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This refers to individuals who do not speak English or who have another language preference and are unable to understand English well enough to participate in meaningful informed consent.
Participants should have the opportunity to take part in research with appropriate protections in place, including interpreter and translation services as needed to support clear communication. The IRB must approve any plans to exclude non-English speaking participants in research.
These expectations are based on Fred Hutch’s core values and commitments to diversity and health equity, and on the 2023 updated FDA guidance and the Washington state law on Diversity in Clinical Trials (RCW 69.78.040).
Yes. The same principles and processes apply when a non-English speaker is acting as a legally authorized representative (LAR) or consenting as the parent/guardian of the participant.
When researchers unexpectedly encounter a potential participant who does not speak English and there is not enough time to translate the consent form before enrollment, a short form consent process may be used with prior IRB approval. A tip sheet supports the process.
The short form includes the required elements of informed consent, and those elements are presented orally to the participant with a qualified interpreter present.
The participant or LAR signs the translated short form. The witness signs both the short form and the English consent form. The person obtaining consent signs the English consent form. A worksheet is available to support this process.
No. The participant should not sign a consent document written in a language they do not understand.
If the participant enrolls, the study team must obtain a translation of the full English consent form in the participant’s preferred language, submit it for IRB review as soon as possible, and provide the approved translation to the participant as soon as possible.
The translated consent form should be submitted as soon as possible, and no later than 30 days after use of the short form.
The fully translated consent form should be provided to the participant as soon as possible, and no later than two weeks after IRB approval of the translated consent form.
No. A re-consent discussion is not required.
No. A signature is not required on the fully translated consent form after short form enrollment.
It may be provided by MyChart, email, mail, or at the next clinic visit (if within the required timeframe).
Yes. Research procedures may begin immediately after the participant consents using the short form process.
This gives participants a written consent document in their own language that they can refer to throughout the study, just like any other participant. It also supports the regulatory expectation that informed consent materials be provided in a language the participant or LAR understands.
Nothing further is needed. The full English consent form only needs to be translated if the participant is enrolled.
Yes. Fred Hutch’s policy is consistent with UW and Seattle Children’s: All three institutions require translation of the full consent form after use of the short form process.
Once a translated full consent form is available in a language, future participants speaking that language should be presented with the fully translated consent form at initial consent. The short form consent process should not be used.
If the participant is still on study and the English consent form is revised, the translated consent form should also be revised and used for any required re-consent process.
Yes. It is best to obtain IRB approval of the revised English consent first, before starting a new translation request, in case the IRB requires changes to the revised English form.
Yes, generally other participant-facing materials should be translated to support participation. This may include study diaries, questionnaires, letters, or other participant-directed communications.
Sometimes. The PI may propose alternatives to translating other participant-facing materials, and the IRB will consider them in the context of the study.
The PI may propose that it be administered orally with an interpreter, depending on the study and whether that approach is appropriate.
Yes. Provide a translation certificate, also called a certificate of accuracy, with translated documents for IRB review. If a certificate is not available, the translator may complete the IRB's Translation Certificate form.
An interpreter should be used for the consent discussion with the parent or guardian, and translated materials may be needed depending on the study.
If the IRB approved an assent process, a verbal assent process facilitated by an interpreter can be used with a non-English speaking child participant, in lieu of a separate written assent.
The consent and assent process should be handled in the appropriate language for each person, with interpreter support as needed.
Investigators should first look for existing study funds to cover translation costs. If needed, bridge funding may be available for qualifying studies. Additional information and FAQs are available on the Bridge Funding for Translations webpage.
Yes. Teams should plan for translation costs in study budgets whenever translation may be needed.
Translation services are available at Fred Hutch through Interviewing, Translation and Interpretation Services (ITIS), part of Shared Resources Collaborative Data Services (CDS), which can translate Spanish in-house and coordinate other languages with vendors.
UW-led studies should review the UW’s resource, Language Access Bridge Funding – Office of Healthcare Equity. If UW-led oncology research requires translation that you’ve confirmed cannot be covered by UW’s fund, you may then apply for Fred Hutch institutional funding.
Qualified medical interpreter services in the Fred Hutch Sloan Clinic are available by contacting interpreter@fredhutch.org.
Contact the Fred Hutch Interviewing, Translation and Interpretation Services (ITIS), part of Shared Resources Collaborative Data Services (CDS).
Resources for translation, interpretation, and other communication services or quotes for services are available on this Clinical Trials Resources page (UW Net ID required). Questions about these resources can be directed to uwlaca@uw.edu.
Yes. 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. Fred Hutch accepts interpreters who are certified or qualified through DSHS, and also accepts CCHI or NBCMI national certification. For remote interpreting, Fred Hutch also accepts vendor-specific testing, training, and quality assurance programs.
It may be acceptable, yes. However, please also be aware of the institutional “Bilingual Employee Policy” (available on PolicyStat), which indicates that to serve in medical roles, the individual must have taken a validated test OR provided proof of university-level education completed in their field of study in a language other than English.
In-person interpretation is preferred. If an in-person interpreter is not available, interpretation may be provided remotely by phone or video.
Yes. Participating sites relying on our IRB must follow Fred Hutch IRB policies, including the requirement to provide a fully translated consent form after use of the short form consent process.
The site should follow the most restrictive applicable policy.
Either may be used. The Fred Hutch Participating Site Supplement, which is required as part of the site’s submission to our IRB, asks the site to identify its plan. That plan may include:
- Fred Hutch short form versions that are already IRB approved. The site does not need to submit these for our IRB review.
- Site-specific short forms that are already approved by the site’s local IRB. The site does not need to submit these for our IRB review.
- Site-specific short forms that are not yet approved. The site must submit the English version and any translated version(s), along with the certificate of translation, for our IRB review.
Yes. The requirement applies to Fred Hutch investigators using the short form process, regardless of the IRB of record.
Teams should follow the most restrictive applicable policy.
Yes. There is a single IRB-approved English short form version that applies under either version of the Common Rule.
Contact the Institutional Review Office at IRO@fredhutch.org.
If you have questions related to a specific IRB submission in process, and that submission has already been assigned an IRB Coordinator in Hutch IRB, please contact that individual instead.
For translation support and estimates, contact Interviewing, Translation and Interpretation Services (ITIS), part of Shared Resources Collaborative Data Services (CDS).
Contact Compliance at request@fredhutch.org.