Non-English Speaking Participants

Interpreter Services in Research

An interpreter should be used to ensure research information is communicated accurately.

The interpreter must be fluent in both languages and able to facilitate the discussion effectively. Whenever possible, use a qualified professional interpreter service. Family members of the participant should not serve as interpreters except in exceptional circumstances, such as emergencies.

In-person interpretation is preferred. If an in-person interpreter is not available, interpretation may be provided remotely by phone or video.

Qualified medical interpreter services in the Fred Hutch Sloan Clinic are available by contacting interpreter@fredhutch.org. 

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Translated Materials in Research

When a study expects to enroll non-English speaking participants who speak a specific language, the materials participants will see or hear during recruitment and throughout the study should be translated, reviewed, and approved by the IRB before use. 

Materials that may need translation include:

• Consent documents
• Recruitment ads, flyers, or broadcasts
• Study tools such as drug diaries and questionnaires
• Participant letters
• Other participant-directed communications

The Fred Hutch Interviewing, Translation and Interpretation Services (ITIS), part of Shared Resources Collaborative Data Services (CDS), can translate study documents into Spanish and coordinate translation requests for most other languages with existing vendors. Use the ITIS REDCap intake form to request a translation or a quote.

General Requirements

• Use simple, clear language in documents that will be translated.
• Submit written participant materials, including scripts of spoken materials, for IRB review and approval before use.
• Provide a translation certificate, also called a certificate of accuracy, with translated documents.  If a certificate is not available, the translator may complete the IRB's Translation Certificate Form.

If the PI proposes to enroll non-English speakers but not translate study materials beyond the consent, the PI must provide a written justification to the IRB. Examples may include:

• A written questionnaire will be administered orally with an interpreter in clinic, when the questionnaire is not validated.
• The questionnaire is not critical to meeting the research aims.
• The non-English speaking participant has an English-speaking caregiver who can interact with English materials, such as completing an English drug diary on the participant's behalf. 
• Limited institutional funds are available for unfunded studies to meet translation expectations.

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Short Form Consent Process

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 Consent Process may be used with prior IRB approval. This process is often used in clinical trials to facilitate enrollment of non-English speakers.

The short form consent document includes the required elements of informed consent as required by 45 CFR 46.116 or, for FDA-regulated studies, 21 CFR 50.25. Those elements are presented orally to the research participant with an interpreter present. 

The current short form consent is available 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 participant agrees to participate in the research, the following signatures are required:

• The 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.

As a rule, 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.

A short form consent process tip sheet and worksheet are available to help teams prepare and document the process.

See an illustration of the short form process, below.

After Short Form Consent

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

If the participant enrolls using the short form consent process, research procedures may begin immediately.  The study team must then:

1. Obtain a translation of the full English consent form in the participant’s preferred language.
   
2. Submit the translated consent form for IRB review as soon as possible, and no later than 30 days after use of the short form.
3. After IRB approval, provide the translated consent form to the participant as soon as possible and within two weeks. 

The translated consent form may be provided by MyChart, email, mail, or at the next clinic visit.  A re-consent discussion is not required. The study team should remain available, with interpreter support as needed, to answer participant questions.

Any other written study materials for participants should also be translated when needed to support participation, unless the IRB has approved an alternative process. 

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Resources

• For answers to common and scenario-specific questions, refer to the FAQ: Non-English Speaking Enrollment and Consent page
• For questions about translation costs and institutional funding, see the Bridge Funding for Translations page
• Translated Short Forms webpage
• Short Form Process Tip Sheet
• Short Form Process Worksheet
• ITIS Translation request form
• The Clinical Research Support group offers an online training module called "Consenting Non-English Speakers."

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