Institutional Review Boards (IRBs) are the surrogates of the FDA for regulating clinical trials by ensuring compliance by the investigators under their purview. But occasionally IRBs may falter in their responsibilities leading to negative audit findings. This is what happened with the IRB at Lousiana State University Health Science Center (LSUHSC) which was found to miss review deadline and poor documentation.
Warning letters to Institutional Review Boards (IRBs) are rare, mostly because the bulk of the clinical trial reviews are conducted by professional non-affiliated IRBs that run them like a business and are diligent to stay compliant. However, local IRBs, usually located within academic centers or small institutions, usually do not have the same urgency as a business enterprise. The local IRBs often take longer to review studies, have a hard time maintaining their rosters of volunteer reviewers, and lack essential resources. But that does not excuse them of the regulatory responsibilities.
The FDA audit of LSUHSC’s IRB found that the IRB did not enforce its annual review policy and maintained inadequate documentation. The IRB’s responses to the FDA inspectors were found to be non-satisfactory mostly because the IRB presented inadequate corrective and preventive actions.
It is not known what happens to the clinical trials monitored by this IRB but it is safe to assume that all those clinical trials are under a microscope at the FDA for possible violations of trial conduct such as adverse event reports and protocol amendments; tasks that primarily related to the IRB oversight of these trial.
For this IRB, this was hopefully a wake-up call. In recent years, many institutional IRBs have recognized their limitations and assigned professional IRBs to review trials under their jurisdiction. Some local IRBs have limited their functions to a select group of specialized trials delegating the rest to professional IRBs. A Federal law requires multi-site trials to use only IRB to review conduct of all sites further limiting the role of local IRBs for such trials.
It won’t be fair to pick to the IRB at LSUHSC as they operate under the limitations listed above. But all local IRBs must appreciate that they cannot and should be excused from their obligations under the law. Sponsor’s must also be diligent when picking local IRBs to ensure that their trials are being adequately supervised, or work with their IRBs to proactively address potential issues.
