561. New Projects: Expedited Review

Updated Oct. 4, 2019

Review of research by the expedited procedure is an alternative to review by the convened IRB for a limited class of research as specified by DHHS: Categories of Research that May Be Reviewed… Expedited Review Procedure). For Expedited Review, one or more qualified IRB members are assigned to review a project. RI staff may assign additional reviewers or a consultant if additional expertise is required (for more information, see HRPP policy for reviewer assignment).

New Project Review Materials

Expedited Reviewers complete a comprehensive review of all documents in the new project submission package (or those flagged for review by RI staff). The materials available for Expedited Review are the same as those required for Full Committee Review with the exception of documents specific to greater than minimal risk research (e.g., plans for safety reviews). For the list of required documents, see the online HRPP Policy Manual for submission requirements for new projects, expedited review  and for information about review materials and worksheets.

The materials in the submission package are sufficient to ensure the Expedited Reviewer can determine whether or not the research meets the DHHS regulatory criteria for approval, and any additional requirements under Subparts B, C, and D, other applicable federal agency regulations, and Nevada state law.

See the online HRPP Policy Manual for information about reviewer recommendations and documentation.

Expedited Review Actions

The range of IRB Actions for Expedited Review of new projects include Approved, Approved with Conditions, and Deferred. If the Expedited Reviewer determines a project may not be approvable, the project is placed on the agenda for Full Committee Review.

Before approving a new project under expedited review procedures, RI staff* or designated IRB member confirms the research meets the criteria for Expedited Review under the DHHS expedited categories and Flex-Exempt under the University IRB Flexibility Policy. *RI staff members are experienced and serve as members of the IRB. The assigned reviewer may determine that the study does not meet the expedited category or determine that the new project should be reviewed as an exempt or scheduled for Full Committee Review at the next convened IRB meeting.

NOTE: Following notification of the expedited review determination, if the researcher disagrees with the recommendations or requested revisions, the project/package may be placed on the agenda for Full Committee Review.

Determining Approval Periods for New Projects

Generally, the approval period for projects approved by Expedited Review is one year. Shorter approval periods are only required when participant risks are determined to be frequent or severe, or greater than minimal risks are not justified by the benefits of the research. Under either of these conditions, the project would not be eligible for Expedited Review.