Research conducted or supported by the Department of Defense (DoD), including its separate components (i.e., the Army, Navy, Air Force and Marine Corps) requires compliance with additional federal regulations, directives and instructions. The DoD has adopted 32 CFR 219, a version of the Common Rule that mirrors 45 CFR 46. The Department of Defense Instruction 3216.02 (DoDI 3216.02) establishes policy and assigns responsibilities for implementation of 32 CFR 219 in protecting human subjects in DoD-supported research. The University of Iowa, its IRBs and investigators involved in DoD research must be knowledgeable about these obligations in order to adhere to them. The Education and Compliance Program has implemented a program to monitor the adherence with the additional requirements for DoD-supported research.
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)
- 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