Life Sciences

Translating Informed Consent Forms: What FDA and the Common Rule Require

FDA rules (21 CFR 50.20) and the Common Rule (45 CFR 46.116(a)(2)) both require that consent information be given "in language understandable to the subject." For participants with limited English proficiency, that means an IRB-approved translated consent form, or an IRB-approved translated short form with a written summary, a witness and qualified interpreters.

Key takeaways

FDA and the Common Rule both require consent information in language understandable to the subject.
The short form method is allowed, with fixed witness, signature and copy requirements.
The IRB must review and approve every translated consent document.
ICH E6(R3) lists all applicable consent translations as essential records.

In this guide

2 rule sets

FDA and the Common Rule share the same core requirement

6 requirements

For the short form method

Jan 6, 2025

ICH E6(R3) endorsed

What Do FDA and the Common Rule Require for Consent in Another Language?

Both rule sets use the same core sentence. Under 21 CFR 50.20, information given to the subject or representative “shall be in language understandable to the subject or the representative.” The Common Rule repeats this requirement at 45 CFR 46.116(a)(2).

FDA’s final guidance, “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors” (August 2023), defines “understandable” as information presented “in a language and at a level” the subjects can comprehend. That includes an explanation of scientific and medical terms.

The same guidance addresses enrollment. It cites the equitable selection requirement at 21 CFR 56.111(a)(3). It states that individuals “should not routinely be excluded” from research simply because they do not understand English.

FDA also notes that organizations receiving HHS financial assistance have separate obligations under Title VI of the Civil Rights Act and Section 1557 of the Affordable Care Act. The guidance itself covers only FDA’s consent regulations.

When Can You Use the Short Form Method?

Both rule sets allow a short form method: 21 CFR 50.27(b)(2) for FDA and 45 CFR 46.117(b)(2) for the Common Rule. The elements of consent are presented orally. The subject signs a short form stating that this happened.

The short form method has fixed requirements:

The IRB approves a written summary of what will be said.

A witness attends the oral presentation, not just the signing.

The subject signs only the short form.

The witness signs both the short form and the summary.

The person obtaining consent signs the summary.

The subject receives copies of both documents.

Under the Common Rule, the short form must also state that the key information required by 46.116(a)(5)(i) was presented first.

FDA recommends an impartial witness. It “strongly recommends” that the witness be fluent in the language of the oral presentation. An interpreter may serve as the witness, but is not required to.

The 2023 guidance describes a fallback for unexpected enrollment. Many IRBs approve generic translated short forms in advance. The IRB-approved English long form then serves as the written summary. After enrollment, the investigator must promptly obtain a translated long form, submit it to the IRB and give it to the subject. FDA calls translation of the long form “critically important” for studies with long-term follow-up.

FDA also cautions that the short form “may not ease or expedite the consent process.”

What Does the IRB Review When Consent Is Translated?

The IRB must review and approve all consent documents used to document consent (21 CFR 50.27(a) and 56.111(a)(4) and (5)). FDA recommends that the IRB also approve procedures ensuring that translations are “prepared by a qualified individual or entity” and that interpretation is available.

When investigators expect to enroll people who speak specific languages, FDA says they should submit translated consent documents before the IRB’s initial review. They should also describe how interpreters will be available during the study.

Adding translated consent documents to an approved study may be a minor change eligible for expedited review under 21 CFR 56.110(b).

Local IRB policies add detail. For example, Duke’s IRB translation policy (May 2024) requires a certificate of translation for certified translations. It requires forward and back translations plus a PI attestation when non-certified bilingual staff translate. Always check the reviewing IRB’s current policy.

What Does ICH E6(R3) Add?

ICH regulatory members endorsed the final E6(R3) Good Clinical Practice guideline on January 6, 2025. FDA published it as final guidance in September 2025.

