Why is IRB Submission Required?
IRB submission is required for all research using “human subjects” as defined below.
An Institutional Review Board (IRB) is a committee designated to review, approve, and monitor research activities involving human subjects. The IRB assures that human subject research is conducted in accordance with federal, institutional, and ethical requirements.
How long does IRB review take?
IRB applications should be submitted at least 1 month prior to the intended research start date.
All IRB submissions are reviewed in the order received (new studies, amendments, continuing reviews, and responses to contingencies). Studies will not be “pulled out of queue” however, the IRB may be able to accommodate funding related deadlines with advance notice.
Full Board studies are reviewed per the IRB meeting deadlines:
What is “human subjects research”?
A study requires IRB review if it conforms to both of the following federal definitions:
- Research: systematic investigation, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- Human Subject: is 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.
How to get IRB review
Submit an ISTAR Application
Applications for IRB review must be submitted online through the iStar system. Subsequent reviews, amendments, and reportable events must also be submitted through iStar.
An account is needed to utilize the system.
Human Subjects Research Certification
The Human Subjects Research course is required of all USC investigators and key personnel* conducting human subjects research or all human subjects research.
Other courses such as Good Clinical Practice may be required, depending on the nature of the research. IRB applications are not approved until the training requirement is met.
*Key personnel are generally those with direct contact with research subjects or with subjects’ identifiable data
IRB Approval Process
- Investigator Submits Study via iStar:
Investigators must indicate if the application requires exempt, expedited, or full board review. The IRB verifies or corrects the selected level of review.
- Faculty Advisor/Department Sign-off:
Once the application is submitted, the faculty advisor or department chair signs-off on the application. This sign-off represents review of scientific merit, availability of resources, or other issues at the department level.
- IRB Office:
After department/faculty advisor approval is obtained, a cursory review is conducted by the IRB staff. IRB staff verify the correct level of review has been selected and evaluate the protocol and supporting documents (e.g., consent form, recruitment materials). If a study is approved as exempt or determined to be “not human subjects research,” a determination letter is issued administratively.
Studies designated as expedited or full board are reviewed by a designated reviewer or the full board, respectively.
- Study Approved and PI Notified:
The researcher will be notified through an iStar generated email when the study has been approved.
- Significant changes to a study after approval must be submitted and reviewed by the IRB prior to implementation.
After Approval: When to contact the IRB
After IRB approval of a study, there are occasions when an additional IRB submission is required to either modify the project, continue the project beyond its initial term of approval, or to report an unexpected adverse event that occurred during the research.
To continue the study beyond the period for which it was initially approved, a Continuing Review application must be submitted. Studies that require Continuing Review will receive email notifications from iStar with instructions for how to submit a Continuing Review application.
Investigators must seek IRB approval before making any changes to an approved research study. Changes to the study protocol may not be implemented until approved by the IRB. When the IRB approves the amendment, the modified study replaces the previously approved study.
However, when a change is necessary to eliminate immediate hazard to the subject a change may be implemented without IRB approval and the IRB must then be notified right away.
See Reportable Events
During the course of research situations may occur that must be reported to the IRB. These include complaints from subjects, protocol deviations, adverse events, and significant new information or findings. An application for submitting a reportable event can be accessed in iStar. Detailed information about reportable events can be read in the policies of the Human Subject Protection Program.
Reportable events include:
- Complaints- Dissatisfaction, a breach of subjects rights/research ethics expressed by a subject or subject’s representative
- Protocol Deviation or Error- when research procedures are intentionally or accidentally not followed.
- Adverse events- any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
- Significant New Information and / or Findings (SNIFs)- If an apparent, immediate hazard to participants is identified, participants must be notified and corrective actions implemented as soon as possible. The IRB must be informed about these occurrences and the investigator must promptly submit a reportable event to the IRB.