May 2005 The Organization requires that all human research projects must be either reviewed and approved by an IRB prior to initiation, or the research must be found by an IRB to be exempt from federal regulations and from Organization exceptions to the federal exempt categories. The Organization has determined that research which may qualify as exempt research under federal regulations may not be considered exempt research locally. Guidance regarding research that may be exempt from federal regulations and that is not considered exempt at the Organization shall be provided to researchers. The JHM IRBs, or any IRB designated by the Organization, have been granted the authority to review proposed research and determine whether it qualifies for an exemption under federal regulation and under local exemption criteria. Further, the IRBs are authorized to determine that proposed research which qualifies for an exemption under federal regulation and local exemption criteria should be referred for an expedited or convened review process. The IRB review process for proposed exempt research will be documented. Documentation will include the IRB’s determination that the research will be conducted in accord with the ethical principles described in the Belmont report. | 
