Abstract

Executive Briefing Series
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Institutional review boards (IRBs) are the ethical guideposts of clinical research, approving and monitoring protocols to ensure that patients’ rights and well-being are protected. Because IRBs operate largely independent of research institutions and have authority to suspend trials, training, knowledge and compliance with federal regulations on human subject research is key to a clinical trial program’s success. Challenges facing IRBs include cutting-edge technologies such as nanomedicine, oversight of international trials and determining when to waive informed consent in order to conduct emergency research. This issue of The Food & Drug Letter focuses on these and other issues facing an IRB.

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