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101.1 Organization Policy on Exempt Research

August 2013

The Organization requires that all human subjects research must be either:  1) reviewed and approved by an IRB prior to initiation; or 2) the research must be found to be exempt from federal regulations and from the Organization’s exceptions to the federal exempt categories.  The Organization has determined some research which may qualify as exempt research under federal regulations may not be considered exempt research locally.  See Guidance on the IRB website entitled “Exempt Research Studies Involving Human Subjects” for the federal and local exemption criteria. 

The JHM IRBs, any IRB designated by the Organization, or designated OHSR Senior Staff, have been granted the authority to review proposed research and determine whether it qualifies as exempt research.  The IRBs are authorized to determine that proposed research which qualifies for an exemption should be referred for an expedited or convened review process.  The IRB review process for proposed exempt research will be documented.