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The research oversight system, says a University of North Carolina at Chapel Hill researcher, has not evolved to keep up with the volume and complexity of the research it oversees.
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The University of Alabama at Birmingham (UAB) was the most recent in a small list of institutions that received letters of determination from the Office for Human Research Protections (OHRP) of Rockville, MD, about allegations of noncompliance.
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The Food and Drug Administration (FDA) has received many lengthy comments expressing concern about its recent draft guidance for IRBs, investigators, and sponsors regarding assessing the qualifications of investigators.
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In June 2011, representatives from various IRBs and federal regulatory bodies met to discuss the development of a new model to improve the multisite study model.
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Experts say IRBs spend much of their time discussing informed consent issues and nuances, and yet this is the area cited most often in recent regulatory letters sent to research institutions.
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The Food and Drug Administration (FDA) has now said that clinicians wishing to perform a fecal transplant for treatment of Clostridium difficile will have to obtain an investigational new drug (IND) application.
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Bioethics, genetic research also addressed at annual conference
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Too often, IRBs spend precious meeting time debating the merits of a studys scientific and other subjective fine points, overlooking issues that have a greater impact on human subject safety, experts say.
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An issue that can frequently arise in the area of genomic research is what to do with incidental findings (IFs) discoveries concerning a research subject that are beyond the scope of the study, but could have potential health importance for the subject.
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IRBs searching for highly effective ways to improve protocol submissions and enhance education and training efforts might check out the SWAT! program at Washington University in St. Louis.
