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- Section 11.C: added withdrawn forms can be recreated and resubmitted once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