Types of IRB Review
To submit an application to the IRB, an appropriate level of review must be requested. The levels of review are based on the level of risk to participants. The IRB will verify or correct the level of review for a study application.
Investigators who will conduct “Human Subjects Research” must complete online Human Subjects training.
What doesn’t need IRB review
Not Human Subjects Research (NHSR)
A Not Human Subjects Research (NHSR) submission is a request for the IRB to determine if a project requires IRB review and approval. Studies are considered “Not Research” when they do not meet the definitions of human subjects and/or research.
Investigators who believe their project may qualify as NHSR can submit the short application in iStar.
- Definitions of “human subjects” and “research”
- Is Your Project Human Subjects Research? A Guide for Investigators
- Classroom research
What needs IRB Review
Human Subjects Research
Any activity that meets OHRP definitions 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.
Research that does not qualify for expedited or exempt review and/or presents more than minimal risks to subjects will receive review by a fully convened committee meeting.
- Full Board Research
- Examples of Full Board IRB Applications
- University Park IRB Submission Deadlines
- Health Sciences IRB Submission Deadlines
Duration of IRB Approval (Continuing Review)
Federal regulations require that every approved study receive continuing review “not less than once per year.” Accordingly, an approval period cannot exceed 364 days. In some cases, the IRB may grant a shorter approval period if the complexity or risk level merits more frequent continuing review.
If an investigator intends to continue the study beyond the period for which it was initially approved, then 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.
- IRB Requirements for Continuing Review After Enrollment and Data Collection are Completed
- IRB Continuing Review for Full Board Studies
What do I do if the approval of my study lapses?
If the expiration date has lapsed, the investigator must formally request (email or telephone is acceptable) 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 enter new subjects until the study’s continuing review has been reviewed and approved by the full board. The investigator will receive a separate correspondence at that time.
It is important that investigators comply with 45 CFR 46. 45 CFR 46.109 (e), which requires the IRB to review a study at intervals appropriate to the degree of risk, but not less than once per year.
More about IRB Submission
- After Approval: When to contact the IRB
- Consent Forms and Templates
- Checklists for IRB Reviewers
- IRB Guidebook (Guidebook for researchers and IRB members)