Revised October 2002 The Johns Hopkins Hospital Oncology Center has established a Clinical Research Review and Monitoring Committee (CRRMC) that is charged with conducting a scientific pre-review of:
- All therapeutic cancer trials at Johns Hopkins University School of Medicine
| - All clinical research performed by faculty with primary Oncology appointments
| - All clinical research using cancer resources
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New applications are signed by the Chairman of the CRRMC, who has been delegated the signature authority by the Chairman of the Department. The JHM IRB and WIRB will not accept new applications, continuing renewal application forms, amendments/addenda, or termination reports for Oncology protocols unless the paperwork has been submitted to the Sidney Kimmel Comprehensive Cancer Center's Clinical Research Office (SKCCC CRO). The CRO will ensure that the appropriate documents are reviewed by the CRRMC and all documents are forwarded to the IRB. In addition, the CRRMC is required to conduct a continuing review of the scientific progress of all therapeutic cancer trials in conjunction with their IRB mandated continuing renewal. The CRRMC will provide the JHM IRB a written critique of these trials. Final renewal by the JHM IRB will be contingent on a satisfactory response of the principal investigator to the CRRMC's comments and questions. The CRRMC meets each week to review applications. The CRO staff is located in Room 1131 in the 550 Building and may be reached at (410) 955-8866. They can provide details regarding the CRRMC review requirements and time frame estimates for completing their review. The CRRMC may impose stipulations for the conduct of oncology studies at Hopkins; IRB approval would be conditional upon meeting such stipulations. Due to the nature of the research conducted by the faculty in the Oncology Center, there are occasions when emergency approval is sought to use an investigational product before full IRB review can be conducted. Such requests for emergency (often called "compassionate") approval must be coordinated through the CRO office and be accompanied by an indication that the Chairman of the CRRMC (or his designee) approves submission of the request. IRB requirements for an emergency request can be found under Emergency Approval Procedures on the JHM IRB website. NIH has stated: "Whenever emergency care is initiated without prior IRB review and approval, the patient may not be considered to be a research subject. Such emergency care may not be claimed as research, nor may the outcome of such care be included in any report of a research activity." Many Oncology Cooperative Group treatment protocols are funded by NIH. Therefore, the NIH statement regarding "emergency care may not be claimed as research..." is applicable to requests for emergency approval to enroll patients into Oncology Cooperative group studies. | 
