IRB review of adverse events in investigational drug studies.
D032962:Consent Forms; D003362:Cost-Benefit Analysis; D064420:Drug-Related Side Effects and Adverse Reactions; D015507:Drugs, Investigational; D026724:Ethical Review; D004989:Ethics; D017041:Ethics Committees; D028744:Ethics Committees, Research; D035082:Federal Government; D006076:Government; D033161:Government Regulation; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D019221:Mandatory Reporting; D012108:Research Personnel; D035842:Research Subjects; D012306:Risk; D018570:Risk Assessment; D012926:Social Control, Formal; D014481:United States; D014486:United States Food and Drug Administration
Biomedical and Behavioral Research; Office for Protection from Research Risks; University of Nebraska Medical Center