Apply for IRB Review

Why is IRB Submission Required?

IRB submission is required for all research projects using “human subjects” as defined by Federal Regulation (Title 45 Part 46).

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.

More about types of IRB review.

What is “human subjects research”?

A study requires IRB review if it conforms to both of the following federal definitions:

  • Research is systematic investigation, 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:
    1. data through intervention or interaction with the individual, or
    2. identifiable private information.

More about human subjects research

How to Obtain IRB Review

  • ISTAR (IRB Submission, Tracking And Review system)
    IRB applications must be submit through the online ISTAR system. Subsequent reviews, amendments, and reportable events must also be submitted through iStar.
    An account is needed to utilize this system.
    Open an ISTAR account
  • 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.
    The Human Subjects Protections Basic course is required for all human subjects research.
    Other courses such as Good Clinical Practice may be required, depending on the nature of the research.
    Read more about CITI.

IRB Approval Process

  1. Investigator Submits Study via iStar:
    Investigators must indicate if the application requires exempt, expedited, or full board review. The IRB verifies or corrects the selected level of review.
  2. Faculty Advisor/Department Sign-off:
    Once the application is submitted the faculty advisor or department chair signs-off on 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/faculty advisor approval is obtained, a cursory review is conducted by the IRB staff.
    The IRB staff verify the correct level of review has been selected and 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,” a determination letter is issued administratively.
    Studies designated as expedited or full board are reviewed by 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.
  5. Significant changes to a study after approval must be submitted and reviewed by the IRB prior to implementation. 

Human Subjects Research Information