Depending on the study, different levels of review may be required. Determination of the level of review is primarily decided based on minimal risk.
Three Levels of IRB Review
1. Exempt 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).)
2. Expedited Review
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.)
3. 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 OneAegis, the online electronic application submission system.
Minimal Risk
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
