**Student Guide to Human Subjects Research**
**Guide to Human Subjects Research for USC Medical Students**

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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?

Research Guidance

• ABC’s of the IRB Process
• IRB Student Mentor
• FAQs on Child and Elder Abuse
• Human Subjects Research Brochures
• Conducting Internet 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 (whether professional or student) conducting research 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/Training, including how to obtain an account, are available here.

• Why is IRB Submission Required?
• Training Required by the IRB
• Model IRB Applications University Park IRB Submissions
• Social-Behavioral Research (University Park IRB Submissions)
• Biomedical Research (Health Sciences IRB Submissions)
• Expedited vs Exempt Studies...perspective of an IRB reviewer

Online Human Subjects Research Education

• CITI (Human Subjects Education Program)

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 human subjects training requirments is available here.

• Responsible Conduct of Research
  

  All students (including undergraduates, graduate students and postdoctoral scholars) supported by the National Science Foundation are required to complete an approved course in Responsible Conduct of Research. Students supported on certain NIH programs, including training grants, are also required to complete RCR training.
  
  OPRS has created a series of 9 RCR booklets to complement the training and introduce students to principles on the ethical conduct of research. For these booklets and for more information on RCR training, click here.

Additional Research Resources

• The ABC’s of the IRB Process for Student/Medical Student Investigators
• IRB Student Mentor
• Human Subjects Research Brochures
• Trojan Health Volunteers
• USC Research Subject Pools