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IRB-HSR > Protocol Review Process > Levels of Review







Levels of Review

For an overall summary of levels of review see theIRB-HSR Submission Types Table

Human Subject Research/ Clinical Investigation of a Test Article

Activities that constitute human subject research or a clinical investigation of a test article require review by an IRB. If unsure if the project meets the definition of human subject research under DHHS regulations or a clinical investigation of a test article under FDA regulations see Determination of Human Subject Research Form

Non- UVa Agent Determination

This determination is made to identify situations where UVa personnel are involved in human subject research but the research is not being done on behalf of UVa. See Determination of UVa Agent Form.

Exempt Determination

If the research engages the researcher in human subject research, the next step is to determine if the research is exempt from additional review. For health sciences research at UVa, this determination is made by IRB-HSR Administrative staff.

To determine if a project meets the criteria for exempt review see Exempt Criteria and Determination of Exemption

Not Engaged in Human Subject Research Determination

If the project does not fall under FDA regulations, but does involve research with human subjects according to DHHS definitions, the research team should then review the project to determine if they are “engaged” in human subject research. See Not Engaged in Human Subject Research

Expedited Review

If the research does not meet the criteria for Exempt Review, the research team should review the expedited criteria to determine if the research meets the criteria for expedited review. See Expedited Review

Review by Convened Meeting of the Full IRB

If research does not meet the criteria for non-UVA agent, exempt, non-engaged or expedited review the research will be assigned to an agenda of a convened meeting of the full IRB for review.

All projects involving the use of investigational drugs, devices, or biologics for which an IND/IDE is required receive full board review.

If the chair, vice-chair or the chair's designee cannot determine the appropriate level of review, the application will be referred to a convened meeting of the full IRB for review.

See Review by Convened Meeting of Full IRB

URGENT IRB Review: see Urgent Review of Applications

Appeal of IRB Decisions: seeRebuttal or Appeal of IRB Decisions