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Contact Information for Questions about Clinical
Investigations
Affected by Natural Disasters
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.
During normal business hours affected parties may call FDA at 301-827-3340 and follow the prompt for questions about the effects of a natural disaster on clinical investigations. These questions will be routed to a voice mailbox from which messages are picked up frequently and 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 301-443-1240 and these questions will also be forwarded to the appropriate Center or office for advice.
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Date created: September 27, 2005; Last updated: August 29, 2008 |
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