A new study published in JAMA reports that around five to 16 percent of human research clinical trials fall into a gap that are not covered by two major federal regulations. These trials studied interventions other than drugs or devices (e.g., behavioral, surgical). The primary federal human subjects protections (HSP) policies in the United States, including requirements for institutional review board review and informed consent, are the U.S. Food and ...
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Thursday, March 6, 2014
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