There are essentially three mechanisms for obtaining informed consent from an individual with LEP: The Form process” involves the translation of the English version of the “Long applicable Long Form The Form process” involves the use of the English Long Form and a translated “Short Short Form. The of Documentation Process” involves oral consent when the IRB waives “Waiver the requirement to obtain the signature of the participant. IRB As applicable to the particular research, the Form” is considered the consent form, “Long parental/guardian permission form, or a pediatric assent document and includes the required HIPAA research authorization language when PHI is involved. In general, written translation of the long forms is expected over the use of the short-form process when the research anticipates the enrollment of five or more research participants with limited English proficiency of the same language (e.g., 6 Spanish speaking participants)., for the following types of research: Phase 0, 1,1/2, 2, 2a, 2b, or 2/3 Clinical trials which are determined to be greater than minimal risk without any anticipated therapeutic benefit for the research participants Studies are determined to be a minor increase over minimal risk, when there is no direct benefit to the research participant; Complex clinical trials; or When required by the sponsor. For the long form process, submit the following for IRB approval: Submit long form in English, with applicable signature blocks. Submit recruitment materials, interview scripts, or other participant related documents (e.g., surveys, information cards, etc.) in English. For the long form process, submit the following for IRB approval as an Amendment, once the English versions are approved. Translated versions of long form(s). Translated interview scripts or other participant related documents. Translated recruitment materials, if targeting a population in non-English. Certificate of translation(s) for all documents. The English back-translation, if obtained and a Word document that shows the comparison (legal backline) of the original English version (approved by the IRB) with the new English back-translation. IRB
There are essentially three mechanisms for obtaining informed consent from an individual with LEP: The “Long Form process” involves the translation of the English version of the applicable Long Form The “Short Form process” involves the use of the English Long Form and a translated Short Form. The “Waiver of Documentation Process” involves oral consent when the IRB waives the requirement to obtain the signature of the participant. IRB As applicable to the particular research, the “Long Form” is considered the consent form, parental/guardian permission form, or a pediatric assent document and includes the required HIPAA research authorization language when PHI is involved. In general, written translation of the long forms is expected over the use of the short-form process when the research anticipates the enrollment of five or more research participants with limited English proficiency of the same language (e.g., 6 Spanish speaking participants)., for the following types of research: Phase 0, 1,1/2, 2, 2a, 2b, or 2/3 Clinical trials which are determined to be greater than minimal risk without any anticipated therapeutic benefit for the research participants Studies are determined to be a minor increase over minimal risk, when there is no direct benefit to the research participant; Complex clinical trials; or When required by the sponsor. For the long form process, submit the following for IRB approval: Submit long form in English, with applicable signature blocks. Submit recruitment materials, interview scripts, or other participant related documents (e.g., surveys, information cards, etc.) in English. For the long form process, submit the following for IRB approval as an Amendment, once the English versions are approved. Translated versions of long form(s). Translated interview scripts or other participant related documents. Translated recruitment materials, if targeting a population in non-English. Certificate of translation(s) for all documents. The English back-translation, if obtained and a Word document that shows the comparison (legal backline) of the original English version (approved by the IRB) with the new English back-translation. IRB