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Accredited IRBs fare better during FDA inspections
The Association for the Accreditation of Human Research Projection Programs (AAHRPP) of Washington, DC, has found in an ongoing study that federal investigators find fewer problems in studies conducted at AAHRPP-accredited organizations.
"We have information from an analysis we've done that clinical investigators who have an FDA inspection fare better if their organization is accredited," says Marjorie Speers, PhD, president and chief executive officer of AAHRPP.
The AAHRPP study has found that a greater percentage of inspections of investigators at accredited organizations resulted in no action from the FDA when compared with inspections of investigators at non-accredited organizations.
For example, of 219 inspections by the FDA's Center for Drug Evaluation and Research, 73% of the 30 inspections involving investigators at accredited organizations indicated no action. By contrast, there were 189 inspections of investigators at unaccredited organizations, and only 53% of these resulted in no action.