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UI Investigator's Guide and IRB SOP - DRAFT
»
Part 2, Ch. 4 - HawkIRB Section III Funding\Support
D. VA Cooperative Group Funding
Manuals
IRB01 Meeting Manual
IRB02 Meeting Manual
Department of Defense Guide for Researchers at the University of Iowa
Food and Drug Administration (FDA) Site Inspection Guide
Investigational New Drug Application (IND) Educational Handout
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
A. Federal Funding Sources
B. Corporate or Industry Funded sources
C. Department Funding
D. VA Cooperative Group Funding
E. Pass Through Funding
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
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