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Committee Resources

IRB Member Tools/Reference Materials

HRPP Materials for IRB Member Reference

• OHRP Guidance
• 45 CFR 46
• FDA Regulations for protection of human subjects
• FDA regulations for Investigational New Drugs (IND)
• FDA regulations for Investigational Device Exemptions (IDE)
• Belmont Report
• Declaration of Helsinki
• The Nuremberg Code

• Department of Defense Research 32CFR 219
• Department of Defense Directive 3210.07
• Department of Defense Directive 3216.02
• Department of Defense Instruction 6200.02

• Air Force human research protections

• Army human research protections

• Navy human research protections

For HIC members, agendas and protocols are available on the member Sharepoint site.

Types of IRB Review

• Full Committee: IRB Procedure 100 PR1
• Continuing Review
• Expedited Review: IRB Procedure 100 PR2 and 100 CH11
• Exemptions: 100 PR3 and 100 GD9
• Research Not Involving Human Subjects