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IRB-HSR > Protocol Review Process > Levels of Review







Levels of Review

Activities that constitute human subject research are determined by the University of Virginia IRBs and the IRBs delegate this decision to the IRB chair, vice chair, experienced member designee or experienced IRB staff. The decision by the chair, vice chair, experienced member designee or experienced IRB staff is based on whether the activity:

  • represents "research," and involves "humans" as participants, (as defined in 45 CFR 46.102(d), 45 CFR 46.102(f) and
  • if the study does not fall under FDA regulations : "engages" the University of Virginia (as defined in the OHRP guidance document "Engagement of Institutions in Research" respectively), or meets the definition of Coded Research (as defined in the OHRP guidance document "Research Involving Coded Private Information or Biological Specimens or
  • represents a clinical investigation of a test article involving one or more humans as participants (as defined in 21 CFR 50.3(c), 21 CFR 50.5(j), and 21 CFR 50.5(f) respectively).

The UVa IRB's designate the chair, vice chair or chair's designee (experienced IRB Member or IRB staff)  to review the entire application and make determinations as to whether a project constitutes human subjects research and, if so, the type of review (full board review, expedited review, or exempt).

Additional information may be found at Activities that Require IRB Review.

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

The IRB staff may make determinations regarding those projects that do not involve human subjects either by not "engaging" the University in Human Subject Research, by those projects which involve Coded Research per OHRP guidance or those which are Exempt per 45CFR46.101.

All human subject research applications are assigned to full board review unless they meet the criteria for exemption or  expedited review criteria.

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


*Taken from UVa IRB-HSR Research Guidance