Non-English Speaking Participants

Overview

It is the policy of Fred Hutchinson Cancer Center (Fred Hutch) that non-English speaking participants are afforded the opportunity to participate in research with appropriate protections in place, including interpreter and translation services as needed 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.

This page refers to “non-English speakers” and this should be understood to include individuals who either do not speak English or those with another language preference who are unable to understand English at a level of proficiency that would allow them to participate in meaningful informed consent. 

The same principles and processes apply when a non-English speaker is acting as the patient’s legally authorized representative (LAR) for informed consent.

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Interpreter Services in Research

Whenever a researcher interacts with a potential or current participant or the participant’s legally authorized representative (LAR) and does not speak that person’s preferred language, an interpreter must be used to ensure information is properly communicated.

The interpreter must be sufficiently fluent in both languages to effectively facilitate communication between the 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. However, there may be circumstances when the interpreter is unable to be physically present, and instead assists with the consent discussion remotely (i.e., phone, video conference, etc.).

In the Fred Hutch clinic, qualified medical interpreter services are available by contacting interpreter@fredhutch.org. 

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Translated Materials in Research

When a study targets a non-English speaking population, the materials a participant would see or hear during recruitment and during the study first need to be translated, reviewed, and approved by the IRB up front. 

Materials requiring translation may include but are not limited to:

• consent documents
• recruitment ads, flyers, or broadcasts
• study tools such as drug diaries, questionnaires, etc.
• participant letters
• other participant-directed communications

The Fred Hutch Interviewing, Translation and Interpretation Services (ITIS), part of the Shared Resources Collaborative Data Services (CDS) group, is available to translate study documents into Spanish and to coordinate translation requests for most other languages with existing vendors. Complete the ITIS REDCap intake form to request a translation or a quote: https://redcap.link/fhcctranslationrequest

General Requirements

• It is especially important to use uncomplicated language in study documents that are to be translated
• The written document(s), including scripts of spoken materials, submitted for review and approval must be translated.
• A translation certificate (also known as a certificate of accuracy) must be provided with the translated documents.  If a certificate is unavailable, the person providing the translation service may complete the IRO's Translation Certificate Form.

If the PI proposes to enroll non-English speakers but not to translate study documents besides the consent, the PI must provide a written memo with sufficient justification to the IRB, such as:

• A written questionnaire will be administered orally using an interpreter in clinic (only appropriate for questionnaires that are not validated).
• A questionnaire will not be administered for non-English speaking participants (only appropriate if the data collection is not critical data to meet the research aims).
• The non-English speaking participant has an English-speaking caregiver who can interact with English materials (i.e., can complete an English drug diary on behalf of the participant). 

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Short Form Consent Process

NEW:  As of January 1, 2025, there is now a requirement to translate the full consent form after you use the short from process to consent a non-English speaker. View the IRO announcement, draft policy, frequently asked questions (FAQs), and a training video here.  

When researchers unexpectedly encounter a potential research participant who does not speak English and there is insufficient time and opportunity to translate the consent form before enrollment, a Short Form Process can be used with prior approval from the IRB. This process is often used in clinical trials to facilitate enrollment of non-English speakers.

A short form consent document captures that the required elements of informed consent (as required by 45 CFR 46.116 or, for FDA-regulated studies, 21 CFR 50.25) were presented orally to the research participant. The investigator uses the short form consent process to consent the participant, with an interpreter present, and then must provide the participant a fully translated study-specific consent form as soon as possible.

The short form consent is currently available translated in over 50 languages.  Download a copy of the translated short form for use with a specific non-English speaker from the Translated Short Forms webpage.

If the IRO does not have the short form translated in a needed language or dialect, the IRO coordinates the translation upon request.

Review the short form process tip sheet to ensure you first have all the requirements in place before using the short form process:

Short Form Process Tip Sheet

This tip sheet supports the use of the short form process for consenting non-English speakers.

Short Form Process Worksheet

This worksheet can be used to help determine who is responsible for signing documents when consenting a non-English speaker.

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 translated short form.
• The witness signs the short form and the English consent form.
• The person obtaining the consent signs the English consent form.

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.

See an illustration of the short form process, below.

After use of the short form

If the participant chooses not to enroll, the short form process ends there.

As of January 1, 2025, if a participant chooses to enroll using the short form process, research procedures may begin immediately.  However, the investigator should then also:

1. Obtain a full translation of the English consent form in the participant’s preferred language (see ITIS information above to obtain translation services).
   
2. Submit the translated consent form for IRB approval within 30 days after use of the short form consent process.
3. After IRB approval, the translated form must be provided to the participant as soon as possible and within 2 weeks. It may be provided to the participant via MyChart, email, mail, or at the next clinic visit.  A re-consent discussion is not required. 

Any other written study materials for participants should be translated as well, to support the individual’s participation, unless the IRB has approved an alternative process.  Note that ITIS also provides services for questionnaire administration in Spanish and may facilitate other services of this type. 

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