title: IRBs, human subjects, and reporting adverse events.
authors.affiliation: The Deem Corporation, P.O. Box 44069, Omaha, NE 68144, USA.
authors.forename: Dennis M
authors.initials: DM
authors.lastname: Maloney
mesh_terms: D002986:Clinical Trials as Topic / Q000009:adverse effects* / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence; D033161:Government Regulation; D017408:Guidelines as Topic; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D006801:Humans; D019221:Mandatory Reporting; D035842:Research Subjects; D014481:United States; D018172:United States Office of Research Integrity