Expedited does not mean that the review is less rigorous or happens more quickly than convened review. It refers, instead, to certain types of research considered to involve minimal risk. Once all application requirements are fulfilled, the expedited review process takes approximately 2 weeks.
All protocols approved through the Expedited Procedure must be submitted for continuing review and approval, as described in Continuing Review & Approval. A final report is also required when the study has ended.
Investigators applying for expedited review should become familiar with all sections of this guidebook and the requirements described in them.
Expedited review is applicable for research activities that involve no more than minimal risk to the human participants and that can be placed in one or more of the nine categories listed on the Expedited Category Review Sheet.
Categories 1 through 7 pertain to both initial and continuing review. Categories 8 and 9 pertain only to continuing review. The definition of minimal risk for the purpose of IRB application is the amount of risk encountered in daily life.
The expedited review procedure cannot be used in the following circumstances:
OHRP has published decision trees that are available online to help in determining whether a research proposal fits the criteria for Expedited review.
There are no deadlines for submission of applications for expedited review.
Page updated: May 8, 2013