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date: 24 March 2018

Abstract and Keywords

This article examines federal and state laws on biomedical research in the United States. It also considers the tension among various regulatory regimes and highlights conflicting regulations that could be better harmonized. The article first describes regulatory regimes that govern protections for human subjects, with particular reference to the federal Common Rule and the Food and Drug Administration’s regulations on the protection of human subjects. The discussion then turns to state laws on informed consent; privacy laws; laws on clinical trials registration and data transparency; financial disclosure requirements; research misconduct such as fabrication, falsification, and plagiarism; and animal research requirements. The article concludes by presenting additional considerations related to federal funding of research.

Keywords: laws, biomedical research, regulations, human subjects, informed consent, privacy, clinical trials, research misconduct, animal research, federal funding

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