The Department of Health and Human Services via the Office for Human Research Protections and the Food and Drug Administration among others provide the regulatory framework for the conduct of human subjects research and human subjects research protections. The department’s respective regulations were modified in 1981 to be compatible; the Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991.
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
- A. Office for Human Reserach Protections and The Common Rule
- B. Food and Drug Administration
- C. Guidelines for Good Clinical Practice (ICH E6 (R1)- GCP)
- D. National Institutes of Health (NIH)
- E. VHA Handbook 1200.05
- F. Department of Defense (DoD)
- G. National Science Foundation (NSF)
- H. Department of Justice (DOJ)\National Institutues of Justice (NIJ)
- I. Department of Education (DOEd)
- J. Department of Energy (DoE)
- 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