New Short Form Translation Requirement

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 the consent discussion, a “short form consent process” can be used with prior approval from the IRB. The participant receives a generic “short form” that is pre-translated into their language but does not include any study-specific information. An interpreter supports the consent discussion, referring to the full English consent form. IRO has the short form pre-translated into over 50 languages.

Review additional details about the short form consent process on IRO’s Non-English Speaking Participants webpage, where there is also a tip sheet and worksheet to support the process.

The Clinical Research Support group offers an online module called “Consenting Non- and Limited-English Speakers,” available via Hutch Learning.

If you have specific questions about the short form consent process or Fred Hutch IRB requirements, contact IRO@fredhutch.org.  

In general, the short form process to consent a non-English speaker remains the same, including who is involved and who signs which document.  What is new is the requirement to follow up the consent conference with a full translation of the English consent form for the study. This gives the non-English speaker a document in their language that they can refer to throughout their participation in research.

1. After the use of the short form process, the PI/study team obtains a translation of the full consent form in the participant’s preferred language and submits it for IRB review as soon as possible, but no later than 30 days after the short form consent is signed.
2. After the IRB approves the translated consent form, it must be provided to the participant as soon as possible. It may be provided via MyChart, email, mail, or in-person at the next study visit. Note that providing the translated consent form does not require a re-consent discussion.

NOTE: Research procedures may begin immediately following the short form consent process, while you obtain the full translation in the background. 

There are many reasons for making this change:

1. Respect for persons and an institutional commitment to diversity, inclusion, and addressing inequities:  Giving a written document to a participant in a language they can read is individually and ethically beneficial.
2. FDA updated guidance in 2023 indicating: “The investigator must obtain a translated copy of the IRB-approved English version of the long form that served as the written summary, which should be done promptly.  The investigator promptly submits it to the IRB for review and approval.  Once the translated long form/written summary is approved by the IRB, the investigator must provide it to the subject or LAR and should do so as soon as possible.  FDA considers this step essential to the requirement that informed consent be documented by the use of a written consent document and that the subject be provided a copy (21 CFR 50.27).  Many of the clinical investigations regulated by FDA involve ongoing interventions and may involve long-term follow-up.  For this reason, translation of the long form is critically important as a means of providing subjects or their LAR an ongoing source of information understandable to them.”
3. A new Washington state law on Diversity in Clinical Trials (RCW 69.78.040) requires that an entity receiving funding from NIH to conduct trials shall “Provide information to trial participants in languages other than English.”

Note that the short form process 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.  

This policy change will apply to all studies approved to use the short form for unexpected enrollment of non-English speakers.  Studies targeting a population expected to speak another language (such as studies in the Yakima Valley) will still be required to translate the full consent form up front, rather than using the short form process.

Existing studies that have previously used the short form process with a non-English speaker do not need to go back and translate the consent form. However, note:

• After January 1, 2025, if an existing study enrolls a new non-English speaker, a translated consent form must be obtained and provided to the participant following the use of the short form process.
• If an existing study has a currently enrolled non-English speaker who was previously enrolled using the short form process without translation, and the English consent is revised after January 1, 2025, and reconsent is required, you should prepare a full translation of the English consent form for the study.

Yes, this applies to all investigators who rely on our IRB. 

The IRB may grant rare exceptions to the requirement to translate the full consent form into the participant’s language after short form usage, for example if the study only involves a single interaction with the participant. The investigator must present rationale for the IRB’s consideration of an exception. The IRB is likely to deny requests if the study involves ongoing data collection from the medical record or if you are storing identifiable specimens in a repository, because participants should have written information in their language about this on-going research activity and how to revoke their participation. 

No, a reconsent process is not required once you have the fully translated consent form. A signature is also not required.

The fully translated consent form may be provided to the participant via MyChart, email, mail, or in-person at the next study visit.

The study team should continue to remain available with interpreter support as needed to answer questions for the participant.

Translation Services:  The Fred Hutch Interviewing, Translation and Interpretation Services (ITIS), part of the Shared Resources Collaborative Data Services (CDS) group, is available to:

• Translate consents into Spanish in-house (fee-based). 
• Coordinate your translation request for other languages with vendors, under pre-existing contracts.  The language service vendors can support over 260 languages.

Example translation costs can be found on the Interviewing, Translation and Interpretation Services (ITIS) at Collaborative Data Services (CDS) service sheet.  Additionally, there is an ITIS REDCap intake form to request translations: https://redcap.link/fhcctranslationrequest

No. Study procedures may begin immediately after a participant has consented using the short form process, while you are working on the translation process in the background. 

Nothing further is needed. The full English consent form only needs to be translated if the participant is enrolled in the study. 

Once you already have a translated full consent form in a specific language, such as Spanish, you should consent future Spanish-speaking participants using the fully translated consent form. You should not use the short form process for that language anymore. 

If the English consent form is later revised and the individual is still on study, the translated consent form needs to be re-translated. Depending on the scope of changes, most translators may be able to only translate the new/updated language, for a lower re-translation fee.

The IRO strongly recommends obtaining IRB approval for the revised English consent form first, before starting the new translation request. This is because the IRB may require further changes to the English consent form. 

The PI should consider whether other participant-facing materials, such as a study drug diary, need to be translated to support the involvement of non-English speakers in research. 

