If the submission meets the necessary criteria for human subjects research, the protocol will be processed according to review type determined by the IRB. (Please contact the IRB with any questions about review type.)
For researchers, understanding whether a protocol falls under expedited or exempt status can often be confusing. “Exemption” does not mean a project is exempt from evaluation: all human subjects studies, without exception, must be submitted to the IRB for a final status determination. This FAQ, however, will help investigators reflect on the distinction between expedited and exempt studies. The section “How does the IRB decide whether a project is expedited or exempt?” offers insight into the thought process the IRB might use when reviewing a study. The side by side chart gives a general comparison of expedited and exempt studies.
Expedited protocols are reviewed on a rolling basis by one or two IRB members, who evaluate the submission and provide feedback (often requiring some changes). Once the researcher has responded to any questions or changes, and the protocol meets the conditions for approval, a letter of approval will be issued by the IRB office. (Only the full board may issue disapproval, regardless of review level.)
Full board protocols must be submitted by the deadlines posted on the IRB home page to be reviewed at the next scheduled meeting. On all full board protocols, PIs should plan to be present for a short segment of the meeting in order to answer questions or provide clarifications.
Typically, one or two IRB members serve as primary reviewers when presenting on the protocol to the full board; however, all IRB members read and review all full board protocols. During the convened IRB meeting, the board discusses all protocols in the context of federal review and approval criteria. Any IRB member with a conflict of interest may participate in discussion but must recuse him/herself from the vote. However, a quorum must be maintained to take any voting action. Additionally, if the non-scientist member must exit or leave the meeting, all discussion/action must stop until that member's return. For any protocols involving incarcerated subjects (whether adults or youth), Federal regulations stipulate that a trained IRB member experienced with the prison population/system must be present as the prisoner representative.
All voting totals (for, opposed, abstentions, recusals) must be documented in the IRB minutes. The PI will be informed of the IRB's decision and feedback within five business days of the meeting.