UI Investigator’s Guide\IRB Standard Operating Procedures - 4/1/24 updates

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.  

As of 4/1/24, there is an updated version of the IRB Standard Operating Procedures and Researcher Guide

Below are the 4/1/24 summary of changes: 

  • Section 2.a.iii: added URL to DSP contracting flowchart
  • Section 8.A.iv: added detail related to new Iowa Code
  • Section 9.C.ii.a: added Director where IRB Chair is referenced
  • Updates to VA (IRB-03) reporting requirements
    • Part I, Section(s) 10.B.ii.d and 19.B.i-vi
  • Section 11.C: added withdrawn forms can be recreated and resubmitted once
  • Section 11.C.iii.b: clarify ClinicalTrials.gov reporting obligation(s) when project closure form is submitted

4/1/24 Rollout Specific Updates

  • Section 11.C.iii.a  Scheduling of Meetings and Applications for Full Board Review: this contains all the guidance regarding setting a meeting date goal 
  • Section 11.C.iv Full Board Review Responsibilities: update on workflow baskets related to setting a meeting date goal

The current  2024 UI Investigator Guide and IRB Standard Operating Procedures, document is available in both a track change and clean copy version to reflect the above mentioned updates.

 

Summary of Changes as of 1/29/24 throughout the Researcher Guide and IRB SOP

  • Removal of gender specific pronouns 
  • Update University of Iowa Operations Manual to University of Iowa Policy Manual 
  • Minor grammatical corrections 
  • Updated hyperlinks 
  • Updated position titles for a number of roles 
  • Added reference to use of external IRBs 

Additional changes (section specific reference)

  • Section I, Part I added local context review responsibilities 
  • Section I, Part 2.J  Clinical Research Unit (CRU): new policy to obtain a partial HIPAA waiver 
  • Removed Section I, Part 2.L as committee was disbanded 
  • Section I, Part 4.B.i  IRB-01 and 4.B.ii IRB-02: updated departments and clarified what each IRB reviews 
  • Section I, Part 4.B.iii IRB-03: clarification regarding use of an IRB other than IRB-03 for VA research 
  • Section I, Part 5.A. Reliance/Deferment Process: clarification regarding use of an IRB other than IRB-03 for VA research 
  • Section I, Part 5.B  Use of a Commercial IRB: removed conditions for submission to a commercial IRB 
  • Section I, Part 5.C  National Cancer Institute (NCI) Central Institutional Review Board Initiative (CIRB): added clarification regarding NCI research process at the Iowa City VA 
  • Section I, Part 7.A.i. Transition plans: updated to current expectations 
  • Section I, Part 8.A  State of Iowa Laws that May Indirectly Affect Research with Human Participants: several changes to State of Iowa laws affecting human subjects research 
  • Section I, Part 9.C  IRB Determinations Requiring Reporting: clarification for external IRB reporting requirements 
  • Section I, Part 9.C.ii  Noncompliance Investigations and Actions: updated definition of continuing noncompliance 
  • Section I, Part 10.B  IRB Chairs & Members: clarified IRB member appointment and compensation information 
  • Section I, Part 11.A.ii  Scope and role of the Human Subjects Office: external IRB tracking and local context review 
  • Section I, Part 11.C  HawkIRB Application Processing/Workflow: new policy regarding withdrawing a project after 60 calendar days of PI\study team unresponsiveness 
  • Section I, Part 11.C.iv.b  Documentation of Meeting Minutes and Board Determinations: new policy regarding dissemination of changes required by the convened IRB. 
  • Section I, Part 12.F Quality Assessment/Quality Improvement: UIHC requirement to register all QA\QI activities occurring in the UIHC 
  • Section II, Part 5.D.i  Link to Privacy Board: definition of Privacy Board 
  • Section II, Part 11.B.i.a.iii Consent Template and HawkIRB: external IRB reference 
  • Section II, Part 11.B.iii.a   Short Form Consent process: removed process and left policy requirements 
  • Section II, Part 11.B.iii.b  Translators: clarification of policy requirements 
  • Section II, Part 15.C.ii  UI ITS requirements: clarification regarding IT security review 
  • Section II, Part 18.A.iii  Grant application: sIRB and data management sharing plan 

File: 

File Access Instructions.docx