UW Research

Policies, Procedures and Guidance

SOP IRB Review


This document describes the procedures used by the University of Washington Institutional Review Boards (IRB) and Human Subjects Division (HSD) for conducting IRB review. It also references the numerous tools (e.g., Worksheets) used by the IRB and HSD in support of the review process.

Change Notes

Move information about transfers of IRB oversight to this SOP from other SOPs – 11.02.2023
Revise Zipline lapsed approval section to include HUDs with expanded access applications – 07.27.2023
Add lapsed approval policy for expanded access applications – 01.26.2023
Revise HSD policy regarding lapsed approval – 08.25.2022
Add section on IRB records – 01.03.2022
Clarify when continuing review is required for OCR Flexibility studies that receive federal support – 11.23.2021
Add eligibility criteria for OCR continuing review Flexibility; update hyperlinks – 10.08.2021
Add information about when a secondary reviewer is required for a convened IRB review – 08.26.2021
Removed references to paper process; updated links – 06.24.2021
Minor revision to section about delegation of authority for limited & expedited IRB review – 02.25.2021
Add information about delegation of IRB authority; revise sections on convened IRB review – 12.09.2020
Significant revision to condense information from several, now retired, documents into a single SOP on IRB Review – 6.26.2020
Added language for the revised Common Rule – 12.28.2018
Updated links – 09.06.2017