Types of Review

Before conducting any research involving human subjects, an Principal Investigator (PI) must submit a protocol application for IRB review and approval.  Depending on the nature of the study and the level of risk involved, the research will fall under one of three types of review: Exempt, Expedited or Full Board.  Please note that in the InfoEd Electronic Protocol System, there is only one application (eForm).  The IRB will make the determination which level of review will apply.

The IRB Program Guide outlines the review processes for each review type.

Exempt Review

“Exempt” does not mean the research is excluded from IRB review.  Although certain research activities are exempt, only the IRB Chair, IRB member, or IRB staff (acting as a designee of the Chair), may determine if a protocol is granted exempt status under the six categories described in 45 CFR 46.101(b). After its review, the IRB will determine a protocol application’s exempt status.  A PI cannot make the final determination of exemption. If a study qualifies as exempt, then it is exempt from expedited or full board IRB review.

Exempt research must be minimal risk. Research activities in which the only involvement of human participants falls under one or more of the specified Exempt Categories are exempt from the Federal Policy for the Protection of Human Participants. Per 45 CFR 46.101(i), the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners or research with children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

Although the regulations do not require informed consent for exempt research, the IRB has determined that informed consent is ethically appropriate to ensure that prospective participants are informed of the research and have an opportunity to decide for themselves whether or not to participate. In most cases, the IRB will waive written consent and ask that the PI prepare an information sheet according to the requirements set forth under 45 CFR 46.116.

Please allow up to three weeks for the exempt review process.

Expedited Review

To receive an expedited review, a study must fall into one or more of the Expedited Categories.  Expedited research does not have to go before the full board to be approved.

Expedited research must involve no more than minimal risk. As defined in the federal regulations, “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 (45 CFR 46.102(i)). Only the expedited IRB reviewers may determine if a protocol is granted expedited status under seven of the nine categories as published in the federal register as 45 CFR 46.110.  Categories 8 and 9 do not pertain to initial review.

Please allow up to six weeks for the expedited review process.

Full Board

Any research involving the use of human participants that does not fall into the exempt or expedited categories must be submitted as full board.  Full board applications are reviewed and approved by all members of the IRB.

The final determination that a research project falls under full board can only be made by the IRB.

You must submit full board applications at least two weeks before the IRB’s regularly scheduled meetings.  All applications that are not received within two weeks of the IRB meeting will be reviewed at the next meeting.  Please allow up to six weeks for the full board review process; longer if the protocol is tabled.