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expedited review category 5

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expedited review category 5

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  1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

  2. expedited review category 5 Developed by: U-MIC University of Michigan IRB Collaborative

  3. Expedited category 5 expedited review • no more than minimal risk • categories defined by HHS and FDA IRB Chair (or designee) may review and approve research without a vote by full IRB. • 45 CFR 46.110 (HHS) • 21 CFR 56.110 (FDA) Developed by: U-MIC

  4. Expedited category 5 expedited review category 5 “…research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).” Category 5 refers only to research that is subject to human subjects research regulations. Developed by: U-MIC

  5. Expedited category 5 expedited review category 5 HHS clarification “…was intended to and should include research involving existing information or specimens that were previously collected for research purposes, provided that they were not collected for the purposes of the current research.” • materials/data collected in the past • research • non-research • materials to be collected in the future • non-research only Developed by: U-MIC

  6. Expedited review category 5 Research categories for expedited review: http://www.hhs.gov/ohrp/policy/expedited98.html(HHS) http://www.fda.gov/ohrms/dockets/98fr/110998b.txt(FDA) HHS Clarification of the scope of category 5: https://www.federalregister.gov/articles/2007/10/26/E7-21126/protection-of-human-subjects-categories-of-research-that-may-be-reviewed-by-the-institutional-review Federal regulations governing expedited review: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.110(HHS) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=56.110(FDA) Criteria for expedited review, per UM HRPP Operations Manual: http://www.hrpp.umich.edu/om/Part3.html Expedited category 5 Developed by: U-MIC

  7. Brian Seabolt IRBMED thank you. Developed by: U-MIC

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