A request for review of continuing research should include a protocol summary
and a status report on the progress of the research including:
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the number of subjects accrued;
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a summary of any unanticipated problems and available information regarding
adverse events (in many cases, such a summary
could be a simple brief statement that there have been no unanticipated
problems and that adverse events have occurred at the expected frequency and
level of severity as documented in the research protocol, the informed
consent document, and any investigator brochure);
-
a summary of any withdrawal of subjects from the research since the last IRB
review;
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a summary of any complaints about the research since the last IRB review;
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a summary of any recent literature that may be relevant to the research and
any amendments or modifications to the research since the last IRB review;
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any relevant multi-center trial reports;
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any other relevant information, especially information about risks
associated with the research; and
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a copy of the current informed consent document and any newly proposed
consent document.
Requests for annual review may be submitted
to the Office of Research, Room 308, Old Main or via email to
amiller@uwyo.edu.