Polaris

SOP# MON-004.0D. Template Consent FormsCompanyEffective Date: DD/MMM/YYUsually, an informed consent template will be developed because each IRB will havespecific wording requirements that will need to be incorporated into the documentused at that facility (e.g., how compensation will be handled in the event of a studyrelatedinjury). The In-House Clinical Research Associate (CRA) will send thetemplate to the Investigator and/or Study Coordinator with the protocol. Sitepersonnel will enter the site-specific wording and will return the document toCompany. The In-House CRA or Monitor will ensure that all elements of consentand other requirements (e.g., layman’s language) are met before the StudyCoordinator will submit the draft document to the IRB for approval. In considerationof the lead times required for submission of documents to the IRB, Company In-House CRA or Monitor will perform the review of the site-specific informed consentpromptly.E. Non-English Informed ConsentWhen a study population includes non-English speaking people, the Monitor willassist the Investigator to ensure that the translated version of the consent form isprepared and that the translation is accurate. The translation from English to anotherlanguage will be accomplished by someone who will certify in writing the accuracyof the translation. For non-English consent forms, the Monitor will ensure thatCompany and site study files contain:1. The name and address of the translator,2. A copy of the translator’s certificate, and3. A memo to the file signed by the translator that states that the foreign languageconsent document is an accurate translation of the English consent form.Note: Informed Consent Form authors should also check individual state laws thatmight concern the translation of legal or other documents. Specific IRBs may alsohave their requirements concerning what is acceptable practice and documentationfor the translation of consent forms.IV.References21 CFR 50.20 – General Requirements for Informed Consent21 CFR 50.23 – Exception From General Requirements21 CFR 50.25 – Elements of Consent21 CFR 50.27 – Documentation of Informed Consent45 CFR 46.116 – General Requirements for Informed Consent45 CFR 46.117 – Documentation of Informed ConsentICH Guidelines for Good Clinical Practice (E6) section 1.28 – Informed ConsentMON-004.0.doc© 2004 by CRC Press LLC