6 Things To Know About Translating Informed Consent Forms
Translating informed consent forms requires precision and clarity to ensure all patients understand their rights and responsibilities. Many experts argue for simplifying the language of Informed Consent Forms (ICFs) to make them more accessible. If native English speakers struggle to comprehend these documents, individuals with limited English proficiency (LEP) face even greater challenges. Accurate, well-structured translations play a crucial role in improving comprehension and ensuring regulatory compliance.
The US Food and Drug Administration (FDA) (21 CFR 50.25 and 21 CFR 50.27) and the US Department of Health and Human Services (DHHS) (45 CFR 46.116and 45 CFR 46.117) both require Informed Consent Forms be translated for all LEP patients. The regulations state that informed consent information must be given in a language that is understood by the patient or study subject (or authorized representative) and that for most situations informed consent be given in writing.
In any United States population, there are a number of people who do not understand spoken and/or written English. However, these same people may potentially provide value to research studies, providing information and insights that may not otherwise be discovered without the inclusion of these LEP populations. The best (and indeed required) way to include LEP individuals in any study is to provide translations of Informed Consent Forms. Additionally, any patient undergoing a medical procedure must understand the ICF they sign for that document to be valid.
Keep reading for a definition and 6 things to know about translating Informed Consent Forms.
Informed Consent Defined
Informed consent is an ongoing, interactive process that helps participants make educated decisions about joining or continuing a study. Participation in any clinical trial is voluntary. Patients must also provide informed consent before undergoing a medical procedure. This consent is officially documented when participants or their authorized representatives sign an Informed Consent Form (ICF).
An ICF must clearly explain the study or procedure in a way participants can understand. It should summarize the purpose, duration, procedures, schedule, potential benefits and risks, alternatives, and the rights and responsibilities of all involved. The form also serves as proof of the participant’s agreement to take part.
Every Informed Consent Form includes two parts: the information sheet and the certificate of consent. Participants must receive a copy of both documents for reference.
Researchers must never pressure participants to sign an ICF. They should only sign once they fully understand the study or procedure and agree to participate. Informed consent must be obtained before any research begins. Even after signing, participants can withdraw at any time.
Hospitals, physicians, clinical research teams, healthcare organizations, and pharmaceutical companies regularly use Informed Consent Forms to meet ethical and regulatory requirements.
1. The Institutional Review Board (IRB), The Clinical Investigator, And The Research Sponsor Are All Responsible For Informed Consent.
The Institutional Review Board (IRB), the clinical investigator and the research sponsor are all responsible for informed consent. The clinical investigator or licensed physician investigator is responsible for getting the informed consent from the study subject and is responsible for the informed consent even if someone else interacted and obtained the informed consent from the participant. An investigator may be assisted by study nurses or study staff in obtaining the consent, but that does not negate the responsibility of the investigator of getting that consent.
2. When To Translate Informed Consent Forms
If consent interviews are conducted in English, the Informed Consent Form should also be in English. However, if the interview is in another language, the Institutional Review Board (IRB) will likely require a translated version for the participant.
There are four key scenarios for translating Informed Consent Forms:
- Participant reads and understands English (sixth-grade level or higher): No translation is needed, and the form can be administered in English.
- Participant cannot read English but understands spoken English: A witness should be present while someone reads the form aloud. Signatures from the participant, reader, and witness must document understanding.
- Participant is fluent and literate in another language: A fully translated Informed Consent Form and all accompanying documents should be provided.
- Participant cannot read or understand English but understands another language orally: The translated form should be read aloud, and oral comprehension should be documented. The participant, witness, and person obtaining consent must sign the form.
In some cases, a short-form translation may be used instead of the full Informed Consent Form. This option is only appropriate when the study involves minimal risk and offers a direct benefit to the participant.
3. Informed Consent Form Translations Must Be Performed To A Patient’s Level Of Understanding
Regulations require Informed Consent Forms to be written in plain language that participants understand. Translations must also follow this standard in the target language. A high-level surgeon or specialist may not be the best choice for this task. Instead, a registered nurse (RN) or a Master of Public Health (MPH) professional may be better suited. These professionals interact with patients daily and know how to communicate complex information in a clear, accessible way.
4. Translating Informed Consent Forms Almost Always Require A Certificate Of Accuracy
5. Back Translation Is Sometimes Required
Back translations help ensure accuracy when translating Informed Consent Forms. If a clinical trial is complex or involves risk, back translation should be part of the process. This extra step enhances quality assurance.
In back translation, an independent translator—unfamiliar with the original text—translates the document back into the source language. A project manager then compares both versions to check for consistency and missing details. Qualified translators must handle both forward and back translations. In some cases, the Institutional Review Board (IRB) requires both versions for review.
6. Offering Interpreting Services Is Also Recommended
Providing translated Informed Consent Forms helps participants understand the study. However, researchers must also ensure someone is available to answer questions. If a participant speaks another language, the study should provide an interpreter or a fluent speaker. The person obtaining consent must clearly explain the study and address concerns.
Informed Consent Forms must also include a contact person, phone number, and relevant details. This ensures participants know who to reach for questions about their rights, potential injuries, or study procedures. Contacts should communicate in a language participants understand.
Informed Consent Forms are required for all studies and medical procedures. When working with limited English proficiency (LEP) individuals, researchers must translate forms, provide interpreters, and make necessary accommodations.
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If a subject signs a translated ICF, for example, signs a Spanish ICF, will the person presenting i.e. the PI after it is translated by a certified translator with the PI present; will the PI the sign and date the Spanish ICF, only attesting that the subject understood the ICF? Or is it allowed for the PI to sign and date only an English approved ICF with the same IRB approval date and version number?
Hi Ernie, thanks for your comment! To answer your question, a person should only be required to sign documents they understand. So a PI who doesn’t speak Spanish fluently should only be required to sign the English-language Informed Consent Form while the Spanish-speaking subject should sign the Spanish translation of that ICF.