Please review the to confirm if your research involves human subjects. If you determine that your study does involve Human Subjects Research, you must complete the IRB Research Protocol Involving Human Subjects, form 1004. Role of the Institutional Review Board (IRB) Mission: The mission of the RVU Institutional Review Board (IRB) is to assure adequate protections of the rights and welfare of human subjects research. To achieve this, the RVU IRB advises investigators in designing research projects in a manner to minimize potential harm to human subjects, review all planned research involving human subjects prior to initiation of the research, approve research that meets established criteria for protection of human subjects, and monitor approved research to ascertain that human subjects are indeed protected. Function: The RVU Institutional Review Board (IRB) reviews all , submitted by students, faculty and/or staff involving human subjects. The IRB has the authority to approve, require modification, or to disapprove any research project, in accordance with standards set by the U.S. Department of Health and Human Services (HHS). For additional information about the IRB’s constitution, see the . (section G.) Research and IRB Review Categories If you are conducting research that involves human subjects, you must determine which research application to submit. The IRB reviews and approves research under three distinctive categories, specified by federal regulations: Exempt, Expedited, and Full IRB Research Review. A. Exempt Review Certain research is exempt from the requirements of the HHS regulations. Nevertheless, a determination that research is exempt does not imply that investigators have no ethical responsibilities to subjects in such research. Rather, it means that the regulatory requirements related to IRB review, informed consent, and assurance of compliance do not apply to the research. At RVU the IRB is responsible for determining whether proposed research is exempt from HHS regulations for the protection of human subjects. To determine if your prospective project may qualify as Exempt, please review the and the . If the project meets the description of an Exempt project, please click here: "Request for Review - EXEMPT Research" and complete the form (1001). B. Expedited Review An Expedited review procedure consists of a review of research involving human subjects by the IRB Chairperson, or by one or more experienced reviewers designated by the Chairperson from among members of the IRB, in accordance with the requirements set forth in 45 CFR 46.110.
Please review the to confirm if your research involves human subjects. If you determine that your study does involve Human Subjects Research, you must complete the IRB Research Protocol Involving Human Subjects, form 1004. Role of the Institutional Review Board (IRB) Mission: The mission of the RVU Institutional Review Board (IRB) is to assure adequate protections of the rights and welfare of human subjects research. To achieve this, the RVU IRB advises investigators in designing research projects in a manner to minimize potential harm to human subjects, review all planned research involving human subjects prior to initiation of the research, approve research that meets established criteria for protection of human subjects, and monitor approved research to ascertain that human subjects are indeed protected. Function: The RVU Institutional Review Board (IRB) reviews all , submitted by students, faculty and/or staff involving human subjects. The IRB has the authority to approve, require modification, or to disapprove any research project, in accordance with standards set by the U.S. Department of Health and Human Services (HHS). For additional information about the IRB’s constitution, see the . (section G.) Research and IRB Review Categories If you are conducting research that involves human subjects, you must determine which research application to submit. The IRB reviews and approves research under three distinctive categories, specified by federal regulations: Exempt, Expedited, and Full IRB Research Review. A. Exempt Review Certain research is exempt from the requirements of the HHS regulations. Nevertheless, a determination that research is exempt does not imply that investigators have no ethical responsibilities to subjects in such research. Rather, it means that the regulatory requirements related to IRB review, informed consent, and assurance of compliance do not apply to the research. At RVU the IRB is responsible for determining whether proposed research is exempt from HHS regulations for the protection of human subjects. To determine if your prospective project may qualify as Exempt, please review the and the . If the project meets the description of an Exempt project, please click here: "Request for Review - EXEMPT Research" and complete the form (1001). B. Expedited Review An Expedited review procedure consists of a review of research involving human subjects by the IRB Chairperson, or by one or more experienced reviewers designated by the Chairperson from among members of the IRB, in accordance with the requirements set forth in 45 CFR 46.110.
IRB-Research-Compliance-and-Quality-Assurance.docx