The informed consent process is one of the most important factors in the success of a clinical trial. Whether recruiting individuals with Limited English Proficiency (LEP) or conducting international clinical trials, any inaccuracies in the translation of informed consent materials can cause delays or compromise ethical standards and thereby patient rights.
To ensure quality and accurate clinical translation services, choosing the right language service provider is critical. Partnering with a provider that has experience dealing with regulatory approval agencies and expertise in clinical research document translation is especially important when translating patient related materials. Requirements for informed consent translation include native language translation and cultural adaptation by a professional translator. In some cases, there are additional requirements, for example, in areas with patient populations who have limited literacy ability.