are:
It is important to note that simply finding a translator to verbally translate a research consent form is not compliant with federal regulations. The verbal process must be accompanied by the written short form.
For specific directions on how to obtain legally effective consent in these circumstances, please consult the document entitled Instructions for Using Short Form Consent Documentation