Corporate Translations

Establishing Best Practices for Translating Informed Consent Forms

Ethical principles of human research require that informed consent must be obtained from any subject who agrees to participate in a clinical trial. In order to obtain informed consent from the participant, an informed consent form (ICF) is created that discloses all relevant information about the research, ensures that the subject comprehends the information being provided, and voluntarily agrees (i.e. is not in any way coerced) to participate in the study. In order to achieve the objective of ensuring that the subject comprehends the information being provided, all ICFs must be presented to the patient in their native language. Consequently, translation of the ICF is a key step in launching any trial where linguistically diverse patient populations will be participating.

Although the informed consent form is a key document in any clinical trial, sponsors often fail to anticipate the requirements to translate the document or to monitor and effectively archive revisions to both the original and its corresponding translations. As a result, practical problems that can cause confusion or even delay the start of their trials are often encountered.

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