IRB Open Library – What’s New
November 18, 2004
Sheila Moore, CIP
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Reminder about Training – see IRB website – Check training
status on the IRB website.
Review of IRB’s Revised Noncompliance Policy
Examples of Serious Noncompliance
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Falsification of IRB documents
Human subjects research conducted without IRB approval
Deviation from the IRB approved consent process
Modification of protocol without IRB prior approval
Failure to maintain regulatory documents
Examples of Continuing Noncompliance
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Missing Renewal Deadlines
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Use of Expired Consent Form
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Not Meeting Training Requirements
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Inaccurate document preparation
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Late Reporting of Serious Adverse Events
Clinical Trial Registration – required for publication? See
www.clinicaltrials.gov for an example
Electronic Submission
Revised Forms/Revised Guidebook
Accreditation for the IRB
200th Protocol Sent to WIRB
More tele-conferences hosted by the Office of the IRB
For 2005 training, make plans now to attend the Ethics In
Minority Health Research Workshop, to be held at UAB on
January 15, 2005. See “New and Noteworthy” web page
and/or contact Linda Delahay (ldelahay@uab.edu, 4-3789)
for details as they become available.