As a result of a natural disaster, clinical investigations and human subject protection programs at institutions in affected areas may be interrupted and unable to function. We have received questions from investigators, institutional review boards (IRBs), sponsors, and others on how to respond to a variety of situations.
In many cases, research records may be severely damaged or destroyed. In other cases, subjects may relocate to other areas, so assuring proper supervision and oversight of subjects, including monitoring subject safety and reporting adverse events, may not be possible. Additionally, the investigational products themselves may have been lost or compromised. These and other extraordinary circumstances are likely to occur, and we recognize the importance of promptly addressing the concerns of investigators, IRBs, institutions, and sponsors with responsibility for clinical investigations in affected areas in dealing with these circumstances. We will approach each situation on a case-by-case basis.
It is difficult to generalize on the steps that affected investigators, IRBs, institutions, and sponsors should take. In some instances it may be appropriate to terminate the conduct of a study where doing so would not endanger the subjects. In other instances it may be appropriate to attempt to find a qualified investigator and IRB outside the affected area to take over the conduct of the study in order to permit the study to continue, particularly where doing so would be in the best interest of subjects (for example, treatment protocols).
Unfortunately, in some instances, studies may be disrupted, subjects and study staff so dispersed, and records and the data so compromised as to render the data unfit for submission to FDA. We understand that affected parties may have questions about their clinical investigations.
In some emergency situations, FDA may set up a special phone number where anyone who is affected can record questions about clinical trials. The questions will be forwarded promptly to the appropriate agency component for response. After business hours, parties may call the FDA emergency operations line at 1-866-300-4374 or 301-796-8240, and these questions will also be forwarded to the appropriate Center or office for advice.