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109.6a Organization Policy on IRB Actions to Disapprove Research

May 2005

It is the policy of the Organization that the IRBs may act to disapprove research, but such action may only be taken at a convened meeting. When an IRB takes action to disapprove research, the principal investigator will be provided with a written notification of the action.  The notification shall explain the reasons for the decision.  The PI may appeal the decision by submitting a response in writing or in person.  In the event that an appeal is not submitted, or the IRB reviews the appeal and does not change its decision to disapprove the research, the decision of the IRB is final.  Institutional officials may not approve research that has been disapproved by the IRB.  No further appeal to override the IRB decision of disapproval may be made to University, Health System, KKI, or Hospital officials.


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