Students Conducting Research

Going through the IRB review process can be scary and confusing. This section of the website can provide some answers to questions you may have regarding the IRB process and how human subjects research is defined.

The IRB Student Mentor is also available to assist students with specific questions about the IRB process and human subjects research.

What is Human Subjects Research?

USC adheres to the Federal Regulations for the Protection of Human Subjects (HHS and FDA). The HHS Regulations (45 CFR 46) define “research” and “human subjects” as follows:

  • Research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge*.
  • Human Subjects: a living individual about whom an investigator conducting research (whether professional or student) obtains:
    1. data through intervention or interaction with the individual or
    2. identifiable private information.

*Note: this definition excludes research that is not generalizable; such as oral histories or classroom projects and exercises.

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.

The USC Institutional Review Boards (IRB) and the Office for the Protection of Research Subjects (OPRS) are ultimately responsible for deciding when an activity constitutes human subjects research and how human subjects research protections must be implemented. These are not the purview of individual researchers.

Submitting IRB Applications Through iStar

Investigators must submit IRB applications through the online IRB Submission Tracking and Review (iStar) system. Subsequent reviews, amendments, and reportable events must also be submitted through iStar. An iStar account is needed to utilize this system. iStar Resources, including how to obtain an account, are available here.

Why is IRB Submission Required?
Training Required by the IRB
Types of IRB Review
Tips for IRB Submissions
Model IRB Applications
Expedited vs Exempt Studies…perspective of an IRB reviewer

Research Guidance