Is your trial accessible to non-English speakers? Ensuring equitable recruitment in clinical research means making studies accessible to all eligible participants, regardless of language proficiency. Approximately 8.6% of individuals in the U.S. speak English less than “very well,” according to estimates from the American Community Survey (ACS). Providing translated documents helps broaden access and supports more inclusive, representative research.
Accurate informed consent form (ICF) translation and ongoing interpretation support are essential for engaging non-English speakers compliantly and ethically. FDA regulations require that informed consent documents be presented “in language understandable to the prospective subject.” Related to this, informed consent must be grounded in three core elements: information, comprehension, and voluntariness. Without research translation services, teams run the risk of non-native speakers not truly understanding what they are agreeing to, even if they speak some English.
Meeting the requirements for informed consent takes more than a one-to-one translation of documents. It involves planning and collaboration between sponsors, sites, IRBs, and translation providers. The five tips below can help you make sure your translations are accurate, compliant, and participant-friendly.
1. Plan Early for Non-English-Speaking Participants
While some trials may enroll non-English speakers unexpectedly, most studies can anticipate translation needs well in advance. For example, a trial in a region with a large Hispanic population should plan from the start to have Spanish-language ICFs and interpreters. Beginning the translation process early ensures that documents are ready when needed and reduces last-minute rushes that can lead to errors, miscommunications, and higher costs.
However, if a study does enroll non-English speakers unexpectedly, there are options to stay compliant and protect participants. Notably, a short form for informed consent can be used. A short form is a consent document written in a language understandable to the non-English-speaking prospective participant that summarizes the required elements of informed consent but does not contain specific study information. The written short form is presented in conjunction with an oral presentation of the informed consent information and a written summary of the oral presentation. A copy of the English version of the study consent form may serve as this summary.
A short form consent is intended only to be used when time is of the essence and a translated consent form is unavailable. If your site reasonably expects that the subject population for your study will include individuals who do not understand English and can anticipate the specific language(s) that they will understand, the consent form should be translated appropriately into that language. Use of a short form consent does not meet the requirements for a valid authorization under the HIPAA Privacy Rule. Authorization should be obtained from the participant using a translated authorization form.
2. Write Informed Consent Documents in Plain Language
The more complex an ICF is, the more difficult it will be to translate. Medical jargon often does not have a direct counterpart in other languages, and the same goes for legal terms. Even if there is a technically accurate translation, cultural nuances and dialect differences may leave participants confused.
The solution is to write informed consent documents in easy-to-understand language. This is a best practice even for English ICFs, as it accounts for varying health literacy and makes trial information more accessible for everyone.
Some tips for simplifying language before ICF translation include:
- Use everyday terms whenever possible in place of medical language; for example, “sore throat” instead of “pharyngitis”
- When complex language is necessary (such as defining risks where a plain-language counterpart leaves out important nuances), add explanations for clarity
- Use active voice where possible, such as “we will draw your blood” instead of “your blood will be drawn”
- Keep sentences focused on one topic at a time
3. Wait to Translate Until You Have Final Documents
Translating an ICF before it’s finalized can lead to unnecessary costs. Even minor changes to the English version require complete retranslations, since certification can usually only be given for the document in its entirety. This means even if a few words change, the word count for the translation (and associated fees) will apply to the full ICF. To avoid these charges, wait for IRB approval of your English ICF before proceeding with translation.
4. Remember Informed Consent Is a Process, Not Just a Document
Informed consent in research doesn’t end when a participant signs a form. It involves clear communication, cultural sensitivity, and ongoing support.
These questions can help you determine if your informed consent process, not just documents, address the needs of non-English speakers:
- Do you have interpreters available at all visits?
- Are native speakers or culturally competent staff available to answer questions during the consent process?
- If using eConsent, do you have systems in place to check comprehension before participants sign?
- Have you considered potential sensitive topics in research, such as risks specific to rare diseases or other vulnerable populations?
5. Work With Experienced, Reputable Translation Partners
When translating informed consent documents, you need to work with qualified translators who specialize in medical language. A word-for-word translation won’t capture the nuances of medical terms and could lead to misunderstandings. Specialized translators who are familiar with the terminology know how to make information accessible to participants.
Pay close attention to regional dialects as well. For example, Spanish used in the U.S. and Puerto Rican Spanish can differ in subtle but significant ways. It’s crucial to ensure that the correct dialect is used to accurately convey the meaning of the consent document. Partnering with certified translation services ensures that you’re working with professionals who understand the cultural and linguistic nuances that can impact comprehension.
Looking for Informed Consent Translation Support?
Ensuring that your informed consent documents are accurately translated is vital to maintaining ethical standards in clinical research. By working with trusted, experienced translation partners and planning ahead, you can avoid delays and costs while ensuring that your documents are culturally and linguistically appropriate.
At Sterling IRB, we understand the importance of high-quality translations that meet regulatory requirements and uphold participant rights. We offer certified research translation services for all documents including informed consent forms, and we work with certified translators who specialize in medical terminology and regional dialects. Sterling IRB also provides translated short forms in over 20 languages for site use. These are available on our secure web portal, SilverLink. Our team is here to help streamline the process and safeguard your research.
Reach out today to learn more about how Sterling IRB can support your ICF translation needs.