UI Investigator’s Guide\IRB Standard Operating Procedures - 1/29/24 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.  

The 2024 version has been updated to include the following updates:

Summary of Changes throughout Investigator’s 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 

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.