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Institutional Review Board

Continuing Review/Progress Reports

      

The JHSPH is responsible for overseeing all human subjects research conducted by its faculty and staff, and for students supervised by our investigators.  Study oversight requires ongoing monitoring of some kind, even for minimal risk studies that qualify under the regulations as meeting criteria for an “Exempt” determination or “Expedited” review.  While the U.S. regulations have relaxed requirements for Exempt and Expedited studies, JHU IRBs may also require Principal Investigators (PI) to submit a “progress report” to facilitate ongoing monitoring of JHU approved Exempt or Expedited studies.  The JHSPH IRB will send notices to PIs reminding them of their obligation to submit these reports.

To keep things simple, the Continuing Review Application will be retitled, “Continuing Review /Progress Report” and will be used for reporting study progress to the IRB. 

The Continuing Review/Progress Report should be limited to informing the IRB about study activity that has occurred since the last IRB approval.  The IRB provides templates that the PI may use to report protocol deviations (Protocol Deviations Summary Form) and Anticipated Events (Anticipated Event Summary Form), as needed.

When JHSPH defers IRB oversight responsibility to an external IRB, the JHSPH IRB is responsible for assuring the qualifications of JHSPH personnel on the study at our site and for complying with local institutional and legal requirements.  The PI should keep the JHSPH IRB informed of study progress by sharing with the JHSPH IRB their reports to the external IRB.