Informed Consent Translation

Professional Informed Consent Translation

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 professional translation services 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.

 How To Prepare for Informed Consent Translation

Preparing for an informed consent translation project is much more than gathering necessary documentation. In order to ensure the most efficient and high-quality translation possible, you should generally adhere to a few guidelines.

  • Make sure patient-related documents conform to regulatory standards and guidelines
  • Create a high-quality source document taking into account literacy levels and using approved terminology
  • Identify patients’ native languages, and whether or not dialects are also spoken
  • Take into account significant cultural factors that could impact the trial and the process of informed consent

 When Translation Is Not Enough

In some cases, an interpreter may be necessary to ensure complete understanding during the informed consent process. Depending on where you are conducting clinical research there may be additional requirements for vulnerable patient populations, such as patients with limited education and resources (e.g. access to healthcare).

When a patient is not able to read the informed consent translation, a medical interpreter who is fluent in the patient’s native language and is familiar with the patient’s culture, must be present during the informed consent process. The role of the medical interpreter is to verbally relay the information on the informed consent form to the patient and ensure that they fully understand what is involved with participating in a specific study.

It is best to contract professionals from an interpreting agency to ensure you hire subject matter experts, who are certified and fluent in your patient’s native languages.

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