All projects that meet the federal definition of research with human subjects (45 CFR 46.102 ) must be reviewed and approved, or receive an exempt determination, by an IRB prior to beginning the research. The IRB staff initially screens submissions to determine the completeness and the appropriate type of review. Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process.
Three Levels of IRB Review
Studies with no more than minimal risk that meet the federal exempt review criteria (e.g., research using anonymous surveys) which are reviewed by the IRB chair or experienced IRB reviewer(s) designated by the chair. (45 C.F.R. 46.101(b).) Exempt Category Guidance
Studies with no more than minimal risk that meet the federal expedited review criteria (e.g., use of data already collected for non-research purposes) which are reviewed by the IRB chair or experienced IRB reviewer(s) designated by the chair. (45 C.F.R. 46.110.) Expedite Category Guidance
Full Board Review
Studies that are not eligible for exempt or expedited review which are reviewed by the full, convened IRB with a recorded vote. (45 C.F.R. 46.109.)
All applications are submitted through InfoED, the online electronic application submission system.
Means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
What Must the Board Determine?
- The proposed research design is scientifically sound and will not unnecessarily expose subjects to risk
- Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of knowledge that may reasonably be expected to result
- Subject selection is equitable
- Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence
- Informed consent is obtained from research subjects or their legally authorized representative(s)
- Risks to subjects are minimized
- Subject privacy and confidentiality are maximized