Types of IRB Review

Prior to submitting a study application to the IRB through iStar, you will need to consider which level of review is appropriate, as this will determine the type of application you will need to submit. The levels of IRB review are based on the level of risk to participants. Ultimately, the IRB has the final decision in verifying the level of review based on the study application. Please note, studies that qualify for “Human Subjects Research” require “Human Subjects Certification” from CITI.

levels of reviewNot Human Subjects Research (NHSR)

Research that does not fit the federal definition of “human subjects” or “research” is referred to as “Not Human Subjects Research” or “NHSR”. To submit a NHSR application in iStar, click on “Does my project qualify as “Not Human Subjects Research? (USC Only) NHSR?”

Human Subjects Research:

Exempt Review

Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the 6 federally designated exempt review categories. Studies that may qualify for “Exempt” must still be submitted to the IRB for review.

Expedited Review

Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the 9 federally designated expedited review categories.

Full-Board Review

Research that does not qualify for expedited or exempt review and/or presents more than minimal risks to subjects will receive Full-Board Review.

Continuing Review

The IRB determines the period of approval and frequency of review for all studies involving human subjects research. If an investigator intends to continue the study beyond the period for which it was approved, then the investigator must complete a Continuing Review application. For Expedited and Full-Board studies that may require Continuing Review, investigators will receive email notifications from iStar with instructions for how to submit a Continuing Review application.

Turn-Around Time for Review

All iStar applications are reviewed in the order received.  Review time is dependent upon the number of studies in queue, but is approximately 5-10 working days for expedited or exempt submissions. Full-Board studies are reviewed, per the IRB meeting schedules.

Other Guidance

If you need additional guidance contact the IRB to which you will be submitting your application:
HSIRB Contact Page
UPIRB Contact Page