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Institutional Review Board

Oncology Research

May 2025

As an NCI designated Cancer Center, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC) is required to provide a mechanism for the internal oversight of the scientific and research aspects of all cancer-related clinical trials being done at the Institution. The Clinical Research Review Committee (CRC) was established for this purpose and thus assures that we conduct the highest quality research in the Institution. The CRC is charged with the pre-review of the scientific merit, priorities, and progress of all clinical research involving cancer patients.

In order to ensure compliance with the NCI’s guidelines, the following process is conducted for NEW applications:

  1. Section 34 of the eIRB application is the mechanism used to collect information on cancer related research.  When an investigator submits an application and Section 34 is marked as “yes,” the application is automatically routed to the SKCC Clinical Research Office (CRO), which provides administrative support for the CRC.
  2. The CRO will make one of two determinations when an application is received: a) The application does not require review by the CRC.  In this case, CRO staff will add a comment in the eIRB system and submit the application to the IRB office; or b) The application requires review by the CRC.  The CRO will ensure that the submission is complete and schedule the review. 
  3. The CRC may approve the application and forward it to the IRB office for review, or disapprove the application and not forward it to the IRB office. 

An application received by the Office of Human Subjects Research may not be marked correctly in Section 34.  If OHSR staff or the IRB should determine that CRC review is required, the application will be returned to the PI for correction.  Once section 34 is completed, the submission process to the CRC will occur.

Process for CRC review of continuing review applications:  In addition to the review of a new application, the CRC is required to conduct a continuing review of the scientific progress of all therapeutic cancer clinical trials.  The CRC’s annual review occurs close to the time of the scheduled IRB continuing review.  

The CRC meets weekly to review applications. The CRO staff is located on the 9th floor in the Skip Viragh Outpatient Cancer Center and may be reached at [email protected] or (410) 955-8866. They can provide details regarding the CRC’s review requirements and time frame estimates for completing their review. 

For more information please visit the CRO website.