Abbreviations

CFR: Code of Federal Regulations

FDA: Food & Drug Administration

HDE: Humanitarian Device Exemption

HUD: Humanitarian Use Device

IDE: Investigational Device Exemption

IG: Guide to Human Subjects Research

IND: Investigational New Drug

IRB: Institutional Review Board

NSR: Nonsignificant Risk

OHRP: Office for Human Research Protections

SOP: UI IRB Standard Operating Procedures

SR: Significant Risk

UI: University of Iowa