2.3 Expedited Review

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for using expedited review procedures for consideration of:

  1. new research proposals;
  2. continuing review of previously approved research;
  3. minor changes in protocol;
  4. minor complaints; and
  5. non-serious noncompliance.

2.0 Policy

It is the policy of the Organization that


3.0 Definitions


4.0 Expedited Review Categories


5.0 Procedures


6.0 Expedited Review Actions


7.0 Development of IRB Expedited Review and Final Approval Letters


8.0 Deadlines for PI Responses


9.0 Review of PI Responses


10.0 Final IRB Approval Letter


11.0 IRB Approval Periods


12.0 Documentation of Expedited Review


13.0 Review by Other Organizational Committees


DOCUMENT HISTORY:

 Written: 4/11/2016 (Approved: 4/11/2016) - original author not recorded

 Revised: 6/13/2018 - revision not documented

 Revised: 3/17/2021 - Clarified that IRB administrator may re-review “inadequate or incomplete responses” by investigators (or refer back to the expedited reviewer for re-review) and further communicate with the investigator to seek modifications or clarifications; deleted regulatory references to pre-2018 Common Rule; deleted list of “other determinations (section 5.4) and referenced policy 2.2 instead; deleted list of other organizational committees (section 13.1) and referenced policy 1.10 instead.

 Revised: 9/16/2021 - Revised time allowed for investigator to respond (section 8.1) to match policy 2.2

 Revised: 8/4/2023 – generally revised for clarity and for consistency with HRPP 2.2; deleted reference to limited IRB review (section 2.4) since the Organization does not utilize limited IRB review, as per policy HRPP 2.8; revised section 5.3 to better describe Expedited Review Procedures; revised section 5.4 to more fully describe Criteria for Expedited IRB Approval and Other Determinations and to clarify requirement for expedited reviewer to determine and document if research needs continuing review; added description of items to be reviewed (section 5.3.2); simplified section 8.0 (Deadlines for PI Responses; clarified that expedited reviewer may refer a protocol to the convened IRB if they believe it would be more appropriately reviewed by the convened IRB (section 6.4.1); corrected typographic and grammatical errors. {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 1/24/2024 – added section 5.4.1 {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #14
Created 24 October 2019 21:26:10 by Autumn M Eberly
Updated 12 March 2025 19:07:36 by Robert A Lewis