Unanticipated Problem Reporting
Update: New Requirements Now Mandatory
Please note that the UHN REB has overhauled the process for the reporting of unanticipated problems, including adverse events and protocol deviations. This is a substantial change from the current practice, and is in keeping with the Canadian Association of Research Ethics Boards’ “Guidance on Reporting of Unanticipated Problems including Adverse Events to Research Ethics Boards in Canada” guidance document, issued in July 2010.
The UHN REB has prepared a guidance document to explain the new reporting requirements, as well as a new form. These documents are intended to provide a new, consolidated framework for reporting unanticipated problems to the UHN REB. A supplementary guidance document has also been provided, to assist investigators in thinking through other reporting requirements that may apply to their studies.
The new guidance replaces previous UHN REB guidance documents entitled “Procedure for Reporting Adverse Events in Research Studies Involving Human Subjects” and “Guidelines for Reporting Protocol Deviations”.
The new form replaces previous UHN REB forms entitled “UHN REB Internal Serious Adverse Event Reporting Form”, “UHN REB External Serious and Unexpected Adverse Event Summary Reporting Form” and “University Health Network Research Ethics Board Protocol Deviation Report Form”.
The REB started accepting submissions on the new Unanticipated Problem Reporting Form effective August 11, 2011. After a 3-month grace-period and presentations at all UHN sites, the new reporting requirements have now been made mandatory. The UHN REB would like to thank all of those who attended the presentations at the UHN sites for their constructive feedback and carefully considered
questions.
A "Letter to Sponsors" from the UHN REB Co-Chairs has been released for use by UHN sites in communicating the new REB requirements to Sponsors.
The purpose of this change is to reduce the administrative burden on both the REB and UHN research teams. To quote the CAREB guidance document: “Unnecessary reporting to the REB of events or problems that do not potentially affect the rights, welfare or safety of research participants in the study may impair the REB’s ability to review and respond in a timely manner to actual situations where research participant rights, welfare or safety are threatened. Single isolated adverse events rarely meet the requirements for reporting to REBs. [...] There is no Health Canada regulation for reporting external adverse events to the REB. ICH requirements will be met if unanticipated problems are reported to the REB as described in this guidance.”
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