Protocol Approval Process

A. Investigational Review Board (IRB) Approval
All biomedical research involving human subjects requires annual approval by the IRB. For more information, please call Mitchell Squire at 202-884-5277. Protocols can be submitted to the IRB and the GAC simultaneously, however, both approvals must be obtained PRIOR TO initiation of any study on the PCRC. Copies of the most up to date IRB approval letter, consent forms and annual progress reports MUST be forwarded to the PCRC Administrative office.

B. GCRC Scientific Advisory Committee (GAC) Review
The GCRC Advisory Committee reviews protocols for scientific merit, statistical methodology, study design and patient safety within the framework and regulations set by the NIH/NCRR GCRC program guidelines. The protocol will be assigned a project number and two reviewers from the advisory committee members. The principal investigator may be contacted by either of the reviewers to clarify any questions prior to the committee's monthly review meeting. For all investigator initiated protocols (category A or B), a scientific and statistical reviewer is assigned. Industry sponsored studies (category D) will undergo a scientific review only. The Research Subject Advocate will review all protocols for human subject safety monitoring issues.
The protocol review will result in either "approved", "approved pending response to required or recommended contingencies", "deferred" or "disapproved."

Definitions:

Approved:
The protocol as been approved for implementation on the PCRC. Please refer to the protocol activation procedure outlined on this site.

Approved Pending Response to Contingencies:

Approved pending response to required contingencies:
The study has been approved but the investigator may not activate the study until he/she has responded in writing to the contingencies outlined in the committee memorandum. The investigator response will be forwarded to the reviewers and GAC chair for final approval; a return to full committee review is not necessary. The protocol will be considered inactive until a satisfactory response is received and the GCRC Administrative Office has issued the final approval letter from the GAC chair. Under special circumstances, a study may be activated before the final approval letter has been issued. In cases in which enrollment of the patient is indicated for medical care and the contingencies are not related to human subject safety issues, but rather statistical or organizational considerations, a study may activated if final IRB approval has been granted. The PCRC Program Director may authorize study activation under these limited circumstances. The investigator is required to address the contingencies within two weeks of enrolling the subject. Following a review of the submitted material the GAC chair will grant final approval for study activation in writing.
Approved with recommended contingencies:
The committee has approved the study but has made recommendation related to the project that the investigator may wish to consider. These recommendations are not binding but rather advisory in nature and a written response it not required.

Deferred:
Major concerns were raised by the committee, which may require significant revisions. The protocol must be resubmitted for full Committee review. The investigator is encouraged to work with PCRC staff and reviewers to address the committee concerns and resubmit the application.

Disapproved:
The protocol in the current format is not suitable for GCRC utilization.
The GCRC Advisory Committee assigns a priority score to the protocol based on scientific merit and need for PCRC services. The score ranges from "Outstanding to Acceptable" on a scale of 1.0 to 5.0. This score may be used to prioritize scheduling on the PCRC as census warrants.

C. Temporary Administrative Approval
In unusual circumstances and investigator may request administrative approval of a protocol. The investigator is required to submit a complete PCRC protocol application package to the PCRC Administrative office explaining the urgency of the request. The PCRC Program Director will review the application and may grant temporary approval to activate the project for a limited number of patients and time period. The study will be reviewed at the next scheduled GCRC Scientific Advisory Committee Meeting and the committee's decision is final.