Welcome to the USC IRB! Below is a list of resources to help you get started for IRB review. Click on the common questions and topics below to learn more about the process.
An activity requires IRB review if it fits the federal definition below for research and human subjects or the FDA definitions of clinical investigation and human subjects.
- Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
and
2. Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Or
3. Meets the FDA definition of clinical investigation and human subject.
Clinical investigation means any experiment that involves a test article and one or more human subjects, and that either: a) must meet the requirements for prior submission to the Food and Drug Administration; or b) the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous. Note: The DHHS regulatory definition of research is different.
Human subject, under FDA regulations, means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient. For device studies, this includes an individual on whom or on whose specimen an investigational device is used. Note: The DHHS regulatory definition of a human subject is different.
Please refer to policy chapters 6.1 and 6.5 for more information.
Not Human Subjects Research (NHSR)
USC policy allows researchers to make a NHSR determination themselves if a project does not meet the regulatory definition of human subjects and/or research. Please view the Not Human Subjects Research (NHSR) page for guidance.
Who may serve as a Principal Investigator
Human research studies require an appropriately qualified individual to serve as the Principal Investigator (PI). A PI must be identified before the IRB will review an application. More information can be found on our PI Eligibility page.
iStar is the USC system for review of human participant research, animal research, radiation safety and biosafety. The USC Institutional Review Boards use iStar to review studies that require IRB review and to certify studies that do not require IRB review.
Go to iStar | istar.usc.edu
Please login to iStar with your USC NetID. If you do not currently have an account, one can be automatically created upon login.
Please contact the iStar Help Desk at iStar@usc.edu for account access inquiries.
For an application to be approved by the USC IRB, all study personnel must complete Human Subjects (HS) research training. Additional training may be required based on study specific factors. The online course used (unless otherwise stated) is provided by the Collaborative Institutional Training Initiative (CITI) at CITI Program. Please refer to the CITI FAQs for further guidance on obtaining an account and adding a course.
Please refer to the Education & Certification page for a list of required courses.
To submit an application to the IRB, an appropriate level of review must be requested. The IRB will verify or correct the level of review requested for an IRB submission.
If you cannot determine the most appropriate level of review please utilize our virtual Office Hours.
Login to your iStar account and click on “Create a New IRB Study.” The iStar system uses a smart form, which will populate questions based on the responses. iStar questions that are marked with a red asterisk (*) require a response from you.
To ensure all submissions to the USC IRBs are reviewed efficiently and thoroughly, review IRB Submission Guidelines prior to submission.
- Learn about the circumstances that may meet the requirements for urgent review.
- Guidance on starting a research trial for both Biomedical and Social Behavioral research at USC.
- Schedule virtual office hours to get assistance with your application.
- Guidance for student researchers and faculty advisors.
Investigators who want to serve as the Lead PI for a multi-site study should review the Requesting USC IRB to Act as sIRB
Investigators who want to participate in a multi-side study and cede IRB review to an external Central/Single IRB should review the Requesting USC to Rely on an External IRB page.
The USC IRB provides protocol, consent, and authorization forms and templates along with other helpful documents on the Forms and Templates page.
Please note that the use of an incorrect protocol will result in the application being returned without review.
IRB Review Process
IRB Review: How to
