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Background: For many years, researchers and Institutional Review Boards (IRBs) have struggled with reports of adverse events that occur in human subjects research. Apart from the overwhelming volume of "paperwork," much of this reporting has been of questionable value to our shared goal of protecting subjects. This is particularly true in multi-site clinical trials, where local IRBs are seldom in position to evaluate external safety reports in a meaningful context. Recent guidance from federal regulatory agencies (including OHRP and FDA, links below) has clarified that much of this reporting is not required and is, in fact, counterproductive. Accordingly, UNC-Chapel Hill has now modified internal policies and procedures in this area.
Effective Date: While the underlying policy is already in effect, major procedural changes will take effect on June 1, 2009.
Policy Summary and Examples: The key to implementing this change is that investigators are only required to report to the IRB "Unanticipated Problems involving risks to subjects or others" (UP), defined as any incident, experience or outcome that is both unexpected and related or possibly related to the research.
Many adverse events that are currently reported do not meet this definition. For example, if nausea is already known to be a common side effect for a drug under investigation and was described in the IRB-approved protocol and consent form, this is not unexpected and need not be reported to the IRB, even if it is clearly related to the research. Conversely, it may be that UPs in non-biomedical areas have been under-reported. For example, a lost laptop that contains sensitive survey data should be reported, because this incident was both unexpected and related to the research. The aim is to improve the "signal-to-noise ratio," allowing both investigators and IRBs to focus on reports that are actually required. Full policy details are linked below.
Online Reporting: A web-based reporting system is now available, employing a user-friendly interface to guide research teams through the reporting process. The first few questions will help you determine if the event is reportable or not, and will provide documentation for your files and sponsors. Events that are reportable as UPs will be processed much like any other IRB submission. Paper-based reports will be returned with instructions for accessing the online reporting system. As an added feature, the web portal may also be used to check IRB status of any submission. While we hope you will find this web portal intuitive to use, an online tutorial is available (link below).
Future Enhancements: We are excited to launch this web-based system, because it opens the door for online submission of all IRB applications and materials. Programming toward this goal is underway, and this initial module for online reporting of Unanticipated Problems is an important first step. We look forward to your feedback, as we work to enhance the performance and oversight of human research at Carolina.
Relevant Links: