Understanding the regulatory foundation behind translated informed consent documents and why many institutional review boards (IRBs) require certificates or attestations of translation.
Informed consent is often described as a process rather than a form. That distinction is important.
Consent isn’t simply obtaining a signature on a document. It’s an ongoing exchange of information that enables a prospective participant, or their legally authorized representative, to make an informed and voluntary decision about research participation.
The document, however, remains central to that process. It’s the written record of the information reviewed and approved by the IRB, the document participants take home with them, and often the primary reference they rely on throughout their participation in the study.
When a prospective participant doesn’t speak or read English, that written record must still fulfill its intended purpose. It must accurately communicate the same information the IRB approved in a language the participant understands.
One common question IRBs receive from sponsors, contract research organizations (CROs), investigators, and research sites is whether Food and Drug Administration (FDA) regulations require a certified translation of an informed consent document. The answer is more nuanced than many expect.
What FDA regulations do not explicitly require is that a translation be completed by a certified translator. They do require informed consent information to be understandable to the participant and documented using IRB-approved consent materials. FDA guidance further supports IRB procedures to help ensure translations are prepared by qualified individuals or entities.
For many IRBs, a certificate or attestation that a translation was completed by a certified translator has become the practical mechanism for documenting that those expectations have been met. Rather than representing an independent regulatory requirement, translation certification serves as a quality-assurance measure that helps demonstrate the translated consent document accurately reflects the IRB-approved English version and was prepared through a reliable translation process.
The regulatory foundation: Understandable informed consent
The starting point for any discussion of translated consent documents is remarkably straightforward.
Under 21 Code of Federal Regulations (CFR) § 50.20, legally effective informed consent must be obtained before involving a human subject in research, and the information provided to the subject or legally authorized representative must be presented in language understandable to that individual. Similarly, 21 CFR § 50.27 requires informed consent to be documented using an IRB-approved written consent form signed by the participant or legally authorized representative.
The IRB’s responsibilities reinforce these requirements. Under 21 CFR § 56.111, an IRB must determine that informed consent will be sought in accordance with Part 50 and appropriately documented before approving a clinical investigation.
The Common Rule establishes essentially the same expectations. 45 CFR § 46.116 requires informed consent information to be presented in language understandable to the participant or legally authorized representative, while 45 CFR § 46.117 requires documented consent using an IRB-approved written consent form unless documentation is waived or another permitted process applies.
Taken together, these regulations establish a simple but important principle: Informed consent cannot be legally effective if the participant cannot understand the language in which it is presented.
From regulatory requirement to IRB practice
Although the regulations clearly establish the requirement for understandable informed consent, they do not prescribe exactly how an IRB should verify the quality of a translated consent document. The approach an IRB uses to assure that a translation is accurate is left to the IRB.
That operational guidance comes primarily from FDA’s August 2023 guidance, “Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors.”
FDA explains that when non-English-speaking participants are enrolled, investigators and IRBs must ensure consent information is presented in language understandable to the participant or legally authorized representative. Importantly, FDA interprets “understandable” to encompass not only the language itself, but also the level of information being presented.
The guidance goes a step further by recommending that IRBs review reasonable procedures to ensure translations are prepared by qualified individuals or entities and that interpretation assistance is available when necessary.
This recommendation is significant because it recognizes the IRB’s responsibility to evaluate the process by which translated consent documents are prepared, including whether certified translators or official certified translations are used. The IRB’s focus isn’t simply the existence of a translated document, but the reliability of the process used to create it.
In other words, the certificate isn’t the regulatory requirement. It’s evidence that the regulatory requirement for understandable informed consent has been satisfied.
Many IRBs, including Advarra, operationalize this expectation by requiring a certified translation. The certificate of translation documents who prepared the translation, affirms that the individual translator or translation service was qualified to perform the work, and provides assurance that the translated document accurately reflects the IRB-approved informed consent source document. Advarra no longer requires that a copy of the actual certificate be submitted. The IRB can most commonly rely on an attestation that the translation was a “certified translation,” and Advarra rarely needs to receive a copy of the translation certificate. However, each IRB has their own procedures as outlined above, and some accredited IRBs do require that a copy of the actual certificate of translation be submitted along with the translated documents.
Will artificial intelligence (AI) change translations? Not yet.
Advances in AI have transformed language translation over the past several years. Modern AI-powered translation platforms and large language models (LLMs) can produce accurate first drafts in dozens of languages within seconds. For routine communications, these tools have become increasingly reliable and continue to improve quickly.
Clinical research, however, requires a different standard.
An informed consent document isn’t simply informational text. It’s a regulated document intended to communicate reasonably foreseeable risks, study procedures, alternatives to participation, confidentiality protections, compensation, injury language, and other legally required elements of informed consent. Small differences in wording, emphasis, or nuance can alter meaning in ways that may affect participant understanding and impact voluntary participation.
