Informed Consent

Most of the large drug companies and CROs that conduct clinical testing internationally require that clinical trials conform to the World Medical Association’s Declaration of Helsinki. These ethical committees require that informed consent be in a language that is clearly understood by the people participating in the clinical studies. This includes translation of the ICF to the local language.

When translating ICFs for use in foreign countries, check for guidelines that can often be obtained from the local government’s Ministry of Health website. This includes the types of forms that must be filed with the ethical committee, and boilerplate text. Boilerplate text need not be translated, and can usually be copied ‘as-is’ from the standard documents.

Global Translation translates informed consents for leading pharmaceutical companies and CROs in English, German, Spanish, Polish, French, Hebrew, Arabic, Russian and Swedish

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