Study examines gap in federal oversight of clinical trials

An analysis of nearly 24,000 active human research clinical trials found that between 5 percent and 16 percent fall into a regulatory gap and are not covered by two major federal regulations, according to a study in JAMA. 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 Drug Administration (FDA) HSP regulations and the Common Rule.