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. New projects that may meet the federal criteria for exemption must be submitted to the JHM IRB for a determination. The research may not start until a JHM IRB determines the project qualifies for exemption and supplies this determination in writing. See Guidance on the IRB website entitled “Exempt Research Studies Involving Human Subjects” for the federal 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.