Informed Consent for Non-English Speakers

Are you planning to enroll non-English speaking subjects in a U.S.-based or global clinical trial? If so, you will need to translate informed consent forms (ICF) and other consent-related documents into the native languages of those individuals to satisfy the requirements of the United States Federal Drug Administration (FDA) and various directives governing clinical trials outside of the U.S. For both ethical and legal reasons, patients must be given enough information to be fully informed before deciding to undergo a major treatment.

Based on the practices of leading life sciences companies and our own experience, here are four tips for successful translation of ICFs and other clinical trial related documents.

  • Use translation memory (TM) tools.  Translation memory (TM) software analyzes repetitive text in the source documents and then queries a translation memory database to identify previously translated segments.  TM tools ensure consistency of terminology, expedite future ICF revisions, and reduce translation costs.
  • Translators are not lawyers.  Make sure translators don’t “play lawyer” and modify key sections of the translated ICF (e.g. Risks, Compensation, or other sections).  Stick to the wording of the original ICF. Since you may not be familiar with the language the ICF is being translated to, make sure you communicate this to your translation provider upfront. If you receive pushback from your language services provider, see tip #4.
  • Readability ensures informed consent. The consent obtained from subjects who do not understand the information in the ICF means that it was not truly “informed.” Readability helps to ensure informed consent.  Aim for the recommended 4th-8th grade reading level of the ICF by using “plain English” and, whenever possible, replacing legalese and scientific terms with simpler terms or by explaining them in the text. See the FDA document “Informed Consent Information Sheet” for more information on language, readability, and consent.
  • Work with professionals. The saying: “Do what you do best and outsource the rest” certainly applies to life sciences and clinical research document translations. If translation is not your core competency, you’re probably in the market for a professional language services provider. Ensure your vendor has experience in the life sciences industry, understands the regulations and nuances of ICF translation and can supply a reputable client list with references.Interested in receiving more tips related to translation of ICFs and other clinical documents? Contact us to receive the complete ICF tip sheet, which contains three more valuable tips including why consistent font size and using first person tenses are important.For more information about professional translation services for life sciences companies, visit our services pages.