Apply for IRB Review
Why is IRB Submission Required?
An Institutional Review Board (IRB) is charged with reviewing the research activities involving human subjects that are being conducted at the institution or by the institution’s faculty and students.
IRB submission is required for all research projects using “human subjects” as defined by Federal Policy.
What is “human subjects research”?
Definitions (from 45 CFR 46)
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject is a living individual about whom an investigator (whether professional or student) conducting research obtains:
- data through intervention or interaction with the individual, or
- identifiable private information.
More information about conducting research using human subjects:
- Are You Conducting Research Using Human Subjects? A Guide for Principal Investigators
- Student Handbook: Making Sense of Human Subjects Research
- Types of IRB Review
- IRB Application at a Glance
- Tips for IRB Submissions
Requirements: iStar and CITI
iStar (IRB Submission, Tracking And Review system)
Investigators must submit IRB applications through the online iStar system. Subsequent reviews, amendments, and reportable events must also be submitted through iStar. An iStar account is needed to utilize this system. For information on how to obtain and use an iStar account, visit iStar Resources.
CITI (Human Subjects Education)
CITI is the online education program required of all USC investigators and key personnel conducting human subjects research. IRB applications are not approved until this education requirement is met. Information on CITI is available here.
IRB Approval Process
(1.) Principal Investigator (Faculty/Staff/Student) Designs and Submits Study via iStar:
Investigators must indicate if the application requires exempt, expedited, or full board review. The final determination of the review category is made by the IRB.
(2.) Faculty Advisor and Department Sign-off:
Once the application is submitted the faculty advisor must review and sign off on the application. In some cases, a departmental representative must also sign the application. This sign-off represents consideration of scientific merit, availability of resources, or other issues at the department level.
(3.) IRB Office:
After department or faculty advisor approval is obtained, an initial review of the application is conducted by the IRB staff or IRB designee. At USC, the IRB staff conducts a thorough pre-review of the application to verify the correct level of review, and to evaluate the protocol and supporting documents (e.g., consent form, recruitment materials). If a study is approved as exempt or determined to be “not human subjects research,” no further IRB action is required. Any significant changes to the approved study must be submitted and reviewed by the IRB prior to implementation of changes. For studies designated as expedited or full board, IRB review is required from a designated reviewer or the full board, respectively.
(4.) Study Approved and PI Notified:
The researcher will be notified through an iStar generated email when the study has been approved.