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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 1
SINGLE INSTITUTIONAL REVIEW BOARDS (s. IRB) IRBMED process Developed by: U-MIC University of Michigan IRB Collaborative
s. IRBs Single IRB (s. IRB) reviewing IRB / IRB of record assumes IRB responsibilities for other sites in multi-site research relying IRB • relying institution • cedes IRB oversight to s. IRB • • • general overview • more detailed information/instructions: • • Developed by: U-MIC IRBMED guidance materials IRBMED regulatory staff 3
s. IRBs Single IRB (s. IRB) • NIH Single IRB Policy for Multi-site Research • • NIH-funded multi-site human subjects research must use s. IRB effective January 25, 2018 • revised Common Rule • 45 CFR 46. 114(b)(1): Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. (Effective January 20, 2020) Developed by: U-MIC 4
s. IRBs IRBMED as s. IRB • UM researchers • complete s. IRB request form in Qualtrics • • general information about proposed project/external sites IRBMED • • informs researchers whether willing to serve as s. IRB works with UM researchers/participating sites on reliance agreements • • • Developed by: U-MIC IRB Authorization Agreement (IAA) document signed by institutions engaged in multi-site research permits one or more institutions to cede IRB oversight 5
s. IRBs Submitting the e. Research application • researchers utilize multi-site research (MSR) application type • application must include • • • Developed by: U-MIC study protocol manual of procedures listing of performance sites template recruitment documents template informed consent materials other supporting documents 6
s. IRBs IRBMED review • performance site • receives • • • provides • • approval letter template documents local context information site-specific documents other requested information receives • • Developed by: U-MIC site activation letter finalized consent materials 7
s. IRBs IRBMED review • If UM is a participating site, submit ceding application • “Requesting Review by a Non-UM IRB” application type • • for U-M ancillary committee review MSR application • • does not route through ancillary committees contains only • • Developed by: U-MIC external site information protocol informed consent templates does not contain UM-specific workflow information 8
s. IRBs IRBMED as relying IRB • To cede oversight to non-UM IRB • UM researchers submit ceding application • • “Requesting Review by a Non-UM IRB” application type reviewed by • • UM ancillary committees IRBMED • delineates institutions’ responsibilities ceding arrangements established through reliance agreement Only IRB regulatory oversight is ceded. • Other workflows/oversight remain at UM. Developed by: U-MIC 9
s. IRBs UM as coordinating center and relying institution • When UM serves as clinical / data coordinating center • • IRBMED not s. IRB study-specific reliance agreements dictate which application • • • MSR application • if IRBMED oversees coordinating center functions • if s. IRB oversees coordinating center functions ceding application When UM is participating site • ceding application required • Developed by: U-MIC for ancillary committees review 10
s. IRBs Single institutional review boards (s. IRBs): IRBMED process Developed by: U-MIC 11
THANK YOU. Nicole Duffy Angela Faber Judy Birk Brian Seabolt IRBMED Developed by: U-MIC 12
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