The UMES IRB may use an expedited review process in accord with Title 45 §46.110 including the review of initial new applications, continuing review applications, or proposed minor changes in previously approved research.
Expedited review procedures are for certain kinds of research involving no more than minimal risk and: 1) meets all applicability criteria in the document “Categories Of Research That May Be Reviewed By The Institutional Review Board (IRB) Through An Expedited Review Procedure” which can be found at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/categories-of-research-expedited-review-procedure-1998/index.html; and or 2) Research for which limited IRB review is a condition of exemption under § 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).
An expedited review will be conducted by the IRB Chair and a designated IRB member and or appointed ad hoc reviewer. Reviewers will provide written comments to the IRB Chair for review and potential presentation at a convened meeting. New applications, continuing review applications, or proposed changes in already approved research that the IRB Chair or reviewer determines may not be approvable per the expedited process must be referred for discussion at a convened meeting.
The IRB Chair will communicate with the IRB Committee a list of all actions taken through the expedited review process via email and as an update at the IRB’s soonest scheduled meeting.
Any member of the IRB may request re-review of research approved using an expedited process. If such a request is made, the application or project will be scheduled for convened meeting discussion.
