Medical Translation of Informed Consent
for Non-English Speaking Individuals

Informed Consent Translation Services for LEP Patients

According to Federal Regulations, informed consent must be received from all patients and subjects prior to performing medical treatment or testing. All information pertaining to informed consent must be presented in writing and in a language understandable to the individual. If the individual is a non-English speaker, all informed consent documentation must also contain a foreign language translation

However, the law does make room for an exception to the written documentation requirement. According to 46.117(b)(2), an oral presentation of informed consent may be used. When oral informed consent is used, both a short form written consent document stating the elements of consent presented and a written summary of the oral presentation must accompany it.

In order to be legally binding, a witness must be present at the time of the oral presentation. Finally, the individual must be given a copy of the short form informed consent document.

When the oral informed consent exception is used with a non-English speaking individual, the following accommodations must be made:

  • The oral presentation must be made in the patient’s language through a foreign language interpreter.
  • The short form written document must contain a foreign language translation.
  • The witness must be fluent in both English and the foreign language of the individual.
  • A boilerplate, English language informed consent document will satisfy the written summary requirement and no foreign language translation is needed.

See, in general, Richards, Edward P. and Katharine C. Rathbun. (1999): Medical Care Law. Boston: Jones & Bartlett Publishers, Inc.; and 45 CFR Sections 46.116 and 117

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