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Subject No. Page RESEARCH EXEMPT FROM FULL HIC REVIEW 231 1 Prepared By Prior Issue Date Human Investigation Committee 6/07/2005 8/25/2008 PURPOSE The purpose of this policy is to determine which.
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Determinations FAQ
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Research Requiring IRB Review The IRB must review and approve all research involving live humans before any such research activities may begin.
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The IRB does not review informed consent documentation or recruitment materials for proposed exempt studies.
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Exempt Categories: Education research. Surveys, interviews, educational tests, public observations (that do not involve children) Benign behavioral interventions. Analysis of previously-collected, identifiable info/specimens. Federal research/demonstration projects. Taste and food evaluation studies.
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Exempt human subjects research is a specific sub-set of “research involving human subjects” that does not require ongoing IRB oversight.
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Exempt Categories Educational research proposals are exempt providing all of the following conditions are met: All of the research is conducted in a commonly accepted educational setting (e.g., public school). The research involves normal educational practices (e.g., comparison of instructional techniques).
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In order to establish an individual research project as exempt, an investigator must complete an IRB application. On the IRB application the investigator should indicate the number of the category under which an exemption is claimed. Final determination as to whether a project is exempt rests with the IRB.
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Exempt Review Categories Include: Research conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn or the assessment of educators.
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“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
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