The informed consent form formalizes communication between a patient and physician and concludes with the patient’s informed authorization to undergo a medical intervention. For medical, ethical and legal reasons, patients must be given enough information to be fully informed before deciding to undergo a major treatment and their informed consent must be verified in writing. In most U.S. institutions today, a signature on a consent form is required for surgery, anesthesia and other invasive or complex medical or radiologic procedures (although the exact requirements vary from state to state and institution to institution). A signed consent form attests to an exchange of information that represents an informed consent. The informed consent form as a text type is unique to Western medicine and does not always have an equivalent in other languages and cultures, which is why translations of such documents is difficult yet very important.

The Fundamental Problem: Informed Consent is Difficult to Do Well in English

Unfortunately, even after signing a consent form, many patients still do not understand all of the risks and benefits of their proposed treatment choices. The Joint Commission, the accreditation agency for most health facilities in the U.S. has found that among patients who sign a consent form, 60 to 70 percent do not read or understand the information contained on the form. Even many native speakers of English struggle to make sense of the medical and legal content of consent forms. This gap between the ideal function of the informed consent form process and everyday reality increases the risk for medical errors, safety breakdowns and malpractice claims. Foreign language and cultural differences add yet another hurdle to an already difficult task.

Several best practices have been suggested to guide communication between patients and physicians to improve the effectiveness of obtaining informed consent. Presumably, these best practices are also adopted for limited English proficiency (LEP) patients, although preparing a translation brief for an informed consent form project is an opportunity to determine how well this ideal holds up. Some health care organizations and systems, in an attempt to service the needs of low literacy populations, have also successfully applied standards for format and readability of their consent forms. The procedural consent forms from the Queensland Government of Australia are considered a model of simplicity, consistency and effectiveness. They even go one step further by anticipating cross-cultural encounters and the use of interpreters. On these forms, interpreters must also sign the consent form when they are involved.

Research done by Hablamos Juntos and others indicate that most English consent forms today are still too complex and legalistic or (as with generic fill-in-the-blank forms) too non-specific. The challenge of producing easier-to-read informed consent forms in English and ideas for practical solutions are the focus of A Practical Guide to Informed Consent – Tool #5 of the More Than Words Toolkit Series and a companion to this guide.

The Need for Translated Consent Forms

The inability to speak English well is widely recognized as a major cause of failed communication in obtaining informed consent and in other health care communications. This explains why many health care organizations employ interpreters to enable discussion of treatment options and/or to sight translate English consent forms (sight translation is verbal translation or oral interpretation of a written text; often without any preparation time). In fact, a variety of state laws, federal policies (e.g., Title VI of the Civil Rights Act of 1964, Office of Minority Health CLAS standards) and accreditation standards (e.g., The Joint Commission, Health Insurance Portability and Accountability Act, National Committee for Quality Assurance) now require health care organizations to ensure all important documents for LEP patients are culturally and linguistically appropriate. More specifically, the U.S. government in Executive Order 13166 requires that informed consent forms be translated into languages spoken by at least 5% or 1,000 of a provider’s patients, whichever is less/fewer.

Within the health care industry, untrained or inadequately-prepared translators are a primary source of health materials translations. Working with health care organizations in ten states, Hablamos Juntos has found that producing non-English informed consent forms is typically a struggle for health care organizations. As with the English versions of these forms, there is a gap between the ideal and reality.

In some cases, the problem can be traced directly to the poor quality of the English version. However, even when the source consent form is exemplary, the translated versions often are difficult to read, even for target audiences with high literacy skills. These difficulties may involve not only practical limitations in budgets and poor translation planning and review, but also technical challenges such as a scarcity of staff experienced in commissioning translations. Tool #3 discusses common obstacles requesters face, including the challenge of distinguishing high-quality translations from low-quality translations. As a result, low-quality translations are common: they not only contain errors in grammar, spelling and vocabulary, but also have problems of over-literalism (i.e., strict word-for-word translation) that obscure the original intent and neglects cultural nuance. Current quality measures such as back-translation into English are not effective as the Example of Word-for-Word Translation shows. What may look correct in English belies awkward, unnatural translation in a target language.

The New Challenge for Translators:  Context and Content in Informed Consent

Assuming for a moment the availability of a high-quality source consent text and the involvement of competent translation professionals, what else would be needed to produce a high-quality translation of an informed consent form? At Hablamos Juntos, we believe the extra challenge involves disabusing the commonly-held view that the objective of a translation project is to produce an equivalent target text. The notion of equivalence is a vague and often controversial term subject to numerous interpretations. Every language is a unique form of communication shaped by underlying cultural practices, values and beliefs. The conventions and elements of a text (i.e., title, tone, writing voice) are dictated by cultural norms associated with the form and purpose of communication. This is why word-for-word renditions of English are often not possible and why approximations of an English text, or faithfulness to the intended meaning of a source text, is more appropriate.

Without an understanding of a source texts use, purpose and goal, even translations produced by well-trained translators may not be useful to target audience. The consequences of low-quality translations can be dire for LEP patients who are on the cusp of making important, often life-changing, health care decisions. Some translation guidelines now emphasize that translations should be measured against criteria agreed upon in advance. The broader purpose and the unstated assumptions (often culturally determined) embedded in a specific type of text need to be identified and the implications for a target text need to be considered (ISO 9000:2000, ASTM International F-2575-06 2006).  With this approach, the scope of translation requires looking beyond a faithful word-for-word translation. Explicitly setting criteria is essential to permitting translators to navigate within a specified degree of variation and subjectivity. Informed consent forms have legally-defined requirements often not stated on the form itself. Translators need specific guidance to pursue a meaning-for-meaning translation, so the contextual elements that are deeply embedded within the informed consent form need to be made clear. Without this type of guidance, the outcome can be translations that are even less understandable in the target language.

As discussed next, the translation brief is a tool designed to convey such guidance.