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Relevant IRB Policies and Procedures

It is the policy of Fred Hutch that non-English speaking participants are afforded the opportunity to participate in research when appropriate protections are in place. When non-English speaking participants are enrolled in research, translation and/or interpretive services must be used to facilitate the proper communication of information to participants. All documents translated from English to another language must receive IRB review and approval before use, to ensure that the rights and welfare of research participants are adequately protected. When translation of documents is not feasible, the investigator must receive IRB approval to use a short form consent process with non-English speaking participants.

It is the principal investigator’s responsibility to ensure that non-English speakers are presented with the same opportunity to participate in a research activity as are English speakers. Any plan to exclude non-English speakers from the research must be justified and approved by the IRB.

At the same time, investigators should carefully consider the ethical and legal ramifications of enrolling participants when a language barrier exists. If the participant does not clearly understand the information presented, the participant's consent will not truly be informed and may not be legally effective.

 

Translating Materials

When a study targets a particular subject population that does not speak or read English, the materials a participant would see or hear during recruitment or during the study need to be translated, reviewed, and approved by the IRB. Materials may include, but are not limited to: recruitment ads, flyers, or broadcasts; consent documents; study tools; letters; or other communications.

General Requirements

  • The written document(s), including transcriptions of spoken materials, submitted for review and approval must be translated
  • A translation certification must be provided with the translated documents. If a certification is unavailable, the person providing the translation service may complete the Translation Certification Form

 

Assisted by Interpreters

Whenever a researcher interacts with a participant or the participant’s legally authorized representative (LAR) and does not speak that person’s language, an interpreter must be used to ensure information is properly communicated. An interpreter must be sufficiently fluent in both languages to effectively facilitate communication between parties. The interpreter should be a member of a qualified professional interpretative service. Family members of the participant shall not serve as interpreters except in exceptional circumstances, such as emergencies. It is preferred that an interpreter be physically present.

 

Short Form Consent Process

When researchers unexpectedly encounter a potential research participant who does not speak English (or who has limited English proficiency), a short form consent process can be used with approval from the IRB. A short form consent document captures that the elements of informed consent required by 45 CFR 46.116 (or, for FDA-regulated studies, 21 CFR 50.25) were presented orally to the research participant.

General Requirements

Documents
  • An IRB-approved written summary of what is to be discussed with the research participant or LAR. The IRB-approved English language informed consent document (the “long form”) may serve as the written summary.
  • An IRB-approved short form written consent document stating that the elements of informed consent have been presented orally to the participant or the participant’s LAR. The short form is written in the language of the research participant or the participant’s LAR.
Conducting Consent

The following individuals, at minimum, must be present to conduct the short form consent process:

  • Person obtaining consent
  • Participant (or the participant's LAR)
  • Witness/Interpreter

The person obtaining consent, with the assistance of an interpreter if needed, verbally provides the participant the elements of informed consent required by regulations at 45 CFR 46.116 and/or 21 CFR 50.25 and any additional pertinent information included in the IRB-approved English version of the long form.

A witness to the oral presentation, proficient in English and in the research participant’s language (or the LAR’s language, if applicable), must be physically present throughout the entire consent process. The witness must be an impartial witness. When the person obtaining consent is assisted by an interpreter, the interpreter may serve as the witness. Alternatively, both an interpreter and a witness may be present during the consent discussion.

If the participant agrees to participate in the research, the following signatures are required by 45 CFR 46.117(b)(2) and/or 21 CFR 50.27(b)(2):

  • The research participant (or LAR) signs the short form.
  • The witness signs the short form and the written summary.
  • The person obtaining the consent signs the written summary.

The rule of thumb is each person signs the form(s) they can read. The participant should not sign a consent document written in a language they do not understand.

Copies of the summary and the short form must be given to the participant or participant's LAR.

See an illustration of the short form process, below.