Exempt Review
The code of federal regulations (45 CFR 46.101(b)) identifies several categories of minimal risk research as exempt from the Federal Policy for the Protection of Research Subjects. This determination must not be made by the PI, but by the IRB or someone appointed by the IRB. For more information, see the U.S. Health and Human Services website, “”.
Expedited Review
The code of federal regulations (45 CFR 46.110 and 21 CFR 56.110) identifies several categories of minimal risk research that may be reviewed through an expedited review process. For more information, see the U.S. Health and Human Services website on “”.
Full Board Review
This is review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting. Generally, studies that undergo full board review are studies involving greater than minimal risk, risky, or novel procedures or vulnerable populations.