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expedited review category 5Developed by:U-MICUniversity of Michigan IRB Collaborative

Expedited category 5

expedited review

no more than minimal riskcategories 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)3Developed by:U-MICExpedited category 5

expedited reviewcategory 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.4Developed by:U-MICExpedited category 5

expedited reviewcategory 5HHS clarificationwas 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 pastresearchnon-researchmaterials to be collected in the futurenon-research only5Developed by:U-MICExpedited category 5

6Developed by:U-MICExpedited 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.htmlthank you.Brian SeaboltIRBMED7Developed by:U-MIC