Some researchers find IRB review to be intimidating. Misconceptions fuel much of the anxiety. Below are clarifications about the review process that are frequently misunderstood:
Does “Exempt” mean IRB review is not needed?
Researchers often interpret the word exempt to mean there is no IRB review needed.
At USC, a study must be reviewed by an IRB in order to be designated as exempt from further review.
Learn more about exempt review
Does an “Expedited” submission get a faster review?
No, expedited is a level of review named and defined by federal regulation. It does not indicate speediness. The speed of an IRB review depends on thoroughness of the application, speed of responses from the applicant to information and edits requested by the IRB.
Learn more about expedited review
How do I get IRB review?
To submit a project for IRB review, the investigator and all study personnel must complete the human subjects protection course at www.citiprogram.org and establish an account in istar.usc.edu before the IRB application can be submitted.
Additional training requirements may apply, depending on the nature of the research project.
Learn more about the steps for IRB submission
Does my project need IRB review?
A study requires IRB review if it involves both of the following:
- Research: systematic investigation, testing, and evaluation, designed to develop or contribute to generalizable knowledge
- Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains:
- data through intervention or interaction with the individual, or
- identifiable private information.
To discuss IRB review for your USC research, contact the IRB
Are all IRB applications reviewed by a committee?
All IRB applications/submissions are reviewed initially by the IRB administrative staff. The IRB Administrator may issue exempt determinations. Expedited studies must be reviewed by both an IRB Administrator and also by a member of the IRB committee. The minority of IRB submissions are reviewed by the “Full Board” at a committee meeting.
Learn about the levels of IRB review
Does the complexity of research determine how it is reviewed?
No, the level of IRB review is primarily determined by the level of risk and the population under study. Populations such as children, prisoners, pregnant women and neonates require added protections per federal regulation.
How long will it take to get IRB approval?
All IRB applications should be submitted a month before the intended start of research. IRB review is an iterative process. A typical IRB application undergoes multiple rounds of revisions before approval. The length of the process is impacted by the level of review, thoroughness of the application and, speed of responses from the applicant for information and edits requested by the IRB.
Do I need approval from more than one IRB for a research project involving multiple locations?
If multiple institutions are engaged in a research project an agreement can be enacted between the relevant IRBs so that only one IRB review is performed. The principal investigator (lead investigator/recipient of funding) must indicate in the IRB application the activities conducted at the other site(s).
To discuss IRB review for your USC research, contact the IRB
What is informed consent?
“Informed Consent” for research is permission or approval from the participant. The required contents of a consent form are specified by federal regulation. Consent is more than just the form – it is an ongoing process that starts with the first contact and ends when the participant’s role in the study ends. Learn more about consent requirements
Is informed consent required for all research projects?
Consent is generally required for all human subjects research except exempt projects. Signed consent can be waived for some situations. Elements of informed consent can be waived or altered if the IRB determines that the study meets criteria for “no more than minimal risk”. Learn more about consent requirements
What level of IRB review is right for my project? What if I pick the wrong level?
The level of IRB review is determined by the level of risk to participants. If the wrong level was marked, the IRB will correct the level of review and may ask the researcher to submit additional information.
Learn more about the Levels of IRB Review
Does the IRB review the science and methodology of a project?
The IRB is obligated to consider the design and methods in terms of demands on the subjects and whether the research questions can be answered by the proposed methods.
