[Irb] Revised Deviation/Violation Procedure

[Armstrong, Charles W.]

Please remove my email address from this mailing list. I have been retired from UT for two years, and no longer have any nvolvement with research at the university.

Charles Armstrong, Ph.D., Professor Emeritus
College of Health Science and Human Service.
________________________________
From: irb-bounces at mailman.utoledo.edu <irb-bounces at mailman.utoledo.edu> on behalf of Snyder, Hillary Morgan <Hillary.Snyder at utoledo.edu>
Sent: Thursday, April 4, 2019 11:36:08 AM
To: 'irb at mailman.utoledo.edu'
Subject: [Irb] Revised Deviation/Violation Procedure


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]


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