In cases of human subjects research under the authority of the University of Iowa IRB(s) but conducted outside of the state of Iowa, the University of Iowa IRB confers with the University of Iowa Office of General Counsel regarding the applicability of other state, national, or international laws to the particular project. These cases are identified in the pre-review process of an application to the IRB and the advice of counsel is sought prior to the approval of the study. In general, the University of Iowa IRB will apply the law of the state in which the research is conducted. For example, if a project involves children and one of the recruitment sites is in a bordering state, the laws of the bordering state will be evaluated to which individuals meet the Department of Health and Human Services and Food and Drug Administration definition of “children” at that site.
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