Medical terminology presents additional challenges. The distinction between phrases such as “may occur,” “is expected,” “unlikely,” or “cannot be ruled out” may appear subtle, yet those differences often carry important scientific, regulatory, and ethical implications. Cultural context, regional dialects, literacy levels, and local expressions further complicate the translation process.
AI is rapidly becoming an invaluable tool for producing high-quality initial translations and supporting multilingual document development. However, at least for now, it hasn’t replaced the need for qualified human review. Human translators remain essential for evaluating context, cultural appropriateness, medical terminology, and the intent behind the original consent language.
As AI translation technologies continue to mature, they will almost certainly become a more important component of the translation workflow. Nevertheless, the regulatory responsibility remains unchanged. Sponsors, investigators, and IRBs must still ensure translated consent documents accurately reflect the IRB-approved English version and communicate the information necessary for legally effective informed consent.
Translation and interpretation are not the same thing
Discussions about language access frequently use the terms “translation” and “interpretation” interchangeably, but they serve fundamentally different purposes.
Translation refers to converting written information from one language into another. Interpretation facilitates spoken communication between individuals who do not share a common language.
Both are essential in clinical research, but each addresses different regulatory objectives.
FDA’s informed consent regulations focus on ensuring prospective participants receive written consent information in language they can understand and that the written materials approved by the IRB accurately communicate the required information. FDA guidance separately recommends that qualified interpretation services be available when necessary to facilitate meaningful discussion during the consent process. Translation supports the integrity of the written consent document, while interpretation supports the informed consent conversation itself.
This clinical research informed consent distinction is sometimes confused with the language access requirements established under Section 1557 of the Affordable Care Act (ACA). Section 1557 was enacted to prevent discrimination in healthcare delivery and to ensure individuals with limited English proficiency have meaningful access to healthcare services. Its primary focus is providing qualified interpreters and other language assistance services that enable patients to access and receive healthcare, not the regulatory process for obtaining legally effective informed consent for participation in clinical research.
Clinical research presents a different statutory and regulatory framework. Although research often occurs within hospitals and healthcare systems that are themselves subject to Section 1557, the informed consent process for FDA-regulated clinical research is governed by the Food, Drug, and Cosmetic Act (FDCA), primarily under 21 CFR Parts 50 and 56, and the Common Rule where applicable.
The central regulatory question isn’t simply whether an interpreter is available. It’s whether the informed consent process—and the written consent document itself—provides the information necessary for legally effective informed consent in language understandable to the prospective participant.
That distinction helps explain why IRBs routinely focus on both the quality of written translations and the availability of qualified interpretation during the consent discussion. One helps ensure the participant receives an accurate, IRB-approved written record of the research. The other helps ensure meaningful communication between the investigator and the prospective participant.
Planning ahead prevents delays
When enrollment of non-English-speaking participants is anticipated, FDA recommends that investigators submit appropriately translated consent documents to the IRB before enrollment begins, together with information regarding interpreter availability. This approach allows translated materials to be reviewed as part of the overall study approval process and helps avoid delays once enrollment begins.
Unexpected enrollment presents a different operational challenge. FDA continues to recognize the short-form consent process as an appropriate mechanism under certain circumstances. However, the guidance also makes clear that investigators should promptly obtain a translated version of the IRB-approved English long-form consent document, submit it for IRB approval, and provide it to the participant following approval. The Office for Human Research Protections (OHRP) provides similar recommendations under the Common Rule.
These expectations reinforce a consistent regulatory principle: Translated consent documents aren’t simply administrative paperwork. They’re fundamental to ensuring participants receive the same information, regardless of the language in which it’s presented.
Why IRBs continue to require translation certification
The practical takeaway for sponsors, CROs, investigators, and research sites is straightforward.
Federal regulations establish the requirement that informed consent be understandable and appropriately documented. FDA guidance recommends that IRBs evaluate procedures for ensuring translations are prepared by qualified individuals or entities. Many IRBs have translated those expectations into practical operational requirements by requesting a certificate or attestation of certified translation.
That approach is neither arbitrary nor unnecessarily burdensome. It’s a quality-assurance practice that helps protect research participants, supports regulatory compliance, and provides confidence that the information participants receive, regardless of language, is complete, accurate, and consistent with the version approved by the IRB.
Bringing clarity to translation requirements
Advarra works with sponsors, CROs, investigators, and research sites around the world to support informed consent processes that are participant-centered, operationally efficient, and aligned with evolving regulatory expectations.
Whether a study involves one translated consent document or dozens of languages across a global clinical development program, thoughtful planning and well-defined translation procedures can help avoid delays while strengthening participant protections.
To learn more about Advarra’s approach to informed consent review and multilingual consent processes, contact our team to discuss how we can support your next clinical study.
