To submit an application to the IRB, an appropriate level of review must be requested. The IRB will verify or correct the level of review requested for an IRB submission.
What doesn’t need IRB review
Not Human Subjects Research (NHSR)
USC policy allows researchers to make a NHSR determination themselves if a project does not meet the regulatory definition of human subjects and/or research.
Some publishers and funders will require an official NHSR determination notice by the IRB. Please follow the guidelines below to request a NHSR determination prior to starting any activities. Determination notices will not be provided retroactively.
Note: NHSR determinations cannot be made on FDA regulated research, including secondary data analysis on de-identified samples and/or data, also known as “coded data.”
- Quality improvement activities (that are not human subjects research)
What needs IRB Review
Human Subjects Research
An activity requires IRB review if it fits the federal definition below for research and human subjects
or the FDA definitions of clinical investigation and human subjects
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Levels of IRB Review
Human subjects research is reviewed by an IRB according to the following categories:
Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted by a member of IRB staff. They do not require a convened committee meeting.
Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the federally designated expedited review categories. Expedited reviews are conducted by a member of the IRB committee. They do not require a convened committee meeting.
Research that does not qualify for expedited or exempt review (presents more than minimal risks to subjects) will receive review at a fully convened IRB committee meeting.
Duration of IRB Approval (Continuing Review)
To continue a 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.
What if study approval lapses?
If the expiration date has lapsed, the investigator must email the IRB a request to continue study subjects currently on the trial and/or continue data analysis. The investigator will receive confirmation from the IRB. The investigator may not recruit or enroll new subjects until the study’s continuing review has been reviewed and approved by the IRB.