[Irb] Revised Deviation/Violation Procedure

[Snyder, Hillary Morgan]

All,
I'd like to draw you attention to a revised "Deviation, Violation and Exception Request Procedure" and associated flow chart on the HRPP website: https://www.utoledo.edu/research/rsp/irb/guidance.html.  This revised IRB procedure clarifies the difference between a deviation and a violation and when these departures must be reported to the IRB.

New:

*         In very specific circumstances a protocol deviation can be reported at the time of continuing review.

*         Introduction of the Single Subject Exception Request.

The associated Deviation/Violation Form has been modified:

*         Biomed/Cancer: https://www.utoledo.edu/research/rsp/irb/bioforms.html

*         SBE: https://www.utoledo.edu/research/rsp/irb/SBEforms.html

Researchers with active studies in IRB Manager can now utilize the Deviation/Violation xform.  The single subject exception request xform should be released next week.

If you have any questions, please contact your HRPP staff member: https://www.utoledo.edu/research/rsp/irb/StaffIRB.html

Sincerely,
Hillary


Hillary Snyder, PhD, CIP
Manager, Human Research Protection Program
Research and Sponsored Programs
2105 CCE, Health Science Campus
419.383.6905
http://www.utoledo.edu/research/rsp/irb


[University of Toledo Logo]

-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://mailman.utoledo.edu/pipermail/irb/attachments/20190404/fcfb9601/attachment-0001.html>
-------------- next part --------------
A non-text attachment was scrubbed...
Name: image002.png
Type: image/png
Size: 12814 bytes
Desc: image002.png
URL: <http://mailman.utoledo.edu/pipermail/irb/attachments/20190404/fcfb9601/attachment-0001.png>