All regulated human subjects research proposals should be submitted through the eIRB system, but there is an abbreviated process for studies that are eligible for an exempt review<\/a>. Unlike expedited and convened full board studies which must complete all tabs of the eIRB system application, exemption-eligible studies (including exempt with a limited review and FLEX exemption studies) only complete the first two tabs of the eIRB application (“Title” and “Description”) and upload all of the supporting documents (including the exemption request form) before submitting the application to the IRB office. Regardless of review level, all studies must comply with all applicable laws, regulations, and the NC State University IRB unit standards<\/a>.<\/p>\n\n\n\n Informed consent is required under the federal regulations governing research with human subjects for all expedited and convened full board studies unless a waiver of consent\/parental permission is requested and granted. The requirements for informed consent are detailed in 45 CFR 46.116<\/a> and for parents and minors at 45 CFR 46.408<\/a>. As a matter of respect for persons and justice, it is the practice of the NC State University IRB to require an informed consent process for all levels of studies, including exemptions, unless there is a scientific justification for not doing so. <\/p>\n\n\n\n Because consent requirements are complex, the NC State IRB office has created editable templates for researchers to use. The templates provide instructions and fill-in-the-blank language that meet the regulatory requirements. You can view each consent template file, but in order to edit the file, you must download the file first. The informed consent process should be designed with your participants in mind and written at a 4th- to 6th-grade level. <\/p>\n\n\n \n \n\n The file contains instructions and several consent form templates for different types of exemption-eligible research compliant with the current federal regulations and NC State University standards. Download the file to be able to edit the applicable template for your protocol. NOTE: Due to the 2023 Parents Bill of Rights law, the parental opt-out form is not allowed if research will be conducted in a K-12 public school in North Carolina. <\/p>\n\n\n\n The exemption consent templates are for minimal-risk research eligible for exemption.<\/p>\n\n\n\n
Informed Consent, Parental Permission, and Minor Assent<\/h2>\n\n\n\n
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Adult Consent Templates<\/h2>\n <\/summary>\n
Exemption Consent Templates<\/h4>\n\n\n\n