The Protocol Review Committee (PRC) conducts initial reviews of protocols that investigators desire to run in the NKI CABI. Review of a protocol by the PRC is only required when the protocol will utilize the resources of the NKI CABI, i.e., the Siemens 1.5 T, SMIS 3T or SMIS 7T MRI systems or related equipment. The PRC reports to the CABI Executive Committee, which assumes overall responsibility for utilization of CABI resources. The PRC considers protocols in terms of: (a) safety; and (b) benefit/risk ratio, which includes consideration of scientific merit. Approval by the PRC is a prerequisite for submission to the NKI Institutional Review Board (IRB) for human protocols, or for submission to the NKI Institutional Animal Care and Use Committee (IACUC).
The PRC requests that investigators submit all documents in electronic form, either as Microsoft Word documents, or as Adobe pdf files. It is usually most convenient for these documents to be transmitted as attachments to Email (submit to: eackerman@nki.rfmh.org). If this is not possible, please contact Mrs. Ackerman at (845) 398-5471.
Following review, each protocol will be considered: (a) approved; (b) approved pending revisions; (c) deferred pending revisions; or (d) disapproved. Approved protocols can be submitted to the IRB without revisions. Protocols approved pending revision must be resubmitted to the Chair of the PRC, who may approve the revisions without convening the entire PRC. Disapproved protocols also must be resubmitted for review by the complete PRC with clear indications of how the concerns of the PRC have been addressed. Deferred protocols must be resubmitted to the PRC with additional information appended.
Investigators may wish to be available to answer questions during PRC meetings, and investigators may be invited to clarify their protocol at the meetings. Investigators will be given the opportunity to present their response to questions and/or concerns at the time of the meeting and prior to a vote, when that is feasible.
An investigator wishing to contest a decision by the PRC may submit a written appeal and/or request for review of the decision to the CABI Executive Committee.
Investigators of approved protocols are required to submit an annual report indicating the year-end status of the protocol, or upon completion of the protocols.
PRC Meetings are held monthly. Protocols must be submitted to the PRC two weeks prior to PRC meetings. A schedule of meetings is available from the CABI Administrative Assistant, and is attached to this document. Protocols submitted after a deadline will automatically be scheduled for the next meeting. Review of protocols will be completed prior to the next IRB submission deadline, to permit subsequent review of PRC-approved protocols by the IRB at its next scheduled meeting. IACUC reviews are scheduled as required.
Protocols should be submitted using the same forms and format required by the NKI IRB or the NKI IACUC (for IRB information, contact Erna Ostrom, (845) 398-5493;
For IACUC information, contact Terry O'Keefe, (845) 398-6556). In addition to the IRB forms, submissions must include a Resource Utilization Form (RUF), a Statement of Collaboration/Relevance, and an Abstract of Proposed Research. These forms are available here. The PRC will review each protocol to consider:
After approval by the PRC, and the NKI IRB or IACUC, investigators must provide a copy of their NKI IRB/IACUC approval, and for human studies, a copy of the Protocol Disposition Form (also provided by the NKI IRB), and only then protocols may be implemented in accordance with the priorities set by the CABI Executive Committee, and the availability of CABI resources. It is the responsibility of investigators to follow strictly all guidelines established for conducting research in the CABI, including the maintenance of logs for all systems, and the filing of screening forms, informed consent forms and exit questionnaires where applicable for human participants.
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This page was last updated on 3/25/2008. |