The information on this page is about student research that is exempt. This includes Social Behavioral and/or Student Secondary Research or medical records and specimens. In all cases, the HRPP is here to help you! Think of the IRB submission process like when you prepare to rent an apartment, buy a car. You need to have all your documents ready to go so that you can submit the information.
- Review the Forms and Templates page for protocol templates, information sheet and recruitment materials.
- Review the iStar tips below for filling out an exempt application and/or student secondary research or medical records.
- Please view this document to understand the difference between confidentiality and anonymity, and tips for filling out Section 26 in iStar.
- Once all your documents are ready: protocol, information sheet, recruitment (as applicable), your CITI training has been completed, you will be ready to complete the iStar process.
- To learn more if you should be using an information sheet or informed consent form, please review this video.
- ONLY upload MS Word documents for the protocol, information sheets and/or consent forms. Do not convert these documents to a PDF.
- Recruitment flyers/survey questions may be uploaded as a PDF.
- iStar application tips if you have interviews/focus groups included in your study
- If you prefer a video format, please view this Youtube video of the same application tips as above.
- iStar application tips for secondary research only
- Youtube video of iStar application tips for submission of medical records and/or specimens.
At USC, faculty who supervise student research are called Faculty Advisors (FAs). FAs play an important role in human subjects protections. The FA bears ultimate responsibility for the ethical conduct of research carried out by the student. The time and effort FAs dedicate to their students has considerable impact on student projects, quality data, and the time required for IRB approval.
Faculty Advisors Must:
- Determine whether projects require IRB review and assist students with the process.
- Discuss research ethics with the students.
- Familiarize themselves and students with ethical and regulatory mandates for human subjects research.
- Complete Human Subjects Training – online at CITI and maintain certification.
- Ensure student iStar applications are complete and describe all study procedures to be conducted; all sections are accurate and all relevant materials (e.g., instruments, consent documents, recruitment materials, etc.) are uploaded. The IRB Office will return incomplete/inadequate applications to students and require FAs to assist them with the contingency responses requested. FAs who repeatedly allow their students to submit incomplete/inadequate applications will have applications returned to their students without an IRB review in order to allow the FAs to fulfill their responsibilities. The HRPP and/or IRB Offices may require additional training/education for those Faculty Advisors.
- Approving the student’s IRB application and signing a Faculty Advisor Assurance outlining their responsibilities.
- Monitor student projects focusing on maintaining confidentiality, privacy, the level of risk, voluntary participation and withdrawal, and informed consent.
- Assure prompt reporting to the IRB of any event that requires reporting in accordance with the IRB policies and procedures for Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.
Student Investigators Must:
- Work with the advisor to develop a study design with merit
- Meet regularly with the advisor to report their progress
- Take online human subjects education training (CITI)
- After the FA approves, submit an application to the IRB
- Obtain IRB approval before initiating any research activities
- Inform the IRB of all proposed changes or additions to the previously approved study before implementing them
Faculty Advisor Approval Form for non-USC Faculty
Generally, a Faculty Advisor is a member of the USC faculty, has an academic appointment, and has a USC email address. However, there may be circumstances when individuals who do not have an academic appointment may be the best person to oversee a student’s research. In such cases, a Faculty Advisor Approval Form must be submitted with the students IRB application in iStar section 40.The approval form can be found under “Other IRB Forms and Templates” on the Forms and Templates page.
Cohort—a single group of students who are all addressing the same research question in the same way.
Submit as a single protocol if all the following are true:
- Targeting the exact same sample (with minor differences such as different schooling levels or different districts)
- Engaging in the exact same data collection methods (I.e., using the exact same survey or interview protocol)
- Undertaking the exact same approach to analysis
In this instance one student would be listed as the principal investigator and the other students would be identified as co-investigators or other study personnel.
Submit individual protocols if any of the following are true:
- Student has defended their proposal before others in cohort
- Research question, the sample, the data collection activities or instruments, or the analysis approach differ from others in cohort
Student researchers must submit their application using the correct review (risk) determination category (e.g., exempt, expedited, etc.). It is the faculty advisor’s responsibility to verify that the correct review category has been selected prior to submitting the application to the IRB. Exempt applications submitted as expedited or Full Board will be returned to the PI, which will delay the review/approval process.
If you, or your faculty advisor, have questions regarding the review type, please reach out to the IRB Office or schedule virtual office hours.
USC recognizes that some student projects are conducted to fulfill course requirements, and involve activities that might appear to be human subjects research. Classroom assignments do not require IRB approval. These projects typically fulfill a course requirements, are often completed in one semester, and are designed to teach research methods. Faculty members design these assignments to engage students in interaction with individuals, gather data about individuals, and/or illustrate concepts covered in the course.
If students or faculty are uncertain if a classroom project must be reviewed by the IRB, they should contact the IRB.