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.
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?”
- Definitions of “Human Subjects” and “Research”
- Is Your Project Human Subjects Research? A Guide for Investigators
Human Subjects Research:
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.
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.
Research that does not qualify for expedited or exempt review and/or presents more than minimal risks to subjects will receive Full-Board Review.
- HSPP Policies and Procedures
- Federal Agencies’ Policies
- UPIRB Full Board/CR Submission Deadlines
- HSIRB Full Board/CR Submission Deadlines
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.
- IRB Requirements for Continuing Review After Enrollment and Data Collection are Completed
- IRB Continuing Review for Full Board Studies
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.
- Consent Forms and Templates
- Tips for IRB Submissions
- Agreements for IRB Review at Other Institutions
- Research Coordinator Guidance
- Biomedical Regulatory Binder: Table of Contents
- Biomedical Subject File
- Social Behavioral Study Binder: Table of Contents
- IRB Guidebook (Guidebook for researchers and IRB members)
- Certificates of Confidentiality
- Human Subjects Regulations Decision Charts
- Research Related Professional Ethics Codes and Guidelines(Word Doc)
- Keeping Out of Legal Trouble -Academic Senate Faculty Guide (PDF)