In this guide, the key steps for creating a translation brief for informed consent forms are summarized. These instructions use the framework provided in Developing a Translation Brief (Tool #3), with a focus specifically on the informed consent form. These four steps provide an organized means of thinking about a consent form translation project, help one develop clear specifications for a translator, and in some cases, cause one to rethink the project all together.

Step 1:   Gather information about the function, overall purpose and end use of the source informed consent form. Learn about the source form and how it is used with the source audience.

Step 2:   Evaluate the quality of the source form to make a GO / NO-GO decision. Poor-quality source texts hinder the production of useful translations.

Step 3:   Compare and contrast the relevant aspects of the source and target audiences to identify implications for the target form. Analyze the content of the source form to identify any evidence of source culture bias that will need to be replaced by target culture conventions, as well as translation challenges that will need to be overcome, including production challenges.

Step 4: Summarize specific needs and special requirements for the translator. These specifications will become the benchmarks to assess the quality of a translation product.

When developing a translation brief for an informed consent form, two concerns unique to this text type need to be considered at every stage of the process. First, because of the potentially high-stake legal and clinical consequences associated with the use of an informed consent form, requesters need to recognize that unlike other text types (e.g., health education materials), there may not be much flexibility in what information is presented. Understanding the intended meaning is critical to creating translations that meet their intended objective of informed consent. Second, for precisely the same reasons just cited, it is crucial that translation products support informed decision-making by the patient as well as satisfy physician and institutional responsibility for full disclosure. To this end, translated consent forms must capture the full original intent of the source text in a way that target audiences can understand.

A fundamental goal of Tool #4 is to make sure that the communicative goal of informed consent forms are met by all translations. Preparing a translation brief, closely analyzing the source text, and comparing and contrasting source and target audiences can help identity potential roadblocks if the source consent form does not represent a good starting point. Informed consent forms written in heavily-legal or medical terms, even if translated by translators knowledgeable in the legal or medical fields, may not be easily understood by target audiences. Requesters can weigh this possible result to make a decision about whether to proceed with a translation project or to explore alternatives such as improving the source informed consent form or developing capacity for sight translation of consent forms for LEP patients.