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 Access Instructions if you have problems accessing the guidance materials.

As of June 14, 2024, there is an updated version of the IRB Standard Operating Procedures and Researcher Guide

The Primary change is to Section I, Part 2: Part 2:  Components of the Human Research Protections Program (HRPP) to account for changes related to the June IRB Efficiency Initiative rollout.  Those changes include to primary updates:

  • moving all Human Research Protection Program (HRPP) approvals after IRB approval for IRB-01, IRB-02 and WCG (WIRB: Western Coperinicus Group)
  • allowance for one modification after IRB approval but prior to release for new project submissions in the event an HRPP committee requires updates prior to the project's release to the Principal Investigator 

The current version of the  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 4/1/24 throughout the Researcher Guide and IRB SOP

  • 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  • Section 11.C: added withdrawn forms can be recreated and resubmitted once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