The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and University policy. Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the University. However, those officials may not approve research if it has been disapproved by the IRB.

For the definitions of what constitutes "research" and "human subjects" please see Chapter 3.

Expedited Review of Minor Changes to Full Board Approved or Conditionally-Approved Studies

Purpose: Provide guidance on determination of ‘minor changes’

Background: 45CFR 46.110(b)(1)(ii) permits expedited review of minor changes in research conditionally approved by the Full Board or amendments to Full Board approved studies that are limited to minor changes. Conditional approval arises when relatively minor changes are required by the Full Board prior to full approval and initiation of research.

Procedure: Expedited review of minor changes to research conditionally approved by the Full Board or amendments to Full Board approved studies is permitted when:

1. The changes pose minimal risk to subjects
2. The changes do not substantially alter
   1. The study aims
   2. The research design or methods
   3. Subject population (change in number of subjects greater than 10% of the originally approved number is considered substantial)
3. The IRB Executive Committee [EC: IRB Chair, Research Compliance Specialist(s), and Director of Research Integrity & Compliance] unanimously agrees that conditions 1 & 2 are met
   1. The EC may consult experts to assess risk
   2. The EC must consult the prisoner advocate for prisoner research changes

Expedited review, when deemed appropriate, will follow standard procedures for review of amendments.