Certified Translation Services IRB

In keeping with our commitment to streamline your workflow, Sterling IRB offers certified translation services for all documents related to the initial and continuing review of research (e.g., informed consent documents, participant handouts, recruitment materials.) We handle the process directly with vendors to ease the administrative burden for sponsors.

What Should Sponsors Know About Informed Consent Translation?

FDA regulations require informed consent to be presented in language each prospective participant can understand. When a study enrolls non-English-speaking participants, the translated consent form must meet the same standard as the English version, so accuracy goes beyond word-for-word conversion. Medical terms need clear equivalents, and regional dialects can shift meaning in subtle ways. Spanish used in the continental U.S. and Puerto Rican Spanish, for example, often differ.

Timing also affects cost. Certification usually applies to a document in its entirety, so even a minor edit to the English version can require a full retranslation. Planning translations early, writing source documents in plain language, and translating only final versions all help keep study startup on schedule. Our ICF translation tips cover each step in more detail.

Certified Translation Services Coordinated by Your IRB

Sterling IRB provides clinical research translation services for every document related to the initial and continuing review of your study, with one team managing the process from submission to approval:

• Translation of informed consent documents, participant handouts, recruitment materials, and other study documents
• Certified translators who specialize in medical terminology and regional dialects
• Direct vendor coordination, so your team doesn’t have to manage translation separately
• Translated short forms in more than 20 languages, available to sites through our SilverLink portal for unexpected enrollment of non-English-speaking participant