Under a Memorandum of Understanding (MOU) between the University of Iowa IRB-03 and the Iowa City Veterans’ Affairs Healthcare System (VAHCS), the University of Iowa provides IRB review for human subjects research conducted at the VAHCS. The agreement specifies that IRB-03 operates under the conditions of the University of Iowa Federalwide Assurance and obligates IRB-03 to operate under any additional VAHCS-specific regulations or policies. A copy of this document is available upon request from the Human Subjects Office. Projects reviewed on behalf of the VAHCS receive the equivalent IRB review as those conducted at the University of Iowa.
Manuals
- UI Investigator's Guide and IRB SOP - DRAFT
- Part 1, Ch. 1 - Intro to the U of I Human Research Protections Program
- Part 1, Ch. 2 - Components of the HRPP (link to flowchart)
- A. Division of Sponsored Programs
- B. Pharmacy and Therapeutics
- C. Pharmacy and Therapeutics Investigational Drug Service
- D. Medical Radiation Protection Committee
- E. Institutional Biosafety Committee
- F. Holden Comprehensive Cancer Center\Protocol Review and Monitorying Committee
- G. Conflict of Interest in Research Committee
- H. Veterans' Affair Health Care System (VAHCS)
- I. Joint Office for Compliance Research Billing
- J. Clinical Research Unit (CRU)
- K. Nursing Research Committee (NRC)
- Part 1, Ch. 3 - Other related entities, programs, or committees involved with Human Subjects Research
- Part 1, Ch. 4 - University of Iowa Institutional Review Board (IRB)
- Part 1, Ch. 5 - Use of an External IRB model
- Part 1, Ch. 6 - Foundation of Human Subjects Protection
- Part 1, Ch. 7 - Regulatory Requirements for IRB Review
- Part 1, Ch. 8 - Legal Requirements for IRB Review
- Part 1, Ch. 9 - Institutional Requirements for IRB Review
- Part 1, Ch. 10 - Operations of the UI IRBs
- Part 1, Ch. 11 - Human Subjects Office
- Part 1, Ch. 12 - University of Iowa Projects Involving Human Subjects or Their Data
- Part 1, Ch. 13 - Exempt Human Subjects Research
- Part 1, Ch. 14 - Expedited Review
- Part 1, Ch. 15 - Overall Approval
- Part 1, Ch. 16 - Concept Approval
- Part 1, Ch. 17 - Umbrella Project Approval
- Part 1, Ch. 18 - Full board Review
- Part 1, Ch. 19 - Notification of Approval
- Part 1, Ch. 20 - Documentation of IRB Approval
- Part 1, Ch. 21 - Appeal of IRB Decision
- Part 1, Ch. 22 - Post Approval Survey
- Part 2, Ch. 1 - Human Subjects Research Application Process
- Part 2, Ch. 2 - Hawk IRB Section I. Project Introduction
- Part 2, Ch. 3 - HawkIRB Section II Research Team
- Part 2, Ch. 4 - HawkIRB Section III Funding\Support
- Part 2, Ch. 5 - HawkIRB Section IV Project Type
- Part 2, Ch. 6 - HawkIRB Section V Other HRPP Committee Review
- Part 2, Ch. 7 - HawkIRB Section VI Subject Enrollment
- Part 2, Ch. 8 HawkIRB Section VII. A. Collaborative Research
- Part 2, Ch. 9 - HawkIRB Section VII.B. Study Design
- Part 2, Ch. 10 - HawkIRB Section VII.C. Genetic Research
- Part 2, Ch. 11 - HawkIRB Section VII.D. Recruitment & Consent process
- Part 2, Ch. 12 - HawkIRB Section VII.E. Study Procedures – What will happen during the course of the study?
- Part 2, Ch. 13 - Section VIII Risks to Subjects
- Part 2, Ch. 14 - Section IX Benefits
- Part 2, Ch. 15 - Section X Privacy & Confidentiality
- Part 2, Ch. 16 - Section XI Data Analysis
- Part 2, Ch. 17 - Section XII Future Research
- Part 2, Ch. 18 - Research related study materials
- Part 2, Ch. 19 - PI Responsibilities after initial IRB approval
- Part 2, Ch. 20 - Continuing Review
- Part 2, Ch. 21 - Reporting Complaints or concerns
- Part 2, Ch. 22 - Project Closure
- Part 2, Ch. 23 - Record Keeping
- Part 2, Ch. 24 - Principal Investigator leaves the University of Iowa