[Irb] Single Subject Exception Request Form

[Snyder, Hillary Morgan]

All,
I'm happy to announce that the "Single Subject Exception Request" form is available on the IRB website and also as an xform in IRB Manager.  The Single Subject Exception Request is described in the recently revised IRB "Deviation, Violation and Exception Request Procedure": https://www.utoledo.edu/research/rsp/irb/guidance.html.

The Single Subject Exception Request form allows a Principal Investigator to request that a UT IRB review a minor protocol departure to an approved study for a single participant prior to the occurrence.  An example is a study was approved by a UT IRB to administer a treatment drug to patients on Day 8; however a patient has a scheduling conflict and cannot come in for treatment until Day 11.  This is known in advance.  https://www.utoledo.edu/research/rsp/irb/docs/Deviation-Flowchart.pdf


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


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