USC
University of Southern California Protection of Research Subjects

Student Researchers

The ABC’s of the IRB Process for Student Investigators (Word) (PDF)
Going through the IRB review process can be scary and confusing. Student researchers may ask questions such as: “Do I need to submit my project to the IRB? How do I submit to the IRB? Where do I start? How long does it take to get IRB approval? Will I be able to graduate on time? Who can help me with my application?” If these questions sound familiar, you’ve come to the right place. This section of the website can provide some answers to questions you may have regarding the IRB process.

Also, the IRB Student Mentor is available to assist students with the IRB process and human subjects research.

A – Setting up an iStar Account
Students must obtain an iStar account prior to beginning the IRB process. iStar is the online IRB application system (http://istar-chla.usc.edu). To obtain an iStar user account, students can send an email request to istar@usc.edu with their name, email address, campus, and department/division.

B – CITI – Online Human Subjects Education
Students who are conducting studies that do not qualify as human subjects research are not required to complete the CITI education course. Students can contact the IRB (upirb@usc.edu), the IRB student mentor (IRB Student Mentor), the Office for the Protection of Research Subjects (oprs?@usc.edu) or check the IRB website if they are unsure if their study qualifies as human subjects research. Once students receive their iStar account, they must complete the required online CITI human subjects education training course. This education course is a requirement for all investigators and personnel involved in human subjects research. Students can work on their iStar application without CITI certification; however they may not submit the application to the IRB unless they have completed the CITI training. For detailed information on CITI visit http://www.usc.edu/admin/provost/oprs/citi.

C – Does Your Study Qualify as Human Subjects Research According to Federal Definitions?
Studies that do not meet the federal definitions of human subjects research do not have to be reviewed and approved by the IRB. Student investigators who are unsure if their proposed study qualifies as Human Subjects Research can find more information in the Is Your Project Human Subjects Research? booklet. This booklet explains the federal definitions of what qualifies as “research” and “human subjects.” It also contains examples of studies that qualify as human subjects research and those that do not. Student investigators can also contact their faculty advisor, the IRB office (upirb@usc.edu), the IRB Student Mentor (IRB Student Mentor), or the Office for the Protection of Research Subjects (oprs@usc.edu) for further assistance.

D – Your Study Qualifies as Human Subjects Research…Now What?
Student investigators can go into their iStar account and start their IRB application by clicking “New Study.” Students are advised to consult with their faculty advisor regarding this process.

E – Need Assistance? Students can find information about the IRB process through their faculty advisor. Other resources can be found in the Student Investigator’s Guide to the IRB Process and Human Subjects Research handbook found in the IRB website, the IRB office, research departments within the student’s school/program (if available), and/or the IRB Student Mentor. (An IRB Student Mentor is available to assist student investigators with the IRB process. The Student Mentor can be reached at irbgara@usc.edu)

F – Which IRB Application do I Need?
Please review the following to find out which application to complete:

    For Human Subjects Research
    Investigators must complete the “New Study Application” by going into their iStar account. (http://istar-chla.usc.edu) More information about each question can be found by going into the Study Application Guidance in the Training Resources section of the iStar website or through the Student Investigator’s Guide to the IRB Process and Human Subjects Research handbook found in the IRB website.

    For NOT Human Subjects Research
    Investigators must complete the Human Subjects Determination Request Application in iStar. (http://istar-chla.usc.edu) Investigators who are unsure if their proposed study qualifies as Human Subjects Research can find more information in the Is Your Project Human Subjects Research? booklet.

    Projects that Analyze Coded Data (Secondary Data) Only
    Investigators must complete the Human Subjects Determination Request Application in iStar. (http://istar-chla.usc.edu) Investigators who are unsure if their proposed study qualifies as Coded Data can find more information in the Is Your Project Human Subjects Research? booklet.

    Projects that Analyze Biological Specimens Only
    Investigators must complete the Human Subjects Determination Request Application in iStar. (http://istar-chla.usc.edu) Investigators who are unsure if their proposed study qualifies as Coded Biological Specimens can find more information in the Is Your Project Human Subjects Research? booklet.

Making Sense of Human Subjects Research: A Student Guide
This guidance is a comprehensive manual aimed at assisting student with the IRB process. It provides information needed to understand the intricacies of human subjects research, a question-by-question explanation of the IRB application, and examples of exempt and expedited applications. Making Sense of Human Subjects Research: A Student Guide (PDF)

Other Student Resources