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How Should Adverse Events Be Reported in US Clinical Trials?: Ethical Considerations
Author(s) -
Shamoo AE,
Katzel LI
Publication year - 2008
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2008.14
Subject(s) - clinical trial , adverse effect , cornerstone , clinical pharmacology , medicine , clinical research , intensive care medicine , pharmacology , art , visual arts
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. Clinical Pharmacology & Therapeutics (2008); 84 , 2, 275–278 doi: 10.1038/clpt.2008.14