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Review Type Overview-Human Subject Research Exempt, Expedited, Full Board Review START HERE NOTE: If you will only be receiving data/specimens and not collecting them yourself- see Receiving Data/ Specimens Are data/specimens existing* and will they meet the criteria of Deidentified or Limited Data Set per HIPAA**? *Existing-specimens are currently in lab or the data is in a file Submit: EXEMPT APPLICATION On Goldenrod answer: Yes to Human Subjects Yes to Exempt Yes **Only HIPAA identifiers allowed: • Address info- zip code or bigger • DOB is under the age of 89 • Age is under the age of 89 No Is the study “Minimal Risk”? Minimal risk is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons (45 CFR 46.303(d)). No Yes Do all of the procedures in the study fall under the Expedited Categories per 45 CFR 46.110 and 21 CFR 56.110 ? No Submit: • IRB Application for Full Board Review OR • Request for IRB Authorization Agreement: • External IRB/Ethics board MUST have an FWA and notify IRB-HSR Director . No • dbGaP Data Use Certification Form if receiving data from dbGaP • On goldenrod answer: • YES to Human Subjects Research • NO to Exempt **NOTE: You will also have to submit Grant Proposal to IRB for review and approval if . the protocol has outside funding. For Grant Submission Process see IRB-HSR Website at http://www.virginia.edu/vpr/irb/hsr/submit_grant.html Yes Submit: IRB Application for Expedited Review OR • Request for IRB Authorization Agreement: • External IRB/Ethics board MUST have an FWA and notify IRB-HSR Director . • dbGaP Data Use Certification Form if receiving data from dbGaP • On goldenrod answer: • YES to Human Subjects Research • NO to Exempt **NOTE: You will also have to submit Grant Proposal to IRB for review and approval if the protocol has outside funding. For Grant Submission Process see IRB-HSR Website at http://www.virginia.edu/vpr/irb/hsr/submit_grant.html Version Date 8/20/15