The PI may propose alternatives to translation of other participant-facing materials, such as proposing a questionnaire be administered via an interpreter in clinic rather than self-administered by the individual with limited English proficiency. The IRB will consider these requests in the context of the study.

No, you would still need to translate the Fred Hutch site-specific consent form if you are enrolling a participant at Fred Hutch. You can’t simply provide our local patient with a translation that has been tailored to another institution, because the content could differ between sites based on local consent requirements.

IRO encourages you to translate the full English consent form ahead of time, because it is always better to have a fully translated consent form that an individual can refer to during the consent discussion. However, this would require you to know what languages will present for enrollment. For example, Spanish is the most used language at the clinic.

Note that the bridge funding would generally not be available to you in this context, as the bridge funding was designed to accommodate translations newly required after use of the short form consent process. If you translate the full consent form up front, you are not using the short form process.

Additionally, if an unexpected language presents at the clinic, you would still need to use the short form consent process and follow it with full translation for that new language. 

While CDS’s ITIS group has certain pre-vetted translation vendors, those are not required. We are aware that sponsors have established relationships with translation vendors, which are fine to use.

No, there is now a single IRB-approved English short form version, which covers the regulatory requirements for studies approved under either version of the Common Rule.  This single form has been translated into over 50 languages and is available on IRO’s website here: Translated Short Forms.

Note:  If an external IRB reviews the study and they require you to submit our short form, you will need to update your study with that IRB to reflect the new, single version. 

For studies with both a screening consent form and a main consent form, two separate short form consent processes may be used.

If the participant consents to the screening using the short form process, you proceed with translation of the screening consent form into the participant’s language. You do not have to start translating the full consent form at that time, because it is still unknown whether or not the participant would qualify. Then if the individual does qualify, you can use the short form consent process a second time, followed by translation of the full consent form (the clock would restart after the second consent process).

Bridge Funds for Translations, process via the Compliance Office: Some institutional funds have been set aside to help cover translation costs for studies that do not yet have this built into the budget. Investigators should plan to ask sponsors to cover translation costs before requesting bridge funding. The mechanism to request funds will be to complete and send a brief form to the Compliance office. An ad-hoc advisory group will make the final determination for allocation of bridge funds.

Note that most industry-sponsored studies should already have translation costs built into the budget as this has been a budget requirement since January 2024 as part of the industry fee letter requirement. Consult your study budget and/or clinical trial agreement.

Example translation costs can be found on the Interviewing, Translation and Interpretation Services (ITIS) at Collaborative Data Services (CDS) service sheet.  Additionally, there is an ITIS REDCap intake form to request translations: https://redcap.link/fhcctranslationrequest

See the process describe above on this page.

Investigators should ensure study budgets include translation costs.  Industry-sponsored trial budgets that have been negotiated since January 2024 include translation costs as this is included in the Industry Fee Letter.

Contact CDS’s ITIS as needed to request translation estimates or refer to Interviewing, Translation and Interpretation Services (ITIS) at Collaborative Data Services (CDS) service sheet.

IRO hopes and expects the institution would support translation funds beyond this fiscal year, based on the institution’s commitments to inclusion and equity and the regulatory requirements to translate consents. We encourage you to raise any concerns to your division leadership so that your voice contributes to this discussion.

Discussions about the institutional funds for translations have centered around unfunded trials and investigator-initiated trials for which the sponsor only provides the drug, so those are the groups of studies we anticipate will most request these funds.  

If study teams know that certain populations will always enroll on their studies (e.g., Spanish speakers), IRO strongly encourages teams to plan for and translate the consent into Spanish up front, because this doesn’t meet the criteria for “unexpected” for use of the short form. You should start incorporating this into your budgets moving forward.

The bridge funding was generally not intended for use in this context. The bridge funding is intended to be requested after a non-English speaker was consented to a study using the short form consent process. This allows the extra funding to be limited to situations where it is known that a translation is absolutely needed for compliance with the new requirement.  

The updated policy applies to all Fred Hutch investigators who use the short form process at our institution, regardless of the IRB of record. Some commonly used IRBs, such as WCG, Advarra, and Seattle Children’s IRB, already require a full translation of the consent form after use of the short form process.

The University of Washington IRB is instituting the same requirement to follow up with a fully translated consent, effective January 1, 2025 as well.

Note that UW is rolling out further substantive changes in response to the FDA guidance and WA state law (see the UW HSD website announcements section for more details). Fred Hutch already has many aspects of diversity planning in place, including IRB application questions about research addressing inequities.  Fred Hutch’s addition of a translation to the short form process is the single major policy change researchers submitting to the Fred Hutch IRB can expect at this time in response to the new federal guidance and WA state law.

When relying on an external IRB, Fred Hutch (and UW) would expect teams to follow the most restrictive policy. This is an institutional requirement, but if the IRB of record has more restrictive policies, you would follow the policies of the IRB of record. 

Yes, this would apply to all studies with Fred Hutch engagement, regardless of IRB of record. The only exception would be if Fred Hutch is not involved in consenting.  

No, there is now a single IRB-approved English short form version, which covers the regulatory requirements for studies approved under either version of the Common Rule.  This single form has been translated into over 50 languages and is available on IRO’s website here: Translated Short Forms.

If an external IRB reviews the study and they require you to submit our short form, you will need to update your study with that IRB to reflect the new single version. 

If you have additional questions that are not addressed above, please contact: