UI Investigator’s Guide\IRB Standard Operating Procedures

The Investigator's Guide and IRB Standard Operating Procedures document is available via institutional log in with UI HawkID@uiowa.edu and HawkID password.  Please review the file titled "Access Instructions.docx" located at the bottom of this page if you have problems accessing the guidance materials.  

The 2022 version has been updated to include the following updates:

  • Update Sr. Associate Vice President of Research to new title, Associate Vice President of Research throughout the document
  • Remove “and Economic Development” from the Office of Vice President for Research throughout document
  • Replace Western Institutional Review Board (WIRB) with new business name WIRB-Copernicus Group, Inc. (WCG) throughout the document
  • Remove WIRB as applicable to recognize expanded use of an external IRB throughout the document
  • Correct references to annual continuing and biennial review for projects approved under an expedited category throughout the document
  • Minor clarification on use of external IRB for studies subject to IBC review (Section I, 2.E)
  • Update location of rosters (Section I, 7.A.i)
  • Clarification to HSO staff review processes. (Section I, 11.C)
  • Update HawkIRB training to include the recorded options in the ICON Course for researchers. (Section I, 11.D.vi.b)
  • Add a section header under IRB members and HSO Office Staff Continuing Education (Section I, 11.D.vi.h)
  • Minor wording change in VAHCS monitoring goal section (Section I, 11.E.ii.g)
  • New section added to outline expectations for submitting modifications to research approved under an exemption category. (Section I, 13)
  • Remove a requirement for Umbrella projects (Section I, 17(8)(a)(iv))
  • Update to IRB meetings minutes section (Section I, 18.F)
  • Update to frequency of post approval survey review. (Section I, 22)
  • Update Student PI training requirements and DoD training requirements (Section II, 1.B and 1.C).
  • Update to Non-UI Team members section (Section II, 3.C)
  • Update to Short Form Consent reference (Section II, 7.I)
  • Update to the Collaborative Research with non-UI Entities section (Section II, 8.B)
  • Update to Lead Site Responsibilities (Section II, 8.D.i)
  • Clarification a protocol is required for research meeting the definition of a clinical trial (Section II, 9.A)
  • Update Expanded Access section (Section II, 9.D.ii)
    1. Add Expanded Access for individual patients via expedited review subsection (Section II, 9.D.ii.a)
  • Add reference to Informed consent checklist tool in the Consent Template and HawkIRB section (Section II, 11.B.i.a.iii)
  • Consistency update compensation amount under the W-9 substitute documentation section (Section II, 12.G.ii)
  • Clarification to Certificate of Confidentiality (CoC) process (Section II, 15.A.i.a)
    1. Removed duplicate information under Section II, 15A.i.c
    2. Removed statement to remain consistent with current NIH CoC processes (Section II, 15.A.i.c)

The 2022 UI Investigator Guide and IRB Standard Operating Procedures, version 1 document is available in both a track change and clean copy version to reflect the above mentioned updates.

File: 

File Access Instructions.docx