title: How should adverse events be reported in US clinical trials?: ethical considerations.
abstract: Research with human subjects, including clinical trials, forms the cornerstone of the development of knowledge on the safety and efficacy of potential drugs and devices. During the conduct of clinical trials, human subjects may experience adverse events ranging from trivial side effects such as mild discomfort to severe complications, including death. Three of the regulatory criteria set forth in the 45 Code of Federal Regulations 46.111 for approval of research(1) focus on risk assessment and minimization of risks. The accurate and full reporting of these adverse events and the assessment of the risk attributable to participation in research are therefore crucial components in the ethical conduct of research.
authors.affiliation: Department of Biochemistry and Molecular Biology, University of Maryland School of Medicine, Baltimore, Maryland, USA. ashamoo@umaryland.edu
authors.forename: A E
authors.initials: AE
authors.lastname: Shamoo
authors.forename: L I
authors.initials: LI
authors.lastname: Katzel
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000941:ethics* / Q000592:standards; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000379:methods* / Q000592:standards; D016265:Conflict of Interest; D028744:Ethics Committees, Research / Q000941:ethics / Q000592:standards; D006801:Humans; D015969:National Academies of Science, Engineering, and Medicine, U.S., Health and Medicine Division; D011358:Product Surveillance, Postmarketing; D012107:Research Design / Q000592:standards*; D012108:Research Personnel / Q000941:ethics* / Q000592:standards; D035842:Research Subjects; D012109:Research Support as Topic; D014481:United States