The Level of Review and Minimal Risk

If your study needs IRB review, the next step is to identify the level of review required – full committee review, expedited review or exempt certification.

The level of review reflects the level of risk to the subject. The risk level is compared to “minimal risk” as defined by the federal regulations:

  • Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(j))(Common Rule).

Greater than minimal risk studies require full committee review, while minimal risk studies may be eligible for expedited review or exempt certification.  The lower the level of risk the faster the review process can be.  Full Board Reviews require much more time to process than Exempt Certification or Expedited Reviews.