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.

Summary of Changes as of 8/27/24 to the IRB Standard Operating Procedures and Researcher Guide

The Human Subjects Office has made a number of revisions to IRB standard operating procedures and guidance materials.  A track change and clean version of the guidance materials are now available for review.  The majority of the changes are as a result of feedback from the University of Iowa Human Research Protection Program reaccreditation review.  Updates to Section I, Part 3.B. are as a result of ongoing work with the University of Iowa Office of the Registrar clarifying University of Iowa policy regarding the human subjects research use of student data categorized under the Family Educational Rights and Privacy Act (FERPA).  Stay tuned for a presentation this fall regarding the FERPA related updates. A summary of the changes include:

  • Section I changes:
    • 2.H.iv  VA Research Compliance Officer (VA RCO): clarification of RCO role
    • 3.B.i  Family Educational Rights and Privacy Act (FERPA) all NEW subsections
      • 3.B.ii Access to Education Records for Research Purposes
      • 3.B.iii Obtaining Consent to Access Records for Research Purposes
      • 3.B.iv Use of Electronic Signatures
      • 3.B.v Subject Recruitment 
      • 3.B.vi Access to Educational Records for Research Purposes Without Obtaining Consent
    • 7.H  Department of Justice (DOJ)\National Institutes of Justice (NIJ): Funder expectations for research with NIJ funding
    • 7.J Department of Energy (DOE): Funder expectations for research with DOE funding
    • 9.C  IRB Determinations Requiring Reporting: IRB reporting requirements for studies under IRB-03
    • 9.C.ii  Noncompliance Investigations and Actions: IRB reporting requirements for studies under IRB-03
    • 9.C.ii.a  Allegations of Noncompliance: IRB reporting requirements for studies under IRB-03
    • 9.C.iii  Review of Unanticipated Problems Involving Risk to Subjects of Others: IRB reporting requirements under IRB-03
    • 10.B.ii.b  Suspension or Termination of IRB Approval: IRB reporting requirements under IRB-03
    • NEW: Part 24: Periodic Evaluation of the Human Research Protection Program: explanation of periodic HRPP review
  • Section II changes:
    • 9.D.v  Emergency Settings: Research in the Emergency Setting (Planned Emergency Research): DoD clarification regarding emergency research
    • 23:  Record Retention Requirements: clarification regarding record retention requirements for research following full ICH-GCP

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 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:  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 Copernicus 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 

An archived 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

An archived 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 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