{
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            "text": "being provided for IRB review. Researchers seeking a determination that their research is exempt are not required to complete CITI training; however, CITI training is strongly recommended for all researchers conducting exempt research."
        },
        {
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            "order": 2,
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            "text": "V. PREPARING FOR RESEARCH REVIEW",
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            "text": "Researchers should contact OSP staff prior to beginning any new research project involving human subjects, even if the researcher believes that their research is exempt. The IRB must review all non-exempt research protocols involving human subjects at a meeting of the full IRB, except in cases when the research qualifies for the expedited review process. The OSP staff member serving as the HRPP specialist/IRB administrator in consultation with the IRB Chair will assist with determining if the research should undergo full IRB review, qualifies for expedited review, or is exempt."
        },
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            "text": "5.1 OSP as Main Point of Contact",
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            "text": "OSP staff will be the main points of contact for researchers seeking IRB approval of their research or a determination as to whether or not their research is exempt. OSP staff will help determine if a project should undergo full review, expedited review, or consideration for exemption. OSP will provide the appropriate application forms to complete for the project, as well as guidance regarding the additional materials to submit."
        },
        {
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            "text": "Once researchers have completed the appropriate form, prepared additional materials that may be needed, and are ready to submit them for review, the researchers will send the materials to OSP staff. If an application requires full or expedited review, OSP staff will in turn provide the application materials to the IRB Chair and other IRB members. Once the IRB reaches a decision on an application, the HRPP specialist/IRB administrator will communicate that decision to the researchers. If the IRB requests revisions to a protocol, the HRPP specialist will communicate the requested revisions to the researchers. In some cases, researchers may communicate directly with the IRB regarding an application, but in general, the HRPP specialist will serve as the liaison between the researchers and the IRB. OSP staff will maintain complete files for each application containing the application materials and communications about the application involving the IRB and the researchers."
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            "text": "5.2 KSU Requirements Regarding Exempt Research",
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            "text": "OHRP guidance indicates that determinations of exempt status should be made by individuals independent of the research who are well-acquainted with interpretation of regulations governing the conduct of human subjects research. For this reason, KSU will require that researchers conducting exempt research complete an application to determine that the research is in fact exempt. In most circumstances, the OSP staff member serving as alternate IRB members can determine if a project is exempt. In cases where it is unclear if a project is exempt, the HRPP specialist will ask for guidance from the IRB Chair and reach a decision with the IRB Chair."
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