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)
A Not Human Subjects Research (NHSR) submission is a short application in iStar to determine if a project requires IRB review. Studies are considered “Not Human Subjects Research” when they do not meet the definitions of human subjects and/or research.
What needs IRB Review
Human Subjects Research
Any activity that fits the federal definition of both “research” and “human subjects” or the FDA definitions of “clinical investigation” and “human subjects” is considered human subjects research.
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 6 federally designated exempt review categories. Studies that may qualify for “Exempt” must still be submitted to the IRB for review.
Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the 9 federally designated expedited review categories.
- Expedited Categories
- Examples- Expedited Applications
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.
- Full Board Research
- University Park IRB Submission Deadlines
- Health Sciences IRB Submission Deadlines
- Examples- Full Board Applications
Duration of IRB Approval (Continuing Review)
Every IRB approved study must receive continuing review “not less than once per year”, per federal regulation. An approval period cannot exceed 364 days. In some cases, the IRB may grant a shorter approval period if the risk level merits more frequent 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.
- Continuing Review After Enrollment and Data Collection Conclude
- After Approval: When to contact the IRB
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.