109.2 Organization Policy on Communicating JHM IRB Actions to Investigators

August 2013

Approval Notices and Approval Stamp

IRB approval of a new application, continuing review application, changes in research application or other study changes is provided in writing to the principal investigator.  An approval notice is provided on letterhead but does not require signature of the chair Approved consent forms and approved print advertisements for recruiting research study participants will have the IRB approval logo stamp. The approval date will be added to the stamped forms. 

Disapproval Notices 

IRB disapproval of a new application, continuing review application, changes in research application or other study changes is provided in writing to the principal investigator. The disapproval notice will identify what has been disapproved and the reason for disapproval. The investigator will have the opportunity to respond in person or in writing.