Short Consent Form Process For Non-English Speaking Subjects

A short form written consent document may be used with incidental, unanticipated non-English speaking potential subjects who present for enrollment. When enrollment of non-English speaking subjects is anticipated, a translated consent form should be used instead of the short form. The IRB has the discretion to allow the use of the short form if the number of anticipated non-English speaking subjects is few, if requiring the investigator to provide a translation of the full consent form would be unduly burdensome, and if the IRB determines that the short form consent process will adequately protect the rights and welfare of potential non-English speaking subjects.

To request approval to use the short form process in an initial submission or amendment request, the Principal Investigator:

  • indicates that non-English speaking subjects will be enrolled;
  • describes the plans for
    • conducting the consent process,
    • communicating with non-English speaking subjects in emergency situations,
    • interpreting during study visits, and
    • translation of additional study materials;
  • specifies the language(s) to be used; and
  • identifies the English narrative describing the study that will be translated during the consent process (which may be the entire IRB-approved consent form).

The IRB will review the submission to ensure that the plans are adequate to ensure that a truly informed, legally effective consent is obtained and to ensure that communication between the research staff and subjects throughout the research will protect the safety and welfare of subjects and the integrity of the research data.

The progress report for continuing review asks whether any subjects have been enrolled using the short form consent process, and if so, how many and in what languages, so that the IRB can consider whether the pattern of short form use indicates that the investigator should instead use a translated consent form.

 The following English and translated versions of the short form do not need to be submitted to or stamped by the IRB because they have already been validated. The English narrative must be approved by the IRB prior to use.

Primary teaching affiliate
of BU School of Medicine