Three provisions matter for translation:

Section 2.8.1(b): consent information “should be as clear and concise as possible, use simple language.”
Section 2.8.7: the consent form is signed, where appropriate, by an impartial witness.
Appendix C: the essential records list includes “Informed consent materials (including all applicable translations).”

That last item makes every translated version, and its approval, part of the trial master file.

Translating consent forms for an upcoming study?

We translate consent forms, short forms and study materials with documented review for IRB submission.

Where Do FDA Diversity Action Plans Stand in 2026?

The Food and Drug Omnibus Reform Act of 2022 (FDORA) added Diversity Action Plan requirements to the FD&C Act at sections 505(z) and 520(g)(9). They cover phase 3 drug trials and certain device studies.

FDA issued draft guidance in June 2024. The guidance was removed from FDA’s website in January 2025. FDA’s page now carries a notice that it was restored under a court order. The page still lists the document as draft guidance dated June 2024.

According to FDA’s report to Congress, the requirement applies to studies whose enrollment begins 180 days after FDA publishes final guidance. FDA had not issued final guidance as of October 5, 2026, so the submission requirement has not taken effect. Confirm with FDA or regulatory counsel before a submission.

How Should Sponsors and Sites Translate a Consent Form?

Step	What Happens	Record to Keep
1. Lock the source	Translate only the IRB-approved English version, with its version number and date.	Approved English ICF
2. Choose languages	Use site demographics and expected enrollment to pick languages and decide on long form or short form.	Language plan
3. Forward translation	A qualified medical translator, native in the target language, translates the full form.	Translator qualifications
4. Independent review	A second linguist checks accuracy, terminology and reading level.	Review log
5. Back translation (if required)	A separate translator renders the text back into English. Discrepancies are reconciled.	Back translation and reconciliation notes
6. Certificate of accuracy	The provider certifies that the translation is complete and accurate.	Signed certificate
7. Layout check	Signature blocks, page numbers and version footers match the source.	Final PDF
8. IRB submission	Submit each language. Record each approval date.	IRB approval letter
9. Version control	When the English form changes, update every language and retire old versions at each site.	Version tracker
10. Interpreter plan	Arrange interpreters for consent and every later visit.	Interpreter procedure

Frequently Asked Questions

Does FDA require back translation of informed consent forms?

No FDA regulation requires back translation. FDA’s 2023 guidance recommends that IRBs approve procedures ensuring that translations are prepared by a qualified individual or entity. Many IRBs set their own rules. Duke’s IRB, for example, requires forward and back translations when non-certified bilingual staff translate. Sponsors also may require back translation in their own procedures.

Can an interpreter serve as the witness for a short form consent?

Yes. FDA’s 2023 guidance states that an interpreter who assists the person obtaining consent may serve as the witness but is not required to. FDA recommends an impartial witness who is fluent in the language of the oral presentation. If possible, the witness should not be related to the subject.

Do translated consent forms need full IRB review?

Not always. FDA’s 2023 guidance states that a protocol amendment adding translated consent documents to an already approved study may be a minor change. A minor change may qualify for expedited review under 21 CFR 56.110(b). The IRB decides. It must still review and approve each translated document before use.

What happens when the English consent form is amended?

Each translated version must be updated to match. Each update is then submitted for IRB approval. ICH E6(R3) lists informed consent materials, including all applicable translations, as essential records. Sites should track which version each participant signed. They should also remove superseded versions from use.

How AsianText Helps

Consent Translations Ready for IRB Review

AsianText translates informed consent forms, assent forms, short forms and participant materials for sponsors, CROs, sites and IRBs. Our translation workflow is ISO 17100 certified. Projects can include medical linguists, independent review, back translation and a certificate of accuracy. We support plain language review, multilingual desktop publishing and interpreting for consent visits. See our life sciences expertise. Contact us to plan your next consent translation.

This article provides general information, not legal advice. Last updated October 5, 2026.

Written by Umar Khan

Part of the AsianText team, writing about language access, translation and interpreting for government, healthcare and life sciences.

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