No standardized process exists for developing a set of agreed upon terms, definitions, and translations in local languages that ensures participants understand both technical and nontechnical terms used in a clinical trial context. HIV prevention trials deal with a disease that is stigmatized and with sexual behaviors that may not be openly discussed, thus care must be taken in the selection of words to ensure terms are appropriate for use in the context of a clinical trial and understandable but not offensive. The lack of a standardized process can make it difficult for researchers to decide which words to use, or to find what terminology choices exist. The lack of consistent translations hinders access to scientific and technical knowledge for clinical trial participants and research communities. A bilingual lexicon is used to ensure consistency in translation across all documents and materials used in a particular clinical trial. This toolkit guides researchers through the process of identifying or improving translations of clinical research terms that are difficult to translate or comprehend. It provides a process for eliciting and field-testing culturally and linguistically valid translations of key research-related terms and concepts.
Ramirez, Catalina B., Natasha Mack, and Barbara Friedland. 2013. "A toolkit for developing bilingual lexicons for international HIV prevention clinical trials." New York: Population Council and FHI 360.